Associate Director, Clinical Data Management

This role provides strategic and operational leadership for clinical data management activities across one or more clinical development programs, including oversight of CRO partners and vendors, driving data quality and inspection readiness, supporting regulatory submissions, and ensuring timely delivery of high-quality clinical trial data.

Accountabilities and Responsibilities
Clinical Data Management Leadership:
- Lead and oversee all clinical data management activities for assigned trials from protocol development through database lock and study closeout.
- Develop and execute data management strategies aligned to timelines, quality objectives, and regulatory readiness.
- Ensure consistent application of GCP, ICH guidelines, company SOPs, and industry best practices.
- Lead and guide CROs/vendors performing outsourced data management.

Vendor and CRO Oversight:
- Serve as the primary sponsor representative for outsourced data management.
- Establish governance and performance oversight (KPIs, quality metrics, issue escalation).
- Review and approve vendor deliverables: Data Management Plans; CRF specifications; Edit Check Specifications; Data Review Plans; Database Validation Documentation; Data Transfer Specifications; Reconciliation Plans.
- Monitor CRO performance for quality, timelines, and budget adherence.

Data Quality and Inspection Readiness:
- Establish/monitor study metrics for data quality, cleaning, query management, and database readiness.
- Review data trends and mitigate risks.
- Ensure audit/inspection readiness; support internal audits and health authority inspections as DSM subject matter expert.

Cross-Functional Collaboration:
- Act as Data Management representative on Clinical Study/Development Teams.
- Communicate status, risks, mitigations, and performance metrics.

Process Improvement:
- Improve clinical data management processes, systems, and efficiencies.
- Contribute to SOPs, templates, and best practices.
- Support innovative technologies and risk-based approaches.

Requirements:
- 8+ years clinical data management experience (biotech/pharma/CRO).
- 3+ years leadership experience overseeing clinical data management and vendor relationships.
- Experience supporting Phase 2, Phase 3, and regulatory submission programs.
- Experience overseeing outsourced clinical data management models.
- Strategic thinker with strong operational execution; excellent vendor management.
- Effective problem-solving and risk management.
- Excellent written and verbal communication.
- Commitment to patient-focused drug development and data quality excellence.
- Rare disease experience preferred.

Strong Understanding Of:
- ICH-GCP; FDA and EMA regulations.
- CDISC standards (SDTM and related submission requirements).
- Clinical trial data lifecycle.
- Risk-based quality management principles.

Location/Work Model:
- Boston, MA; flexible hybrid model with at least 2 days/week in office.