Bayer Country Lead Monitor in United States
Your tasks and responsibilities
Bayer seeks high energy leaders ready to help shape the future by confronting new challenges, embracing new experiences and taking on increasing responsibilities.
Due to the increased scrutiny of regulatory authorities on the quality of clinical trial data, and increased business demands to conduct clinical trials in an efficient manner, the focus of the Senior CRA and CLM position is strengthened to reflect greater focus on quality and oversight and achieving commitments.
More specifically related to this role, the incumbent will have responsibilities to include, but not limited to:
To ensure consistency, quality and efficiency across the Country CRA Study Team, a CLM is assigned for every participating country and is responsible for and oversees the CRAs and study progress at the country level from study feasibility to study archive. Requires significant country cross functional collaboration throughout the study conduct. Responsibility includes:
• Managing the cross-functional Country Feasibility team and process, involving the local Monitoring and Site Management and local Medical organizations. A reliable operational feasibility assessment is critical to the overall planning conduct of the global study. The CLM provides the GMSM country head (LHMSM or CCRM) with advice on operational feasibility of study design, timelines, cost, patient enrollment projections, and potential sites. This process must be consistent with the Study Concept provided by the GCL and requires significant collaboration on a local cross functional level.
• Leading cross-functional Site Selection Team to identify and determine interest and suitability of investigator’s for participation in the assigned study.
• Developing Core Country Study Documents to initiate the study and ensures all study sites are initiated according to planned study timelines.
• Developing the Country Enrollment and Retention Plan. Managing and tracking country site initiation, enrollment, data cleaning activities to ensure they are consistent with country commitments and study timelines. Develops contingency plan to ensure site and country commitments are met.
• Managing and tracking the Study Country Level Budget, providing monthly country budget information to Local Controlling, LHMSM and Study Manager, as well as identifying budget/estimate issues and proactively developing a plan for resolving study finance issues. The CLM manages country budget and payments in appropriate tools.
• Ensuring all country CRAs are trained sufficiently for the trial.
• Identifies training gaps if additional training is required at country level works with the Study Lead Monitor to develop further training plans. Responsible for training all new CRAs for the study.
• Overseeing Country Study Oversight Plan to ensure quality and compliance which may include co-monitoring visits and coordinating Data Verification Initiatives.
• Proactively identifying potential or actual country related issues. Responsible for Country Level Corrective Action / Preventive Action Plans (CAPAs) to ensure timely and sufficient resolution of issues that may impact the quality and compliance of the data, keeping SLM and LHMSM well informed of the status of the CAPAs
• Creating Country Monthly report and proactively notifying SLM and LHMSM of any potential issues with proposed solutions to ensure country participation remains consistent with country commitments.
• For outsourced studies: the CLM is the primary contact with the country CRO team and will support the CRO with regulatory and ethics submissions. The CLM will keep the Country Medical Director and local MSM teams informed of the status of the study. In addition, the CLM may conduct co-monitoring visits with the CRO as detailed in the Study Oversight Plan
Who you are
Your success will be driven by your demonstration of our LIFE (Leadership, Integrity, Flexibility, Efficiency) values. Related to this position, we are seeking an incumbent who possess the following:
• The incumbent must have a Bachelor’s Degree (or equivalent) with 6 – 7 years of relevant healthcare experience including 4 years of monitoring & site management experience.
• The incumbent is responsible for site management and monitoring of applicable Phase I and all Phase II-IV complex and global clinical trials. This requires an in-depth knowledge of the drug development process including monitoring and site management, local and international regulations, ICH – GCP, drug safety requirements, data management processes and investigator grant parameters. The position also requires awareness and understanding of cultural differences as well as regional operational differences and budget management.
• Effective written and verbal English communication skills, strong oral presentation, 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.
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer Minorities / Females / Protected Veterans / Disabled