Global Studies Leader Job

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

Top Skills You Should Possess:
- Provides direction and leadership to one or more study teams to ensure delivery of all cross functional activities to meet study plans outlined by the clinical development plan.
- Builds and maintains effective high performing teams with clear roles, responsibilities and accountabilities for members.
- Finalize study budget based upon raw budget estimate from OPL, input from GSM and in alignment with DBA, LCT/DST and SMT assumptions.

What You'll Be Doing:
- Ensures study team receives study specific and therapeutic training.
- Creates and manages study timelines, budget, resource, risk and quality plans
- Drives setting of study team goals and milestones and monitors progress.
- Establishes and maintains accurate study level timeline and resourcing plans and works with Functional Management to have correct resources in place.
- Leads development of protocol level feasibility and finalizes country selection with OPL input.
- Ensures groups provide input to develop and finalize core study documents including protocol, informed consent form, CRF and SSPM (study-specific procedures manual).
- Accountable for the drug supply requirements
- Accountable for study budgets, with appropriate input from the GSM to ensure efficient expenditure.
- Accountable for accuracy of forecasting at RFP rounds and ensuring adjustments are made as necessary.
- Ensure clinical data are reviewed in accordance with study Data Quality plans.
- Oversees the safety reporting activities and timelines.
- Provides direction and oversight of outsourced activities to ensure CRO and vendor delivery.
- Inputs into the contract and budget negotiation led by Business Manager.
- Identifies and contributes to areas of best practice and process improvements of quality, productivity and efficiency.
- Incorporates learnings and recommendations from study debriefs and best practices.
- Contributes to functional excellence activities.
- Leads study debriefs. Provides study specific mentoring to GSMs and GSAs Ensures study adherence to ICH/GCP and SOPs. As part of a clearly defined development plan, can take responsibility for additional activities in support of project level planning and implementation project.

What You Need to Bring to the Table:
- Strong leaderships and motivational skills developed through leading successful global multi-functional Matrix study teams through all stages of clinical studies
- Demonstrated consistent achievement of team delivery against commitments and goals.
- Experienced project manager, having led the development and implementation of risk management plans, managed complex study budgets and resourcing plans.
- Proven experience of all aspects of clinical studies including vendor/CRO management, leading/working as part of a HQ development team and coordinating study level activities to deliver data for filing or publication purposes.
- Experience of influencing and negotiating at all levels to achieve team delivery.
- Self-motivated and achievement driven.
- Excellent written and verbal communications skills Competencies
- Project Management
- Decision Making
- Collaboration and Teamwork
- Influencing
- Cost and Financial Awareness
- Facilitation

Bonus Points! Otherwise Known As Preferred Qualifications:
- Life sciences degree or nursing equivalent.

WHAT ARE YOU WAITING FOR? APPLY NOW!

RECRUITER: Rob West

Yoh, a DayTHIS ADDRESS IS EXCLUSIVELY FOR INDIVIDUALS WITH DISABILITIES REQUESTING APPLICATION ASSISTANCE.

J2W: SCIENTIFIC

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SFSF: LS