About This Role
This role is responsible for the overall management of the strategy and operations of the Clinical Research Unit (CRU), ensuring studies are planned and executed according to timelines. The Associate Director oversees resourcing, study planning, metrics, performance management, and supervises and mentors direct reports. They also manage study portfolio activities, contribute to the strategic development of the facility, and identify capital expenditure requirements.
Responsibilities
- Ensure studies are planned and executed according to committed timelines
- Maintain plans for short-term and long-term study activities at LCCP
- Lead strategy for LCCP CRU study portfolio, ensuring appropriate study types and volume
- Actively participate in global scheduling and sourcing discussions with early phase clinical operations and business units
- Work with Lilly partners to source facilities and studies outside LCCP as appropriate
- Account for overall operation and performance of LCCP CRU
- Account for utilisation of CRU staff and equipment resources
- Be responsible for the organisational structure of CRU staff
- Account for CRU Team performance
- Develop annual CRU business plan (including staffing and budgeting)
- Provide and review CRU financial data for OPEX and CAPEX forecasting and reporting
- Ensure appropriate assignment of operational work to the CRU staff
- Account for metrics for clinical activity at the study milestone and CRU usage level
- Drive LCCP wide metrics reporting
- Ensure studies are carried out in accordance to approved protocol, IRB requirements, Good Clinical Practice (GCP), Lilly global policies and local standard operating procedures
- Review relevant Safety & Efficacy Quality System (SEQS) procedures in liaison with appropriate Subject Matter Experts, the Area Quality Manager or equivalent, and the Medical Director
- Provide input for periodic review of local SOPs and approval of changes, additions and removal of SOPs for the CRU, Pharmacy and other relevant procedures
- Ensure compliance of personal and staff training
- Work with the Quality team to ensure appropriate curricula remain in place for staff groups
- Maintain awareness of local and (where relevant) global regulatory requirements to ensure compliance of business operations
- Oversee IRB submissions and liaise with Ethics Committees as needed
- Participate in applicable audit and inspection visits by Lilly and external agencies and ensure follow-up to issues takes place
- Be a key member of the Quality governance committee and lead remedial initiatives
- Provide process and execution expertise to problem solving and process improvement activities within LCCP and across the early phase medical organization
