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 - Study Team Representation: Serve as the primary Data Management representative on Trial Management Teams.
- Stakeholder Alignment: Actively partner with Biostatistics, Statistical Programming, Clinical Operations, Medical Writing, and Regulatory Affairs to ensure data management timelines align seamlessly with broader corporate objectives.
Qualifications:- Education: BS/BA in a scientific, informatics, or healthcare discipline (Master's or Ph.D. preferred).
- A minimum of 8+ years of experience in clinical drug development directly focused on Clinical Data Management within a pharmaceutical, biotech, or CRO environment.
- Deep expertise in industry-standard Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Veeva Vault CDMS).
- Advanced knowledge of global regulatory frameworks, including ICH-GCP, FDA guidelines, EMA requirements, and CDISC standards.
- Proven track record of successfully managing full-service data management CROs and external vendors for complex or multi-center clinical trials.
- Deep oncology or rare disease trial experience preferred.
- Experience supporting clinical programs from IND through NDA submission and regulatory approval, including registrational trials and Inspection Readiness.
- Operates well in ambiguity; makes sound decisions with incomplete information; moves quickly without cutting corners and brings the team with them.
Salary Range:$187,000 - $230,000 USD
This range reflects the expected base salary for this position, plus bonus, equity, and benefits as applicable. Actual salaries may vary based on factors, such as skill, experience, and qualification for the role.
