Lead Clinical Study Manager
An exciting research and development organisation are looking for an energetic Clinical Study Manager to join their Cambridge based office. If you are passionate about working with others to develop new medicines then this is the life changing role for you.
- Create Clinical Development plans, budget forecasting; CRO and vendor management plans and knowledgebase of suitable vendors.
- CRO contract preparation and management; budget management and invoice approval at the study level or work order level for specific contracted out activities.
- Selection and use of appropriate qualified consultants and CROs for outsourced services.
- Day to day decisions for managing clinical studies and outsourced clinical study related work; approval of contracts and change orders within a clinical study.
- Data management activities such as CRF/ ePRO/ eDiary development, data checks, DMP/ data handling, data integration, Data transfer plans, data transfer specifications etc.
- Medical writing activities including IB and CSR generation
- Utilise project management tools such as CTMS to manage projects through their lifecycle including contingency planning and risk management to identify any risks or issues for resolution.
- Manage internal processes and systems used within CRD for clinical study activities including ETMF, Mail archive, archiving of study data.
Skills and Requirements
- Minimum of Bachelor's degree in pharmacy or equivalent.
- 3+ years of experience in the pharmaceutical/biotechnology industry, including experience with IMP requirements.
- 3+ years demonstrated work experience of successfully managing clinical trials within the pharmaceutical industry, including CRO and contract vendor management.
- Ability to plan and execute a clinical trial from an operational perspective.
- Experience in protocol development/writing.
- Financial management skills as applicable to oversee project expenditures.
- Possess advanced computer skills (Microsoft applications, spreadsheets, etc.)
- Cross-functional and cross-cultural awareness.
- Fluent in written and spoken English.
Please click on the Apply button. Kindly include a short note outlining why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Matthew Pike at 02074400639 or upload your CV on our website - www.proclinical.com/send-cv
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.