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Reference Number:
DF-GLOB
Job Description:
IF YOU ARE INTERESTED AND QUALIFIED IN THIS POSITION PLEASE SEND ME AN UPDATED RESUME IN A WORD DOCUMENT TO danielle@sunrisesys.com I LOOK FORWARD TO WORKING WITH YOU.
Main Responsibilities and Accountabilities:
- 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 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 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 .
- 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 responsibilityfor additional activities in support of project level planning and implementation (in agreement with OPL and GSL's FM). The OPL retains overall accountability for the project.(see supplemental information)
Experience Level:
Unspecified
Requirements:
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