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Job Details

PW-6772 Clinical Science Manager

Company: AXESS
Location:
Reference: PW-6772
Closing Date: 22 Dec 16
Type: Contract
Salary (£): Competitive
Benefits: Competitive Daily Fee / PAYE Option / Central London / Good transport links

Job Summary:

Exciting opportunity for an experienced clinical research scientist to join an early phase development organisation’s dedicated Translational Science Team. Responsibility includes supporting strategic development planning, and clinical science data review / analysis for trials. Supportive line manager, small and friendly team, office based in Central London, offered on a 12 month fixed term contract.

Requirements:

BACKGROUND

Global Pharma Company

London Based

Fixed term contract 6 / 9 / 12 months

 

PRIMARY DUTIES

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.

 

TO APPLY

For a confidential discussion please telephone Andrea Litovszky at AXESS Limited on 020 8560 2300. To apply, please send your CV to jobs@axess.co.uk quoting reference PW-6772.

 

Keywords:

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 / Clinical Science roles /clinical scientist / clinical analyst / clinical scientific analyst / clinical project scientist / roles / contract / interim

 

ABOUT AXESS:

AXESS has been operating since 1990

We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development

We match professional candidates to the best permanent, contract and interim roles in the market

Visit us at www.axess.co.uk

 

Apply for this job:  PW-6772 Clinical Science Manager

Contact Information:

Address:  Head Office
Isabella House,
12 Union Court,
Richmond upon Thames,
Surrey
TW9 1AA
England
Tel:  +44 (0)20 8560 2300
Fax:  +44 (0)20 8560 2033
Website:  Visit Our Web Site

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