1,114 Clinical Trial Safety jobs in India

Patient Safety Analyst

Bengaluru, Karnataka HCLTech

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Job Description

Experience - 3- 7 yrs

Location- PAN India

Notice Period- immediate to 45 days


Job Description:

  • You should have experience in Press Ganey HRP
  • Hands on experience in Risk Management
  • Should have good understanding/experience in patient experience and patient safety


In case you are interested please apply here/ share resume to

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Specialist, International Patient Safety

Hyderabad, Andhra Pradesh ₹900000 - ₹1200000 Y Bristol Myers Squibb

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Job Description

Working with Us

Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: .

Pl

Position Summary

The International Patient Safety (IPS) team ensures robust, compliant, and consistent safety and risk management across all territories in which BMS operates, including Distributor and Local Representative (LR) markets.

This role is responsible for executing various pharmacovigilance (PV) activities in accordance with local regulatory and legal requirements, as well as BMS procedures, under the direction of the IPS Leader (or designee).

Duties/Responsibilities

  • Contribute to the creation and maintenance of risk management plans & provides support for the effective implementation of Additional Risk Minimisation measures.
  • Safety mailbox and communications management.
  • Support Aggregate Report related activities.
  • Maintenance of PV Awareness and other related Training content.
  • Implementation of Pharmacovigilance Agreements.
  • Individual Case Safety Report (ICSR) related activities, including literature screening, and submissions to local Health Authorities and Ethics Committees.
  • Safety Data Quality activities e.g. PV System Master File maintenance, deviations/CAPA management, other quality control and oversight activities.
  • Compilation of PV-related documentation for third parties responsible for Distributor/Local Representative Markets.
  • Oversight of the performance of Distributor / Local Representative Market third parties, in line with PV Agreement key performance indicators.
  • PV activity planning and tracking e.g. signal communications to Health Authorities.
  • Collaborate and support cross-functional teams to ensure effective conduct of PV activities.
  • PV Audit and Inspection support (including preparation, conduct and follow-up actions.)

The responsibilities listed above are only a summary, and other responsibilities will be determined by the IPS Leader, as required.

Reporting Relationship

Functional and Managerial reporting lines into IPS.

Qualifications / Experience

  • Ability to provide quality work using strong organizational, facilitation and interpersonal skills in a cross-functional team.
  • Strong interpersonal, verbal and written communication skills, ideally including the ability to communicate effectively across geographies and cultures, both live interactions and virtually.
  • Able to research, compile and provide (safety) information in a clear, concise manner.
  • An ability to understand local, regional and any other relevant legislation regarding PV (e.g. ICH, CIOMS).
  • Demonstrated ability to review (safety) information with attention to detail and accuracy, while managing multiple tasks & prioritizing work to meet strict deadlines.
  • Utilizes effective problem-solving approaches to address (PV) issues, seeking support from supervisor when necessary. Ability to comply with relevant internal and external processes/guidelines/regulations.
  • Operational Skills:

  • Technical Proficiency: Basic use of standard operational software and tools for automation

  • Process Management: Understanding of processes and ability to evaluate and suggest digital improvements.
  • Problem-Solving: Addresses straightforward problems with simple digital solutions.
  • Analytical Skills:

  • Data Management: Processes and records data and information in structured computer readable formats

  • Critical Thinking: Identifies flaws and inconsistencies in data or business processes by considering the system wide impact.
  • Data Analysis: Can perform basic data gathering and reporting using standard tools.
  • Strategic Skills:

  • Strategic Thinking: Understands the role of basic digital tools in achieving specific operational goals and can articulate simple digital-based strategies.

  • Decision-Making: Uses data summaries to support decisions based on clearly defined options and guidelines
  • Change Management: Supports digital change initiatives and communicates their immediate benefits.

University graduates with no or limited experience of working in the pharmaceutical industry or a medical environment.

University degree (preferably life science) or nursing qualification.

Written and spoken English communication skills are required (equivalent to Cambridge C2 level proficiency)

Minimal travel is required for this position. Trips could include travel to BMS sites and attending professional meetings and seminars.

ease find attached

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

This advertiser has chosen not to accept applicants from your region.

Associate I, Patient Safety

Bengaluru, Karnataka ₹900000 - ₹1200000 Y Alcon

Posted 1 day ago

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Job Description

Job Purpose
(State in one sentence the overall objective of the job)

The role provides day-to-day case monitoring, assessment and reporting of quality and adverse event complaint records involving Alcon manufactured products and responds to complaint activities required to comply with local and international regulations, guidelines, and applicable directives. This role may be required to work in shifts.

Major
Accountabilities
(Describe the main results of the job to be achieved)

Case Processing:- Process case files according to Standard Operating Procedures (SOP).
- Work with affiliate offices to ensure required dataset has been received/requested.
- Re-assess the data, ensure accurate product selection and assign required event code(s) in the system.
- Complete initial and follow-up reporting assessments as information is received (initial report, follow-up questionnaires, phone calls, investigation findings).
- Respond to Manufacturing Quality Assurance (QA) requests and Health Authority inquiries
- Launch required quality investigation records.
- Schedule expedited and periodic regulatory reports based on local and international reporting regulations.
- Perform and receive quality feedback on case management and coding.
- Adherence to all corporate compliance guidelines & corporate programs.
- Maintains a working knowledge of the following:

  • Alcon Products for assigned therapeutic areas and corresponding documentation (Product Information, Directions for Use, Manuals, Promotional materials)
  • Eye anatomy
  • Common diseases
  • Ophthalmic evaluation procedures
  • Eye terminology and abbreviations
  • Safety database(s) and reporting tools
  • Process and review Surgical – Intra Ocular Lens (IOL) complaint records in accordance with Alcon Standard Operating Procedures (SOPs)
  • Provide support in reconciliation activities and audit as required.
  • Evaluate and escalate potential safety issues to management.

Role Dimensions:

Number of associates:
None

Financial responsibility:
None

Impact on the organization:
Low

Key Performance Indicators
(Indicate how performance will be measured: indicators, activities…)

KPIs will be outlined in detail in the goal sheet, and will largely be around below parameters:

  • Meets internal and external quality standards
  • Review and close files within prescribed timelines
  • Creates high quality regulatory reports for submission on or before assigned due dates

Ideal Background
(State the minimum and desirable education and experience level)
Education
Minimum: Graduation in Science

Desirable: Graduation in Optometry/ Pharmacy/M. Pharm/B. Pharm /BDS/BAMS/BHMS/ Biomedical Engineering / Registered Nurse

Experience requirement:
Minimum: Healthcare professional with 1-2 years of experience

Desirable: Experience in Device Vigilance / Pharmacovigilance / Regulatory Submissions / Clinical Research / PVPI/ Medical Coding

Languages:
Minimum: English (written and spoken)

Specific Professional Competencies:
Indicate any other soft/technical/professional knowledge and skills requirements

Excellent listening ability and communication skills

Excellent decision quality and negotiation skills

Ability to manage multiple tasks, attention to detail, prioritize work and manage time well

Knowledge and understanding of national and international medical device regulations and regulatory guidelines

Knowledge of medical aspects of medical device safety, medical device vigilance in pre- and post-marketing safety practice

Basic knowledge of MS Office

ATTENTION: Current Alcon Employee/Contingent Worker
If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

Find Jobs for Employees

Find Jobs for Contingent Worker

Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital status, disability, or any other reason.

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Manager, International Patient Safety

Hyderabad, Andhra Pradesh ₹600000 - ₹1200000 Y Bristol Myers Squibb

Posted 1 day ago

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Job Description

Working with Us

Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: .

Pl

Position Summary

The International Patient Safety (IPS) team ensures robust, compliant, and consistent safety and risk management across all territories in which BMS operates, including Distributor and Local Representative (LR) markets.

This role is responsible for executing various pharmacovigilance (PV) activities in accordance with local regulatory and legal requirements, as well as BMS procedures, under the direction of the IPS Leader (or designee).

Duties/Responsibilities

  • Oversee, mentor and guide Senior Specialists in IPS, to ensure high-quality safety deliverables across the team.
  • Contribute to/Lead the creation and maintenance of risk management plans & provides support for the effective implementation of Additional Risk Minimisation measures.
  • Safety mailbox and communications management.
  • Support/Lead Aggregate Report related activities.
  • Lead the creation/update of PV Awareness and other related Training content.
  • Implementation of Pharmacovigilance Agreements.
  • Individual Case Safety Report (ICSR) related activities, including literature screening, and submissions to local Health Authorities and Ethics Committees.
  • Safety Data Quality activities e.g. PV System Master File maintenance, deviations/CAPA management, other quality control and oversight activities.
  • Compilation of PV-related documentation for third parties responsible for Distributor/Local Representative Markets.
  • Lead the oversight of the performance of Distributor / Local Representative Market third parties, in line with PV Agreement key performance indicators.
  • PV activity planning and tracking e.g. signal communications to Health Authorities.
  • Collaborate and support cross-functional teams to ensure effective conduct of PV activities.
  • PV Audit and Inspection support (including preparation, conduct and follow-up actions.)

The responsibilities listed above are only a summary, and other responsibilities will be determined by the IPS Leader, as required.

Reporting Relationship

Functional and Managerial reporting lines into IPS.

Qualifications / Experience

  • Ability to provide quality work using strong organizational, facilitation and interpersonal skills in a cross-functional team, under minimal supervision.
  • Strong interpersonal, verbal and written communication skills, including the ability to communicate effectively across geographies and cultures, both live interactions and virtually.
  • Able to research, compile and provide safety information in a clear, concise manner.
  • An understanding of local, regional and any other relevant legislation regarding PV (e.g. ICH, CIOMS).
  • Demonstrated ability to review safety information with attention to detail and accuracy, while managing multiple tasks & prioritizing work to meet strict deadlines.
  • Utilizes effective problem-solving approaches to address PV issues, seeking support from supervisor when necessary. Ability to comply with relevant internal and external processes/guidelines/regulations.
  • Operational Skills:

  • Technical Proficiency: Experienced in advanced functionalities of operational tools. Integrates/utilises digital automations tools into daily workflows.

  • Problem-Solving: Solves complex problems by reviewing data flows and leveraging digital tools and methods.
  • Process Management: Ability to optimize existing processes through incremental improvements and digital enhancements to help pre and post process teams.
  • Analytical Skills:

  • Data Analysis: Uses advanced analytical tools and techniques to interpret and visualize data.

  • Critical Thinking: Critically evaluates different options based on evidence and context to form reasoned judgments.
  • Data Management: Monitors and reviews data with an eye for anomalies and patterns that could impact workflow or output quality.
  • Strategic Skills:

  • Strategic Thinking: Understands the role of basic digital tools in achieving specific operational goals and can articulate simple digital-based strategies.

  • Decision-Making: Uses data summaries to support decisions based on clearly defined options and guidelines
  • Change Management: Supports digital change initiatives and communicates their immediate benefits.

2-3 years' experience of working in the pharmaceutical industry or a medical environment. Ideally having provided PV or medical/scientific information service in a health care environment.

University degree (preferably life science) or nursing qualification.

Written and spoken English communication skills are required (equivalent to Cambridge C2 level proficiency)

Minimal travel is required for this position. Trips could include travel to BMS sites and attending professional meetings and seminars.

ease find attached

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

This advertiser has chosen not to accept applicants from your region.

Clinical Trials Fellow

Dehradun, Uttarakhand ₹1200000 - ₹3600000 Y Lister Fertility Clinic

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Job Description

Role:
Clinical Trials Fellow

Town / Site:
The Sarah Cannon Research Institute, 93 Harley Street, London, W1G 6AD

Part time:
24 Hrs Per Week

Permanent:
There are opportunities for additional shifts, k.

Salary:
Offering a highly competitive salary.

We're looking for a Clinical Trials Fellow to join the Sarah Cannon Research Institute, Located in Central London.

It's a unique opportunity to join a company operating at the very forefront of clinical innovation where you can work with, and learn from some of the country's leading consultants. All in a world-class environment, equipped with the very latest technology, such as robotics, and some of the most advanced therapies and treatments currently licenced in the UK. And, with exceptionally strong colleague to patient ratios, you'll have all the time you need to provide truly bespoke care to your patients.

While we are a Consultant Led Service, we believe in empowering our Resident Doctors, so your role could become expand as much as you wish. You'll have the chance to be involved in audits, projects and quality improvement initiatives alongside the opportunity to join a variety of internal networks. This could be to help steer the services you deliver, speaking up or patient satisfaction focus groups, clinical governance or MDT meetings. Giving you an opportunity to network with your peers, share best practice and expand your knowledge in an unrivalled setting.

At HCA UK we care about what you care about. We care that you want to deliver the very best care. We care that you want a career you can be proud of. We care that you want working conditions that support your health and wellbeing. Let us care for you and your career, the same way you do for others.
What You'll Bring

  • GMC Registration and License to Practice in the UK
  • Completion of Foundation Training and ideally 4 years further experience in Specialist Training.
  • Relevant Medical qualifications / Post Grads.
  • A passion for team-work, patient focused care with the ability to build and share best practice and offer a first-class patient experience
  • Desire to develop within the role.

Why HCA UK?
Originally founded over 50 years ago by Dr Thomas Frist, HCA has gone on to become one of the world's leading healthcare providers. In the UK, we're one of the largest providers of privately funded healthcare and have invested over £500 million in the latest treatments, technology, techniques, medication and facilities. Being part of a large multisite, established healthcare group we can offer you unrivalled opportunities for career progression through internal and external courses, as well as working conditions that prioritise both your mental and physical wellbeing.

Benefits
We believe that by caring for our employees, we empower them to provide exceptional care for our patients. That's why we offer a host of flexible benefits that reflect the invaluable contribution they make every day. As a Resident Doctor Oncology you'll be eligible for:

  • For 40 hours full time contracts, 264 hours holiday each year (inclusive of bank holidays) increasing with service, with option to buy or sell leave to suit you. This is pro-rata for part time contracts.
  • Private Healthcare Insurance for treatment at our leading hospitals Private pension contribution which increases with length of service
  • Season Ticket Loan and Cycle to Work scheme
  • Group Life Assurance from day one
  • Critical illness cover
  • Enhanced Maternity and Paternity pay
  • Corporate staff discount for all facilities including Maternity packages at The Portland
  • Comprehensive range of flexible health, protection and lifestyle benefits to suit you
  • Discounts with over 800 major retailers
  • Access to wellbeing support tools, through our thrive 365 channels, onsite mental health first aiders, and free counselling up to 6 sessions per annum
  • Paid Indemnity

How We Can Support Your Development

  • As Doctor with us you'll have access to a dedicated study budget and study leave for courses relevant to your specialty
  • We can also offer you access to a comprehensive learning academy where you can enrol on courses or Harvard Business Course case review forums
  • If you'd like to develop further, we're able to offer grants and sponsorship for research, as well as funding for personal development through courses such as the 'Executive Masters in Medical Leadership' in partnership with Bayes Business School, or other courses such as MBA's or PhDs
  • Should you wish, you can also work closely with globally recognised professors and medical mentors to help produce publications papers or research documents

Culture And Values
At HCA UK we believe exceptional care starts with our people. We celebrate the unique perspectives and different experiences each of us bring as we know that when you feel seen, heard and supported you can be at your best for our patients, and each other.

Our Mission Is Simple, Above All Else We're Committed To The Care And Improvement Of Human Life, a Clear Statement That Extends To Both Our Patients And Colleagues. To Achieve This, We Live And Breathe Four Core Values

  • Unique and Individual: We recognise and value everyone as unique and individual
  • Kindness and compassion: We treat people with kindness and compassion
  • Honesty, integrity and fairness: - We act with absolute honesty, integrity and fairness
  • Loyalty, respect and dignity: We trust and treat one another as valued members of the HCA UK family with loyalty, respect and dignity

Reasonable Adjustments
We believe everyone should feel comfortable to bring their full self to work and be afforded the same opportunities. As a Disability Confident committed organisation, we're happy to discuss flexible working arrangements to suit your needs as well as offer reasonable adjustments throughout our recruitment process, and in the workplace, to anyone that needs them.

International Candidates
HCA Healthcare UK hold a Tier 2 sponsorship licence which permits us to be able to recruit the best talent in the UK as well as overseas. The license allows us to support General Visas as well as the Intra-company Transfer Visa for candidates that meet the specific role requirements. Your recruiter will be able to discuss whether this would be applicable to you during the application process, as well as running through any potential financial support with relocation.

This advertiser has chosen not to accept applicants from your region.

Clinical Trials Specialist

₹2000000 - ₹2500000 Y FEATHERSOFT

Posted 1 day ago

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Job Description

Job Summary

We are seeking a highly experienced Clinical Trials Specialist with a background in pharmaceuticals or a Contract Research Organization (CRO) to join our product development team. This is a unique opportunity to step out of the traditional clinical operations role and apply your deep domain expertise to shape the next generation of clinical trial software. You will serve as the subject matter expert, ensuring our AI platforms are built on a solid foundation of real-world clinical research principles and address the most pressing challenges in trial design and execution.

Key Responsibilities

  • Subject Matter Expertise: Act as the primary internal consultant on all aspects of clinical trial design, planning, and protocol development.

  • Product Development Collaboration: Work closely with software engineers, data scientists, and product managers to translate complex clinical trial concepts into functional software requirements and AI model features.

  • Protocol & Design Input: Provide expert review and guidance on trial protocols, study designs (e.g., adaptive trials, decentralized trials, basket trials), and endpoint selection to inform the logic to automate the workflows of our platforms.

  • Feature Validation: Test and validate new software features and AI-driven recommendations to ensure they are clinically sound, compliant, and user-friendly for research professionals.

  • Content & Algorithm Curation: Assist in curating, extracting and, structuring clinical data from scientific literature, and regulatory guidelines to train and refine our AI models.

  • Market & User Insights: Stay abreast of industry trends, regulatory changes (e.g., ICH, CDSCO), and the evolving needs of clinical research professionals to guide product strategy.

Requirements

Required Qualifications & Experience

  • Educational Background: A degree in Life Sciences, Pharmacy, Medicine, or a related field is required. An advanced degree (Masters, PhD, PharmD) is highly preferred.

  • Industry Experience: A minimum of 7-10 years of hands-on experience working within a pharmaceutical company or a CRO.

  • Core Expertise: Proven, significant experience in the design and development of clinical trial protocols across different therapeutic areas and phases (Phase I-IV). Must have prepared and submitted clinical trial-enabling documents.

  • Regulatory Knowledge: Deep understanding of the end-to-end clinical trial process, Good Clinical Practice (GCP), and international/local regulatory guidelines (e.g., ICH-GCP, FDA, EMA, CDSCO).

  • Analytical Mindset: Strong analytical skills with the ability to deconstruct complex clinical processes into logical steps.

Desired Skills

  • Passion for technology and innovation in the life sciences sector

  • Familiarity with the software development lifecycle or experience working with technology teams is a huge plus.

  • Exposure to or a keen interest in learning Artificial Intelligence, Machine Learning, and data analytics.

  • Excellent communication and interpersonal skills, with the ability to articulate complex scientific concepts to a non-scientific audience.

  • A proactive, problem-solving mindset and the ability to thrive in a fast-paced, collaborative startup environment.

This advertiser has chosen not to accept applicants from your region.

Clinical Trials Finance Officer - Research Operations and Clinical Trials

Prayagraj, Uttar Pradesh ACT Health

Posted today

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Job Description

Clinical Trials Finance Officer - Research Operations and Clinical Trials (

Job Number:

 02OAS)
 

Description

Employment Type: Full Time, Temporary 12 Month Contract with the possibility of extension and/or permanency
Classification: Administrative Service Officer Level 4 (PN 18368) 
Salary: $84,901 – $1,501 (Plus 12% Super) 
Location: Canberra Hospital, Garran
Section: Research Operations and Clinical Trials
Closing Date: 7th October 2025

What can we offer you: 

• 

Competitive pay rates and excellent working conditions within a tertiary hospital.

• 

Salary Packaging with many options that provide full fringe benefits tax concessions.

• 

Flexible working conditions.

• 

Access to Employee Assistance Program.

Access to discounted gym membership.

Access to onsite Physiotherapists.

Onsite cafes, staff cafeteria, pharmacy and gift shop.

Up to $12K reimbursement of elocation expenses for interstate candidates (subject to review and approval).

About the Role:

The Clinical Trials Unit provides support for the conduct of clinical research at Canberra Hospital. The Unit currently has active trials in varying stages ranging from ethics submissions to trial close outs. The number of participants in each trial varies from approximately 1 to 1000 participants. These trials are either Pharmaceutical Sponsored trials, Observational or Investigator Led trials that are funded by grants such as the National Health & Medical Research Council.

The Clinical Trials Unit Finance Officer provides key support to clinical research projects undertaken by the Clinical Trials Unit at Canberra Hospital. The main responsibilities of the Finance Officer will be to provide timely, accurate, high quality accounting information and support under supervision. Other responsibilities will include assistance with human resource management activities managed by the Clinical Trials Unit. Proficiency in the use of computerised information systems for financial processing, spreadsheets, word and data processing is essential.
 

For more information regarding the position duties click here for the Position Description.

Please note prior to commencement successful candidates will be required to:

Undergo a pre-employment National Police Check.

To Apply: 

Please apply online by submitting a copy of your CV along with a 2-page Pitch, responding to the Selection Criteria, listed in the Position Description.

***Please note applications submitted via an agency will not be accepted for this position***

Canberra Health Services (CHS) is focussed on the delivery of high quality, effective, person centred care. It provides acute, sub-acute, primary and community‐based health services, to the Australian Capital Territory (ACT) and surrounding region. More information can be found on the CHS website. 

Our Vision : creating exceptional health care together 
Our Role : to be a health service that is trusted by our community
Our Values : Reliable, Progressive, Respectful and Kind

CHS is committed to workforce diversity and to creating an inclusive workplace. As part of this commitment, we welcome applications from all diversity groups. Aboriginal and Torres Strait Islander peoples, people with disability and people who identify as LGBTQIA+ are particularly encouraged to apply.

The new state-of-the-art Building 5 is now officially open at Canberra Hospital. This 44,000sqm, nine-storey facility, the largest healthcare infrastructure project in the Territory’s history, delivers cutting-edge acute clinical services. Building 5 seamlessly integrates with existing campus buildings, ensuring smooth public access, patient transportation, and efficient logistics. 

If you would like further information regarding this opportunity, please contact Chris Burton at .

#LI-DNI

Job

: General/Administrative

Salary Range

: 84,901.00 - 91,501.00

Contact Name

: Christopher Burton

Contact Email

Closing Date

: 07/Oct/2025, 12:59:00 PM 

This advertiser has chosen not to accept applicants from your region.
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Data Coordinator (Clinical Trials)

Sun Pharmaceuticals, Inc

Posted 13 days ago

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Job Description

**Job Title:**
Database Coordinator (Clinical Research)
**Business Unit:**
Clinical Research
**Location:**
Mumbai
At Sun Pharma, we commit to helping you **Create your own sunshine** by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
**Are You Ready to Create Your Own Sunshine?**
As you enter the Sun Pharma world, youll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each others journeys.
**Key responsibilities:**
+ Preparation & Review of start-up Documents: eCRF completion Guidelines, DMP, SAE reconciliation plan, Clinical Coding Plan
+ Preparation of Edit specification document (ESD), Test Plan and Data Entry Guideline
+ Screen design UAT
+ Edit checks UAT in CDMS as per ESD
+ Discrepancy Management
+ Support Data Manager in URS review for IWRS
+ Ensure timely completion of SAE reconciliation activities
+ Ensure timely completion of closeout activities including database lock
+ Preparation and update of Master Data Management File to ensure its completeness
+ Preparation & Review of Data Management Report
**Job Requirements**
**Educational Qualification**
Pharmacy / Science Post-Graduate
**Experience**
At least 5 years of experience in the clinical data management domain in Pharma/CRO industry
**Additional Skills:**
+ Experience in, development of data management documents, development of validation plan, screen UAT, edit check UAT, clinical data query management etc.
**Your Success Matters to Us**
At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. _Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Lets create a brighter future together!_
**_Disclaimer:_** _The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s)._
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
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Project Manager (Clinical Trials)

Sun Pharmaceuticals, Inc

Posted 14 days ago

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Job Description

**Job Title:**
Project Manager (Clinical Studies)
**Business Unit:**
Clinical Research
**Location:**
Mumbai
At Sun Pharma, we commit to helping you **Create your own sunshine** by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
**Are You Ready to Create Your Own Sunshine?**
As you enter the Sun Pharma world, youll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each others journeys.
**Key responsibilities:**
+ Lead a team of clinical research professionals and collaborate with cross-functional stakeholders.
+ Develop and implement project plans, including timelines, milestones, and resource allocation.
+ Define project objectives, deliverables, and success criteria in collaboration with stakeholders.
+ Identify risks and develop mitigation strategies to ensure project success.
+ Allocate resources, assign tasks, and monitor team performance to ensure project goals are met.
+ Develop project budgets, track expenses, and ensure cost-effective utilization of resources.
+ Collaborate with finance and procurement teams to manage contracts, vendor selection, and outsourcing activities.
+ Monitor project progress and resource allocation to ensure efficient utilization and adherence to budgetary guidelines.
+ Ensure adherence to applicable regulatory guidelines, Good Clinical Practice (GCP), and other relevant standards.
+ Oversee the preparation and submission of regulatory documents to ethics committees and regulatory authorities.
+ Implement quality control measures to ensure data integrity, accuracy, and compliance throughout the project
**Job Requirements**
**Educational Qualification**
Bachelor's or Master's degree in a field related to Science, Healthcare, Clinical Research or Life Sciences like Biology, Pharmacology, Nursing, or a related discipline, and/or Post-graduate Diploma in Clinical Research.
**Experience**
Relevant experience of 5-10 years minimum in the field of Clinical Research.
**Additional Skills:**
+ Knowledge on GCP practices, regulatory guidelines in Clinical Trials
+ Phase III and Phase IV Clinical Trials knowledge expertise
+ Site Management expertise
+ Collaboration with cross functional stakeholders
+ Team Management and creating high performing teams
**Your Success Matters to Us**
At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. _Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Lets create a brighter future together!_
**_Disclaimer:_** _The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s)._
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
This advertiser has chosen not to accept applicants from your region.

Clinical Trials Disclosure Mgr

Hyderabad, Andhra Pradesh Amgen

Posted 14 days ago

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Job Description

**ABOUT AMGEN**
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
**Roles & Responsibilities:**
+ Lead the preparation of clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with applicable regulations, guidance, and company requirements
+ Work closely with the transparency and disclosure team and with cross functional stakeholders to define redaction strategy, to ensure timely and accurate registration and results review/approval process, including the redaction process, for US and EU registries, lead cross functional review and approval, ensure submission readiness, and hand off for timely submission or posting
+ Support trend analysis and continuous improvement initiatives
+ Manage projects, coordinate the work of other staff, and prioritize work in order to meet internal and external deadlines
**Required Skills:**
+ Experience understanding and interpreting data/information and its practical application
+ Working experience with redaction/anonymization of clinical trial documents e.g. for EU CTR, HC-PRCI
+ Working experience with disclosures on public registries e.g. ClinicalTrials.gov
+ Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through
+ Good communication skills including excellent spoken and written English
+ Ability to follow controlled processes
+ Leadership skills, including ability to teach, negotiate and influence
+ Project management skills, including ability to prioritize work in order to meet required deadlines
+ Problem solving ability
+ Serve as Process Administer for CTRS, support active CTRS users, system access, inquiries, and issue resolution
**Basic Qualifications:**
+ Graduate degree and 2 years of relevant work experience in the pharmaceutical industry
OR
+ Bachelor's degree, and 4 years relevant work experience in the pharmaceutical industry
+ Minimum of 2 years experience in preparation of regulatory documents for public disclosure
+ Familiarity with international regulations, guidance and best practices on clinical transparency & disclosure, including protection of personal information and commercially confidential information
**EQUAL OPPORTUNITY STATEMENT**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
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