The Clinical Trial Manager will be the senior site-level leader for the trial, responsible for ensuring high-quality implementation of the study. The CTM will coordinate all operational, regulatory, and reporting activities, supervise the trial team, ensure compliance with GCP and SOPs, and serve as the point of contact with the JHU Trial Coordinating Team and the Country Co- PIs.

Duties & Responsibilities

1. Leadership & Oversight

   • Lead site-level trial operations from start-up to close-out.

   • Supervise and mentor trial coordinators, clinical coordinators, study nurses, and support staff.

   • Ensure recruitment, randomization, and follow-up targets are met.

2. Regulatory & Ethics

   • Ensure approvals from local ECs, regulatory authority and Sponsor ethics committees are in place before initiation.

   • Ensure compliance with regulatory authority requirements (import permits, IP accountability, progress and adverse event reporting).

3. Trial Conduct

   • Ensure informed consent is appropriately obtained, randomization, intervention storage, preparation, and administration is detailed in the trial protocol and SOP.

   • Lead preparation of trial related SOP’S

   • Lead Virtual and onsite meetings related to trial

   • Attend meeting with WHO and JHU

   • Ateend meetings with SPHMMC.AHRI and CHOP

   • Ensure timely reporting trial progress

   • Ensure SAE reporting, causality assessment, and DSMB communications are timely and accurate.

4. Data & Quality

   • Ensure data collection, entry, query resolution, and data quality assurance are performed timely.

   • Support site monitoring visits, audits, and inspections.

5. Logistics & Finance

   • Oversee supply chain management of supplements, placebos, and laboratory supplies.

   • Monitor site budgets and financial accountability.

or in a related field of study with relevant work experience

Job Requirements

Required Qualification 

• Advanced degree (MD, MPH, MSc in Clinical Trials, Pharmacy, or related).

• ≥3 years’ experience in large-scale clinical trials as a clinical trial manager or ≥5-year experience as a clinical trial coordinator.

• Strong knowledge of ICH-GCP, regulatory processes, and trial monitoring.

• Experience in neonatal, pediatric, or maternal-child health trials preferred.

• Excellent leadership, communication, and project management skills.

Number of positions: 01

Salary: Competitive and as per AHRI’s salary scale

Duty Location: Based at AHRI, with frequent travel to Gandhi Memorial Hospital and SPHMMC study sites.

How To Apply

How to Apply: application letter (detailing your motivation and suitability), CV (maximum of three pages with clear indication of your educational background and experience) and copies of your documents and certificates as one PDF file Submit you’re through THIS LINK