Medical Monitor

COD Reseach

2 - 7 years

4 - 9 Lacs

ahmedabad

Posted:2 days ago| Platform:

Apply

Skills Required

data analysis clinical operations medical coding clinical trials vice president nda html pharmacology regulatory affairs rfp

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Description :
Key Responsibilities:

Literature search to prepare, review, and finalization of any clinical/non-clinical document

Review of feasibility and related request for proposal (RFP) study synopsis

Review of clinical documents, not limited to protocol, informed consent documents, subject diary, clinical study report and similar other documents etc

Preparation and review of medical monitoring plan

Therapeutic training of all stakeholders and if applicable to the site team via in-person / virtual for safety reporting in clinical trials along with medical monitoring plan and safety monitoring plan

Participation presentation in Subject Experts Committee (SEC) meeting, PI meet Site Initiation Visit etc

Review medical data ie eligibility documents, periodic data listing of efficacy and safety variables along with completed CRF data and medical coding of essential study data

Interacting with Investigators for patient eligibility medical monitoring activities

Communicate various study related aspects with the stake holders ie study team at site, various regulatory agencies and sponsor s medical team

Interaction discussion with KOL for medical inputs for all clinical documents, data monitoring committees and other regulatory requirements

Assist in data analysis and identifying risks

Review of IB, IMPD etc

Review of clinical and non-clinical overviews and summaries

Review of briefing documents for EMA, USFDA and other submissions for various filings ie MAA, NDA, 510(k), BLA, 505(b)(2) etc

Address sponsor , sites , internal clinical operations team regulatory queries

Review, author and update SOP and support in global initiatives for ensuring enhanced quality and compliance

Qualifications :

MD Pharmacology is mandatory

Minimum 2 years of relevant experience

Strong written and oral communication skills

Self-motivated to work in CT environment as individual contributors

More Jobs at COD Reseach

Clinical Research Associate

ahmedabad

2.0 - 3.0 yrs

INR 4 - 5 Lacs

Medical Monitor

ahmedabad

2.0 - 7.0 yrs

INR 4 - 9 Lacs

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.