Associate Director Clinical Data Management

Vor Bio•Boston, MA

21h•Hybrid

About The Position

The Associate Director, Clinical Data Management (CDM) is an individual contributor and leadership role within Vor's Biometrics organization, responsible for strategic oversight and operational delivery of all clinical data management activities across Vor's clinical portfolio. This individual will serve as one of Vor's internal CDM experts leading study and program-level data governance, owning EDC architecture and data standards, managing CRO and vendor partnerships, and ensuring continuous regulatory inspection readiness. This role will be accountable for department-level strategy, SOP ownership, regulatory inspection representation as a named CDM subject matter expert, and cross-regional data integration from multi-national studies. The Associate Director serves as a senior escalation point and represents the CDM function at program governance forums and regulatory interactions.

Requirements

Bachelor's degree in Life Sciences, Health Informatics, Computer Science, or related field required.
Minimum 10 years of clinical data management experience in pharmaceutical, biotech, or CRO settings, with at least 3 years in a senior lead or management role.
Expert-level proficiency with Medidata Rave EDC — including study build, CRF design, edit check authoring, library management, UAT oversight, and production release governance.
Demonstrated prior experience as the named CDM representative in FDA or EMA regulatory inspections — directly answering inspector questions on data management practices, audit trails, and data integrity.
Hands-on experience with multi-regional clinical data management including integration of data from China-based or other non-US studies, data transfer reconciliation, and bridging study data strategies.
Deep knowledge of CDISC standards (CDASH, SDTM), ICH guidelines (E6, E8, E9, E17), FDA 21 CFR Part 11, EU Annex 11, and GCDMP.
Proven CRO and vendor oversight experience across full study lifecycles from startup through database lock and archiving.
Proficiency with coding dictionaries (MedDRA, WHODrug) and data review/cleaning methodologies.
Demonstrated ability to communicate complex data management concepts clearly and concisely — both in polished written deliverables and confident oral presentations — to diverse audiences including clinical teams, regulatory inspectors, senior leadership, and external partners.
Strategic thinking with the ability to anticipate downstream data quality and submission risks and take proactive, documented action.
Exceptional attention to detail combined with ability to manage multiple concurrent programs under tight timelines.
Ability to lead and influence cross-functionally without requiring direct authority over all stakeholders.
Comfort operating hands-on in a lean, fast-paced clinical-stage biotech alongside strategic departmental oversight.
Strong vendor management and project delivery track record for high-quality data packages on time.
Collaborative, patient-centered mindset aligned with Vor's mission.

Nice To Haves

Advanced degree (Master's or equivalent) preferred.
CCDM (Certified Clinical Data Manager) certification is a plus.
Background in autoimmune disease and/or rare disease is a plus.
Prior experience with front-line communications during regulatory inspections.
Prior experience building or scaling a CDM function in a lean, clinical-stage biotech environment.
Familiarity with eSource, decentralized trial (DCT) components, and real-time data monitoring technologies.
Experience with Medidata Rave Architect and/or Rave EDC Modules (eConsent, eCOA, Medidata AI).
Working knowledge of R/R Shiny/Posit Connect or other similar tools for data quality review, reconciliation, and dashboards is a plus.

Responsibilities

Contribute to the strategic and operational leadership for multiple CDM activities across Vor's clinical portfolio, from protocol synopsis through database lock, archiving, and regulatory submission.
Serve as the CDM functional lead on program teams, contributing to clinical development plans, protocol design, and study feasibility assessments from a data quality and operability perspective.
Define and communicate CDM strategy, standards, and milestone timelines at the study and program level; identify risks early and communicate mitigation plans to senior leadership.
Partner with Biostatistics and Statistical Programming to ensure seamless data flow from EDC through SDTM/ADaM datasets and downstream regulatory analyses.
Serve as Vor's primary subject matter expert (SME) and platform owner for Medidata Rave EDC, governing the full ecosystem: study build, library management, edit check strategy, change control, and system validation.
Lead development and governance of Vor's CDASH-aligned CRF standards library within Medidata Rave — ensuring consistency, reusability, version control, and regulatory/submission alignment across all programs.
Oversee CRF design, database build specifications, UAT strategy, and production release quality control across all active studies.
Ensure EDC configurations comply with CDISC CDASH/SDTM standards, facilitating optimal downstream dataset programming for regulatory submissions.
Evaluate and implement emerging Medidata capabilities (e.g., eConsent, eCOA integrations, Medidata AI data monitoring) to advance quality and operational efficiency.
Maintain governance of edit check specifications, data review guidelines, and coding conventions (MedDRA, WHODrug) across all Vor studies.
Lead the CDM strategy for multi-regional clinical trials, including studies with non-US-originated or non-US-concurrent data (e.g., bridging studies, ICH E17-compliant global programs).
Oversee data transfer, reconciliation, and harmonization from non-US regional CROs and data platforms, ensuring data integrity when integrating datasets from non-US investigational sites or partners into global submissions.
Partner with Regulatory Affairs and Biostatistics to define data requirements for integrated global analyses and data pooling strategies (per ICH E17) for FDA and EMA submissions.
Ensure regional data collection practices — including eCRF language localization, coding dictionary alignment, and site training materials — satisfy both local regulatory requirements and Vor global data standards.
Manage data transfer specifications and reconciliation protocols for all third-party data streams: central labs, IRT, safety databases, eCOA, and regional CRO-generated datasets.
Ensure Vor's CDM documentation, TMF data management sections, and EDC audit trails are maintained in a state of continuous inspection readiness throughout the study lifecycle.
Serve as the CDM subject matter expert and primary spokesperson in regulatory inspections (FDA, EMA, competent authority), audits, and quality reviews — directly answering inspector and auditor questions on data management practices, EDC systems, data integrity, and audit trail review.
Prepare CDM inspection packages including data management plans, system validation documentation, audit trail narratives, and data quality metrics for regulatory review.
Serve as Vor's senior CDM oversight lead for external CRO DM partners — including contract scope definition, performance governance, issue escalation authority, and quality review.
Establish and enforce CDM expectations, SOW deliverables, and quality metrics for all external vendors: CROs, EDC service providers, central labs, IRT vendors, and eCOA/ePRO platforms.
Review and approve all key DM vendor deliverables: data management plans, CRF completion guidelines, edit check specifications, data transfer agreements, and database lock packages.
Lead vendor qualification activities and contribute to CRO selection processes as a CDM technical evaluator.
Develop, maintain, and continuously improve Vor's CDM SOPs, work instructions, templates, and data management plans in alignment with ICH E6(R3), FDA 21 CFR Part 11, EU Annex 11, GCDMP, and CDISC standards.
Ensure compliance with electronic records and electronic signatures regulations across all EDC systems and data management platforms.
Track and report data quality metrics, query resolution rates, cleaning milestones, and database lock timelines to program teams and leadership.
Collaborate closely with Biostatistics, Statistical Programming, Clinical Operations, Regulatory Affairs, Medical Writing, and Safety to ensure CDM activities support all downstream deliverables.
Partner with Clinical Operations on site training, data entry guidance, and site data quality monitoring.
Provide CDM input into clinical study reports, regulatory briefing documents, and submission-ready data packages.
Represent CDM on study teams, program governance boards, and senior leadership forums.
Provide mentorship, technical guidance, and professional development support to Sr. Data Managers and Data Managers within the CDM team.
Contribute to workforce planning and hiring, helping define and scale CDM capabilities as Vor's pipeline grows.
Foster a high-performance, quality-first team culture aligned with Vor's clinical mission.