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
Competencies Required:
Behavioral Competencies:
- Communication 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.
