Piramal Life Sciences Limited (PLSL) is an independent research-driven drug company that was recently demerged from Piramal Healthcare Limited (Formerly known as Nicholas Piramal India Limited). PLSL was formerly the NCE R&D division of NPIL. PLSL has state-of-the-art R&D laboratories built over 200,000 square-feet of space in Mumbai, India and over 300 scientists engaged in drug discovery and development.
PLSL is focused on four therapeutic areas - Cancer, Diabetes, Inflammation and Infectious Diseases. The Company has a pipeline of fourteen compounds, including four in clinical trials. PLSL's lead chemical compound, a Cdk-4 inhibitor, has completed two Phase I studies and is being tested in another Phase I/II trial for Multiple Myeloma. PLSL has drug discovery and development agreements with Eli Lilly & Company and Merck & Company, two of the leading pharmaceutical companies in the world.
Post: Clinical Research Manager
Job Description:
1. Coordinate with all functions of Clinical Research and Development department and serve as the point of coordination with Project Management teams for issues related to the study. Likewise, to communicate action items discussed in the Project Management teams with the concerned team member and to follow up for the resolution of the same.
2. Draw up a Clinical Management Plan for the execution of assigned trials conceived by the Clinical Research and Development Department.
3. Identification and tracking of the key milestones in trial progress including timelines and resources.
4. Liaison with formulation, IMP mfg., randomizing, blinding & labeling teams and ensure that these activities occur within timelines identified for the execution of the trial.
5. Ensure complete IMP accountability (both in-house and at sites) at all times during trial conduct.
6. Play a key role in the finalization of CRO/ SMO/ Central Lab/ Local labs/ CTSF as required for study conduct.
7. To help the purchase team in negotiations with identified vendors.
8. Ensure adequate trial insurance is available at all times during the recruitment and follow up phase of the trial.
9. Coordinate with the medical affairs and regulatory teams to ensure timely regulatory submissions & approvals
10. Support the process of PIS, ICF, subject diary translation through suitable vendors and through timely identification of issues related to translations.
11. Prepare a comprehensive database through networking to identify the best sites in the country and abroad for the conduct of high quality trials.
12. Steer the process of site feasibility and coordinate/ personally conduct site selection visits to finalise sites for the study.
13. Liaison with legal team for finalization of clinical trial agreements for sites and for vendors.
14. Coordinate for timely IRB submissions
15. To address IRB queries through inputs from the concerned team member and to follow up with sites for IRB approvals.
16. To train the Project teams (both in-house and at sites) on project conduct and to provide periodic updates to the teams regarding new trial requirements.
17. Control the proceedings involving the Investigator’s Meeting.
18. Ensure timely collection of all essential documents from sites in order to be able to conduct a timely Site Initiation Visit (SIV)
19. To monitor and co-monitor sites for the allocated projects as per the clinical management plan.
20. To review monitoring visit reports (MVRs) prepared by the CREs and to identify key issues at sites and resolve/ escalate the same in a timely manner.
21. To ensure that frequency of monitoring visits is adhering to the clinical management plan.
22. To support quality control measures for other studies by conducting co-monitoring visits for sites of those studies.
23. Periodic review of study files (CSF) & filing (PMF)
24. To support audit related activities for in-house as well as site-related audits.
25. Adequately control trial related finances and maintain a check on the payments made to sites and vendors by thorough scrutiny of invoices and by close coordination with finance team.
26. Facilitate the archiving of trial files in a systematic fashion so as to guarantee speedy and accurate retrieval of the same.
27. Adequately communicate the trial status at periodic intervals to all stakeholders in the trial including trial sites and higher management.
28. To mentor and motivate the team in order to boost team spirit.
29. To continuously improve systems and processes by identification of errors in the current processes and by brain-storming to arrive at better processes.
30. Summarise the key learning from the study and discuss the same with the team at trial closure/ interim periods to facilitate smoother trial conduct for subsequent trials.
Desired Profile:
6+ yeras Relevant Experience handling clinical operation at Managerial level. MUST have handled team of clinical operations professionals.
Excellant Communications skills with pleasing personality
Post Graduate in clinical profession is MUST
Additional Information:
Experience: min. 6 Years
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Healthcare, Medical, R&D
Education: B.Pharma,B.Sc, B.Tech/B.E., M.Pharma,M.Sc, MBBS
Location: Mumbai
Email your CV to, research.recruitment@piramal.com
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