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Job Details

Data Manager I

Company: Pharm-Olam International
Location: Bracknell
Reference: 2018-1738
Closing Date: 03 Oct 18
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

Job holder is accountable for the quality of work performed. Responsible for effectively participating in the start-up and completion of multiple Data Management projects according to Sponsor and contract requirements and in accordance with applicable standard operating procedures. May be a study lead for Data Project Manager (DPM) and liaise as appropriate with Sponsor and project team on key issues and progress updates.

Requirements:

Responsibilities:

Effective supervision of all data management aspects of the assigned project(s) from setup to lock.

Attend regular meetings with the Sponsor and project team, for discussions relating to data management issues and provides status updates for the project with guidance from DPM.

Report on quality and performance metrics, including timelines, to DPM and, if required,  Management.

Participate in in-house and external training courses, where required.

Work in strict adherence to SOPs as well as current ICH-GCP guidelines and other applicable standards required by Regulatory Authorities.

Participate in the preparation/review of Data Management process control documents, including but not limited to Data Management Plan, Data Quality Checks Specification, User Acceptance Testing and Data Transfer Agreements/Specifications, reconciliation plans, data review & quality plans.

May review database validation documentation and approve deployment in conjunction with Data Systems and DPM.

Coordinate and manage training for investigators, coordinators, data entry and CRAs on using the selected applications for data entry and cleaning, as applicable to study parameters.

Review, freeze and/or lock data in accordance with DM control documents for accuracy, completeness, consistency, and validity, generate queries as necessary to sites, as well as the project team.

Perform ongoing quality control and data review.

Participate in the production/coordination of reports and listings for team reviews and DSMBs (Data Safety Monitoring Boards).

Coordinate with Medical Data Reviewer and/or Medical Monitor for the coding of medical terminology, as required.

Participate in development and finalization of any third party transfer specifications for electronic database load both to and from Pharm-Olam.

Maintain Data Management study documentation on ePOI in an ‘audit-ready’ status, including periodic QC of documentation versioning, approvals, and appropriateness.

Perform reconciliation, including but not limited to SAS/AE, Electronic Data Files (EDF) and third-party data such as central labs and IVR,  against the clinical database and track issues to resolution.

Provide DPM with status updates and any issues/risks to deliverables to ensure the project team and  Sponsors’ are kept informed of all issues and quality performance achieved.

May present at investigator meetings and PM/CRA training sessions.

Identifies and recommends process improvements to the management team, as identified.

 

Working Relationships:

Direct reporting line to Manager, Data Management, with the functional reporting line to ADPM or others as appropriate.

Collaborate with DPM, Pharm-Olam DMs and project team members.

Collaborate with Data Systems Team, SAS Programmers, Statisticians and Medical Writers  (internal and/or external).

Collaborate with Data Entry staff and study CRA’s.

Support site investigators and study coordinators with regard to EDC training, problems and query resolution.

 

Qualifications:

Preferably a minimum of a Bachelor's degree in a Life Science, Nursing, Computer Science or related discipline.

3-5years experience in clinical data management.

Experience within the CRO industry.

Proven knowledge of clinical data management process and clinical database systems, including Electronic Data Capture applications.

Good communication skills: written and verbal.

Effective working knowledge of Microsoft Office Suite including Word and Excel.

Demonstrated problem solving, analytical, organizational and time management skills

Demonstrated flexibility and ability to work well in a team environment.

Full knowledge of clinical data flow and research design.

Demonstrated ability to be compliant with ICH-GCP/regional regulatory guidelines and POI SOPs.

Comprehension of study documentation standards including Trial Master File organization and archival processes.

Awareness of data standards, preferably CDISC STDM.

Apply for this job: Data Manager I

Contact Information:

Address:  Pharm-Olam International, UK
The Brackens, London Road, Ascot, Berkshire
SL5 8BJ
England
Tel:  +44 (0) 1344 891121
Fax:  +44 (0) 1344 890335
Website:  Visit Our Web Site

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