Associate Director, Clinical Data Management

Remix Therapeutics; Watertown (MA); Sur place; USD 187 000 - 230 000; Plein temps

Résumé du poste

Remix Therapeutics, based in Watertown, MA, seeks an Associate Director of Clinical Data Management to lead data management activities for REM-422 and related programs. You will manage CROs, set governance, and ensure data quality across trials in oncology/rare disease indications.

Reporting to the SVP of Clinical Development Operations, you will drive CDISC/CDASH standardization, oversee budgets, and ensure readiness for regulatory submissions while guiding the DM team through IND to NDA

Qualifications

• BS/BA in a scientific, informatics, or healthcare discipline; advanced degree preferred.
• 8+ years in clinical drug development focused on Clinical Data Management.
• Deep expertise in EDC systems (Medidata Rave, Veeva Vault CDMS).
• Advanced knowledge of ICH-GCP, FDA/EMA guidelines, and CDISC standards.
• Proven track record managing full-service data management CROs and vendors.
• Oncology or rare disease trial experience preferred.
• Experience supporting programs from IND through NDA submissions and inspections.

Responsabilités

• Oversee DM CROs and vendors, ensuring deliverables meet quality standards.
• Establish KPIs, governance, and oversight meetings to track progress and resolve issues.
• Participate in CRO selection, RFPs, and budget management including SoW and change orders.
• Review and approve DMPs, eCRF designs, edit checks, UAT setups, and data transfer specs.
• Lead data management lifecycle from study start-up to archival and closure.
• Ensure data integrity through listings and data visualization, identifying risks.
• Ensure compliance with ICH-GCP and prepare for inspections; act as SME during audits.
• Collaborate on CDISC/CDASH standards for downstream submissions.

Connaissances

Leadership

Data management

Cross-functional collaboration

Analytical thinking

Formation

BS/BA in a scientific/informatics/healthcare discipline

Master's or Ph.D. preferred

Outils

Medidata Rave

Veeva Vault CDMS

Description du poste

Associate Director, Clinical Data Management

Watertown, MA

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 a n 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:

• 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.