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.
Apply: https://careers.sunpharma.com/job/Mumbai-Manager-2-Global-Trial-Manager/21152544/