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Global Studies ManagerRef: DT24147

Salary:£400 - £450 per day

Added:14 May 2019

Region: UK

Sector: Pharmaceutical

Sub Sector: Clinical Research

Main Responsibilities and Accountabilities: *Provides direction and leadership to one or more clinical operations teams *Develops operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management. *Builds effective and efficient high performing operations teams and ensures team members are aware of their accountabilities, responsibilities and deliverables. *Creates team culture and promotes team spirit. *Develops and maintains effective working relationships with SMT members, with particular focus on affiliate teams, external CRO (for outsourced teams) and co-development partner study teams. *In collaboration with functional management, coaches, mentors, supports, and provides study specific direction to Study Management team members. *Oversees the development and maintenance of study specific manuals created by the GSA. *Contributes to the development and management of the study timelines, resources, budget, risk and quality plans *Ensures operational tracking tools are identified, including systems to meet the needs of the operations team and ensures reporting to the GSL. *Develops and manages clinical study budgets (including HQ budget) and contributes to staffing/resourcing plans. Communicates variances in the budget and action plan for resolution to the GSL. *Establishes study milestones and ensures accurate tracking and reporting of study metrics. *Provides operational input into the development of protocol feasibility questionnaires. *Provides clinical operations expertise to ensure operational feasibility and delivery *Leads the development and finalization of site feasibility questionnaires. *Leads the creation of the study level patient recruitment plan and retention strategies based on feasibility data and input from the affiliate teams and consultation with the GSL and OPL. *Provides operational input and insight into all study related documentation (including protocol and informed consent form) and processes. *Analyzes the feasibility data across countries with input from the affiliates and makes recommendations to the GSL for the strategic country and site distribution and patient numbers. *Oversees forecasting of clinical/non-clinical supplies *Designs drug assumption and supply chain process in partnership with Pharma Technical Drug Supplies, affiliates and GSL. *Oversees the forecasting and management of non-clinical supplies to ensure sites have supplies to run clinical study. *Delivers the operational elements of the study plan *Chairs operations team meeting and organizes the investigator meetings, monitor training, CRO kick-off meetings. *Ensures that reporting of SUSARs is established and maintained for the duration of the study. *Proactively manages actual study level recruitment versus planned patient recruitment status and communicates variance to the GSL and implements contingencies in consultation with the GSL. *Primary contact with affiliates to maintain oversight of performance, issues, and their resolution and identify systematic issues and coordinates any corrective action. *Ensures the completion and finalization of any corrective and preventative action plans resulting from internal site audits. *Oversees the maintenance of drug supplies and resolution of issues with input from the Pharma Technical Drug Supplies. *Coordinates responses to study questions or issues from Health Authorities or IRBs/IECs. *Provides operational input into the development and tracking of SMT goals. *Provides the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work *Performs ongoing vendor management (e.g., CROs, Central Labs, IVRS, Reading Centers), including independent negotiation of scope of work, budgets, performance management, and issue resolution. *Develops and executes appropriate site and CRO/vendor audit and quality plans. *Identifies areas of best practice and process improvements *Participates in Pharma Development Operations initiatives and programs as assigned. *Maintains oversight and ensures consistency of the operational aspects across studies within a project. *Ensures study adherence to ICH/GCP and SOPs

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