Reference: PW 6667
Closing Date: 11 Nov 16
Salary (£): Competitive
Benefits: Bonus / Pension / Travel Allowance / Good transport links, modern offices in the heart of London.
Global Pharma Company
Main responsibility for the Clinical Science Manager is 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.
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.
QUALIFICATIONS / EXPERIENCE REQUIRED:
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 Pharmaceutical or Biotechnology Company.
Thorough knowledge of regulatory requirements, clinical development, and clinical study procedures.
Demonstrated proficiency with ICH/GCP guidelines.
Proven ability for working independently with minimal supervision. A “can-do” attitude.
Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.
For a confidential discussion please telephone Andrea Litovszky at AXESS Limited on 020 8560 2300. To apply, please send your CV to firstname.lastname@example.org quoting reference PW 6667.
London / London / Clinical Science Manager / Clinical Science / Clinical Scientists / CSM / Clinical Development / London / Clinical Science roles / jobs / careers / CSM positions in London / pharma scientists London / Central London
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