Position: Medical Monitor/Medical Reviewer for Global clinical trials

Job Location- Faridabad

Exp: - 2 Yrs. - 8 Yrs.

Qualifications: MBBS, MD, (clinical trial experience in Psychiatry / Neurology will be preferred)

1. Primary Purpose:

- Supporting and enabling the sponsor and investigator in diligent conduct of clinical trial in alignment with local regulations and international good clinical practice standards in a systematized and timely manner.

- Helps Sponsor with local medical practice, regulatory issues, and operational considerations when developing/ finalizing protocols.

- To be involved in optimizing the function of Operations Team. Their primary responsibilities include (but are not limited to):

- Providing input on clinical development plans, medical monitoring plan. Reviewing and analysing efficacy and safety trends

- Identify, flag and mitigate potential discrepancies/errors in study conduct on an individual subject level or site level or country level based on the clinical and administrative data that has been collected through various sources (Site visit, EDC Review, communications, observation from prevailing practices etc)

- Contribute as part of the medical team in reviewing all study team deliverables, such as medical/coding/lab and other relevant reports and listing, analyse and review statistical data and clinical study reports, Providing therapeutic and project specific training.

2. Major accountabilities of position

- Ensure effective communication with PIs, medical team members of the sponsors for smooth execution of medical monitoring responsibilities.

- Travel to participate in various meetings and visits to clinical trial investigational sites across country and internationally.

- Attend meetings (Regulatory, IM, site initiation, monitoring) to ensure active participation and imparts training on protocol, Efficacy and safety reporting, scales, and procedures (therapeutic area based).

- Review, collaborate in depth and advise corrective steps to data management on medical related matters.

- Prepare plan such as medical monitoring, review plans such as study plan, data management plans and to other SOPs as necessary.

- Ensure effective documentation of all activities related to medical monitoring and medical affairs in general.

- Respond to EC, investigator and regulatory queries pertaining to medical issues, sponsor queries on safety and efficacy issues

- Prepare/provide inputs to SOPs related to medical affairs

- Help PVG team in timely and effective reporting of serious adverse event (SAE)/adverse drug reaction (ADR) to applicable regulatory authorities.

- Ensure appropriate medical interpretation and consistency are applied to adverse event case assessment, where applicable.

- Serve as scientific / medical mentor for the team.

3. Work relations (context - main interfaces - functional report)

Reports to Director - Medical Affairs.

- Interacts with monitoring team, QA, Sites, Sponsors

4. Travel Requirement

- Travelling nationally and internationally is an absolute requirement (up to 20%)

5. Skills, experience and qualifications required for the job

Background:

- Modern Medicine graduate with good understanding of clinical research methodologies and desirably participated in clinical trials in any capacity. Ability to interpret, analyse and reason clinical data from an electronic and paper-based case report forms is an imperative skillset requirement.

Skills: Fundamental computer skills - Mandatory- Microsoft word, Excel, Power point, Teams, Outlook etc. Analytical ability, Teamwork, effective Interpersonal skills, decision making capability.

- Knowledge of psychopharmacological products

- Knowledge of ICH Good Clinical Practice

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