Priya Mukherjee is currently recruiting for four Contract Global Data Managers to join a leading Pharmaceutical organisation in Belgium.

Contract Global Data Manager Job Description:

As Contract Global Data Manager, you will be:

• Accountable for the project management, complete oversight and timely delivery of clinical trial data and documentation according to agreed upon timelines and quality expectations
• The liaison between the trial customer, the CRO(s) and other functional partners(s) for all issues related to data for assigned trial(s)
• A member of SMT and Clinical Working Group(s) and leads the trial subteam(s)/workstream(s) for data management deliverables (e.g., eCRF design, Database Lock).

As Contract Global Data Manager, your main responsibilities will include:

• To liaise 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:

1.  Gathers content and integration requirements for eCRF and other data collection tools

2. Establishes conventions and quality expectations for clinical data

3. Establishes expectations for dataset content and structure

4. Sets timeline and follow-up regularly to ensure delivery of all Data Management milestones

• Perform trial level oversight controls as described in the oversight plan, QC process and work instructions.
• Prepare or review clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format and consistency; ensure compliance with regulatory guidelines and the documentation matrix.
• Ensure real-time inspection readiness of all deliverables for the trial; Participate in Regulatory Agency and audits as necessary.
• Plan and track content, format, quality, and timing of data management deliverables, including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival; ensure deliverables are on time and within budget.
• Support the assigned clinical working group(s) to ensure deliverables are met.
• Provide input trial initiation needs (scope of work, budget, resources), and CRO selection in non-standard situations as appropriate.
• Identify and communicate lessons learned, best practices and frequently asked questions at trial level.
• Identify and participates in process, system, and tool improvement initiatives.
• Present and train at investigator and monitor meetings.

To be considered for this Contract Global Data Manager you will have the following skills, qualifications and experience:

• BSc in Life Sciences (OR Equivalent) with proven experience of working within the Pharmaceutical industry
• Experience of working within the Oncology therapy area together with knowledge and understanding of current industry standards (i.e. CDISC , SDTM , CDASH , etc.).
• Knowledge of technology platforms for data exchange, outstanding written and oral communication skills, negotiation skills and project Management Skills
• The ability to effectively prioritise and manage multiple tasks simultaneously.

How to apply:

Click here to apply online now.

For more information please contact Priya Mukherjee on +44(0)1438 870028 or email pmukherjee@ckclinical.co.uk. Please quote reference CL23467 in all correspondence.

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