Assistant Director of Clinical Data Management

Position Focus :

Lead all Clinical Data Management (CDM) activities for Yale Cardiovascular Research Group (YCRG) studies under the leadership of the YCRG Director.

Provide CDM expertise for multiple projects, including multi-site projects, to meet the needs of clinical research studies, including overseeing data standards development, validation activities, monitoring project timelines, and communicating with stakeholders.

Supervise, train, mentor, and develop Data Management team to build skills and meet client expectations. Supervise and create database specifications and Electronic Data Capture (EDC) Case Report from study builds.

Develop, implement, and maintain libraries to support both industry and YCRG internal data standards (, CDISC SDTM). Work collaboratively with internal and external teams to implement eSource data projects ( integration of EHR and other external data sources).

Identify opportunities to build process efficiencies, and improve and expand process documentation (, Standard Operating Procedures), and increase data quality.

As an integral member of the YCRG academic research organization, the position ensures an environment that promotes quality research management and facilitates interdisciplinary research activities.

The Assistant Director of Clinical Data Management further promotes a compliant culture appropriate for a large physician organization with clinical affiliations across multiple academic and non-academic medical centers including coordinating initiatives that identify, prevent, and appropriately mitigate multisite trials and FDA Part 11 research system compliance risk, and ensure that YSM, YM, YNHH compliance efforts align with the university's broader compliance strategy and framework.

The position coordinates effectively with other units / departments within the university such as Project Management (YCRG), Biostats (YCRG and YCAS), and EHR research team (JDAT);

clinical trails sponsors and vendors; and with research teams at other academic centers.

Familiarity with a variety of the field's concepts, practices, and procedures and relies on experience and judgment to plan and accomplish goals.

This position may require remote work on either a regular or temporary, part-time or full-time basis.

Essential Duties

1. Oversees the execution and implementation of detailed project plans in concert with stakeholders. 2. Manages several routine projects simultaneously and ensures that the design, testing, training, documentation and prioritization objectives are met.

3. Assists in refining and re-sequencing during the implementation and execution phases of assigned projects, as needed.

4. Works closely with business analysts, technical professionals, end users and project stake holders during the requirements, solutions design and implementation phases to develop detailed project plans for implementation.

5. Works on risk assessment, communication planning, development of performance metrics, and project entry criteria. 6. Creates detailed project plans including timelines, budgets, and resource allocation to ensure successful project completion.

7. Manages client expectations and provides issue / risk identification and escalation pathways. 8. May supervise the implementation team of cross-functional project and technical resources.

9. Designs, develops, and executes communication systems to ensure effective exchange of information between project stakeholders, senior management, and staff.

10. Resolves complex project issues that involve representatives from multiple organizations. 11. Complies with standard policies and procedures.

12. May supervise and train junior project managers. 13. May perform other duties as assigned.

Required Education and Experience

Bachelor’s Degree in a related field and five years of related, demonstrated work experience or equivalent combination of education and demonstrated experience.

Required Skill / Ability 1 :

Demonstrated experience working as a Data Manager for an industry Sponsor or CRO or ARO managing FDA and / or EMA-regulated clinical trials.

Extensive experience in all facets of study start-up / activation, on-going management of multiple protocols, study close-out, and regulatory submission.

Ability to manage and lead a team.

Required Skill / Ability 2 :

Demonstrated experience with EDC, CTMS, and eTMF systems. Knowledge of 21 CFR Part 11 requirements.

Required Skill / Ability 3 :

Demonstrated experience in creating database specifications and building studies in one or more Electronic Data Capture (EDC) systems ( Medidata Rave, Oracle InForm, IBM Clinical Development, Medrio, REDCap, etc.)

Required Skill / Ability 4 :

Comprehensive technical knowledge of FDA and EMA clinical data standards and regulations, data management practices (GCDMP), and medical coding (MedDRA, WHODrug).

Knowledge of SDTM data standards (CDASH, SDTM, ADaM).

Required Skill / Ability 5 :

Demonstrated experience with project management and computer validation projects. Professionalism, maturity, good judgment, and ability to work with confidential material.

The ability to work remotely; including an adequate workspace with internet access.

Weekend Hours Required?

Occasional

Evening Hours Required?

Occasional

Drug Screen

Health Screening

Background Check Requirements

All candidates for employment will be subject to pre-employment background screening for this position, which may include motor vehicle, DOT certification, drug testing and credit checks based on the position description and job requirements.

All offers are contingent upon the successful completion of the background check. For additional information on the background check requirements and process visit "Learn about background checks" under the Applicant Support Resources section of Careers on the It's Your Yale website.

Posting Disclaimer

The intent of this job description is to provide a representative summary of the essential functions that will be required of the position and should not be construed as a declaration of specific duties and responsibilities of the particular position.

Employees will be assigned specific job-related duties through their hiring departments.