Company: CK Clinical
Closing Date: 20 Dec 16
Salary (£): Competitive
Jim Gleeson is recruiting for a Clinical Science Manager to join a leading Global Pharmaceutical company, on a full time, interim basis for 12 months...
Jim Gleeson is recruiting for a Clinical Science Manager to join a leading Global Pharmaceutical company, on a full time, interim basis for 12 months in the first instance, to be based in London.
The Clinical Science Manager (CSM)'s main role is in the planning and clinical science data review/analysis for the clinical trial(s). Under the guidance of the Clinical Science Director (CSD), the CSM will work closely with the Project Team, Service Providers (SPs) and external consultants to establish clinical study protocol(s) as well as to ensure the quality and integrity of data and risk management of clinical trial(s) consistent with the clinical development plan, protocol and any other study specific requirements.
Key Accountabilities/Responsibilities of a Clinical Science Manager will include the following:
- Responsibility 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.
- Responsibility 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.
- Providing input to other study documents, e.g., including but not limited to, study management 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.
- Liaising with appropriate internal and external functions to conduct the review and 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.
- With liaison with the COM, actively contribute to study meetings / training.
- Developing a project strategy and clinical development plan for the project(s). This may involve interacting with Key Opinion Leaders (KOLs) 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 project team in the appropriate forum.
As a Clinical Science Manager, you will have the following qualifications, skills and experience:
- 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 (CRO), pharmaceutical, or Biotechnology Company.
- Thorough knowledge of regulatory requirements, clinical development, and clinical study procedures.
- Demonstrated proficiency with ICH/GCP guidelines.
- 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.
- Experience working in a team environment under time and resource pressures.
- Good negotiation skills
- Strong written and spoken English
- Excellent communication skills (verbal and written), organisation, presentation and time management skills
- Proficient computer skills in Word, Excel, PowerPoint, email and Internet.
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL37642 in all correspondence.
9 High Street
|Tel:||+44 (0)1438 743047|
|Fax:||+44 (0) 1438723800|
|Website:||Visit Our Web Site|
PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.