Global Studies Manager
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
More Jobs from Key People
- Senior Associate Project Manager
- Project Engineer
- Study Start Up Specialist
- Principal Medical Writer
- Senior Regulatory Manager
- Study Data Manager
- Pharmacovigilance Manager / Senior Manager
- Group Health Economics Manager
- Clinical Project Manager
- Quality Manager
- SAS Programmer - Paris
- Clinical Programmer
- Regulatory Affairs Manager, 12 month contract
- Regulatory Affairs Director
- Senior Statistical Programmer
- Labelling Consultant - 6 month contract
- Senior Regulatory Officer
- Data Manager - Paris
- Regulatory Affairs Manager, Labelling
- Regulatory Affairs Associate