Clinical Trial Coordinator

Merck; Gurugram District; On-site; INR 600,000 - 900,000; Full time

Job summary

Merck & Co., Inc. in India is seeking a Clinical Trial Coordinator to manage trial and site administration, document control and regulatory submissions. You will ensure timely site readiness, support IRB/ERC submissions and collaborate with COM, CRM and CRA teams, while coordinating CTRAs and vendor payments.

The role emphasizes updating CTMS, managing study tools, and maintaining compliant documentation across cross-functional teams in a fast-paced environment.

Responsibilities

• Track essential documents and report safety data for trials and sites.
• Collate, distribute and archive study tools and documents.
• Update CTMS databases and trial trackers to ensure accuracy.
• Coordinate clinical and non-clinical supply management with country teams.
• Manage labeling and translation change requests with relevant teams.
• Prepare investigator trial file binders and translate materials as needed.
• Support site start-up activities and regulatory submissions with country partners.
• Plan and organize meetings, memos and protocols for project governance.

Skills

Adaptability

Clinical Research

Clinical Site Management

Clinical Trial Compliance

Data Archiving

Regulatory Compliance

Regulatory Affairs Compliance

Clinical Trial Documentation

Clinical Trial Management

Pharmacovigilance

Patient Recruitment

ICH GCP Guidelines

Job description

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

• 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

• Adaptability


• Best Practices Research


• Clinical Research


• Clinical Site Management


• Clinical Trial Agreements (CTA)


• Clinical Trial Compliance


• Clinical Trial Documentation


• Clinical Trial Management


• Clinical Trial Planning


• Clinical Trials


• Clinical Trials Monitoring


• Clinical Trials Operations


• Cross-Cultural Awareness


• Data Archiving


• Economic Forecasting


• Financial Administration


• Financial Forecasting


• ICH GCP Guidelines


• Legal Archiving


• Medical Research


• Patient Recruitment


• Pharmacovigilance


• Regulatory Affairs Compliance


• Regulatory Compliance

Company Details

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA

Employee Status

Regular

Flexible Work Arrangements

Not Applicable

Job Posting End Date

09/11/2026