Medical Clinical Operations Partner
JOB_52430204588187Job type
ContractLocation
Welwyn Garden CityWorking Pattern
Full-timeSpecialism
Clinical ResearchIndustry
PharmaceuticalsPay
Daily rate
Exp. RWE Clin Study Manager 6 month rolling
Global pharma is looking to recruit an experienced Contract Clinical Study Manager with evidence of project management skills developed through leading successful study teams in all stages of clinical studies. The role focusses on the management of Investigator Initiated Studies (IIS) and managed
Real World Evidence activities (RWE), and/or the country management of global studies. You will be a creative problem solver, critical thinker and create collaborative relationships across the organisation and with key stakeholders.
Real World Evidence activities (RWE), and/or the country management of global studies. You will be a creative problem solver, critical thinker and create collaborative relationships across the organisation and with key stakeholders.
Duties
- Manage study teams and ensure team members are aware of their accountabilities, responsibilities and deliverables
- Ensure adherence to relevant guidelines (ICH GCP/GVP/GPP), regulations and procedural documents. Ensure study inspection readiness at all times. Ensure the completion and finalisation of any corrective and preventive action plans resulting from site audits and inspection- Manage study teams and ensure team members are aware of their accountabilities, responsibilities and deliverables
- Maintain study plans and systems, including study documentation and track study metrics.
- Maintain study budgets and approve invoices, identify and communicate any issues/variances with study budgets with action plans for resolution. Review and negotiate
work orders and study agreements, as applicable.
- Manage study feasibility and site selection as well as site relations
Accountable for vendor study deliverables, according to timelines, budget, operational procedures, quality/compliance and performance standards. Maintain oversight of vendor performance and issues, and ensure vendors receive appropriate training
- Accountable for the tracking of HA and EC approvals, as applicable
Experience
A proven clinical study manager professional with experience in managing investigator initiated and non-interventional studies.Relevant degree
Medical Clinical Operations PartnerJOB_524302045881872024-07-192024-10-18
Talk to Claire Helliwell, the specialist consultant managing this position
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JOB_52430204588187