Global Studies Leader Nr ref.: /JOBS.pl Reference Number: 895110-P Type of placement: 12+ months Contract Location: Basel, Switzerland Purpose: The Global Studies Leader leads one or more cross functional global Oncology Study Management Teams. He/she is accountable for efficient delivery of clinical studies through all phases (phase 1b-IV) and stages (start-up, conduct and close down) in accordance with appropriate quality standards including ICH/GCP and applicable regulations. Main Responsibilities: Provides direction and leadership to one or more global Study Management Teams (SMTs) to ensure delivery of all cross functional activities in line with the clinical development plan Builds and maintains effective high performing SMTs by ensuring clarity of roles, responsibilities, accountabilities and deliverables for members Chairs SMT meetings and other meetings involving external stakeholders (Investigator, Steering Committee, Vendors as appropriate). Primary SMT contact for key internal stakeholders e.g. Operations Project Leader (OPL) Represents the SMT at various cross-functional teams (e.g., Global Development Team GDT, Clinical Filing Team) as required, and may serve as an ad hoc member Ensures SMT receives applicable training: including therapeutic area training, protocol training, etc. at study kickoff Ensures escalation of issues and risks that significantly affect timelines, budget or quality to the GDT (via OPL) Responsible for study-level decision making and issue and risks identification and ensuring escalation and resolution as appropriate 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 milestones; ensures relevant systems are appropriately maintained Leads development of protocol level feasibility and finalises country selection with OPL input Ensures all relevant functional groups provide input to develop and finalize core study documents including protocol, informed consent form, CRF etc. Oversees the development and active management of the study patient recruitment strategies Accountable for the drug supply requirements and availability across studies Finalize study budget based upon raw budget estimate from Operations Program Leader, input from Global Trial Managers and in alignment with project and study-level assumptions Accountable for study budgets, with appropriate input from the GTM to ensure efficient expenditure and minimal variance between actual and planned spend. 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 ensures reporting timelines are met Provides direction and oversight of outsourced activities to ensure CRO and vendor delivery against contracted scope of work In partnership with the Business Manager, leads the identification and selection of vendors and ensures cross functional input into the scope of work Contributes to contract and budget negotiations led by Business Manager Accountable for vendor performance, issue identification, escalation and resolution to ensure studies are delivered in line with the agreed scope of work Identifies and contributes to areas of best practice and process improvements Ensures ongoing cross-functional review of study quality, productivity and efficiency; identifies efficiencies and raises issues as appropriate Incorporates learnings and recommendations from lessons-learned meetings and best practices Contributes to functional excellence activities, both within and across Therapeutic Areas (TAs) Leads study debriefs (as appropriate) Provides study specific mentoring to GTMs and Global Trials Associates (GTAs) and partners with functional managers to contribute to GTMs and GTAs development needs Ensures study adherence to ICH/GCP and SOPs Drives roll-out of new processes within the SMT and ensures appropriate implementation Qualifications and experience: Degree in Life Sciences or nursing equivalent is required Strong leadership and motivational skills developed through leading successful global multi-functional matrix study teams through all stages of clinical studies. Global experience preferred Applies critical thinking and aims to simplify work. Strives for efficiency Ability to influence, negotiate and manage conflicts Demonstrated consistent achievement of team deliverables against commitments and goals. Experienced project manager, having led the development and implementation of plans including but not limited to study milestone and risk management plans. Must have experience creating and managing complex study budgets. 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. Clear understanding and experience applying ICH/GCP Strong knowledge and experience of the drug development process and the pharmaceutical industry Oncology and/or Haematology experience is an asset Experienced in influencing and negotiating at all levels to achieve team alignment and commitment to deliverables. Self-motivated and achievement driven. Excellent written and verbal communications skills Willing for some travel Relevant working/residency permit or Swiss/EU-Citizenship required Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .
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