What are the responsibilities and job description for the AD / Director, Clinical Operations position at TalentCraft?
Responsibilities including but not limited to :
- Independently / proactively manage all aspects of multiple clinical studies within a complex program, including the study team and all external vendors.
- Provide oversight and guidance to internal Clinical Operations team.
- Accountable for clinical operations timelines and working closely with Core Team Program Manager to keep internal / external teams on track.
- Maintain expert knowledge of Clinical Development programs. Can independently interpret data and make recommendations on next steps.
- Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships.
- Develop and ensure execution of activities outlined in various study plans (sponsor oversight, monitoring, deviation, training, and study communication plans).
- Co-monitor or monitor studies if needed for the program.
- Drive communication and escalate issues to Head of Clinical Operations as appropriate, Clinical Sub Team.
- Navigate team structure (Study execution meeting and clinical meetings) and decision makers to independently resolve issues and escalate challenges / obstacles effectively.
- Participate in preparation of regulatory filings (e.g. US IND, EU CTIS, UK MHRA) as needed.
- Experience managing / collaborating with CROs and other study vendors.
- Support and lead Study Execution Team meetings.
- Lead cross-functional teams, pro-actively shaping team dynamics to support collaboration and accountability.
- Oversee performance, manage, and serve as point of contact for all CROs and vendors.
- Manage vendor scope and budgets in alignment with study (program) budget.
- Manage study resources, internally and externally, to optimize performance to study deliverables.
- Demonstrate ability to mitigate and escalate changes in scope appropriately.
- Create and manage standardized clinical trial tools, processes, and SOPs.
- Be accountable for clinical trial enrollment (ie develop recruitment strategies) and risk mitigations.
- Ability to be accountable for decisions made as Clinical Operations lead, and escalate issues / risks in real time.
- Experience managing / mentoring direct / indirect reports.
Qualifications :
