Director, Data Systems and Clinical Programming

12+ years of relevant experience and has earned a BS or equivalent degree; MS or MBA a plus

Experience supporting Ph I-IV clinical trials, both in-house and through CRO partners

Strong knowledge and experience in EDC and other key technologies (e.g., IXRS, data visualization)

Proficiency in CDISC standards (CDASH, SDTM, ADaM)

Experience with SAS, SQL and/or other clinical programming tools

Proficiency in clinical research regulations and guidance, including FDA CFR and ICH GCP

Lead and manage the Data Systems and Clinical Programming function within DM

Drive the implementation of various technology solutions to augment existing DM processes, optimize efficiency and enhance overall data quality assurance

Lead and/or participate in AI-related initiatives for DM

Develop and implement strategies for optimizing data flow, database builds, and integration of external technologies.

Oversee the validation of the EDC platform, ensuring ongoing system optimization.

Manage relationships with key external vendors, ensuring alignment with organizational goals.