Sr.Manager - Medical Affairs and Regulatory affairs

Key Responsibilities:

- Preparation, review, and amendments of clinical trial related documents like protocols, ICFs, data collection tools (except CRF), and clinical trial reports as per departmental SOPs.

- Medical Monitoring for all phases of clinical trials- Provide expert assistance in all phases of a trial e.g., during recruiting, data collection etc.

- Medical monitoring related training

- Monitoring of the appropriateness of the patient population enrolled in the trial by ongoing review of eligibility and support to investigator during the enrollment

- Review of AE/Adverse drug Reactions (ADRs), SAEs and reported pregnancies (if any)

- Review of Laboratory Parameters

- Review of Concomitant Medications

- Evaluation of Protocol Deviations

- Handling of Protocol queries (Medical)

- Handling of Ethics committee queries (Medical)

- Review and follow-up of pregnancies occurring in clinical trial subjects

- Review of serious Adverse Event (SAE) reports and ensure reporting of SAEs according to applicable regulations and sponsor requirements for all clinical trials wherein he/she works as Medical Monitor/Back-up Medical Monitor.

- Review of MedDRA, and WHO-DDE coding

- Carry out analysis and Clinical Study Report(CSR) writing in co-ordination with Head-CD and Sponsor.

- Development of departmental SOPs and training of CD personnel and stake holders on the same

- Impart training to the CD personnel/stake holders on SOPs, guidelines, functions of the CD, special topics, and therapeutic area training after being designated by head-CD.

- Training clinical research staff, investigators and relevant personnel on clinical trial requirements in investigator meetings and site initiation visits

- Training clinical research staff on therapeutic areas as and when necessary

- Assist the Head-CD in coordinating with the Legal department for finalizing all relevant agreements and contracts necessary during the conduct of in-house clinical trials

- Prepare and coordinate for CQA Audits

- Review of SVQs (Site Validation Questionnaires) for feasibility of studies

- Perform other responsibilities related to the Medical Affairs department and responsibility assigned by Department Head

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