70 Clinical Research Manager jobs in India

Medical Research Associate (Entrylevel)

Bengaluru, Karnataka Pharexcel Consulting Private Limited

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Job Description

**Study Coordination**:

- Assist in the design and development of study protocols and case report forms (CRFs)
- Coordinate the logistics of clinical trials or medical research projects
- Manage timelines, budgets, and resources for research studies

**Site & Data Management**:

- Support site selection and initiation
- Monitor clinical trial sites to ensure compliance with protocols and regulations
- Collect, review, and verify study data for accuracy and completeness
- Maintain regulatory documentation and study master files

**Regulatory & Ethical Compliance**:

- Ensure adherence to Good Clinical Practice (GCP), ICH guidelines, and applicable laws (e.g., CDSCO in India, FDA in the US)
- Assist in ethics committee/institutional review board (IRB) submissions and communications
- Support preparation of study reports and submissions to regulatory authorities

Pay: From ₹10,000.00 per month

Schedule:

- Day shift

Supplemental Pay:

- Performance bonus

Work Location: In person
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Senior Manager - Clinical Research

Gurugram, Uttar Pradesh Transformative Ventures

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Job Description

Job Summary:

The Manager of Clinical Research will lead and manage clinical trials and research studies, ensuring that they are completed on time, within budget, and in compliance with regulatory standards. The manager will supervise research teams, collaborate with cross-functional departments, and provide strategic direction for clinical research activities.


Key Responsibilities:

1. Clinical Trial Management:

o Plan, initiate, and manage clinical research projects from start to finish.

o Coordinate and oversee the execution of clinical trials, ensuring adherence to protocols, timelines, and budgets.

o Ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and ethical standards.

o Provide oversight on the recruitment, enrolment, and monitoring of clinical trial subjects.

o Manage relationships with clinical research organizations (CROs), investigators, and external vendors.

2. Team Leadership:

o Lead and mentor clinical research staff, ensuring they are trained and performing effectively.

o Assign tasks and responsibilities to team members based on project needs.

o Develop training programs and provide ongoing professional development for research teams.

3. Regulatory Compliance:

o Oversee the preparation and submission of regulatory documentation, including Institutional Review Board (IRB) applications and clinical trial applications.

o Monitor compliance with federal, state, and local regulations, as well as company policies.

o Ensure timely reporting of adverse events and ensure the study meets ethical and regulatory standards.

4. Study Design & Protocol Development:

o Work with scientific and medical teams to develop clinical trial protocols.

o Ensure protocols meet study objectives, regulatory standards, and ethical guidelines.

o Evaluate feasibility and risk of proposed studies.

5. Data Management and Reporting:

o Ensure data collection, monitoring, and analysis are conducted efficiently and accurately.

o Review and analyse clinical trial data to ensure quality and integrity.

o Prepare and present progress reports to senior leadership and stakeholders.

6. Budget and Resource Management:

o Develop and manage project budgets, ensuring that clinical trials are completed within financial constraints.

o Oversee resource allocation, including personnel, equipment, and materials.

7. Collaboration and Communication:

o Foster communication between internal teams, external partners, and key stakeholders.

o Collaborate with clinical research coordinators, data managers, and other departments to ensure effective study execution.

o Resolve any issues related to clinical trial execution and provide solutions.

8. Continuous Improvement:

o Identify areas for process improvement in clinical trial execution and management.

o Implement best practices to optimize research efficiency and compliance.

Qualifications:

Education:

o Bachelor's degree in Life Sciences, Clinical Research, or a related field (Master's or higher preferred).


Experience:

o Experience in clinical research, with at least 2-3 years in a managerial or supervisory role.

o In-depth knowledge of clinical trial management, regulatory requirements, and GCP.

Skills:

o Strong project management, leadership, and organizational skills.

o Excellent communication and interpersonal skills, with the ability to interact effectively with internal and external stakeholders.

o Proficiency in clinical research software and data management systems.

o Strong problem-solving and decision-making abilities

Certifications:

o Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) certification preferred (or equivalent).

Working Conditions:

Full-time, in-office or remote, with occasional travel required to clinical trial sites and partner organizations




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Senior Manager - Clinical Research

Gurgaon, Haryana Transformative Ventures

Posted 27 days ago

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Job Description

full-time

Job Summary:

The Manager of Clinical Research will lead and manage clinical trials and research studies, ensuring that they are completed on time, within budget, and in compliance with regulatory standards. The manager will supervise research teams, collaborate with cross-functional departments, and provide strategic direction for clinical research activities.


Key Responsibilities:

1. Clinical Trial Management:

o Plan, initiate, and manage clinical research projects from start to finish.

o Coordinate and oversee the execution of clinical trials, ensuring adherence to protocols, timelines, and budgets.

o Ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and ethical standards.

o Provide oversight on the recruitment, enrolment, and monitoring of clinical trial subjects.

o Manage relationships with clinical research organizations (CROs), investigators, and external vendors.

2. Team Leadership:

o Lead and mentor clinical research staff, ensuring they are trained and performing effectively.

o Assign tasks and responsibilities to team members based on project needs.

o Develop training programs and provide ongoing professional development for research teams.

3. Regulatory Compliance:

o Oversee the preparation and submission of regulatory documentation, including Institutional Review Board (IRB) applications and clinical trial applications.

o Monitor compliance with federal, state, and local regulations, as well as company policies.

o Ensure timely reporting of adverse events and ensure the study meets ethical and regulatory standards.

4. Study Design & Protocol Development:

o Work with scientific and medical teams to develop clinical trial protocols.

o Ensure protocols meet study objectives, regulatory standards, and ethical guidelines.

o Evaluate feasibility and risk of proposed studies.

5. Data Management and Reporting:

o Ensure data collection, monitoring, and analysis are conducted efficiently and accurately.

o Review and analyse clinical trial data to ensure quality and integrity.

o Prepare and present progress reports to senior leadership and stakeholders.

6. Budget and Resource Management:

o Develop and manage project budgets, ensuring that clinical trials are completed within financial constraints.

o Oversee resource allocation, including personnel, equipment, and materials.

7. Collaboration and Communication:

o Foster communication between internal teams, external partners, and key stakeholders.

o Collaborate with clinical research coordinators, data managers, and other departments to ensure effective study execution.

o Resolve any issues related to clinical trial execution and provide solutions.

8. Continuous Improvement:

o Identify areas for process improvement in clinical trial execution and management.

o Implement best practices to optimize research efficiency and compliance.

Qualifications:

Education:

o Bachelor's degree in Life Sciences, Clinical Research, or a related field (Master's or higher preferred).


Experience:

o Experience in clinical research, with at least 2-3 years in a managerial or supervisory role.

o In-depth knowledge of clinical trial management, regulatory requirements, and GCP.

Skills:

o Strong project management, leadership, and organizational skills.

o Excellent communication and interpersonal skills, with the ability to interact effectively with internal and external stakeholders.

o Proficiency in clinical research software and data management systems.

o Strong problem-solving and decision-making abilities

Certifications:

o Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) certification preferred (or equivalent).

Working Conditions:

Full-time, in-office or remote, with occasional travel required to clinical trial sites and partner organizations




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Senior Clinical Research (CRA) Manager - Based in Navi Mumbai, India

Navi Mumbai, Maharashtra MEDPACE

Posted today

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Job Description

Overview

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

Why Medpace?

People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

Medpace Perks

  • Flexible work environment 
  • Competitive compensation and benefits package
  • Competitive PTO packages
  • Structured career paths with opportunities for professional growth
  • Company-sponsored employee appreciation events
  • Employee health and wellness initiatives
  • Awards

  • Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
  • Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
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    R3 Southern Cluster Manager - Research Operations and Clinical Trials

    Prayagraj, Uttar Pradesh ACT Health

    Posted today

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    Job Description

    R3 Southern Cluster Manager - Research Operations and Clinical Trials (

    Job Number:

     02NZ4)
     

    Description

    Employment Type: Full Time, Permanent
    Classification: Senior Officer Grade C (PN 10965)
    Salary: $125,344 – $34,527 (Plus 12% Super) 
    Location:
    The Canberra Hospital, Garran
    Section: Research Operations and Clinical Trials
    Closing Date:
    4th September 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 re ocation expenses for interstate candidates (subject to review and approval).

    About the Role:

    The Rural, Regional and Remote Clinical Trials Enabling Program (R3-CTEP) is a decentralised clinical trial initiative enabling patients in rural, regional and remote areas of the ACT and NSW to participate in trials by reducing the need for travel to major centres. Distance is a significant healthcare barrier for 30% of Australians living in rural, regional and remote areas. R3-CTEP is an initiative supported by funding from the Australian Government under the Medical Research Future Fund (MRFF) which aims to improve access to innovative healthcare. The Southern Cluster includes Canberra Health Services (CHS), Illawarra-Shoalhaven Local Health District (ISLHD), Murrumbidgee Local Health District (MLHD), and Southern NSW Local Health District (SNSWLHD).

    The role of the Southern Cluster Manager is to provide strategic and operational leadership for the Southern Cluster in the R3-CTEP program, ensuring that the cluster achieves its goals of increasing the conduct of, and participation in, clinical trials in rural, regional, and remote areas in southern NSW and the ACT.

    Please note selection may be based off written application and referee reports only.

    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 August Marchesi at .

    #LI-DNI

    Job

    : General/Administrative

    Salary Range

    : 125,344.00 - 134,527.00

    Contact Name

    : August Marchesi

    Contact Email

    Closing Date

    : 04/Sep/2025, 1:59:00 PM 

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    Healthcare Research & Data Analyst

    Bengaluru, Karnataka Clarivate

    Posted today

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    Job Description

    About Clarivate

  • Clarivate provides innovative data and analytical solutions to the largest biopharmaceutical and medical technology companies in the world. Clarivate’s Medtech Data team harnesses real-world healthcare data and identifies meaningful insights from large data and metadata sources to help medical device companies make some of their most important business decisions.
  • Who are you?

  • You are passionate about data and have at least 2 years of hands-on experience wrangling through large data using SQL/ Python.
  • You are also an effective communicator who can explain complex ideas using clear and concise language, including through written communication.
  • You are comfortable collaborating with a diverse group of internal colleagues, including subject matter experts, product managers, sales leaders, technical experts, and other client-facing analysts.
  • You are solution-oriented and understand the importance of timely execution while juggling multiple priorities. 
  • What will you do?

  • Understand the worldview and pain points of Clarivate customers, working closely with the stake holders as a problem-solver.
  • Effectively build, mine, and manage multiple datasets, which will be required for market modelling and analysis. 
  • Maintain existing Medtech product catalogs.
  • Research and understand novel device markets, including major competitors, uses, and product segmentation.
  • Evaluate data outputs for market trends and draw insights; correct any potential errors and issues.
  • Identify opportunities and issues for data analysis and experiments, with bias towards driving customer delight.
  • Work with clients to understand the business requirements and provide data driven insights.
  • Contribute your vision; influence the evolution of our products, data models, and data usage strategy.
  • What do you know?

  • You have strong quantitative foundations, as evidenced by your educational and professional background. 
  • You are more than proficient with Excel, SQL and want to continue to improve your skills.
  • You have a background and/or interest in Life Sciences and are keen to learn a lot more about medical devices and supplies in Latin American region.
  • You know how to deliver an effective presentation.
  • Requirements:

  • Expertise in understanding data variables and connecting the dots in various datasets.
  • Expertise in handling and manipulating large datasets.
  • Proficiency with written and oral communications and must be able to communicate complex quantitative ideas to internal and external stakeholders.
  • Should have handled short/long term projects end to end.
  • Skills:

  • Expertise in MS SQL.
  • Strong MS Office and Excel skills is mandatory.
  • Analytical Skills
  • Ability to do secondary research and synthesize the findings.
  • Problem solving ability.
  • Education:

  • Any graduate/ Post-graduate, B.E or M.Sc. in the disciplines of Biotechnology, Medical Electronics, Pharmacy preferred.
  • Preferred (Good to have) skills:

  • Understanding of Medtech data and Healthcare in the Latin American countries
  • Exposure to Medtech or Claims/Pharmacy data.
  • Experience working with data from data vendors.
  • Expertise in anyone (or more) of the data analysis tools/languages such as – R/Python is a plus.
  • Work Mode: Hybrid, Monday to Friday 12:00 pm to 8:00 pm

    At Clarivate, we are committed to providing equal employment opportunities for all qualified persons with respect to hiring, compensation, promotion, training, and other terms, conditions, and privileges of employment. We comply with applicable laws and regulations governing non-discrimination in all locations.

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    Sr. Manager - QC & Training (Clinical Research)

    Sun Pharmaceuticals, Inc

    Posted 3 days ago

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    Job Description

    **YOUR TASKS AND RESPONSIBILITIES:**
    This role will be responsible for oversight on end-to-end clinical trial activities from quality perspective. This role will be accountable for Quality Compliance (QC) activities of Clinical Trial Medical Science team and Operations team, Clinical Trial Supply Management (CTSM) team, and Clinical Data Management team by way of Review of all study related activities, processes, procedures and adherence to applicable regulations and guidelines to ensure 24x7 Inspection/audit readiness.
    This role will be responsible for establishing the procedures and trainings of teams which ensure protection of human subjects from research risk, reliability/Integrity of the data, and thereby assures internal consistency and Quality Compliance measures.
    **Systems and Processes:**
    + Develop, implement and maintain a Quality Management System (QMS) for clinical trial team in consultation with Head Quality Compliance & Training and ensure oversight on team on quality aspect as per defined SOPs and applicable regulations.
    + Implement and oversee the Quality Compliance procedures/processes/systems for clinical trials managed by the Medical science and Clinical Operations department.
    + To assist in designing a process to write, review and approve the risk assessments for new trials and for ongoing projects and working closely with Project Managers and Operation Head as needed.
    + To ensure a process in place to provide assurance on review of all study documentation for accuracy, consistency and completeness.
    + Ensure effective systems and processes in place to maintain consistency and quality compliance parameters in medical science, operations, data management and drug depot for end-to-end activities of each function as per applicable regulatory requirements.
    + Work with Clinical Research QC team, Medical Science team, Clinical Operations team, Clinical Data Management team and Study Management team to create and implement study specific QC plans that outline the scope of Quality Compliance procedures to be followed during clinical trials, ensuring QC processes are in alignment with SOPs and study protocols.
    + Ensure completeness of training of study team on SOPs and job specific training as per role and responsibilities. Ensure periodic review of training files for all study team.
    + Assess and identify the training requirement of study team and ensure completion of training.
    + Well versed with electronic systems used in Clinical Trial operations, Data Management and Project Management which includes project specific deliverables tracking and important milestone related alarms, protocol compliance tracking, deviations tracking and electronic systems used for managing Trial Master File (TMF) and Drug accountability.
    + Assist in developing system/process to work with the clinical trial team to schedule pre-execution and post-execution QC activities to ensure that all requirements of the QC plans are planned as required and executed.
    + Plan, design, and update process and systems for clinical trial activities like development and utilization of QC assessment parameters and other QC tools designed to document/track the QC review process for clinical research activities in line with recent regulatory requirement.
    + Ensure Quality Management System at Medical Science, Data Management team, Operation team to ensure the department is ready for audit/inspection 24x7.
    + Ensure periodic review of Vendors and renewals as per applicable policies & procedures.
    + Identify and recommend process improvement initiatives where required.
    + Create and evaluate metrics to assess performance and implement plans for course correction.
    **Activities:**
    + Should be effective team player who can work closely with different study teams and collaborate well with team members to achieve defined QC targets.
    + Develop and implement a risk-based and flexible approach to Quality Compliance (QC) within the function, which will ensure that trial participants and data are safeguarded in compliance with applicable regulatory requirements and best practices.
    + Identify and decide team members job specific SOP training requirements in view of their role and maintain oversight of training to ensure all team members are trained on each SOP as required.
    + Preparation of SOPs related to QC function and support in review of SOPs specific to Medical science, Clinical team and Data Management team.
    + Quality review of the clinical trial medical science related activities like Synopsis, Protocol, Clinical Study Report (CSR) and appendices, and SOPs in line with ICH GCP requirement, Indian and global regulatory requirement.
    + Quality review of the clinical trial operation related activities, related tools, plans and documentation like site feasibility, site selection visit, site initiation, Ethic committee documentation, monitoring site specific reports, Site Documents, logs and close out activities in line with ICH GCP requirement, Indian and global regulatory requirement.
    + Ensure Quality review of SOPs and oversight on quality parameters specific to Clinical Trial Supply Management (CTSM) and other activities like receipt, handling of study sample, labelling, storage, temperature monitoring systems and distribution to trial sites.
    + Final QC review of study close out activities including returned goods reconciliation, inventory destruction processing and archiving of documents.
    + Review and communication of QC findings to respective department in stipulated timelines.
    + Arrange monthly meeting or meetings as and when required depending on criticality of the issues with concerned team to discuss and communicate the findings from QC reviews to the internal stakeholders via QC summaries, reports as required.
    + Maintain the repository of QC findings as per the department and specific function and present the trend analysis, training requirement and action plan with timelines to Head Medical Affairs and clinical for course correction on quarterly basis.
    + Ensure training of SOPs, on job training and reviewing training files on regular basis.
    + QC review and Support in preparation of clinical study manuals/documents/Plan such as the IMP handling manual, Study plans.
    + Ensure record maintenance for all activities for traceability in line with regulatory requirement.
    **WHO YOU ARE:**
    + >5 years experience in a CRO/Pharma/Biotech organization in Quality department with experience of Quality activities in Clinical Research department.
    + Strong eye for detail and ability to spot inconsistencies a must and good conflict management skills.
    + Must have experience in handling audits & inspections of DCGI, US FDA.
    + Thorough knowledge of recent GCP guidelines, ICMR guidelines, Drugs and Cosmetic Act regulations and other applicable regulations pertaining to clinical trials.
    + Experience of working in matrix business environments preferred.
    + Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards.
    + Quality oriented mindset and skill set.
    + Experience in auditing processes and procedures, including the development of plans for corrective and preventive action (CAPA).
    + In-depth working knowledge of clinical trial regulations, good clinical practice (GCP) guidelines and other frameworks, and their implications for clinical research.
    + Proactive approach to reviewing, updating and improving processes based on current knowledge of the regulatory requirements.
    + Have strong analytical and problem-solving skills and the ability to present solutions.
    + Able to work under pressure and prioritize workload effectively, able to ensure timely completion of tasks to high quality in a matrix organization.
    + Eye for details, Sense of urgency & desire to excel.
    + Proficiency with Excel or other quality management systems/ tools.
    + Result oriented and performance driven.
    + Excellent interpersonal & communication skills to effectively interact with a broad range of audience.
    **Job** location: Sun House, Goregaon East, Mumbai
    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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    Sr. Manager - QC & Training (Clinical Research)

    Mumbai, Maharashtra SUN PHARMA

    Posted today

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    Job Description

    YOUR TASKS AND RESPONSIBILITIES: This role will be responsible for oversight on end-to-end clinical trial activities from quality perspective. This role will be accountable for Quality Compliance (QC) activities of Clinical Trial Medical Science team and Operations team, Clinical Trial Supply Management (CTSM) team, and Clinical Data Management team by way of Review of all study related activities, processes, procedures and adherence to applicable regulations and guidelines to ensure 24x7 Inspection/audit readiness. This role will be responsible for establishing the procedures and trainings of teams which ensure protection of human subjects from research risk, reliability/Integrity of the data, and thereby assures internal consistency and Quality Compliance measures. Systems and Processes:
  • Develop, implement and maintain a Quality Management System (QMS) for clinical trial team in consultation with Head Quality Compliance & Training and ensure oversight on team on quality aspect as per defined SOPs and applicable regulations.
  • Implement and oversee the Quality Compliance procedures/processes/systems for clinical trials managed by the Medical science and Clinical Operations department.
  • To assist in designing a process to write, review and approve the risk assessments for new trials and for ongoing projects and working closely with Project Managers and Operation Head as needed.
  • To ensure a process in place to provide assurance on review of all study documentation for accuracy, consistency and completeness.
  • Ensure effective systems and processes in place to maintain consistency and quality compliance parameters in medical science, operations, data management and drug depot for end-to-end activities of each function as per applicable regulatory requirements.
  • Work with Clinical Research QC team, Medical Science team, Clinical Operations team, Clinical Data Management team and Study Management team to create and implement study specific QC plans that outline the scope of Quality Compliance procedures to be followed during clinical trials, ensuring QC processes are in alignment with SOPs and study protocols.
  • Ensure completeness of training of study team on SOPs and job specific training as per role and responsibilities. Ensure periodic review of training files for all study team.
  • Assess and identify the training requirement of study team and ensure completion of training.
  • Well versed with electronic systems used in Clinical Trial operations, Data Management and Project Management which includes project specific deliverables tracking and important milestone related alarms, protocol compliance tracking, deviations tracking and electronic systems used for managing Trial Master File (TMF) and Drug accountability.
  • Assist in developing system/process to work with the clinical trial team to schedule pre-execution and post-execution QC activities to ensure that all requirements of the QC plans are planned as required and executed.
  • Plan, design, and update process and systems for clinical trial activities like development and utilization of QC assessment parameters and other QC tools designed to document/track the QC review process for clinical research activities in line with recent regulatory requirement.
  • Ensure Quality Management System at Medical Science, Data Management team, Operation team to ensure the department is ready for audit/inspection 24x7.
  • Ensure periodic review of Vendors and renewals as per applicable policies & procedures.
  • Identify and recommend process improvement initiatives where required.
  • Create and evaluate metrics to assess performance and implement plans for course correction.
  • Activities:
  • Should be effective team player who can work closely with different study teams and collaborate well with team members to achieve defined QC targets.
  • Develop and implement a risk-based and flexible approach to Quality Compliance (QC) within the function, which will ensure that trial participants and data are safeguarded in compliance with applicable regulatory requirements and best practices.
  • Identify and decide team members job specific SOP training requirements in view of their role and maintain oversight of training to ensure all team members are trained on each SOP as required.
  • Preparation of SOPs related to QC function and support in review of SOPs specific to Medical science, Clinical team and Data Management team.
  • Quality review of the clinical trial medical science related activities like Synopsis, Protocol, Clinical Study Report (CSR) and appendices, and SOPs in line with ICH GCP requirement, Indian and global regulatory requirement.
  • Quality review of the clinical trial operation related activities, related tools, plans and documentation like site feasibility, site selection visit, site initiation, Ethic committee documentation, monitoring site specific reports, Site Documents, logs and close out activities in line with ICH GCP requirement, Indian and global regulatory requirement.
  • Ensure Quality review of SOPs and oversight on quality parameters specific to Clinical Trial Supply Management (CTSM) and other activities like receipt, handling of study sample, labelling, storage, temperature monitoring systems and distribution to trial sites.
  • Final QC review of study close out activities including returned goods reconciliation, inventory destruction processing and archiving of documents.
  • Review and communication of QC findings to respective department in stipulated timelines.
  • Arrange monthly meeting or meetings as and when required depending on criticality of the issues with concerned team to discuss and communicate the findings from QC reviews to the internal stakeholders via QC summaries, reports as required.
  • Maintain the repository of QC findings as per the department and specific function and present the trend analysis, training requirement and action plan with timelines to Head Medical Affairs and clinical for course correction on quarterly basis.
  • Ensure training of SOPs, on job training and reviewing training files on regular basis.
  • QC review and Support in preparation of clinical study manuals/documents/Plan such as the IMP handling manual, Study plans.
  • Ensure record maintenance for all activities for traceability in line with regulatory requirement.
  • WHO YOU ARE:
  • >5 years experience in a CRO/Pharma/Biotech organization in Quality department with experience of Quality activities in Clinical Research department.
  • Strong eye for detail and ability to spot inconsistencies a must and good conflict management skills.
  • Must have experience in handling audits & inspections of DCGI, US FDA.
  • Thorough knowledge of recent GCP guidelines, ICMR guidelines, Drugs and Cosmetic Act regulations and other applicable regulations pertaining to clinical trials.
  • Experience of working in matrix business environments preferred.
  • Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards.
  • Quality oriented mindset and skill set.
  • Experience in auditing processes and procedures, including the development of plans for corrective and preventive action (CAPA).
  • In-depth working knowledge of clinical trial regulations, good clinical practice (GCP) guidelines and other frameworks, and their implications for clinical research.
  • Proactive approach to reviewing, updating and improving processes based on current knowledge of the regulatory requirements.
  • Have strong analytical and problem-solving skills and the ability to present solutions.
  • Able to work under pressure and prioritize workload effectively, able to ensure timely completion of tasks to high quality in a matrix organization.
  • Eye for details, Sense of urgency & desire to excel.
  • Proficiency with Excel or other quality management systems/ tools.
  • Result oriented and performance driven.
  • Excellent interpersonal & communication skills to effectively interact with a broad range of audience.
  • Job location: Sun House, Goregaon East, Mumbai

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

    Clinical Research Medical Advisor

    Mumbai, Maharashtra Novartis

    Posted today

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    Job Description

    Job Description Summary

    #LI-Hybrid
    Location: Mumbai / Hyderabad, India

    Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

    About the Role:

    As the Clinical Research Medical Advisor (CRMA), your responsibility lies within the development of Global Clinical Trials – this includes medical oversight for all trials, portfolio and/or protocol medical feasibility, scientific engagement of investigators, protocol and TA training for internal and external stakeholders, medical issue or question management, safety review, strategic input in pre-launch planning.

    You will drive compliance across all aspects of clinical trials and CRMA related activities. It will be critical to ensure good communication and stakeholder management cross-functionally within the local country organisation as well as between global and regional teams.

    Job Description

    Key Responsibilities:

    • Medical oversight of clinical trials across all stages and contribute to operational trial deliverables, according to timelines, quality/compliance, and performance standards.
    • Drive portfolio/trial medical feasibility within the Global Development framework and provide country clinical strategic guidance and proposals in collaboration with Study and Site Operations Team and Medical Affairs Team.
    • Identify and propose new sites for clinical trials, analyse capability, assess patient pool and country treatment landscape, and make recommendations for potential trial inclusion.
    • Provide robust indication and protocol training to CRAs, CSMs, RSMs and other functions in the country as needed.
    • Responsible for medical related education, implementation and compliance to protocol, standards (SOPs) and best practices for clinical development within assigned clinical trial(s) and within clinical program(s), including sharing lessons learned.
    • Provide medical expertise to clinical/operational activities for patient eligibility, medical question-management, safety, amendments, etc.
    • Collaborate cross-functionally for the early product launch planning process to ensure Global Development trials conducted are aligned with the local country strategy.
    • Support medical/clinical team discussions with local regulatory interactions as needed.

    Essential Requirements:

    • Medical Degree (MD, MBBS).
    • Proven experience in medical practice or pharmaceutical industry experience with a background in clinical trials/medical affairs/life sciences/research in all aspects of drug development including clinical research, GCP, and local regulatory requirements.
    • Demonstrated experience in managing projects, feasibility conduct and the execution of strategic plans from a medical perspective.
    • Outstanding internal and external stakeholder engagement experience.

    Commitment to Diversity and Inclusion / EEO paragraph:

    Novartis is committed to building an outstanding, inclusive work environment and diverse teams

    representative of the patients and communities we serve.

    Accessibility and Accommodation:

    Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

    Skills Desired

    Building Construction, Clinical Practices, Clinical Research, Clinical Trials, Drug Development, Hazard Identification, Health Sciences, Immunology, Intensive Care UnIT (Icu), Internal Control, Internal Medicine, Job Description, Medical Information, Organization Skills, Patient Care, Stakeholder Engagement, Tcp/Ip Protocols, Utilization Management (Um)
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    Clinical research medical advisor

    Mumbai, Maharashtra Novartis

    Posted today

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    Job Description

    permanent
    Job Description Summary #LI-HybridLocation: Mumbai / Hyderabad, India Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.About the Role:As the Clinical Research Medical Advisor (CRMA), your responsibility lies within the development of Global Clinical Trials – this includes medical oversight for all trials, portfolio and/or protocol medical feasibility, scientific engagement of investigators, protocol and TA training for internal and external stakeholders, medical issue or question management, safety review, strategic input in pre-launch planning.You will drive compliance across all aspects of clinical trials and CRMA related activities. It will be critical to ensure good communication and stakeholder management cross-functionally within the local country organisation as well as between global and regional teams.Job Description Key Responsibilities: Medical oversight of clinical trials across all stages and contribute to operational trial deliverables, according to timelines, quality/compliance, and performance standards. Drive portfolio/trial medical feasibility within the Global Development framework and provide country clinical strategic guidance and proposals in collaboration with Study and Site Operations Team and Medical Affairs Team. Identify and propose new sites for clinical trials, analyse capability, assess patient pool and country treatment landscape, and make recommendations for potential trial inclusion. Provide robust indication and protocol training to CRAs, CSMs, RSMs and other functions in the country as needed. Responsible for medical related education, implementation and compliance to protocol, standards (SOPs) and best practices for clinical development within assigned clinical trial(s) and within clinical program(s), including sharing lessons learned. Provide medical expertise to clinical/operational activities for patient eligibility, medical question-management, safety, amendments, etc. Collaborate cross-functionally for the early product launch planning process to ensure Global Development trials conducted are aligned with the local country strategy. Support medical/clinical team discussions with local regulatory interactions as needed. Essential Requirements: Medical Degree (MD, MBBS). Proven experience in medical practice or pharmaceutical industry experience with a background in clinical trials/medical affairs/life sciences/research in all aspects of drug development including clinical research, GCP, and local regulatory requirements. Demonstrated experience in managing projects, feasibility conduct and the execution of strategic plans from a medical perspective. Outstanding internal and external stakeholder engagement experience. Commitment to Diversity and Inclusion / EEO paragraph: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Accessibility and Accommodation: Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Skills Desired Building Construction, Clinical Practices, Clinical Research, Clinical Trials, Drug Development, Hazard Identification, Health Sciences, Immunology, Intensive Care Un IT (Icu), Internal Control, Internal Medicine, Job Description, Medical Information, Organization Skills, Patient Care, Stakeholder Engagement, Tcp/Ip Protocols, Utilization Management (Um)
    This advertiser has chosen not to accept applicants from your region.
     

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