Job Description
Job Title
Sr. Clinical Data Manager
Department
Clinical Operations
Location
Remote
Overview
As the Senior Clinical Data Manager (SCDM), you will lead the end-to-end data management lifecycle for our early-to-late-phase oncology trials. In a small biotech setting, this means you aren’t just a cog in a machine; you are the architect of our data strategy, overseeing CROs while remaining "hands-on" with database design and data integrity.
Key Responsibilities
- Study Leadership: Act as the primary DM point of contact for cross-functional teams (Clinical Ops, Biostatistics, and Clinical).
- End-to-End Oversight: Lead the design and development of CRFs, Edit Checks, Data Transfer Agreements (DTAs), and Data Management Plans (DMPs).
- Vendor Management: Accountable for oversight of CROs and external vendors to ensure high-quality, consistency, adherence to timelines, and alignment with study and regulatory expectations.
- Oncology Specifics: Handle complex data types common in oncology, such as RECIST 1.1 assessments, local/central lab data, grading of adverse events (CTCAE criteria) and biomarkers.
- Quality & Compliance: Lead data cleaning, reconciliation, and UAT for database builds to ensure "submission-ready" data.
- Process Improvement: Help build our internal DM infrastructure, from SOP development to selecting new EDC platforms.
Minimum Experience Required
- Experience: 6+ years in Clinical Data Management, with a significant focus (3+ years) on Oncology (Phase I-III) within the pharmaceutical, biotech or CRO industry. Experience in hematologic malignancies is highly preferred.
- Small Biotech Mindset: You are comfortable wearing multiple hats and moving quickly without a massive corporate structure.
- Technical Savvy: Expert-level knowledge of EDC systems (e.g., Medidata Rave) and CDASH/CDISC standards.
- Analytical Rigor: Deep understanding of oncology-specific data challenges, including complex dosing, adaptive trial designs, and extensive medical and treatment history.
- Vendor Oversight: Demonstrated experience managing external CROs and specialty labs to ensure data quality and timeline adherence.
Additional Preferred Qualifications:
- Recent experience working on clinical trials in hematologic malignancies, particularly AML.
- Previous experience in a small-company environment is highly preferred, showing you can manage high-level strategy while executing tactical tasks.
Education
- Minimum: Bachelor’s degree in Life Sciences, Bioinformatics, Health Data Science, or a related field.
- Preferred: Master’s degree (MPH, MS) or PhD in a scientific or technical discipline.
- Certification: CCDM (Certified Clinical Data Manager) credential is a strong plus.