Clinical Project Manager
- Experience Level
Hobson Prior are looking for a Clinical Project Manager for an exciting opportunity to join a top biotechnology organisation on a permanent basis in Stevenage. Our client concentrates on developing pioneering gene therapies to enable people living with chronic diseases live a better life.
- You will lead the plan and execute clinical studies from Phase I to IV in adherence to Good Clinical Practice, Standard Operating Procedures, Food and Drug Administration regulations, EU Directives & Guidance, and International Conference on Harmonisation guidelines.
- To lead site selection and site qualification discussions with project team and CRO.
- Ensure 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 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.
- Ensure CRO selection is appropriate for the study planned.
- Validate the study plans provided by the CRO through to study close out.
- Accountable 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.
- Recognise 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 organisation's quality measures.
- To analyse CRO performance trends within a clinical study or across several studies and resolve or escalate accordingly.
- Contributes towards development and implementation of process to ensure clinical studies are managed within a robust regulatory and operational framework.
- Co-operates 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.
- A degree in a relevant discipline.
- A minimum of 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.
- Familiarity with a broad spectrum of clinical operations concepts, practices, and procedures.
- An understanding of the process and regulations that apply to clinical investigations including knowledge of EMA/FDA regulatory requirements and ICH GCP guidelines.
- Strong scientific, operational and regulatory expertise.
- Demonstrates knowledge of design and operational management of clinical studies globally, including regulatory requirements, CRO capabilities and compliance practices
- Ability to communicate effectively, including with therapy area experts and patient advocacy groups.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.