Job Summary
- Sun is seeking a Global Trial Manager, Clinical operations within its clinical development Team in Mumbai
- The Global Trial Manager, Clinical Operations will report into Global Trial leader, Clinical Operations
- Under the direction of the Global Trial leader, Clinical Operations, the Global Trial Manager, Clinical Operations will assist Global Trial leader in providing global, regional or complex local management of Sun Pharmaceutical s clinical trials
- This role will be Instrumental in providing operational oversight of assigned project(s) for end-to-end clinical trial management including start-up, execution, close-out, and study report finalization
- Responsibilities include reviewing study plans and study documents, monitoring study progress and data quality and coordinating trial tasks and timelines, ensuring all teams and tasks are on track
Responsibilities :
Oversight of CRO / other vendors and study management-
- Oversees CRO pre-site selection and site initiation, interim close-out and co-monitoring visits to ensure compliance with protocol and regulatory requirements and to assure good site performance
- Assists in the management of CROs and other vendors to ensure project requirements are met
- Ensure proper overview and communicate to teams (including on-time or high quality) of monitoring activities, data flow, data validation
- Evaluating and monitoring the project progress and resources to ensure projects are on time and within budget
- Reviewing operational aspects of trial activity and clinical protocols, providing oversight for trial implementation activities
- User of systems and business technologies to document and track study and user progress
- Assist in review of clinical protocols, amendments, informed consents, CRF/source document design, protocol specific training documentation, administrative letters etc.
- Oversee TMF management and review TMF documents as necessary
Perform regular reviews of data according to data review/monitoring guidelines (CTMS, EDC, IVRS etc.)
- Work with QA for CAPA documentation and resolution
- Assists in forecasting of IP requirement during the study and prepare IP requisition.
- Assists in preparing and obtaining approval for clinical trial budget and for any change in the budget during the study; annual forecasting and tracking of spend.
- Assist in overall project planning and execution for clinical protocols
- This position requires approximately 10% travel to domestic and international locations
Collaboration with cross functional teams-
- Coordinate with cross functional teams (e.g. Medical monitor, Regulatory Affairs, supply chain, statistics, Data management, QA and QC, CRO, vendors etc.)Works cross-functionally and with external vendors to proactively manage the execution of the clinical trials
- Provide administrative support around meeting management, assembly of presentations for Investigator meeting and CRO/vendor kick-off meetings as required
- Interacting with various internal and external teams to facilitate successful project completion
- Assist in managing study team meetings with both internal and external resources
Soft skills-
- Strong problem-solving and decision-making capabilities, with the ability to navigate complex challenges.
- Industry Awareness: Stay current with industry trends, emerging therapies, and advancements in clinical trial methodologies.
- Interpersonal Skills: Collaborative and able to build strong relationships with internal teams and external partners.
- Contributes to a team culture that promotes continuous improvement, ownership, professional growth, and inclusion.
Qualifications:
- Minimum 6 years clinical study management experience with at least 2 years direct multinational study management experience
- 2 + years dermatology experience
- Ability to manage delegated aspects of assigned clinical trials
- Ability to manage CROs and Clinical Study vendors
- Bachelor s level degree in life sciences, pharmacy or nursing
- Robust understanding of ICH/GCP, and knowledge of regulatory requirements
- Proficiency in MS office including Word, Excel, PowerPoint and other applications
- Strong clinical study/project management skills
- Outstanding communication skills, both verbal and written
- Ability to work independently and prioritize duties
- Understanding of Electronic Data capture (EDC), CDMS, IRT etc.
