Global Clinical Study Manager Job

GLOBAL STUDY MANAGER needed for a CONTRACT opportunity with Yoh's client located in South San Francisco, CA.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Clinical Operations
- Site Monitoring
- Risk Mitigation
- Clinical Supply Management
- Clinical Trials

WHAT YOU'LL BE DOING:

- 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.
- Ensures operational tracking tools are identified, including systems to meet the needs of the operations team and ensures reporting to the GSL.
- 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.

WHAT YOU NEED TO BRING TO THE TABLE:

- Proven clinical development experience of the operational aspects of 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.
- Experience of project managing operational aspects of a clinical study including development of timelines, budgets and resource plans.
- Good knowledge of ICH GCP.
- Proven ability to successfully achieve results within a multi-cultural and geographically diverse team.
- Experience working as part of a large team and leading small study or functional teams, with a proven ability to be an active member of the team and motivate and lead a small team to deliver against commitments.

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Krista Leach

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: CLINICAL

MONJOBJ2WSWSCI

Ref:

SFSF: LS