R&D Clinical Trial Support Team Lead

The CTSM Team leader is responsible to support the clinical study leadership to execute and deliver on our clinical studies. The CTSM Team Leader will oversee and support a team of Clinical Trial Support Managers (CTSM) assigned to studies, to ensure that the assigned deliverables are met. The CTSM Team Leader will be responsible for the direct line management of, and for ensuring the training, coaching, motivation, and development of the CTSMs to maximize their expertise knowledge, capabilities, performance, and overall utility while supporting the clinical studies. The CTSM Team Leader will report to the CSO Study Management Head (India)and functionally to the Clinical Trial Support Head.

Main responsibilities include:

• Accountable to ensure the qualification, expertise, onboarding, support and training for the in their team. They will drive the success of the CTSMs in their project roles
• Provide individualized coaching, mentoring and performance management.
• Create and manage individual performance and development plans, conduct regular performance reviews and goal setting sessions with each CTSM.
• Promote a positive team culture by encouraging open communication, teamwork and recognition of team member achievements.
• Provide guidance and support for escalations from the CTSMs and provide them with guidance to problem solve.
• Foster peer-to-peer collaboration.

Training and Development

• Organize and facilitate training sessions for their team of CTSMs.
• Build documentation to support onboarding, training, and team processes.
• Lead recruiting and hiring for any new team members.
• High level understanding of the projects and priorities within their assigned CTMS team. Provide oversight of these studies to ensure adequate resource planning and support for the CTSM team to ensure the timelines and milestones of the studies are achieved.
• Ensure synergy and consistency of processes and tasks among the CTSMs.
• Support ongoing process improvement activities and ensure processes are shared with all CTSMs.
• Implement best practices and share lessons learned among the CTSMs.
• Maintain close collaboration with other CTSM team leaders as well as the Clinical Trial Support Leads and Clinical Trial Support Head. There could be instances where the CTSM Team Leader may have to interact with the Study Teams or other members of Clinical Science and Operations.
• Organize, participate, and lead meetings with their direct report CTSMs, but also with CTSL and CTSH.

About you

• Experience - Organize, participate, and lead meetings with their direct report CTSMs, but also with CTSL and CTSH.
• Basic knowledge of clinical development, GCP & ICH guidelines, regulations by major regulatory bodies such as FDA (Food and Drug Administration) and EMA (European Medicines Agency), and SOPs/ QDs.
• Demonstrated ability to work efficiently with clinical study leader within the same project, ability to collaborate with cross-functional team members and external partners using collaborative negotiation skills.
• Ability to anticipate potential issues, proactively identify ways to resolve/mitigate, timely escalate with appropriate action plans.
• Readily adapt to new environment, technologies and processes (e.g. new digital tools)
• Good organizational skills: ability to multi-task, skill in establishing priorities and meeting deadlines.
• Ability to work autonomously.
• Strong written and verbal communication skills. English language skill: ability to exchange fluently (incl. negotiation), lead international meetings, write meeting minutes/ emails/ study documents, internal & external communications.
• Organize, participate, and lead meetings with their direct report CTSMs, but also with CTSL and CTSH.