Back to jobs
New

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 Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve.
 
Led by Tassos Giannakakos, Jay Edelberg, M.D. and Bob McDowell, Ph.D., Kardigan’s co-founders have reunited after leading MyoKardia to discover and develop mavacamten, the first cardiac myosin inhibitor, resulting in an acquisition by Bristol Myers Squibb in 2020.
 
We have a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team that is driven to improve the lives of patients.
 
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: Associate Director, Data Management

Department: Clinical Data Management

Reports To: Head of CDM

Location: Princeton, NJ or South San Francisco, CA – On-site 4 days per week (Mon to Thurs)

 

Job Overview 

Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will be responsible for ensuring highquality 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 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) 

 

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

$176,000 - $247,000 USD

Create a Job Alert

Interested in building your career at Kardigan? Get future opportunities sent straight to your email.

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Education

Select...
Select...
Select...
Select...
Select...
Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Kardigan’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.