Description
Key Features --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.
-Chairs team meetings. Primary contact for key stakeholders eg OPL.
-Represents the study team at DST (ad hoc). 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 all relevant functional groups provide input to develop and finalize core study documents including protocol, informed consent form, CRF and SSPM (study-specific procedures manual).
-Oversees the development and active management of the study patient recruitment strategies.
-Accountable for the drug supply requirements and availability across studies in liaison with the Pharma Technical Drug Supplies.
-Finalize study budget based upon raw budget estimate from OPL, input from GSM and in alignment with DBA, LCT/DST and SMT assumptions.
-Accountable for study budgets, with appropriate input from the GSM 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.
-Ensures CTMS is updated and accurate. 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.
-Leads the identification and selection of vendors and ensures cross functional input into the scope of work.
-Inputs into the contract and budget negotiation led by Business Manager.
-Accountable for performance, issues and their 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 Cross study review of quality, productivity and efficiency.
-Incorporates learnings and recommendations from study debriefs and best practices.
-Contributes to functional excellence activities.
-Leads study debriefs (as appropriate).
-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.
Skills & Experience -
-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