MSD Hiring Clinical Trial Coordinator
Clinical Trial Coordinator Job Vacancies at MSD: Join Team in Gurgaon, Haryana, India
Are you passionate about clinical research and looking for an opportunity to work with a global leader in pharmaceuticals? MSD is currently hiring for the position of Clinical Trial Coordinator in Gurgaon, Haryana, India. This role offers an exciting opportunity to be part of a dynamic team dedicated to advancing medical research and improving patient outcomes.
Job Overview
Position: Clinical Trial Coordinator
Location: MSD, Gurgaon, Haryana, India
Qualification: Bachelor’s degree or job training in office management, administration, finance, or healthcare preferred
Experience: Relevant experience in clinical research administration
Application Deadline: 11/21/2024
Clinical Trial Coordinator:
Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable.
The role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages to IRB/ERC and Health Authorities. The role will collaborate at local level closely with COM, CRM and CRA. And the person collaborates with finance/budgeting representatives to manage CTRAs and payments.
Responsibilities include, but are not limited to:
• Trial and site administration:
- Track (e.g. essential documents) and report (e.g. Safety Reports)
- Ensure collation and distribution of study tools and documents
- Update clinical trial databases (CTMS) and trackers
- Clinical supply & non-clinical supply management, in collaboration with other country roles
- Manage Labeling requirements and coordinate/sign translation change request, in collaboration with other country roles (if applicable)
• Document management:
- Prepare documents and correspondence
- Collate, distribute/ship, and archive clinical documents, e.g. eTMF
- Assist with eTMF reconciliation
- Execute eTMF Quality Control Plan
- Update manuals/documents (e.g., patient diaries, instructions)
- Document proper destruction of clinical supplies.
- Prepare Investigator trial file binders
- Obtain translations of documents
• Regulatory & Site Start-Up responsibilities: Collaborate with other country roles to:
- In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
- Obtain, track and update study insurance certificates
- Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.
- Publish study results for GCTO and RA where required per local legislation
• Budgeting, Agreement and Payments: Collaborate with finance/budgeting representatives for:
- Develop, control, update and close-out country and site budgets (including Split site budget)
- Develop, negotiate, approve and maintain contracts (e.g. CTRAs)
- Track and report contract negotiations
- Update and maintain contract templates (in cooperation with Legal Department)
- Calculate and execute payments (to investigators, vendors, grants)
- Ensure adherence to financial and compliance procedures
- Monitor and track adherence and disclosures
- Maintain tracking tools
- Obtain and process FCPA documentation in a timely manner
• Meeting Planning:
- Organize meetings (create & track study memos/letters/protocols)
- Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)
Required Skills and Qualifications
- Fluent in local languages and proficient in English (verbal and written).
- Strong understanding of global, country, and regional clinical research guidelines.
- Hands-on knowledge of Good Documentation Practices and ICH-GCP guidelines.
- Proficient IT skills, especially in MS Office and clinical IT applications.
- Excellent time management, organizational, and interpersonal skills.
- Ability to work independently and proactively solve problems.
- Effective communication skills with external customers and within a multicultural environment.
- Strong sense of accountability and urgency, with the ability to handle multiple tasks simultaneously.
Application Details
How to Apply: Interested candidates should prepare a comprehensive resume detailing their educational background and relevant experience. Ensure all applications are submitted before the deadline on 11/21, 2024. For more information and to apply online, visit MSD Careers.
Application Deadline: 11/22, 2024
