Associate Director, Clinical Data Management - Kardigan

Position Title: Associate Director, Data Management

Department: Clinical Data Management

Reports To: Director of Clinical Data Management

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

Job Overview 

Reporting to the 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 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.