Clinical Science Manager
- Experience Level
An exciting permanent and contract opportunity has arisen in London for a Clinical Science Manager to join a leading pharmaceutical organisation. This position will work closely with the organisation's Clinical Operations Manager and under the guidance of CSD, the CSM is responsible for all appropriate clinical science aspects of the study. To be considered for this role you must already live and have the right to work in the UK.
- Accountability for ensuring the quality of all clinical science aspects of the trial, e.g., including but not limited to, clinical protocol development and clinical science data review and clinical study report development.
- Accountability for developing and maintaining study documents related to clinical science aspects of the trial, e.g., including but not limited to, a clinical study protocol, clinical study report, investigator brochure, clinical IMPD, data review charter, and clinical science review plan.
- Provide input to other study documents, e.g., including but not limited to, study management oversight plan, RFPs, contracts, statistical analysis plan, data management plan, CRF.
- Responsibility for the clinical science review of trial data, e.g., including but not limited to, demographic, efficacy and safety data, protocol violations (specifically to ensure correct number of subjects are evaluable for protocol objectives), detection of data trends and safety signals and to ensure adherence to protocol so that study objectives are met.
- Communicate with appropriate internal and external functions to conduct the review and will report the results of the ongoing science review regularly to the study team.
- Managing SPs/contractors and overseeing their performance and quality of work to ensure they meet an agreed project plan, contracts and any study specific requirements related to any clinical science aspects of the trial.
- Communicate with the Clinical Pharmacology Manager, actively contribute to the oversight of the pharmacokinetic data production and analysis (including but not limited to the oversight of any external SPs/contractors sample analysis plan, statistical analysis plan).
- Developing a project strategy and clinical development plan for the projects (this may involve interacting with Key Opinion Leaders or SPs to obtain appropriate information).
- Being up-to-date with all developments in relevant therapeutic area including competitor activity and highlight relevant subjects to the organisation's project team in the appropriate forum.
- Any other assigned duties.
- Flexibility and the ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment.
- Able to interact effectively at all levels within the organisation, as well as with external partners and clients.
- Proven ability for working independently with minimal supervision.
- A can-do attitude with a willingness to get actively involved.
- Must be diplomatic and tactful in liaising with staff and management.
- Must be meticulous and methodical, with the ability to review both data and procedures in detail and the ability to see the greater overall picture.
- Minimum BSc in the life sciences, nursing degree, or equivalent combination of education and experience (a higher degree (Masters, PhD) is preferred).
- Significant demonstrable experience in the scientific aspects of clinical development gained within a contract research organisation, pharmaceutical, or biotechnology company.
- In-depth knowledge of regulatory requirements, clinical development, and clinical study procedures.
- Demonstrated proficiency with ICH/GCP guidelines.
- Experience working in a team environment under time and resource pressures.
- Proficient computer skills in Word, Excel, PowerPoint, email and Internet.
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.
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