Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world' s leading biotech companies, with multiple products on the market and a promising development pipeline.
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 the 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 drugs supplies and resolution of issues with input from the Pharma Technical Drugs 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
Life sciences degree or nursing equivalent and 5-7 years of experience in a clinical research/a healthcare environment.
Compass Consulting Group