Clinical Project Manager

Main Responsibilities and Accountabilities:

Provides direction and leadership to one or more clinical operations teams.

Develops operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management.

Builds effective and efficient high performing operations teams and ensures team members are aware of their accountabilities, responsibilities and deliverables. Creates team culture and promotes team spirit.

Develops and maintains effective working relationships with SMT members, with particular focus on affiliate teams, external CRO (for outsourced teams) and co-development partner study teams. In collaboration with functional management, coaches, mentors, supports, and provides study specific direction to Study Management team members.

Oversees the development and maintenance of study specific manuals created by the GSA.

Contributes to the development and management of the study timelines, resources, budget, risk and quality plans.

Develops and manages clinical study budgets (including HQ budget) and contributes to staffing/resourcing plans. Communicates variances in the budget and action plan for resolution to the GSL.

Establishes study milestones and ensures accurate tracking and reporting of study metrics. Provides operational input into the development of protocol feasibility questionnaires.

Experience:

- Must have proven clinical development experience in all stages of clinical studies (preferably working in a Global environment and/or including monitoring or leading affiliate teams, working with vendors and/or CROs, drug supply management and planning operational activities to achieve database lock).
- Good knowledge of ICH / GCP
- Well developed written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization.

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