20 Aug
|
SUN PHARMA
|
Gurugram
20 Aug
SUN PHARMA
Gurugram
Job Title:
Regional Trial Lead
Business Unit:
GDO
Job Grade
G10/G9B
Location :
Gurgaon
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.
Job Summary
RTL/Sr. RTL is responsible and accountable for deliveries of studies allocated to RCO unit, performing end to end study related project management for studies managed in-house with-in agreed timelines, budget and desired quality standards. For Outsourced study, RTL/Sr. RTL will be responsible to provide an effective Sponsor Oversight and accountable for key deliverables and study success.
RTL/Sr.
RTL is expected to adhere to required procedures and quality in compliance with Sun Procedural Documents, ICH-GCP and local regulations.
Area Of Responsibility
- Planning and Execution of trials as per agreed timelines, budget and ensuring Quality across processes.
- Planning and Facilitating HA submission in coordination with IRA team
- Perform Preliminary site feasibilities, ensure site database is updated on periodic basis with feasibility results
- Plan and Accountable for the conduct of Site Selection visits, ensure actions from SSV s are followed up.
- Planning and performing IRB submissions in an efficient manner to secure timely approvals, ensure IRB/IEC dossiers are prepared and submitted as per requirements.
- Ensure Translation process are followed up for all trial related documents
- Track all vendor related payments and ensure timely payments
- Negotiate study budgets with sites, ensure Clinical Trial Agreements are executed in timely ma
📌 Regional Trial Leader (Gurugram)
🏢 SUN PHARMA
📍 Gurugram