Kardigan · 1 day ago
Associate Director, Data Management
Princeton, NJ
Full-time
Hybrid
Lead/Staff, Director/Executive
$176K/yr - $247K/yr
10+ years expKardigan is a heart health company focused on making cardiovascular disease preventable and curable. The Associate Director, Clinical Data Management will oversee the management of clinical trial data, ensuring high-quality standards and regulatory compliance across multiple studies.
Artificial Intelligence (AI)BiopharmaHealth CareMedical
Responsibilities
DM Study Lead one or more studies
Work collaboratively with various stakeholders such as Medical Affairs, Regulatory, PV, CRO vendors and provide guidance on clinical data management to CDM staff, study teams, vendors, and management and represent CDM in cross-functional meetings
Ensure DM project deliverables are completed on time and in accordance with quality standards and regulatory requirements from study start-up through study closure/archival
Apply effective vendor management and build strong sustainable relationships with multiple CRO/vendors
Accountable for ensuring all data quality and timeliness of CDM deliverables are met and aligned with the business goals; Coordinate with all functions to drive data cleaning
Review, track, and report status of all data management project(s) to senior leadership. Proactively identify project challenges and risks and manage the escalation of study related issues and communicate as appropriately with management
Drive and lead the development of all data management activities including databases and eCRF design, development and implementation of database validation and UAT activities, critical data management plans, manuals guidelines and documents development and maintenance
Oversee data transfers set up and validation, including review of test data transfers for consistency with data transfer agreements
Participate in study document reviews, e.g. Study protocols, Study Management Plans, statistical analysis plans (SAPs), etc
Perform supplemental data reviews, ensure quality checking and reporting according to the study data validation specifications or data review plans
Development of EDC custom report specifications, SAS Clinical Programming report specifications and/or associated outputs as needed
Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the trial master file (TMF)
Qualification
Required
10+ years of relevant experience and has earned a BS or equivalent degree
Extensive knowledge and experience in clinical data management; Accountable for the data quality and data integrity for highly complex or pivotal clinical studies
Extensive knowledge reviewing study planning documents such as Edit Check Specs, UAT scripts, Data Management Plans. Comprehensive understanding of database and dictionary structures (MedDRA, WHO DRUG)
Demonstrated experience in managing multiple CROs/vendors with CRO outsourcing model as well as in-house model
Strong knowledge and experience in EDC and other key technologies (e.g., IXRS, data visualization)
Proficiency in CDISC standards (CDASH, SDTM, ADaM), and deep understanding of clinical research regulations and guidance, including FDA CFR and ICH GCP
Strong interpersonal, communication (oral and written), and organizational skills
Logical thinking, attention to detail and accuracy, ability to prioritize and work in a fast-paced environment
Company
Kardigan
Kardigan develops personalized medicines using AI and data to target and treat the root causes of cardiovascular diseases.
51-200 employees
H1B Sponsorship
Kardigan has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
Funding
Current Stage
Growth StageTotal Funding
$554MKey Investors
ARCH Venture Partners,Perceptive Advisors,Sequoia Heritage
2025-10-14Series B· $254M
2025-01-10Series A· $300M
Leadership Team
Brianne Jahn
Chief Financial Officer
Diane Hagerty
Chief Quality Officer
Recent News
2025-12-16
2025-11-19
Company data provided by crunchbase