Clinical Project Leader
- Experience Level
International Pharmaceutical Manufacturer seeks a Clinical Project Lead.
About the role:
To lead and oversee the setup, development, and management of global clinical trial programmes and studies in accordance with policies and procedures, Good Clinical Practice guidelines, and applicable regulation to support strategic initiatives. To ensure that clinical trial programmes adhere to agreed-upon timelines and budget while ensuring patient safety and data quality. Provide management of clinical trial documentation and submission activities, including management of resource. Support and contribute to the ongoing improvement and review of clinical and regulatory documentation.
Duties may include:
- Feasibility/Recruitment - Identification and selection of investigators willing to participate in clinical trials and managing study recruitment with respect to timelines and budget.
- Delivery of Clinical Trial - Includes Set-up, Maintenance and Close-out Procedures. Ensuring prompt identification and resolution upon any patient or trial related problems to satisfactory conclusion. Overall management and delivery of clinical trial in accordance with Standard Operating Procedures.
- Investigational Medicinal Product (IMP) and Supplies Management - ensure availability, sourcing, tracking and return of IMP and other required supplies in a timely manner and in accordance with Standard Operating Procedures.
- CRO and Vendor Management - prepare and lead Request for Proposal and Selection of Suppliers. Oversee and manage setup, study delivery and close-out activities, while maintaining effective external partnerships. Ensure delegated responsibilities are being managed appropriately and according to contract. May lead contract negotiations with CROs and other third party companies, if necessary in conjunction with other departments.
- Budget Management -manage overall life of study budget, including scenario planning, setup and approval, phasing/forecast and invoice reconciliation. Escalate any over/under spend as required. Manage spend for assigned clinical research programmes and studies on an ongoing basis, escalating any trends and change orders as appropriate.
- Risk Management Strategies - manage and develop study and programme risk and action plans.
- Quality Assurance and Audits - ensure overall clinical programmes or studies maintain satisfactory compliance based on annual audit plans. Ensure any findings and observations are addressed to resolution. May include preparation and participation in regulatory inspections of selected clinical trials or sites.
- Meeting Presentations - Prepare and present at investigator meetings, at conferences. Attend and represent the company at meetings with Regulatory Authorities.
Skills and experience:
- Science degree
- Advanced degree
- Relevant work experience within the Pharmaceutical or allied Industry
- Capable of planning and managing multi-centre, multi-national clinical trials with minimum supervision
- Able to lead multi-functional teams
- Able to communicate effectively, both oral and written
- Ability to interpret and analyse scientific and clinical data
- Experience of working within the clinical research environment
- Experience of managing projects to set timelines and budgets
- In depth knowledge of the clinical research process, Good Clinical Practice and relevant legislation