Associate Director, Data Management

Parabilis Medicines•Cambridge, MA

1d•Onsite

About The Position

The Associate Director, Data Management provides strategic and operational leadership for clinical data management activities across one or more clinical programs. This role is critical to ensuring the integrity, quality, and timely delivery of clinical trial data to support regulatory submissions and key development decisions. This is a very hands-on role with the clinical data while utilizing an outsourcing model. You will partner closely with cross-functional teams including Clinical Operations, Biostatistics, Regulatory, and external vendors, serving as a key leader within Biometrics. This position offers the opportunity to influence data management strategy, drive process improvements, and contribute to the successful execution of Parabilis’ growing clinical pipeline.

Requirements

Bachelor’s degree (or higher) in life sciences, mathematics, or related field.
10+ years of clinical data management experience in biotech, pharmaceutical, or CRO environments.
Demonstrated experience leading multiple studies and/or programs, including vendor oversight.
Prior people management experience strongly preferred.
Previous experience leading a Phase 3 trial and interactions or readiness for Health Authority interactions
Strong knowledge of GCP, ICH guidelines, FDA regulations, and clinical data standards.
Experience with EDC systems (e.g., Veeva, Medidata RAVE) and CDISC standards (CDASH, SDTM, ADaM).
Experience working with data visualization and query tools
Proven leadership, strategic thinking, and problem-solving skills.
Excellent communication and cross-functional collaboration abilities.
Demonstrated ability to utilize AI tools for day-to-day work; baseline proficiency is expected, and advanced or innovative use of AI is a strong plus.

Responsibilities

Provide strategic leadership and oversight of data management activities across multiple clinical programs, ensuring high-quality, inspection-ready data deliverables.
Lead and develop data management staff while fostering collaboration across internal teams and external partners, including CROs and vendors.
Oversee the end-to-end data management lifecycle, including study start-up, database build, data review, and database lock.
Drive vendor oversight, study execution, and cross-functional coordination to ensure timelines, budgets, and quality expectations are met.
Establish and enhance data management standards, SOPs, and processes to ensure compliance with GCP, ICH, and regulatory requirements.
Provide strategic input into resource planning, budgeting, and continuous improvement initiatives across the function.