The Associate Director, Clinical Project Lead is responsible to lead the Cross-Functional Clinical Sub-Teams to define study specifications, achieve study milestones through operational feasibility and budget and timeline estimates and operational accountability and management of study deliverables and is the primary point of contact interfacing between functional groups, investigator sites and vendors.
The Associate Director will drive the scope of work, oversee CROs and will proactively manage patient safety and data integrity to ensure inspection readiness and compliance.
The Associate Director, CPL may be accountable for setting and managing operations across multiple studies and may be a member of the Core Team depending on the scope of the project.
Job Duties & Responsibilities
Accountable for the planning, implementation and execution of pivotal clinical trials, including study deliverables, milestones and data quality.
Leads the Clinical Trial Team. Management oversight of CROs and relevant study vendors.
Oversee third party vendors to operationalize these study specifications.
Directs the operational execution of clinical study activities in accordance with Alexion SOPs, ICH Guidelines, and Good Clinical Practices (GCP) to ensure overall data quality, integrity;
and patient protection.
Accountable for planning, tracking and forecasting the Global Clinical Operations budget and timelines for the studies against the agreed goals.
Develops and maintains budgets for study(s) that include short and long-range clinical forecasting and monthly accruals based on clinical activity to support Clinical Development financial goals.
Manages CRO relationship to ensure the appropriate scope of work, oversight and training of clinical investigators and achievement of study milestones within agreed upon timelines and budget.
Communicates clinical studies performance data to other members of the management and scientific team.
Prepare and maintain required study and regulatory documentation, e.g. : reports for Competent Authority submissions, master patient informed consent, Monitoring Plan, Pharmacy Manual, Investigator Agreements and budgets.
Key contributor to the development, review and approval of study documents including but not limited to protocol, ICF, statistical analysis plan, and clinical study report.
Conducts lessons learned exercises to provide continuous process improvement and sharing of best practices.
Participate in and / or lead departmental initiatives.
10 years of clinical research experience, 5 of which in a leading role accountable for the planning and execution of global clinical trials.
Bachelor’s degree or equivalent in one of the disciplines related to clinical practice / health care, life sciences, or drug development.
Ability to lead cross-functional teams and provide management oversight of CROs.
Experience in developing study budgets, forecasting and financial oversight of a project.
Advanced degree (Master, PhD, MD) is desirable.
PMP certification desirable.