Senior Clinical Project Manager
- Experience Level
Stevenage based with 2 days working from home.
My client are a cutting edge Biotech company that are working in Gene Therapy Ophthalmology. They have been through a cultural shift and have big growth plans. They are very agile, very innovative are need an experienced, proactive Clinical Project Manager to represent this culture. They are supported by scientific founders with expertise in ophthalmology, immunology, gene therapy and targeted surgical delivery.
- Responsible for clinical operational oversight and execution of all assigned studies including milestones, deliverables and timelines, for one or more clinical studies
- Responsible for the oversight and management of fully outsourced clinical studies from protocol development through to clinical study report
- Ensure that the planning, implementation, coordination and reporting of the clinical studies
- Act as the key study contact for studies and effectively plan
- Support and monitor CRO and third-party vendor activities, including study set-up, project management, monitoring, data management, biostatistics and clinical study report
- Monitor progress of studies, identify study-related trends/issues and work with the Director of Clinical Operations and CRO to implement corrective actions when necessary
- Conduct co-evaluation visits with CRO monitors
- Prepare and/or review Study Plans, Vendor Specifications and Scopes of Work
- Contribute to the preparation, design and/or review of essential regulatory study documents, ethics and other required local/national submission requirements
- Drive the identification and selection of clinical trial investigators as per clinical operations strategy
- Review and maintain QMS for clinical programs
- Develop Surgical Manual and Training Plans in conjunction with Surgical Liaison/Director of Clinical Operations
- Develop and maintain Study Risk Management Plan
- Coordinate with CMC for the shipment of IP and ancillary supplies to investigator sites
- Work with Research Dept and specialist laboratory vendors to ensure clinical biological sample collection, shipment, storage and analysis
- Coordinate and lead contract and budget negotiations with sites and third party vendors
- Lead study operational and/or scientific feasibility, and site set-up activities as per clinical operations strategy
- Prepare study training materials and present at Monitors Workshops and Investigator Meetings
- Maintain study trackers to provide financial and management accountability
- Set up and chair study meetings, including DSMB, Steering Committee and/or Advisory Board
- Ensure study certifications, insurance, licenses and registrations are maintained.
- Must have strategic Clinical Project Management experience and be a problem solver.
- Experience in pharmaceutical or Biotechnology company.
- Phase I experience essential.
- Gene Therapy experience is desirable.
If you would like to discuss this vacancy further or to discuss your career options in confidence, please call Tiffany Gardner on 02039288385 or email: email@example.com
If this role isn’t suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!
About Planet Pharma
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.