Associate Director, Clinical Data Management

Remix Therapeutics is a clinical-stage biopharmaceutical company that has pioneered a new class of small molecule medicines targeting the RNA splicing machinery — correcting the disease-causing errors that drive cancers and other serious conditions at their source.
REM-422 is our lead program currently focused on developing a therapy for Adenoid Cystic Carcinoma (ACC), a rare cancer for which there is no approved therapy. REM-422 is concurrently being evaluated as a treatment for AML/.HR-MDS with aspirations to evolve into other oncology indications with high unmet need. REM-422 is at a critical inflection point in its clinical development and Remix is building the team to bring this novel molecule forward as a medicine for patients.
Position Summary:
Remix is seeking an Associate Director, Clinical Data Management to provide technical expertise and vendor oversight at a pivotal moment for REM-422 and the ACC patients we serve. Reporting to the SVP, Clinical Development Operations & Patient Advocacy and based at our Watertown, MA headquarters, this role is the first to be solely dedicated to the Clinical Data Management function. Accordingly, the role will be responsible for developing and executing Remix standards and processes tailored to the oversight of outsourced solutions suitable for Registration programs as well as early development programs to follow.
Key Responsibilities:
CRO & Vendor Management
Oversight & Accountability: Manage and provide robust operational oversight of functional deliverables from data management CROs and specialized vendors (e.g., central labs, ePRO, IRT).
Governance & Metrics: Establish and monitor CRO performance metrics, Key Performance Indicators (KPIs), and quality metrics. Lead routine governance and alignment meetings to track study progress and resolve data issues.
Financial Control: Participate in CRO selection, Request for Proposal (RFP) evaluations, and bid defense meetings. Review and manage the DM vendor budget, including the evaluation of Statements of Work (SoW) and potential Change Orders.
Deliverable Approval: Critically review and approve core vendor deliverables, including Data Management Plans (DMPs), Case Report Form (eCRF) designs, Edit Check Specifications, User Acceptance Testing (UAT) setups, and Data Transfer Specifications.
Data Management Operations & Quality Assurance
Trial Lifecycle Leadership: Lead data management activities from initial protocol review and study start-up through database cleaning, lock, and archival.
Data Integrity & Review: Conduct ongoing data reviews via data listings and visualization tools to identify data anomalies, trends, and systemic risks across clinical programs.
Compliance & Inspection Readiness: Ensure all data operations strictly adhere to ICH-GCP guidelines, corporate SOPs, and regulatory expectations. Serve as the Data Management Subject Matter Expert (SME) during internal audits and Health Authority inspections.
Standardization: Collaborate on the design and maintenance of corporate data standards (e.g., CDISC/CDASH) to ensure downstream compatibility for biostatistics and electronic submissions.
Cross-Functional Leadership