Data Management Consultant

Walker Cole International is partnering with a leading biotech company to recruit an experienced and motivated Data Management Consultant to support multiple clinical studies. This is an exciting opportunity to play a key role in ensuring high-quality data delivery across global trials, working closely with cross-functional teams and external CROs.

What You'll Be Doing:

• Act as the Data Management lead on Clinical Study Teams (CSTs)
• Provide expert input during protocol development and amendments
• Oversee CRO selection and performance for data management services
• Ensure timely, compliant, and high-quality data delivery (ICH-GCP, CDISC)
• Maintain and execute the Data Management Oversight Plan
• Lead oversight meetings and ensure TMF documentation is audit-ready
• Collaborate with Quality & Compliance on audits and CAPAs
• Drive process improvements across the data function

Data Standards & Submissions:

• Review CRF design and SDTM datasets for CDISC compliance
• Oversee creation of define.xml, annotated CRFs, and reviewer guides
• Advise on SDTM conformance and resolve data/metadata issues

What We're Looking For:

• Master's degree in Life Sciences or related field
• 7-10 years' experience in clinical data management (biotech, pharma, or CRO)
• Strong knowledge of CDISC SDTM and regulatory submission standards
• Proven experience managing CROs and external vendors
• Familiarity with CDMS and TMF systems
• Excellent communication and stakeholder management skills

6-Month Contract Biotech Hybrid