Clinical Data Management Lead

Contact: Neisha Camacho/Terra Parsons -
No 3rd party candidates

Clinical Data Management Lead
CNS Focus / Phase II Development

We are partnering with a growing biotech organization that is seeking a Clinical Data Management Lead to support ongoing and upcoming clinical programs across multiple CNS indications including schizophrenia bipolar disorder and depression.

This role will operate within a cross-functional clinical development team and be responsible for leading end-to-end data management activities with a strong focus on quality oversight and execution. The ideal candidate will bring a combination of hands-on data management expertise and leadership capability with experience supporting Phase II clinical trials in a fast-paced biotech environment.

• Lead clinical data management activities across multiple studies from study start-up through database lock
• Provide oversight of external partners (CROs vendors labs technology providers) to ensure high-quality timely data delivery
• Collaborate cross-functionally with Clinical Biostatistics Programming and Medical teams to define data collection and review strategies
• Contribute to and oversee development of key deliverables including:
  
  • Data Management Plans (DMPs)
  • eCRF design and completion guidelines
  • Edit checks and query logic
    User Acceptance Testing (UAT)
  • Data review and cleaning processes
• Ensure consistency and quality of data across studies to support statistical analysis and regulatory reporting
• Drive data standards process improvements and operational efficiencies across programs
• Support inspection readiness and ensure compliance with regulatory requirements and industry standards

• BS in a scientific or clinical discipline; advanced degree preferred
  10 years of clinical data management experience within biotech pharma or CRO environments
• Strong hands-on experience with EDC systems (e.g. Medidata Rave Oracle Veeva)
• Working knowledge of CDISC standards (SDTM/ADaM) and downstream data usage
• Experience supporting Phase II clinical trials; CNS experience is a plus
• Demonstrated experience managing and overseeing CROs and external vendors
• Strong understanding of data structures and dictionaries (e.g. MedDRA WHODrug)
• Proven ability to work cross-functionally and influence stakeholders across Clinical Biometrics and Operations
• Detail-oriented proactive and comfortable operating in a dynamic evolving environment