55 Clinicalsafety jobs in India
Process Safety Management Specialist
Posted 3 days ago
Job Viewed
Job Description
Biostatistician - Clinical Trials
Posted 7 days ago
Job Viewed
Job Description
Clinical Trials Manager
Posted 7 days ago
Job Viewed
Job Description
Clinical Trials Disclosure Mgr
Posted 8 days ago
Job Viewed
Job Description
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.
Associate - PAI & Clinical Trials
Posted 17 days ago
Job Viewed
Job Description
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**What you will do**
Let's do this. Let's change the world. In this vital role you will report to the Amgen India R&D Finance lead. The R&D Finance Associate will assist in planning, quarter close and consolidation activities. The candidate is also expected to expand the centralization, automation and standardization practices established in R&D Finance team.
+ FP&A professional skilled in comprehensive financial data management, financial analysis and forecasting, ad hoc project financial support, and process optimization.
+ Support functional and consolidation teams in R&D finance
+ Master Data Maintenance including but not limited to managing and updating financial master data across all systems to ensure accuracy and integrity, cost center creation, modification, and deactivation, aligning them with the organizational structure, creation of Work Breakdown Structures (WBS) for precise project tracking and financial reporting.
+ Provide headcount and staffing support by maintaining relevant data and assisting in workforce planning. Support efficient data migration from the business planning tool to financial system
+ FE&O and Staff Support planning and Variance Analysis: Conduct variance analysis to identify trends and discrepancies between actuals and forecasts. Forecasting of certain trended/low risk planning accounts
+ Product Coding and Recovery Optimization: Support product coding processes and recovery methods to improve financial accuracy and efficiency.
+ Handle Ad hoc requests: Providing accurate and timely support to stakeholders.
We are all different, yet we all use our unique contributions to serve patients.
**Basic Qualifications:**
Master's degree and 0 to 2 years of accounting and/or finance (OR)
Bachelor's degree and 0 to 2 years accounting and/or finance (OR)
**Preferred Qualifications:**
Pharmaceutical / biotechnology industry experience
Knowledge and understanding of financial planning processes, quarter close activities
Strong analytical skills and exceptional attention to detail
Excellent discernment (e.g., knowledge of business drivers, finding solutions, and knowledge of accounting, finance, and other business areas)
**Good To Have Skills**
Big 4 and Fortune 500 FP&A experience
Capable of building models and financial reports
Technical finance knowledge and skills (accounting, planning, modeling, etc.)
Overall knowledge of financial systems and tools (e.g., SAP, Hyperion, Anaplan, Excel)
Business partnering skills. Ability to work effectively in ambiguous situations and team environment
**Soft Skills:**
Effective analytical and communication skills (both verbal and written)
Ability to work effectively with global, virtual teams
High degree of initiative and self-motivation.
Ability to manage multiple priorities successfully.
Collaborative, with a focus on achieving team goals
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now for a career that defies imagination**
Objects in your future are closer than they appear. Join us.
careers.amgen.com
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided 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 accommodation.
Senior Biostatistician - Clinical Trials
Posted today
Job Viewed
Job Description
Lead Biostatistician - Clinical Trials
Posted 7 days ago
Job Viewed
Job Description
- Develop and finalize Statistical Analysis Plans (SAPs) for clinical trials.
- Design and implement statistical methodologies for data analysis.
- Oversee the programming and execution of statistical analyses using SAS or R.
- Interpret and communicate complex statistical findings to clinical teams and stakeholders.
- Ensure statistical analyses comply with regulatory requirements (e.g., ICH guidelines).
- Lead and mentor a team of biostatisticians and statistical programmers.
- Collaborate with clinical investigators and data managers to ensure data quality.
- Contribute to the design of clinical trial protocols and case report forms.
- Prepare statistical sections of clinical study reports and regulatory submissions.
- Stay current with advancements in biostatistics and clinical trial methodologies.
- Master's or PhD in Biostatistics, Statistics, or a related quantitative field.
- Minimum of 7 years of experience in biostatistics, with a focus on clinical trial data analysis.
- Expertise in statistical software (SAS, R) and data management tools.
- Thorough understanding of clinical trial design and regulatory guidelines.
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication skills, with the ability to present complex data clearly.
- Proven leadership and team management experience.
Be The First To Know
About the latest Clinicalsafety Jobs in India !
Clinical Trials Disclosure Associate
Posted today
Job Viewed
Job Description
**Role Name**:Clinical Transparency & Disclosure Sr. Associate
**Department Name**:Global Regulatory Affairs & Strategy (GRAAS)
**Role GCF**:3
**Hiring Manager Name**:Jennifer Vande Weghe
**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**:
- Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with regulatory requirements and the agreed strategy defined by the cross functional team
- Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting
- Collaborate with team members to resolve problems and escalate issues
- Record and maintain written redaction strategy for the study and product
- Manage timelines and coordinate work across team
**Required Skills**:
- Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through
- Ability to follow controlled processes
- Excellent spoken and written English
- Project management skills, including ability to prioritize work in order to meet required deadlines
- Problem solving ability
**Basic Qualifications**:
- Bachelor’s degree
- Minimum of 1 year experience working with regulatory documents in a biotech/ pharmaceutical environment
- Familiarity with clinical research and clinical regulatory documents
- Knowledge of clinical trial disclosure regulations, guidelines, and best practices
**Preferred Qualifications**:
- One year experience preparing regulatory documents for public disclosure
**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.
Clinical Trials Specialist / Product Leader
Posted today
Job Viewed
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.
Requirements
• 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.
Admin Officer/Receptionist | Clinical Trials
Posted today
Job Viewed
Job Description
Full Job Description
Our client is a well-established private clinical research organisation with over 20 years of experience in Australia. With a strong national presence, they have successfully delivered clinical trials across a wide range of therapeutic areas. The team is passionate about advancing healthcare outcomes, and this is a fantastic opportunity to contribute to meaningful work in a professional, welcoming environment.
We are seeking a proactive and friendly Receptionist / Administration Officer to assist in the smooth day-to-day running of the office. This is a 4-week short-term casual assignment with the potential to extend. The role offers the chance to support a dedicated team working on important health studies.
Your duties & responsibilities will include:
- Professional reception duties, including answering phones and greeting visitors
- Welcoming trial participants and performing identification checks
- Assisting with scheduling and general office coordination
- Providing ad hoc administrative support to staff as required
About You
We are looking for someone who is organised, approachable, and able to hit the ground running. To be successful in this role, you will have:
- Excellent communication and interpersonal skills
- Strong reliability and attention to detail
- Full working rights in Australia
- Availability to commence immediately
- Prior experience in medical reception or administrative roles (highly regarded)
Why Apply?
This role is perfect for someone looking to gain exposure to the clinical research industry in a supportive, professional environment. You will have the opportunity to work with a passionate team, and the satisfaction of contributing to projects that improve healthcare outcomes.
Contact Details
If you meet the above criteria and would like to be considered for this role for an ASAP start, please click 'APPLY' now. Alternatively, please contact Bree on for a confidential discussion.
KE Select are a leading provider of Scientific, Medical and Technical recruitment services. With a candidate and client network spanning ANZ and more recently into APAC, KE Select are no.1 choice for many professionals operating within the Biotechnology and Medical Technology market.