Director, Data Management

SHATTUCK LABS, INC.•Durham, NC

About The Position

The Director, Data Management, will ensure the integrity, accuracy, and quality of clinical study data and deliver a high-quality data package within the agreed upon timelines. The individual in this role will serve as the expert in end-to-end data management activities, providing CRO oversight and guiding clinical data review by the Shattuck team in compliance with Good Clinical Practice (GCP) guidelines. The Director, Data Management, will help select, coordinate, and manage external vendors and perform day-to-day clinical data review as needed. This position will also ensure clinical team awareness of technological advancements in clinical data management and train internal and external staff as required to support study requirements.

Requirements

Bachelor’s degree in science or healthcare with a minimum of 10+ years of clinical data management experience.
Strong experience serving as Sponsor Data Management Lead overseeing all data management activities performed by the CRO.
Knowledge of clinical drug development, with experience in Phases I-III.
Demonstrated experience managing outsourced clinical data management activities with CRO partners.
Strong experience with multiple EDC systems such as Medidata RAVE, Veeva EDC, Oracle Inform, etc.
Experience with eCOA systems.
Knowledge of clinical coding dictionaries (MedDRA and WHO Drug).
Familiarity with CDISC standards (CDASH and SDTM).
Strong interpersonal skills with demonstrated ability to effectively work with internal cross-functional as well as external groups.
Self-starter with an entrepreneurial spirit and a good team player. Able to operate both strategically and hands-on in a lean biotech environment.
Strong computer skills with demonstrated experience in working with the MS Office platform.
Thorough understanding of ICH GCP and FDA guidelines.

Nice To Haves

Experience supporting regulatory submissions (IND, NDA, or BLA).
Experience with inflammatory or autoimmune disease clinical trials such as Crohn’s disease or ulcerative colitis.
Familiarity with data visualization or clinical data review tools such as Spotfire, Tableau, or JMP Clinical.

Responsibilities

Develop and implement data management strategies aligned with company objectives.
Serve as Sponsor Data Management Lead overseeing all data management activities performed by the CRO.
Provide oversight of CRO deliverables including but not limited to eCRF design, database development, edit check specifications, data validation, data cleaning, and database lock activities.
Review and approve CRO data management documents including but not limited to Data Management Plans, Data Validation Specifications, CRF Completion Guidelines, and external data transfer specifications.
Monitor CRO performance, timelines, and quality metrics to ensure compliance with study timelines and sponsor expectations.
Lead regular CRO governance and data review meetings to address data quality, operational issues, and study progress.
Monitor data quality metrics, query trends, and key study data to proactively identify and resolve issues.
Partner with Clinical Operations, Biostatistics, Statistical Programming, Pharmacovigilance, Regulatory Affairs, and Medical to ensure alignment on clinical data standards and study deliverables.
Provide data management expertise during protocol development, study startup, and Statistical Analysis Plan development.
Support preparation of clinical study reports and regulatory submissions.
Oversee reconciliation and integration of external data sources including central laboratories, imaging vendors, ePRO/eCOA systems, and randomization/IRT systems.
Ensure external data transfers are complete, timely, and meet data quality standards.
Establish internal data management standards and expectations appropriate for a small biotech operating with outsourced clinical trial execution.
Ensure appropriate implementation of CDISC standards (CDASH and SDTM).
Ensure clinical data management activities comply with ICH GCP, 21 CFR Part 11, and applicable regulatory requirements.
Maintain sponsor oversight of outsourced activities in accordance with regulatory expectations.
Support regulatory inspections and audits as the data management subject matter expert.
In coordination with the cross-functional team, participate in the RFP process and ultimately select CROs and other vendors for clinical trials.