Amneal Pharma Hiring for Deputy Manager / Clinical Trials | 5–7 Yrs Exp | M.Pharm | Ahmedabad | Regulated Markets
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Amneal, a leading global generic and specialty pharmaceutical company, is urgently hiring an experienced Deputy Manager / Manager – Clinical Trials Management for its Clinical Research team based in Ahmedabad, Gujarat, India. This is a high-visibility role for M.Pharm professionals with 5–7 years of hands-on experience in managing bioavailability/bioequivalence (BA/BE) and clinical endpoint studies for highly regulated markets (USFDA, EU, Health Canada, ANVISA, etc.). Amneal Pharma Hiring for Deputy Manager / Clinical Trials
If you have strong protocol review, CRO oversight, and patient-based PK/CEP study experience, this is your opportunity to lead end-to-end clinical trial operations at one of India’s fastest-growing USFDA-approved companies. Amneal Pharma Hiring for Deputy Manager / Clinical Trials
Job Highlights Box
Position: Deputy Manager / Manager – Clinical Trials Management
Location: Ahmedabad City, Gujarat, India (On-site) + 1 more location
Qualification: M.Pharm (Clinical Pharmacy / Pharmacology)
Experience: 5–7 years in Clinical Trials / BA-BE Studies
Must-Have: Protocol & ICF review, CRO oversight, EDC/eCRF review, SIV & close-out visits, Regulated market studies (USFDA/EU)
Department: Clinical Research / Bioequivalence
Job Nature: Full-Time | Individual Contributor with CRO coordination
Company: Amneal Pharmaceuticals India Pvt Ltd
About Amneal Pharmaceuticals
Amneal is a globally recognized generic and specialty pharmaceutical company with state-of-the-art R&D and manufacturing facilities approved by USFDA, EU, MHRA, Health Canada, and other stringent regulatory bodies. Headquartered in the US and with major operations in India, Amneal is committed to delivering high-quality, affordable medicines worldwide. Amneal Pharma Hiring for Deputy Manager / Clinical Trials
Amneal is an equal opportunity employer that values diversity, merit, and inclusion. Amneal Pharma Hiring for Deputy Manager / Clinical Trials
Detailed Job Responsibilities
As Deputy Manager/Manager – Clinical Trials Management, you will be the clinical operations owner for patient-based pharmacokinetic (PK) and clinical endpoint (CEP) studies. Your key responsibilities will include: Amneal Pharma Hiring for Deputy Manager / Clinical Trials
- Scientific review of study protocols, Informed Consent Forms (ICF), Case Report Forms (CRF), statistical analysis plans, monitoring plans, and all study-related documents for regulatory compliance (ICH-GCP, USFDA, EMA, Health Canada guidelines).
- Review Site Initiation Visit (SIV) presentations prepared by the CRO and ensure 100% alignment with protocol and regulatory requirements.
- Hands-on review of eCRF design and edit checks in various EDC platforms (Medidata Rave, Oracle Inform, Veeva CDMS, etc.).
- Accompany CRO personnel during Site Initiation Visits (SIV) and resolve all scientific, operational, and GCP-related queries on the spot for smooth study start-up.
- Actively track patient recruitment across sites and drive the CRO to meet enrollment targets and project milestones.
- Perform ongoing oversight monitoring of study data, safety trends, and protocol deviations.
- Resolve all critical and major findings identified during CRO monitoring visits in the best interest of study integrity and timelines.
- Track and process CRO invoices and payments strictly as per agreed milestones and contract terms.
- Participate in site close-out visits, ensure database lock readiness, and resolve all pending queries.
- Lead scientific review of final Clinical Study Reports (CSR) and ensure accuracy of data interpretation and regulatory submission readiness.
- Mandatory experience in managing patient-based PK studies and clinical endpoint (CEP) studies for regulated markets (USFDA, EU, Canada, Australia, etc.).
- Act as the primary point of contact between Amneal and CRO for all clinical operational matters.
Required Qualifications & Experience
- M.Pharm in Clinical Pharmacy or Pharmacology from a recognized university
- 5–7 years of relevant experience in clinical trial management of BA/BE and patient-based studies
- Proven track record of handling studies for regulated markets (USFDA, EMA, Health Canada, TGA, etc.)
- Prior experience in protocol writing/review, ICF review, and CSR review is mandatory
- Hands-on experience in EDC platforms and eCRF edit check review
- Experience in conducting/accompanying SIV and close-out visits
- Strong understanding of ICH-GCP, Schedule Y, and global bioequivalence guidelines
- Excellent communication, coordination, and stakeholder management skills
- Ability to work in a fast-paced environment and manage multiple studies simultaneously
Amneal Pharma Hiring for Deputy Manager / Clinical Trials
Key Skills That Will Make You Stand Out
- CRO/vendor management and oversight
- Patient recruitment strategies for competitive studies
- Risk-based monitoring and quality oversight
- Root cause analysis and CAPA implementation
- Bioanalytical data review (PK/PD parameters)
- Exposure to BE study designs (2×2 crossover, replicate, parallel, fasting/fed)
- Proficiency in MS Office, EDC systems, and CTMS
Why Join Amneal’s Clinical Research Team?
- Work on high-priority submissions for the US, Europe, and Canada markets
- Direct impact on product approvals and revenue generation
- Excellent learning and global exposure
- Fast-track career growth into Senior Manager/AGM roles
- Competitive salary, performance bonus, and best-in-class benefits
- Modern R&D facility with latest clinical and bioanalytical infrastructure
Amneal Pharma Hiring for Deputy Manager / Clinical Trials
How to Apply (Step-by-Step)
- Update your resume highlighting:
– Total years in clinical trials/BA-BE
– Number of patient PK and CEP studies managed
– Regulated market experience (USFDA/EU/Canada)
– EDC platforms worked on
– CRO oversight and SIV/close-out visit experience - Visit the official Amneal Careers portal: https://jobs.amneal.com
- Search using keywords:
“Deputy Manager Clinical Trials” OR “Manager Clinical Trials” OR “Ahmedabad Clinical Research” - Click on the job titled Deputy Manager / Manager – Clinical Trials Management
- Hit the “Apply Now” or “Be the First to Apply” button
- Register or log in to your candidate profile
- Upload your updated resume and fill in all required fields
- Submit your application
Amneal Pharma Hiring for Deputy Manager / Clinical Trials
Important: Only applications submitted through the official Amneal careers website will be considered. Applications via email, LinkedIn, or consultants will NOT be accepted.
Pro Tip: This is marked as “Be the First to Apply” — early applications have a significant advantage! Amneal Pharma Hiring for Deputy Manager / Clinical Trials
Take the next big step in your clinical research career with a company that is shaping the future of generic and specialty pharmaceuticals globally. Amneal Pharma Hiring for Deputy Manager / Clinical Trials
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