Freelance Clinical Project Manager
An international biotechnology company is recruiting a Freelance Clinical Project Manager to their American office. The organisation focuses on gene therapy to treat the suffering of people suffering from chronic systemic diseases. With a next-generation gene therapy platform to provide treatments for a wide range of diseases, this position represents an exciting opportunity to work with a leading company. This is a contract position that will be home-based.
- Ensure that the timing of the major study milestones and the associated budget meet the needs of the overall development plan agreed by the Project Team.
- Lead site selection and site qualification discussions with project team and CRO.
- Lead document writing and review for the protocol and amendments, Investigator brochure, and Clinical Study Report; additional medical writing tasks may involve ICF, CRF and associated guidelines, safety communications, DSUR and additional key documents.
- Lead the study team meetings.
- Lead the creation of the Trial Oversight Plan and ensure adherence.
- Ensure CRO selection is appropriate for the study planned.
- Validate the study plans provided by the CRO through to study close out.
- Responsible for management of CRO performance to ensure adherence to scope of work within timelines and budget at an overall study level.
- Specifically, track major study milestones and monitor overall operational performance metrics through the life of the study.
- Identify issues early and propose solutions
- Create the budget at study planning and monitor the overall agreed budget against trial progress.
- Oversee the CRO and provide timely input to ensure that the study is executed according to the agreed project plan.
- Provide oversight of the CRO to ensure compliance with the company's quality measures.
- Contribute towards development and implementation of process to ensure clinical studies are managed within a robust regulatory and operational framework.
- Collaborate with other key functions to maintain audit and inspection readiness.
- Engage and build relationships with clinical sites in North America (and potentially South America).
- Oversee CRO performance in US site set up, recruitment and patient follow up.
Skills and Requirements:
- Degree in a relevant discipline.
- 5+ years' experience within the pharmaceutical industry in clinical operations, including project management experience, ideally at national and international level.
- Strong experience of vendor management and oversight of clinical studies and study teams across all phases of development including.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Matthew Pike at +44 207 440 0639 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.