Company: Docs Global (Continental Europe)
Reference: Ref AS-020430
Closing Date: 01 Mar 17
Salary (£): Competitive
Benefits: Excellent & Comprehensive
DOCS has partnered with a highly prestigious organizations with one of the most robust pipeline within the industry. A fantastic opportunity for an experienced Data Manager that is ready to take on a new challenge.
Roles & Responsibilities of the position
• Provides DM leadership and subject matter expertise to the study team(s) and is responsible for overseeing and managing all DM activities for the study.
• Serves as an “ad hoc” member of the study team(s) and is accountable for all DM-related communications, specifications, and documentation. The includes, but is not limited to the Data Management Plan (DMP).
• The DMQL is responsible for the overall quality and integrity of the database with respect to “Critical to Quality” (CTQ) data points predefined by Clinical and Biostats prior to the start of a study.
• The DMQL will “project manager” the Data Quality Plan to ensure CTQ data points are of the highest integrity and completeness.
• The DMQL will typically be assigned to no more than 4 studies within a given therapeutic area, depending on size and complexity.
Major duties and responsibilities:
• Serves as the expert in Clinical Research Data Management to provide oversight and advice to the clinical project team(s) regarding the CRDM activities and deliverables
• Development and oversight of DM processes and standards and functional leadership
• Management and oversight of vendor contracts, resourcing and budgets
• Operational Responsibilities
• Education: Minimum of a BS in life sciences or computer science degree
o Strong Data Management experience in the Biotech/Pharma/CRO industry
• Certified Clinical Data Manager (CCDM) via the Society of Clinical Data Management (Preferred)
· Office based work, no travelling
· Basic salary + annual bonus + benefits
· Work in the unique in Poland organization - global R&D clinical research team. This is not regional, but truly global range.
· Development opportunities with rapid growing organization (eg. during last 2 years 50% of employees was promoted for new positions)
· Teamwork and people oriented atmosphere
· Flexible arrangements in working time
2 Globeside, Globeside Business Park
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