Senior Study Manager

Job Description

The Senior Study Manager manages and is responsible for all aspects of assigned Phase I and extended Phase I/II complex clinical trials, within the approved Clinical Sciences Development Plan (CSDP). These studies are conducted within the standards set by Bayer and according to Good Clinical Practices (GCP) and applicable regulatory and legal requirements. The Sr. Study Manager manages all study related activities from approved study concept to the final clinical research report (CSR) and ensures that study execution is on track.

As a member of the Operational Sub-team of the ECT/CST, he/she provides input to this team to ensure there is accurate tracking. Within the framework given by the ECL/CPL and the OPL, the Sr. Study Manager develops controls and is accountable for the overall study budget and informs the team on budget issues and/or concerns. The Sr. Study Manager implements, manages and leads a cross functional study team for the entire duration of the study.

The overall objective for the Sr. Study Manager is to manage the planning, implementation, analysis and reporting of assigned clinical pharmacology studies within the established timelines and budget, ensuring high quality of study conduct and data obtained as well as all requirements necessary for global regulatory approvals. The Sr. Study Manager is expected to proactively provide and implement ideas and suggestions for global process improvement efforts.

The incumbent will:

• Manages and is responsible for all activities related to clinical pharmacology, complex phase I, extended phase I/II oncology clinical trials from the approved study concept to the clinical study report.
• Manages all Study Team activities as defined per SOPs/OIs and ensures the organization of
• Manages the selection and oversight of External Suppliers (e.g. site management and monitoring CROs, Central Labs, central ECG reading center, etc.)
• Develops and manages budget, timelines and quality of the study and its deliverables.
• Responsible for forecasting and tracking of study costs. Ensuring all relevant IT-systems are updated with current and accurate information (e.g. IMPACT)
• Responsible for all start up activities e.g. CRO selection, CRF development, drug forecasting, study manuals, monitoring plan, data management plan, definition of end points, selection of safety and efficacy assessments, recruitment planning and oversight.
• Writes protocols and amendments in collaboration with study team members
• Responsible for study specific feasibility and site selection to meet study enrollment and timelines.
• Together with OPL and ECL/CPL responsible for developing the total external study budget and accountable for providing monthly and yearly estimates, tracking study budget, initiating payments, providing monthly information to controlling, OPL, ECL/CPL, identifying budget/estimate issues and proactively developing a plan for resolving study finance issues.
• Tracks and compiles patient enrollment, data quality and cleaning progress and overall study progress and ensures study timelines are met
• Responsible for training and oversight of CROs to ensure compliance with timelines and budget.
• Develops appropriate study related training for monitors and site personnel according to GCP and company standards
• The incumbent is responsible for the direct management of Phase I & IIa complex oncology global clinical trials. This requires an in-depth knowledge of study management/project management. In addition Good Clinical Practices (GCP), federal regulations and international regulations (International Harmonization Committee-ICH regulations).

The position also requires strong awareness and understanding of cultural differences as well as regional operational differences.

• Demonstrated leadership in project management and vendor management.
• The incumbent requires 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.

Qualifications

• 
  • Bachelor’s degree or equivalent education with 8+ years of relevant healthcare experience of which 5 years working in early clinical operations pharmaceutical (preferably oncology) including direct monitoring and clinical trial/study management experience.
• Ideal candidate will have solid clinical operations experience working as a study manager including 2 years of monitoring experience and a minimum of 3 years of study management (early oncology) experience is preferred

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