Dear AllStat,

CK Clinical is recruiting for a Data Manager to join a global Pharmaceutical company at their site based in France on a permanent basis

As Data Manager, your responsibilities will include the following:

- Provide timely and professional ongoing management of clinical trial data by identifying and resolving errors and inconsistencies in eCRF data to ensure consistently high standard database(s) with respect to cost, quality and timelines

- Provide professional DM input on Clinical Trial Team(s)

- Input to and review of clinical trial database design including User Acceptance Testing (UAT).

- Responsible for the Validation and Analysis Plan (VAP) meeting for the clinical trial, which includes chairing the meeting, writing the study specific validation checks and necessary reports to ensure high quality and consistent data.

- Identify errors/inconsistencies and resolve them or initiate their resolution either via the field monitor or directly with the investigational site, to ensure high quality and timely database locks.

- Review and contribute to the preparation of protocols, specifically related to the data management section, visit schema and study design.

- Prepare Case Report Forms (CRFs) and CRF completion Guidelines (CCGs), electronic or paper .

- Support and assist Assistant Data Managers and other Data Managers for allocated trials.

- Freeze and lock data as appropriate in time for statistical review, blinded interim quality review, interim and final database lock.

- Perform training on the generic electronic database and study specific eCRF to sites and the company personnel at the Investigator meeting for all trials across all TAs. Travel is required as needed.

 

As Data Manager, you will have the following qualifications, skills and experience:

- Degree in life sciences, pharmacy, nursing or equivalent relevant experience.

- Languages: Fluent English (oral and written).

- Experience in drug development, including  in Data Management activities.

- Good understanding of clinical trial methodology,GCP and medical terminology.

- Good computer skills.

- Attention to detail & quality focused.

- Good organizational and project management skills.

- Good interpersonal and communication skills and the ability to operate effectively in an international

environment.

- Good understanding of physiology, pharmacology, clinical study objectives and the drug development

process.

- Good problem solving skills.

- Good presentation skills.

- Ability to work as part of a team and without close supervision.

- Ability to work under pressure and meet timelines.

 

For more information or to apply for this Data Manager position, please contact Mylene Paumier on +44 (0)207 470 5672 or email: [log in to unmask]" target="_blank">[log in to unmask].

Best regards,

Mylene

 

 

Mylene Paumier

European Recruitment Consultant

 

CK Clinical Limited

Crown House

72, Hammersmith Road

London

W14 8TH

 

DD: +44 (0)207 470 5672

Tel: +44 (0)207 470 5670

[log in to unmask]

 

www.ckagroup.co.uk

 

CK Clinical, CK IT, CK Regulatory and CK Science are trade names of CK Associates Limited

Registered in England No 2611749

 

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