Clinical Project Manager
Proclinical has partnered with an established CRO who are looking for a Clinical Project Manager to join their growing team. They are running several phase II/III studies.
You will be responsible for overseeing studies where you will manage also manage vendors. There is a lot of opportunity to take on a range of responsibilities whilst working in an autonomous and driven environment.
This is a great opportunity to move into a truly global role and to join a company several high-profile studies ongoing.
- Coordinate and oversee project activities
- Organise project activities and evaluate timeframes
- Manage the administrative aspects of studies
- Manage study materials (re-supply/drug expiration/re-labelling of drugs, various materials)
- Prepare study specific procedures and tools (if applicable) - Prepare feasibility questionnaires (if applicable)
- Manage the vendors involved in the study
- Review and approve the Investigator's Folder and Trial Master File prototype
- Verify compliance with operating procedures
- Ensure that the monitoring activities are conducted as per monitoring plan requirements
- Review monitoring, remote monitoring, contact and telephone contact reports
- Send regular updates to the Sponsor
- Ensure that the enrolment curve is on track and take actions in case of under-performance
- Keep track of terminating studies and do the final check of the completeness of TMFs
- Maintain contacts with clinical staff as necessary
- Manage relationships with Data Centres
- Perform co-monitoring visits with CRAs, if necessary
- Coordinate/participate in Investigator's Meeting, Monitor's Meeting and project meetings
- May act as Clinical Project Leader for international projects
- Collaborate to on-boarding of new associates and act as a mentor of junior staff
- Collaborate in establishing and maintaining SOPs related to Clinical Operations Unit
Skills and Requirements
- University/college degree (life science or medical degree preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
- Significant experience in project management of clinical trials (minimum 1 year of Project Management experience)
- Previous or current CRO/sponsor experience or Medical Device Manufacturer experience
- Broad knowledge of medical terminology, clinical patient management and clinical research
- Advanced team leadership skills
- Advanced decision-making skills
- Demonstrates sound judgment in decision making process and has strong understanding of scope of contracts, including milestones and recognition of changes
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.