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Job Details

Clinical Data Manager

Company: ProClinical Ltd
Location: Brussels
Reference: CR.SW.14266
Closing Date: 20 Nov 17
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

ProClinical has a brilliant opportunity for a Clinical Data Manager to be based in Belgium. This job will be with one of the largest workforce management solutions companies in the world who specialise in multiple scientific and engineering sectors. The Clinical Data Manager will be accountable for the project management, complete oversight and timely delivery of clinical trial data and documentation according to agree upon timelines and quality expectations. ...

Requirements:

ProClinical has a brilliant opportunity for a Clinical Data Manager to be based in Belgium. This job will be with one of the largest workforce management solutions companies in the world who specialise in multiple scientific and engineering sectors. The Clinical Data Manager will be accountable for the project management, complete oversight and timely delivery of clinical trial data and documentation according to agree upon timelines and quality expectations. They are the liaison between the trial customer, the CRO(s) and other functional partners(s) for all issues related to data for assigned trial(s) Ensures Inspection Readiness of all data management deliverable and ensures adequate archiving of data management documentation

Job Responsibilities: 

  • Liaises continually between the CRO, the trial customer(s) and other internal and external partners to establish, align and confirm data management expectations for assigned trial(s)
  • With the trial customer, CRO and other functional partners:
  • Gathers content and integration requirements for eCRF and other data collection tools
  • Establishes conventions and quality expectations for clinical data
  • Establishes expectations for dataset content and structure
  • Sets timeline and follow-up regularly to ensure delivery of all Data Management milestones
  • Performs trial level oversight controls as described in the oversight plan, QC process and work instructions
  • Prepares or reviews clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format and consistency; ensures compliance with regulatory guidelines and the documentation matrix
  • Ensures real-time inspection readiness of all IDS deliverable for the trial; Participates in Regulatory Agency and J&J internal audits as necessary
  • Plans and tracks content, format, quality, and timing of data management deliverable, including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival; ensures deliverable are on time and within budget
  • Supports the assigned clinical working group(s) to ensure that IDS and TA trial needs and deliverable are met
  • Provides input to the DML on trial initiation needs (scope of work, budget, resources), and CRO selection in non-standard situations as appropriate
  • Identifies and communicates lessons learned, best practices and frequently asked questions at trial level
  • Identifies and participates in continuous process and tool improvement initiatives the company
  • Presents and trains at investigator and monitor meetings
  • Participates in company training and coaching sessions on advanced Clinical Data Management skills (hard and soft)

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Sam Walker on +44 203 8569 336 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Apply for this job: Clinical Data Manager

Contact Information:

Address:  ProClinical Ltd
Eldon House Eldon Street London
EC2M 7LS
England
Tel:  0800 988 4437
Fax:  +44 (0)207 834 9470
Website:  Visit Our Web Site

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