- Provides functional input and strategic clinical programs input to Clinical Development Team and Program Management Team as required.
- Has a thorough understanding of the clinical trial(s) protocol(s) and is able to anticipate potential issues that may arise during the conduct of the trial in close collaboration with CROs
- Has in-depth knowledge of global regulatory/industry guidelines (e.g. ICH/GCP, guidelines and labeling) to drive the clinical trial application process.
- Effectively represents the interests and perspectives of Clinical Operations Department.
- Presents program/study(ies) overviews/status to senior management, cross functional team, and external partners as necessary.
- Acts as the main escalation point of contact for strategic CRO for the assigned program and the key stakeholder for clinical operations within the Clinical Development organization
- Co-leads inspection readiness activities, and acts as subject matter expert during regulatory inspections.
- Vendor selection including critical review of contracts, and/or work orders and management of ongoing performance.
- Collaboration with internal functions to ensure successful implementation of program/study
- Conducting study level training.
- Alignment of program for cross-functional team regarding execution.
- Reporting of program / study milestones including mitigation.
- Works closely with Global Development team, finance business partner, and/or study team(s) to generate and review forecasts and accruals for clinical studies; and ensures finances align with agreed development plan, and budget variances are escalated to management as appropriate.
- Mentors junior staff.
- May be involved in interviewing, hiring, and training employees.
- Provides feedback on employee performance.
- Collaborates on SOP development and harmonization
- Identifies or participates in innovative initiatives targeted to improve/revise clinical development processes.