Medical Advisor or Medical Monitor

7 days ago

New Delhi, India CliniRx Full time

**1. Primary Purpose**:

- Helps Sponsor with local medical practice, regulatory issues, and operational considerations when developing/ finalizing protocols
- Medical Advisor optimizes the function of the Operations Team. Their primary responsibilities include (but are not limited to):

- Providing input on clinical development plans, protocol design, and risk assessments. Reviewing and analyzing safety and efficacy trends,
- Reviewing all study team deliverables, such as final narratives and clinical study reports, Providing therapeutic and project specific training.

**2. Major accountabilities of position**:

- Ensures effective communication with PIs, medical monitors of the sponsors for smooth execution of medical monitoring responsibilities.
- Travels (internationally also) to participate in meetings with Sponsor, to IMs, to sites and to RAs/Has
- Attends meetings (Regulatory, IM, site initiation, monitoring) to ensure active participation and imparts training on protocol, safety reporting, scales and procedures (therapeutic area based).
- Reviews and advises corrective steps to data management on medical related queries.
- Prepares plan such as medical monitoring, reviews plan such study plan, data management plans etc
- Ensures effective documentation of all activities related to medical monitoring.
- Responds to EC, investigator and regulatory queries pertaining to medical issues, sponsors queries on safety and efficacy issues
- Prepares/provides inputs to SOPs (including medical and pharmacovigilance).
- Helps PVG team in timely and effective reporting of serious adverse event (SAE)/adverse drug reaction (ADR) to applicable regulatory authorities.
- Ensures appropriate medical interpretation and consistency are applied to adverse event case assessment, where applicable.
- Serves 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**:

- **Qualifications**: MD/DNB in Psychiatry preferred /MBBS with proven experience in Psychiatry / Neurology
- **Experience**: 3- 4 years of experience in clinical psychiatry with focus on inpatient / outpatient management of major mental disorders. Good practical experience of various Psychopharmacological molecules.
- **Skills**: Analytical ability, Teamwork, effective Interpersonal skills, decision making capability.
- Knowledge of psychopharmacological products

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