ProClinical is currently seeking a Senior Clinical Study Manager, a permanent position, working within the Global Clinical Operation team for a global healthcare company focused on making high quality medicines available to everyone who needs them. The successful candidate will work with the executive teams of Global Clinical Operations and Clinical Development to execute clinical research studies through Contract Research Organizations (CROs). The Clinical Project Manager role is the primary point of contact for the operational execution of the study and is accountable for study delivery through oversight of the chosen CRO(s) and interface with internal resources.
- Acting as the primary point of contact for the operational execution of assigned clinical and/or non-clinical studies, Phase I-IV.
- Delivery of study through oversight of chosen CRO(s) and interface with internal resources for appropriate facets of the operational execution and delivery.
- Oversight of day to day operational activities of clinical projects
- Ownership of study risk management plan including timely communication of study progress, risks and risk mitigation strategy to Programme Leadership.
- Tracking study progress against the study schedule as detailed in the Integrated Programme Plan.
- Managing study costs against budget and providing budget forecast data as required.
- Contribution to and review of key clinical documents, in close collaboration with other line functions e.g. Regulatory Affairs, Clinical Supplies, Clinical Development Pharmacovigilance.
- Providing input to the preparation of regulatory authority submission documents e.g. IND,CTA, ANDA, MAA and supporting regulatory defence activities as needed.
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 call Matthew Pike on +44 207 4400 639 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.