Clinical Trial System Specialist (eTMF)

Job Title

Sr. Exe/Manager 2- Clinical Trial System Specialist (eTMF) Implementation

Business Unit

Clinical Development

Job Grade

G11B/G11A

Location :

Gurgaon/Mumbai

At Sun Pharma, we commit to helping you Create your own sunshine— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine

As you enter the Sun Pharma world, you'll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other's journeys.

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List Of Responsibilities/Job Functions

• Support eTMF implementation process, periodic enhancements, perform UAT, Coordinate closely with vendor on configuration and system readiness.
• Ensure thorough understanding of the system and system requirements.
• Responsible for user access management for Sun Pharma internal as well as external users to the clinical systems.
• Support setting up trials, EDL, TOC and ensure timely go live with in timelines
• Responsible to resolve user support queries either by answering questions, troubleshooting problems or identify system performance issues.
• Escalate technical issues to the Vendor Support team.
• Manage the review of Clinical system processes and procedures.
• Support CTSM for creating applicable SOP's, prepare work instructions, training materials, guides to ensure effective understating of systems across users.
• Support CTSM for system validation and integration activities.
• Support CTSM in any ad-hoc task assigned.
• Build reports and/or data extracts to support business analysis
• Provide BAU support and user assistance for eTMF‑related queries.
• Log, track, and resolve eTMF system tickets within defined SLAs.
• Conduct periodic TMF quality reviews in accordance with SOPs and TMF Reference Model.
• Monitor study‑level TMF completeness, timeliness, and quality metrics.
• Identify TMF gaps and follow up with stakeholders for timely remediation.
• Ensure consistent application of TMF processes across assigned studies.
• Support internal audits, vendor audits, and health authority inspections.
• Escalate system issues and coordinate with vendors or internal IT teams.
• Support CTSM in overseeing eTMF system usage, configurations, and enhancements.
• Support updates to TMF SOPs, user guides, and training materials.
• Drive TMF training and knowledge‑sharing initiatives.
• Collaborate with CTSM, Clinical Operations, Study Teams, CROs, and other stakeholders.
• Support TMF process improvement initiatives aligned with organizational priorities
  
  

Behavioral Competencies

Competencies Required :

• Communicat i on skills
• Collaboration and team work
• Minimum graduation /post-graduation in life sciences or Information technology and allied domains.
• Should have at-least 08-10 years of experience in a similar capacity with experience in handling and managing clinical systems.
  
  

Travel Estimate

Job Requirements

Educational Qualification –

Graduation/Post-Graduation in life sciences or Information technology.

Experience –

Tenure : 8+ Years

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let's create a brighter future together!

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).