Clinical Trial Coordinator at MSD
About MSD
MSD, known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada, has been a global leader in healthcare for over a century. We are dedicated to bringing innovative health solutions to some of the world’s most challenging diseases. Our mission is to save and improve lives through our extensive research and development efforts, focusing on creating medicines and vaccines that address critical health issues worldwide.
Position Overview
Job Title: Clinical Trial Coordinator
Location: Gurgaon, Haryana
Experience Required: 0 to 2 Years
Educational Qualification: B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Life Sciences
Salary: Not disclosed
As a Clinical Trial Coordinator (CTC) at MSD, you will play a crucial role in the administration of clinical trials. This position involves comprehensive trial and site management, supporting clinical supply management, and ensuring timely updates of tracking and reporting tools. The CTC is essential in meeting planned Site Ready dates and will collaborate closely with various teams at the local level, including Clinical Operations Manager (COM), Clinical Research Manager (CRM), and Clinical Research Associates (CRA).
Key Responsibilities
Trial and Site Administration
- Tracking and Reporting: Manage essential documents and Safety Reports.
- Study Tools and Documents: Ensure collation and distribution of necessary study materials.
- Database Management: Update clinical trial management systems (CTMS) and trackers.
- Supply Management: Coordinate clinical and non-clinical supply management in collaboration with country-specific roles.
- Labeling: Oversee labeling requirements and manage translation change requests.
Document Management
- Document Preparation: Prepare necessary documents and correspondence.
- Archiving: Collate, distribute, ship, and archive clinical documents, including the eTrial Master File (eTMF).
- Quality Control: Execute the eTMF Quality Control Plan and assist with eTMF reconciliation.
- Documentation: Manage the proper destruction of clinical supplies and update manuals/documents as required.
Regulatory & Site Start-Up
- Collaboration: Work with other country roles to manage site evaluation/validation, site start-up, and submissions.
- Insurance and Regulatory Support: Obtain and track study insurance certificates, support the preparation of submission packages for Institutional Review Board (IRB)/Ethics Review Committee (ERC), and regulatory agencies.
Budgeting, Agreements, and Payments
- Budget Management: Develop, control, update, and close-out country and site budgets.
- Contract Management: Negotiate, approve, and maintain contracts, including Clinical Trial Research Agreements (CTRAs).
- Financial Compliance: Ensure adherence to financial and compliance procedures, monitor disclosures, and maintain tracking tools.
Meeting Planning
- Organize Meetings: Manage study-related meetings, prepare materials, and support local investigator meetings.
Skills and Qualifications
- Languages: Proficiency in local languages and business-level English (verbal and written).
- Clinical Research Guidelines: Understanding of global and country-specific clinical research guidelines.
- Good Documentation Practices: Knowledge and hands-on experience.
- IT Skills: Strong MS Office skills, particularly Excel, and adaptability to new IT applications.
- Negotiation and Time Management: Excellent negotiation skills, effective time management, and organizational abilities.
- Interpersonal Skills: Ability to work in a multicultural environment and maintain culturally sensitive working relationships.
- Customer Focus: Demonstrates commitment to both internal and external customer focus.
- Independence: Ability to work independently with a proactive problem-solving attitude.
Who We Are Looking For
At MSD, we seek individuals who are intellectually curious and driven by a passion for helping others. If you thrive in a collaborative environment and are committed to making a global impact, we encourage you to apply. Join us and be part of a team that is dedicated to advancing health solutions worldwide.
How to Apply
Interested candidates can apply
Conclusion
MSD is an equal opportunity employer, committed to fostering an inclusive and diverse workplace. We believe that innovation flourishes when diverse ideas come together in a supportive environment. Join us and contribute to a healthier future for all.
