Position Summary:-

Accountable for end-to-end study operational oversight and delivery at country level, ensuring adherence to timelines, budget and quality standards.

Duties/Responsibilities:-

- Acts as the main point of contact for a country with global study team members and accountable for the coordination with local country cross functional teams.
- Implements the local country and site feasibility process, including proposal and validation of country study targets, as endorsed by country leadership.
- Plans, develops and executes timelines and activities for start-up in collaboration with the local study team, Global Trial Acceleration Centre (GTAC) and other relevant stakeholders.
- Implement country and site level patient recruitment strategy and risk mitigation. Coordinates and ensures country level study enrolment targets and timelines are met in collaboration with relevant stakeholders.
- Leads problem solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to the appropriate stakeholder/s.
- Assessment and set up the of vendors during study start up period (locally)
- Investigator Meeting participation and preparation.
- Ensures data entered in the Clinical Trial Management System (CTMS) is current and complete, and access to eDC and vendor systems is available for the country and clinical trial site personnel. This includes entering necessary data and uploading documents in eTMF.
- Validation of study related materials (i.e. protocol, ICF, patient material).
- Supports the review of country and site-specific documents (e.g. ICF, patient material), and where applicable may include the preparation of site level ICF and other documents.
- May support preparation of materials for Site Initiation Visits.
- Responsible for verifying and confirming with local team eTMF completeness (Country and Site level).
- Prepare investigator sites to conduct clinical trials through verifying acceptability of Clinical Trial Package (CTP) documentation.
- Acknowledges Site Monitoring visit reports,



takes action within the timelines specified and escalates issues and ensures appropriate documentation of issues.
- Coordination of database locks and query follow up. Ensures timelines are met.
- Ensure inspection readiness of assigned trials within country. Provide support to Health Authority inspection and pre-inspection activities.
- Coordinates and completes the Corrective Actions / Preventive Actions (CAPA) and ensures implementation for Country audit level findings. Drives CAPA review, implementation and completion.
- Coordinate study team meetings locally.
- Supports GTAC in the resolution of queries related to site invoices and supports in the coordination of patient compensation claims (if applicable).
- Collaborates with the local study team to support the management of site relationships (may include CRO related issues).
- May support Investigator Site Assessment Visits (ISAs) and Site Initiation Visits (SIVs).
- May perform site closure activities, including post-close out.
- May act as point of contact for Sites.
- As required per country requirements, perform or support the preparation of submissions to Health Authorities including follow up until approval. This includes substantial amendments and any other documentation requiring HA submission.
- Perform submission to Ethics Committees and governance offices, where applicable, including follow up until approval (protocol, amendments/IB and any other documents requiring EC submission). Coordinate the MOH responses with regulatory and central teams, as applicable.
- May support the collection and distribution of documents to and from sites.
- Support the approval for the closure of funds/POs




- May update national registries where applicable.
- Serves as coordinating resource on country regulatory requirements and keeps up to date with evolving regulation in collaboration with Regulatory and Legal.

Qualifications:-

- Bachelors or Masters degree required. Field of study within life sciences or equivalent

Experience Requirements

- Clinical Trial Manager: Minimum of 4 years industry related experience.
- Senior Clinical Trial Manager: At least 6 years of industry related experience.
- Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives.
- Thorough understanding of GCP, ICH Guidelines and Country regulatory workplace.
- In depth knowledge and understanding of clinical research processes, regulations and methodology.
- Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management.
- Demonstrated organizational and planning skills and independent decision-making ability.
- Strong organization and time management skills and ability to effectively manage multiple competing priorities.
- Ability of critical thinking and risk analysis.
- Strong communication skills with a strong customer focus, able to manage both internal and external clients at all organizational levels.
- Skilled in the use of technology.
- Good verbal and written communication skills (both in English and local language).

Software that must be used independently and without assistance (Microsoft Suite, Clinical Trial Management Systems (CTMS), Electronic Data Capture Systems (eDC); Electronic Trial Master File (eTMF).

Travel Required (nature and frequency).:-

Occasional local travel requirement

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Clinical Trial Manager (Mumbai)
🏢 Bristol-Myers Squibb
📍 Mumbai