- Directly manages and develops all assigned staff. Assures hiring, training, development, compensation and advancement are in line with talent and job expectations. Routinely assesses talent for direct reports to ensure full development.
- Provides expertise and strong leadership and management to direct reports and maintains a motivated and competent staff.
- Ensure projects/studies are resourced appropriately by allocating or hiring the appropriate staff to deliver project/study goals and by critically analyzing project/study needs while also managing and measuring the workload and requirements of direct reports. These activities are done in close alignment with CHand peers according to CDO and SM strategy.
PROJECT EXECUTION & DELIVERABLES:
- Is accountable for all site management procedures and activities. Ensures they are conducted according to ICH-GCP, Declaration of Helsinki, local and global requirements, remaining current with local laws, regulations and guidances. This includes country feasibility, site selection, site initiation, patient enrollment, patient adverse event reporting and data cleaning processes for which their direct reports are responsible.
- Ensures that each direct report delivers high quality study data required to support regulatory submissions in compliance with ethical and global operating standards. Is accountable that country's objectives andKPIs are met, providing direct reports with the resources to achieve his/her objectives and commitments.
- Is responsible for managing internal costs associated with direct reports and collaborates with the CH of SM preparation and tracking of the overall departmental operating budget target including indirect responsibility for insourced costs. Ensures CLMs provide accurate data for country study budget. It is expected that the TL reviews External Clinical Grants data toensure budgeting components are within the approved budget parameters, as well as ensuring accuracy, equity, and supporting the CLM in resolving any discrepancies.
QUALITY & COMPLIANCE:
- Ensures quality oversight based on quality risk indicators and KPIs. Oversees Corrective Actions/Preventative Actions (CAPAs) of direct reports to ensure timely and sufficient resolution. Conducts Performance Assessment Visits as well as any other study oversight activity to ensure appropriate oversight of direct reports and to identify potential training or development needs.
- Participates in Audit/Inspection Review Meetings and coordinates/reviews all responses to audit findings prior to submission. Proactively identifies actions to be taken at the country level to improve upon audit and inspection findings. Actively supports Bayer regulatory inspection in cooperation with CH. Supports CH with follow up of all Regulatory Inspections, Regulatory concerns related to investigator integrity, GCP, and the veracity of all clinical data in NDA, CTD, PLA, SNDA, and IND submissions.
PROCESS IMPROVEMENT & COLLABORATION:
- Continuously and proactively identifies and proposes solutions for process improvements opportunities to CH and communicates best practices to entire team.
- Leads or participates in Expert Working Groups and provides feedback on SOP updates.