International Clinical Trial Manager
Provides the operational expertise and leadership to one or more clinical operations teams to ensure the effective and efficient delivery of all operational aspects of one or more studies through all phases of Clinical Study Management (Start-up, Conduct, Close), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations.
Provides direction and leadership to one or more clinical operations teams (depending on competency level, International Clinical Trial Manager may not have leadership responsibilities) .
- 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 the Study Management Team members, with particular focus on affiliate teams, external providers and collaborative partners.
- In collaboration with functional management, coaches, supports, and provides study specific direction to Study Management Team members.
- Oversees the development and maintenance of study specific manuals created by the International Clinical Trial Associate
- Responsible and/or Contributes to the development and management of the study timelines, resources, budget, risk and quality plans
- Responsible to identify and update operational tracking tools, including systems to meet the needs of the operations team and ensures reporting to the International Clinical Program Leader
- Develops and manages clinical study budgets. Communicates variances in the budget and action plan for resolution to the International Clinical Program Leader(ICPL)
- Establishes study milestones and ensures accurate tracking and reporting of study metrics
- Provides clinical operations expertise to ensure operational feasibility and delivery
- Develops the site feasibility questionnaires and creates the study level patient recruitment plan and retention strategies based on feasibility data and input from the CRO and affiliates and in consultation with the International Clinical Program Leader(ICPL) and Therapeutic Area Team(TAT)
- Analyses the feasibility data across countries with input from the affiliates and provides the strategic country and site distribution and patient numbers to the International Clinical Program Leader.
- Provides operational input and insight into all study related documentation (including protocol and informed consent form) and processes
- Oversees forecasting of clinical/non-clinical supplies
- Designs drug assumption and supply chain process in partnership with Drug Supply Coordinator, affiliates and International Clinical Program Leader
- 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 (depending on competency level)
- Ensures that safety reporting is established and maintained for the duration of the study and that reporting timelines are met
- Proactively manages actual study level recruitment versus planned patient recruitment status and communicates variance to the International Clinical Program Leader and implements contingencies in consultation with the International Clinical Program Leader
- Primary contact with CRO and 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 Clinical Drug Supply coordinator
- Coordinates responses to study questions or issues from Health Authorities or IRBs/IECs
- Provides operational input into the development and tracking of Study Management Team 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 in collaboration with Product Development Quality.
- Identifies areas of best practice and process improvements
- Participates in 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
- Is responsible for acting in line with legal, regulatory and company standards and codes of practice
- Completes all required training modules as a priority
Qualifications and Experience:
- Life sciences degree or nursing equivalent or substantial experience in a clinical research/a healthcare environment is required
- Proven clinical development experience of the operational aspects of all stages of clinical studies preferably working in a Global environment and/or including monitoring or leading affiliate teams, working with vendors and/or CROs, drug supply management and planning operational activities to achieve database lock
- Experience of project managing operational aspects of a clinical study including development of timelines, budgets and resource plans
- Proven ability to successfully achieve results within a multi-cultural and geographically diverse team
- Experience of working as part of a large team and leading small study or functional teams, with a proven ability to be an active member of the team and motivate and lead a small team to deliver against commitments
- Well developed written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization
- Fluency in written and spoken English
- Relevant working/residency permit or Swiss/EU-Citizenship required