Data Management Leader and Standards Consultant Mechelen (BE) • Oxford Global Resources

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Do you have experience in Data Management and are used to work with SDTM standards? Are you communicative, detail oriented and enthusiastic to contribute in a dynamic, growing Biotech company? Don't hesitate and apply now!

Job Description

As a Data Management Leader & Standards Consultant, you will be performing oversight activities for clinical trials, supporting the Clinical Study Team (CST) through managing the collection, review and reporting of clinical data and related activities during the planning, set-up, conduct, and close-out of clinical trials.

Responsibilities

• Providing feedback on CRF design and SDTM datasets to ensure data are collected and represented in a manner that support regulatory requirements to comply with CDISC standards and standard extensions to CDISC
• Oversee the creation of SDTM define.xml, annotated CRF and Clinical Study Data Reviewer's Guides for both Health Authorities submissions
• Consult across different projects on conformance issues for SDTM and work with the study team to resolve the problem either by correcting the data or metadata, or by providing an appropriate explanation
• Participate in CST meetings as DM representative, and closely interact with Data Science, Medical, Clinical Operations and other functional representatives
• Provide data management expertise during protocol development, including for any amendments
• Coordinate DM Contract Research Organization (CRO) Request for Proposal (RfP) selection process, create necessary Purchase Order (PO) Requests and follow up on related Goods Receipt (GR)
• Act as first point of contact for DM CRO counterparts, and ensure clinical study data management deliverables within agreed budget and timelines, and with high quality
• Organize relevant data management oversight meetings, and ensure minutes are documented
• Create and maintain Data Management Oversight Plan, and ensure proper execution of necessary quality control steps
• Ensure proper and timely filing of DM-specific documents and files in Trial Master File or other dedicated environment
• Actively participate in DM and Data Science team meetings
• Adhere to relevant policies and procedures, and ensure timely completion of relevant training
• Interact with Quality & Compliance to follow up on audit and inspection reports and assigned Corrective Action/Preventive Action plans in timely manner; participate in audits and inspections where needed
• Lead or contribute to Process Improvement initiatives as required

Requirements

• You have a Masters' degree in a Life Sciences field, followed by at least 7-10 years' experience in a pharmaceutical/biotech environment (and/or relevant experience with a large CRO) in a clinical data management or closely related discipline
• You have a strong understanding of CDISC SDTM
• You are able to organize and plan multiple priorities, and to coordinate external service providers
• You have a good understanding of the drug development process, applicable regulatory guidelines, and Clinical Data Management Systems
• You are a team player, and can work autonomously
• Of course, your English oral and written communication skills are excellent!

Benefits

• Fulltime position as a Employee or Freelancer
• Remote / Office based : 1 day/week at the office in Mechelen or Leiden
• A balanced salary package based on your capabilities and experience, including extra legal benefits

Vacancy number : 26102