LabCorp Clinical Trials/Covance, a provider of laboratory testing services to support the drug development process, has the following position available in our Mechelen - Belgium facility:
Function objective: The Project Manager Coordinates and implements Clinical Trials projects. Manages daily activities of established clinical trials.
Responsibilities: 1. Accountable for successful delivery of assigned clinical trials projects. Ensures that study specifications and deliverables are consistent with corporate and client expectations. Ensures that scope and timelines are clearly documented and agreed, according to client, protocol and internal requirements. 2. Coordinates and implements plans associated with kits and logistics, specimen management, data management, laboratory operations and third party vendors, as required. Coordinates timelines and resource requirements with other functional areas. 3. Ensures that validation and quality control requirements are fulfilled and documented on time and in accordance with standard operating procedures. Ensures all required internal and sponsor approvals are obtained. 4. Organizes kick-off meetings and/or training sessions as required to communicate study requirements internally and externally. Documents all required study training in project files. 5. Travels as required to attend Investigator meetings, client and/or site meetings to provide instruction on specimen collection, packaging and shipping procedures. 6. Provides daily management of the project through internal and external co-ordination and follow up during the project life cycle. 7. Interacts with Project Team members to resolve and troubleshoot problems related to specimens, result reporting and site compliance. Provides Sponsors and/or Investigators with resolution to problems or referral to appropriate sources. 8. Reviews status of assigned projects through regular Project Team meetings. Provides additional updates and metrics as required to Supervisor, Business Development and/or Alliance Manager in support of broader global program oversight. 9. Proactively manages and anticipates risks to successful project delivery and escalates issues promptly in accordance with global escalation policy. 10. Maintains clear and frequent communication with the client and supervisor to provide project status updates. 11. Manages study budget and invoicing activities to ensure these aspects are always aligned. 12. Maintains up-to-date project status parameters within the company electronic tracking tools and databases. 13. Interacts with Clinical Trials Quality Assurance when need to participate in audits, inspections and other QA/QC issues. Responds promptly to requests for information associated with these activities. 14. Completes all tasks in accordance with standard operating procedures and policies, and assists in assuring ongoing compliance within the project team. Maintains up-to-date personnel file including all required training documentation. 15. Performs any other duties assigned by the immediate supervisor including, but not limited to, process improvement/standardization projects and SOP development and review.
Profile: The chosen candidate will have:
Knowledge of clinical trials. College/university education in science or health related disciplines (or equivalent combination of education and experience) is preferred. Excellent written and verbal communication skills, Strong organization skills and attention to detail, Time management and prioritization skills, Negotiation skills, presentation skills and the ability to work in a fast-paced team environment. Familiarity with database software, information systems, and MS Office applications is also required. Approximately 10% travel is required.
We Offer: The opportunity to work within an experienced and highly skilled team. We offers a comprehensive benefits package including health cover and contributory pension.
We help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. This is your chance to become part of a team that helps to bring miracle of medicine to market sooner.