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Associate Director, Clinical Data Management

South San Francisco, California, United States, Princeton, New Jersey, United States

About Us 

Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. It is our mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve. 

At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. Driven by patients and their families, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in being authentic—leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted. With an eagerness to learn, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to winning as a team with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to enable the impossible because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries.   

These values are the foundation of our work, empowering us to make a real difference, every day.  

 

Position Title: AD, Clinical Data Management

Department: Data Management

Reports To: Head of Data Management

 

Job Overview

Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will be responsible for ensuring high-quality management of clinical trial data in a rapidly evolving environment, in accordance with industry standards. The AD, DM will be responsible for executing DM activities and deliverables across multiple studies, overseeing the start-up and execution of multiple, complex trials with a CRO and supporting upcoming submissions. The individual will coordinate and manage daily data management and vendor oversight activities for multiple clinical trials to support both the internal project team and the CROs.

Essential Duties and 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 represents 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 COR/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 appropriate with management
  • Drive and lead the development of all data management actives 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)

 

Qualifications and Preferred Skills

  • 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.

Exact Compensation may vary based on skills, experience and location.

Pay range

$180,000 - $220,000 USD

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