Overview
Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. Kardigan’s mission is to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve. Led by co-founders with a track record in cardiac drug development, Kardigan has a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team focused on improving patients’ lives. Our values guide how we work, interact, and achieve our goals: driven by patients and their families; being authentic; eagerness to learn; winning as a team; and enabling the impossible to advance scientific discoveries.
These values are the foundation of our work, empowering us to make a real difference every day.
Position
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 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 for one or more studies Work collaboratively with stakeholders such as Medical Affairs, Regulatory, PV, CRO vendors; provide guidance on clinical data management to CDM staff, study teams, vendors, and management; 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 Ensure data quality and timeliness of CDM deliverables; coordinate with all functions to drive data cleaning Review, track, and report status of data management projects to senior leadership; identify challenges and risks and escalate as appropriate Lead development of data management activities including databases and eCRF design, DB validation, UAT, data management plans, manuals and documents maintenance Oversee data transfers setup and validation, including review of test data transfers for consistency with data transfer agreements Participate in study document reviews (e.g., Study Protocols, Management Plans, SAPs) Perform supplemental data reviews; ensure quality checking and reporting per data validation specs Development of EDC report specifications and associated outputs as needed Maintain data integrity in compliance with GCP and regulatory requirements; document in the TMF
Qualifications and Preferred Skills
10+ years of relevant experience and a BS or equivalent degree Extensive knowledge in clinical data management; accountable for data quality and integrity for complex or pivotal studies Experience with planning documents (Edit Check Specs, UAT scripts, DMPs); understanding of database structures (MedDRA, WHO DRUG) Experience managing multiple CROs/vendors in outsourcing and in-house models Strong knowledge of EDC and technologies (IXRS, data visualization) Proficiency in CDISC standards (CDASH, SDTM, ADaM); understanding of FDA CFR and ICH GCP Strong interpersonal, communication, and organizational skills Attention to detail, ability to prioritize, and the ability to work in a fast-paced environment
Exact Compensation may vary based on skills, experience and location.
Pay range:
$176,000 - $247,000 USD
Equal Opportunity
Disability Status and voluntary self-identification information is requested in accordance with applicable laws and company policy. The information collected is used for equal opportunity monitoring and to improve our hiring processes. Participation is voluntary and confidential.
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Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. Kardigan’s mission is to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve. Led by co-founders with a track record in cardiac drug development, Kardigan has a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team focused on improving patients’ lives. Our values guide how we work, interact, and achieve our goals: driven by patients and their families; being authentic; eagerness to learn; winning as a team; and enabling the impossible to advance scientific discoveries.
These values are the foundation of our work, empowering us to make a real difference every day.
Position
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 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 for one or more studies Work collaboratively with stakeholders such as Medical Affairs, Regulatory, PV, CRO vendors; provide guidance on clinical data management to CDM staff, study teams, vendors, and management; 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 Ensure data quality and timeliness of CDM deliverables; coordinate with all functions to drive data cleaning Review, track, and report status of data management projects to senior leadership; identify challenges and risks and escalate as appropriate Lead development of data management activities including databases and eCRF design, DB validation, UAT, data management plans, manuals and documents maintenance Oversee data transfers setup and validation, including review of test data transfers for consistency with data transfer agreements Participate in study document reviews (e.g., Study Protocols, Management Plans, SAPs) Perform supplemental data reviews; ensure quality checking and reporting per data validation specs Development of EDC report specifications and associated outputs as needed Maintain data integrity in compliance with GCP and regulatory requirements; document in the TMF
Qualifications and Preferred Skills
10+ years of relevant experience and a BS or equivalent degree Extensive knowledge in clinical data management; accountable for data quality and integrity for complex or pivotal studies Experience with planning documents (Edit Check Specs, UAT scripts, DMPs); understanding of database structures (MedDRA, WHO DRUG) Experience managing multiple CROs/vendors in outsourcing and in-house models Strong knowledge of EDC and technologies (IXRS, data visualization) Proficiency in CDISC standards (CDASH, SDTM, ADaM); understanding of FDA CFR and ICH GCP Strong interpersonal, communication, and organizational skills Attention to detail, ability to prioritize, and the ability to work in a fast-paced environment
Exact Compensation may vary based on skills, experience and location.
Pay range:
$176,000 - $247,000 USD
Equal Opportunity
Disability Status and voluntary self-identification information is requested in accordance with applicable laws and company policy. The information collected is used for equal opportunity monitoring and to improve our hiring processes. Participation is voluntary and confidential.
#J-18808-Ljbffr