The Associate Director, Clinical Data Management will serve as the lead data manager for one or more clinical programs, providing strategic and operational oversight of study-level data management activities from study start-up through database lock.
Compensation
Per Year Salary Range
$162,000—$205,000 USD
Responsibilities
Serve as the lead data manager for assigned phase 3 clinical studies and programs
Develop and maintain study-specific data management strategies, timelines, and deliverables
Provide oversight of CRO and vendor data management activities to ensure quality, compliance, and adherence to timelines
Review and approve key data management documents, including Data Management Plans (DMPs), Data Validation Plans (DVPs), edit check specifications, eCRF specifications, and database build documentation
Lead data review, query management, reconciliation, and database lock activities
Design, develop, validate, and maintain clinical study databases within EDC systems, ensuring data quality, protocol compliance, and timely study deliverables in alignment with regulatory and organizational standards.
Responsibilities
Design and develop clinical study databases within EDC systems as per protocol and CRF specifications.
Configure eCRFs, visit structures, edit checks, derivations, and study workflows.
Perform database validation and execute UAT to ensure system functionality and compliance.
Create and maintain edit check specifications and test scripts.
Support data cleaning activities by troubleshooting and resolving system-related queries.
Requirements
Bachelor’s/master’s degree in Computer Science/Information Technology
Nice to have: Training in GCP
Nice to have: Training in CDISC
Nice to have: Certification in Clinical Data Management or EDC systems
Responsible for supporting the design, deployment, configuration, and oversight of electronic Clinical Outcome Assessment (eCOA) solutions and Randomization and Trial Supply Management (RTSM) across global clinical studies.
Responsibilities
Act as eCOA and RTSM subject matter expert during study start-up, maintenance, and close-out
Define functional requirements and participate in the design and configuration of eCOA and RTSM solutions
Draft and maintain system specifications, user requirements, edit checks, notifications, and reporting requirements
Assist with the design of eCOA-related Case Report Forms (CRFs)
Create User Acceptance Testing (UAT) test scripts and coordinate or perform system validation testing
Requirements
Bachelor’s degree in Life Sciences, Computer Science, Health Sciences, or related field
Responsible for supporting the design, deployment, configuration, and oversight of electronic Clinical Outcome Assessment (eCOA) solutions and Randomization and Trial Supply Management (RTSM) across global clinical studies.
Responsibilities
Act as eCOA and RTSM subject matter expert during study start‑up, maintenance, and close‑out
Define functional requirements and participate in the design and configuration of eCOA and RTSM solutions
Draft and maintain system specifications, user requirements, edit checks, notifications, and reporting requirements
Assist with the design of eCOA‑related Case Report Forms (CRFs)
Create User Acceptance Testing (UAT) test scripts and coordinate or perform system validation testing
Requirements
Bachelor’s degree in Life Sciences, Computer Science, Health Sciences, or related field
Responsible for supporting the design, deployment, configuration, and oversight of electronic Clinical Outcome Assessment (eCOA) solutions and Randomization and Trial Supply Management (RTSM) across global clinical studies.
Responsibilities
Act as eCOA and RTSM subject matter expert during study start‑up, maintenance, and close‑out
Define functional requirements and participate in the design and configuration of eCOA and RTSM solutions
Draft and maintain system specifications, user requirements, edit checks, notifications, and reporting requirements
Assist with the design of eCOA‑related Case Report Forms (CRFs)
Create User Acceptance Testing (UAT) test scripts and coordinate or perform system validation testing
Requirements
Bachelor’s degree in Life Sciences, Computer Science, Health Sciences, or related field
Lead Tester responsible for testing and validating clinical study databases, electronic case report forms, edit checks, integrations, and study workflows, ensuring compliance with Good Clinical Practice and regulatory standards.
Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
Responsibilities
Review study protocols, specifications, eCRF design documents, and related study documentation to understand system requirements.
Develop and execute test plans, test cases, and test scripts for clinical database validation activities.
Perform functional testing of electronic Case Report Forms, edit checks, integrations, and study workflows.
Validate simple and complex edit checks to ensure accurate system functionality and data quality.
Identify, document, track, and verify defects through established issue management processes.
Hiring Manager Notes:
Priority is programming and data warehousing, applied within a clinical environment.
Needs strong SAS programming experience.
Needs intermediate-to-advanced SQL.
Must have data warehouse development and maintenance experience, including clinical database management.
Still needs solid understanding of CDISC, CDASH and SDTM.
Needs real clinical trial data experience. Generic SAS or SQL backgrounds without it won't work.
External data acquisition applies here too: vendor data, SFTP transfers, and integration and transformation of that data.
Builds database schemas and edit checks, and maintains studies in the CDR across the study lifecycle.
AI programming/automation exposure is a preferred plus.
If choosing between a strong clinical systems/CDISC candidate and a strong SAS/SQL/warehouse candidate, the manager picks the SAS/SQL/warehouse one for this role.
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