Study Monitor Lead

Major Responsibilities：

• Responsible for overseeing all operational aspects of monitoring and site management activities for the assigned less complex Phase II-IV internally monitored and outsourced clinical trials for Bayer Global Clinical Development and Global Medical Affairs. The SLM is a core member of the Study Team, representing Global Monitoring and Site Management as well as the Clinical Trail Investigators and Site Staff.
• Advisor to Study Team as expert in all operational aspects of conducting a clinical trial from the monitor and Investigator perspectives. Ensures study processes and expectations correspond to the practicality of conducing the trial from the operational perspective, from study feasibility to study close out.
• Leads and manages the assigned Country Lead Monitors (CLMs) and CRAs globally. Supports GMSM Country Management in overseeing the operational conduct and quality oversight of the study from the country perspective. Reviews Country Monthly Reports, tracks operational study activities and progress, proactively identifies issues and escalates appropriately to ensure timely corrective and preventive actions are taken. Consolidates Country Monthly Reports for Study Manager. Identifies potential study specific resource constraints and liaises with LHMSM for LHMSM to resource study appropriately.
• Collaborates with GCO-Business Management (GCO-BM)&Operational Oversight-GCO (OO-GCO) to develop Monitoring and Site Management component of the Operational Quality Oversight Plan and if required, Data Verification Initiatives. Conducts co-monitoring visits and reviews Periodic Monitoring Visit Reports according to the Operational Quality Oversight Plan. Is an active member of the Fraud &Misconduct Team and/or Inspection Team, if applicable.
• Responsible and accountable for developing the study specific Monitor Training Plan and Investigator Site Training Plan. Obtains requisite functional and legal/compliance approvals and coordinates activities related to multi-center Monitor and Investigator Site Training Meetings. Accountable for developing Monitor training materials, ensure study specific training of Monitors, trains new Monitors to the study and reviews and approves training content changes. Develops Investigator and Site staff training material for functional and operational study activities. Makes presentations as assigned at Investigator Site and/or Monitor Training as assigned.
• Responsible and accountable for developing the Study Monitoring Plan and determining Investigator delegation responsibilities for the study and obtains requisite functional approvals. Develops training material and training plan to ensure all Monitors assigned to the study have a thorough understanding of the Monitoring Plan and study expectations.
• Works in close collaboration with Study Data Manager (SDM) to ensure consistent monitoring and data management objectives for the trial. Member of the Study Data Manager (SDM) to ensure consistent monitoring and data management objectives for the trial. Member of the Study Data Acquisition and Management Package Development Team (SDAMP-DT) and works closely with the EDC Developer in developing the eCRF, edit checks and eCRF instructions. Coordinates GMSM User Acceptance Testing and system access for Monitors continuous and current flow of data cleaning. Works with GCO-BM and OO-CGO to identify trends to effectively manage thequality and operational oversight of the study.
• Above responsibilities are applicable for all internally monitored clinical trials.
• For outsourced trials, the SLM is the primary contact with CLMs, LHMSMs and Country Medical Directors and ensures applicable information is cascaded in a timely manner and ensures required country review of applicable documentation. In addition, the SLM:
• Review study specific Monitor and Investigator Site Staff Training Plans and Investigator Meeting Approval Forms, obtaining requisite functional and legal/compliance approval.
• Reviews Study Monitoring Plan and ensures plan is consistent with Bayer expectations.
• Collaborates with GCO-Business Management (GCO-BM) & Operational Oversight-GCO (GCO-OO) to develop Operational Quality Oversight Plan, if required and Data Verification Initiatives.
• Oversees Operational Quality Oversight Plan by conducting co-monitoring visits, overseeing co-monitoring visits, reviewing Monitoring Visit Reports, etc as defined in the Operational Quality Oversight Plan. Escalates operational issues or potential issues to StM and GCO as applicable.
• Leads and coordinates assigned Country Lead Monitors (CLM).

Requirement：

• The incumbent must have a Bachelor’s degree or equivalent with at least 5 years of relevant healthcare experience with 5 years of direct monitoring experience in the pharmaceutical industry.
• As the expert of monitoring and site management processes and activities on the Global Study Team, this position requires in-depth knowledge of Good Clinical Practices (GCP) and ICH-GCP (International Conference of Harmonization-Harmonized Tripartite Guidelines) and federal and international regulations. This position also requires awareness and understanding of cultural differences as well as regional operational differences.
• The incumbent requires comprehensive knowledge of the drug development process including: monitoring and site management processes; regulatory and drug safety requirements; and data management processes. This position is a global position therefore effective written and verbal English communication skills, strong oral presentation, interpersonal, problem solving, decision making, issue identification and issue resolution skills are required. In addition, the incumbent requires effective planning and organizational skills, attention to detail and excellent follow through.