Global Study Manager, Oncology
Position Duties & Responsibilities:
1. Leader of the Global Study Team
- Identifies, implements, leads and manages a global, cross-functional Study Team for the duration of the study, working with functional line management to identify team members and resolve issues. Leads the yearly goal setting process for the study(ies) in scope in close collaboration with study team and all clinical team members
- Represents the study team as a member of the Global Clinical Team
- Disseminates relevant information to study team in an effective and timely manner
- Chairs study team meetings and investigator meetings, leads organization of investigator meetings, holds vendor kick-off meetings
- Develops in cooperation with respective functions appropriate study related training for study team representatives and site personnel according to GCP and BAG Pharmaceuticals development standards to ensure quality and requirements necessary for global regulatory approvals and marketing needs are met.
- In more complex and/or higher priority studies the StM may work alongside a SrStM assuming a co-study manager role
- Supports protocol feasibility; leads the operational planning and tracking of the site feasibility
- Reports status, issues and important feedback to GCT
- Supports analysis of feasibility data
- Based on the feasibility summary, develops study timelines incl. enrollment projections, milestones and proposed external study budget
3. Manage Study Activities
- The StM manages all study related activities from an approved study concept to the final Clinical Study Report (CSR) to ensure study is conducted in high quality and within the given timeline and budget.
- Manages the possible changes in project scope, timelines and budget
- Develops and implements patient recruitment and retention strategy in close collaboration with the study team.
- Supports development and implementation of integrated data review plan (IDRP) as well as ongoing data cleaning as defined in the IDRP
- Responsible for set-up, regular filing and completeness of study documentation (TMF)
- Liaises with various functions to ensure seamless study conduct throughout set-up, maintenance and closure and initiates actions to resolve issues.
- Supports during Authority Inspections and internal audits and is responsible to get study conduct related findings solved.
4. Preparation of Documents
- Provides operational input and insight into the preparation of the study protocol and contributes to other core study documents in close collaboration with the study team
- Develops the comprehensive overview and operational plans for the study such as the Study Plan, Oversight Plan etc.
5. Tracking and Reporting
- Measures study performance using appropriate systems, tools and techniques
- As a team member of the Global Clinical Team (GCT), the StM provides input to the GCT to enable accurate tracking and management of the overall Clinical Development Plan (CDP).
- Establishes study milestones with the study team and ensures accurate tracking and reporting of study metrics such as recruitment projections, patient enrolment, data cleaning progress and overall study progress.
- Oversees forecasting of clinical/non-clinical supplies
6. Risk Identification and Handling
- Leads study risk levelling and risk mitigation strategies
- Contributes to risk management activities of GCT
- Assesses and analyses study information for variances and takes necessary actions within his/her responsibility to resolve variances, if necessary
- Responsible for study specific oversight
- Can be assigned as responsible person for the study risk profile ensuring appropriate follow up of mitigation actions agreed at KOMs and FU meetings
- CAPA (Corrective And Preventative Action) identification and follow up
7. Plans and Tracks Study Budget
- Responsible for developing and tracking the total external study budget and accountable for providing monthly, quarterly and yearly estimates information to the Clinical Team and to Controlling.
- Forecasting study budget in close cooperation with the Resource Management and System Integration (RMSI) group.
- Communicates variances in the budget and action plan for resolution to the Clinical Team
8. Manage External Vendors
- Acts as Responsible Outsourcing Person in outsourced studies and manages the selection and oversight of external suppliers (e.g. CRO, Central Laboratory, Central Reading Center, etc.).
- Defines outsourced tasks and develops contract specifications for external supplier in collaboration with global strategic sourcing manager.
- Liaises with quality functions to ensure vendors are qualified.
- Performs ongoing vendor management, including negotiation of scope of work, budgets (incl. change orders), performance management, and issue resolution.
- Identifies milestone achievements to initiate payments to vendors.
- In case the StM is assigned to an out-sourced program under a POM (Partnership Operational Manual) the StM acts as an ‘oversight manager’. This is an assignment not a job title. The distribution of tasks is done based on the POM.
9. System Maintenance and Continuous Improvement
- Ensures all relevant IT-systems are updated with current and accurate information (e.g. IMPACT, CTPS).
- Participates in expert working groups, project standard teams etc.
- Contributes to global process improvement efforts
10. Additional Tasks: Study Operations
- May lead, motivate and inform country teams
- May ensure training and oversight of monitoring
- May track and report operational progress
- May develop additional operational plans
Education, Experience & Special Skills:
- Bachelor’s degree or equivalent
Skill & Competency Requirements:
- 3 years of experience as a study manager including recent experience within the oncology therapeutic area.
- 7 years of relevant healthcare experience
- In-depth knowledge of Good Clinical Practices (GCP), federal regulations and international regulations (International Conference on Harmonization-ICH regulations) with a proven track record leading the initiation and completion of clinical studies
- Comprehensive knowledge of the drug development process including, monitoring, regulatory requirements, drug safety requirements, data management processes and budget parameters.
- Effective written and verbal communication, thorough knowledge of oral and written English, strong oral presentation, and excellent interpersonal, decision-making and issue resolution skills are required. In addition, the incumbent requires effective planning and organization skills, attention to detail and excellent follow through.