The COM is responsible for establishing clinical operations processes and performance standards, and ensuring that all appropriate documentation of such processes and standards are developed and maintained in a manner consistent with Good Clinical Practice (GCP). The COM is responsible for ensuring the successful execution of the clinical services offered to clients consistent with those processes and standards, and including all customer specifications, timelines and budgets, and strict adherence to industry quality and regulatory requirements. The COM supervises all staff belonging to the Clinical Operations Department.
- To manage resourcing, staff turnover, training and capacity needs.
- To manage performance and skill development of all internal and outsourced clinical operations staff.
- To ensure accurate identification and implementation of client and project requirements.
- To bear end responsibility for all aspects of delivering clinical services.
- To stay abreast of new developments and regulations in the industry and ensure that operational processes and standards reflect those developments.
- To advise customers of latest evolutions for efficiently designing and managing the requested services.
- To ensure close communications and coordination between operational teams, partners and vendors.
- Any other task that may be requested as far as can reasonably be expected, including those tasks that are linked to the job description of the Project Manager (PM), the Clinical Research Associate (CRA) or the Clinical Trial Assistant (CTA)
Any task that is required to fulfill the above responsibilities.
Bachelor or Master degree
Minimum of 10 years of relevant clinical research experience in pharmaceutical or CRO company; Minimum 3 years experience in line management
Fluent in English, Dutch and French; another European language is an asset
Microsoft Office (Outlook, Word, Excel, PowerPoint), internet, experience with CTMS-, eCRF systems is an advantage
Excellent knowledge of ICH-GCP and all applicable regulatory requirements
- Motivational leadership skills including vision, clarity and passion
- Ability to maintain big picture perspective while being attentive to details
- Outstanding communication and presentation skills
- High performer with strong organization and planning skills, and problem solving and analytical capabilities
- Effective team player, diplomatic, tactful and supportive
- Ability to work independently, take initiative, and handle stress
- Highly flexible
- Willingness to travel (nationally and internationally if applicable)