Clinical Data Manager

For our client, a leader in the Pharmaceuticals & Biotech space, we are seeking a Clinical Data Manager to turn data into practical insight that improves visibility, decision-making, and business performance. You will partner with business, technical, and operational stakeholders to build reporting, surface trends, and translate analysis into action. This role offers the opportunity to strengthen data-driven execution and help teams focus on the metrics that matter most within a life sciences environment.

Location: Remote - US based candidates only, no visa sponsorship available.

Responsibilities

• Lead end-to-end clinical data management activities for companion diagnostics projects
• Oversee EDC/CRF system design, validation, and maintenance
• Collaborate with Biostatistics to develop submission-ready datasets for regulatory submissions
• Prepare clinical data packages for various regulatory filings including PMA and 510(k)
• Apply risk-based principles to identify and mitigate data quality risks
• Ensure inspection readiness and act as a data management SME during audits
• Develop and maintain data management documentation throughout the study lifecycle

Qualifications

• Bachelor's or Master's degree in relevant fields; advanced degrees preferred
• 5-8 years of clinical data management experience in biotechnology, pharmaceuticals, or diagnostics
• Hands-on knowledge of CDISC standards including SDTM, ADaM, and Define.xml
• Experience with EDC platforms like Medidata Rave, Veeva CDMS, or Oracle InForm
• Prior involvement in oncology clinical trials or companion diagnostics is strongly preferred
• Ability to interpret and apply regulatory standards effectively
• Proven ability to manage multiple, fast-paced projects

Benefits

• Flexible work-from-home options
• Full-time weekly schedule with no end date for the position
• Access to stock and eligibility for bonuses
• Comprehensive benefits package available

Pay

$105,280 – $197,400 annually