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Study Manager

vor 1 Monat

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**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.**

**Study Manager**

The overall objective of the Study Manager (STM) is to manage the planning, conduct, analysis and reporting of assigned global studies and complex local studies within the established timeframes and budget, with the quality and requirements necessary for global regulatory approvals.

**Key Tasks**:

- 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, 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 VS1.3 may work alongside a STM VS2.0 assuming a co-study manager role
- FEASIBILITY
- Supports protocol feasibility; leads the operational planning and trackng 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
- 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.
- 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.
- 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
- 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
- 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.
- Comm