YCCI Senior Data Manager

Position Focus :

The day-to-day requirements of this position include : 1). Serve as the project manager for the planning of data management tasks and deliverables for assigned studies.

Create and manage project plans and timelines. Monitor metrics and key performance indicators. 2). Manages cross-functional team expectations and provides issue / risk identification and escalation pathways.

Resolves complex project issues that involve representatives from multiple organizations. 3). Supervise and train junior data management staff.

4). Assists in the development and preparation of data management budgets. Assists with billing of data management activities.

5). Using a risk-based approach and operating according to regulatory requirements and Standard Operating Procedures, responsible for end-to-end clinical data management activities during study start up, study conduct, and study close out.

6). Develop and maintain electronic data capture systems per study protocols. 7). Write, maintain, and file documents including data management plans, data validation plans and specifications, data transfer agreements, reconciliation guidelines, CRF completion guidelines, training documents, mid-study changes, and SOPs and process documents.

8). Operating within the entire cross-functional team (including sponsor-investigator, study site(s), monitors, statisticians, and external collaborators), ensure data quality, completeness, and integrity for all assigned studies.

9). Maintain strong customer relationships with internal and external cross-functional team. 10). Generate and review listings for routine and ad hoc reporting to sponsor-investigator, regulatory authorities, funding agencies and collaborators, and data and safety monitoring groups.

11). Suggest and / or implement data management process improvements. 12). Ensure study team is trained on EDC systems and study-specific data collection;

manage EDC user access. 13). Data reconciliation, including serious adverse events and samples shipped to external labs.

9). Data mapping, curation, and sharing to public repositories. 14). Ensure all DM activities and communications are compliant with study-specific blinding / masking plans;

as required, ensure de-identification of data. 15). May perform other duties as assigned. 16). Familiar with a variety of the field's concepts, practices, and procedures and relies on experience and judgment to plan and accomplish goals.

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

Essential Duties

1. Consult to faculty and researchers regarding their projects and needs related to data infrastructure and processes. Discuss suggested project designs solutions and develop requirements for new university needs and capacities, where Work with procurement and legal teams to assist researchers to locate and acquire more complex data resources.

Serve as resource to university on improving these processes as needs Design plans and protocols for maintenance and management of data through all phases of research lifecycle;

review progress and assure accuracy and compliance of data being acquired and Provide technical support and computing assistance to faculty and researchers in the university’s social science departments and Investigate new computing technologies (in areas such as hardware, software, and networking, depending on the candidate's interests and expertise).

5. Implement statistical methods for descriptive and causal designs and learn new research methods as Develop technical solutions for archiving and dissemination solutions for research across Serve as mentor and resource to less experienced members of team.

8. May perform other duties as assigned.

Required Education and Experience

Bachelor's Degree in a related field and minimum of 7 years of related experience in academic or scientific research support or an equivalent combination of education and experience.

Required Skill / Ability 1 :

Demonstrated experience performing and managing clinical data activities throughout the entire DM lifecycle (start-up, conduct, and close-out).

Required Skill / Ability 2 :

Attention to detail and highly organized.

Required Skill / Ability 3 :

Ability to work independently and problem-solve as well as enlist the support of other team members within the organization.

Required Skill / Ability 4 :

Strong interpersonal skills to interact effectively and represent the school well with faculty, study team, sponsor, funding agency, and external collaborators.

Required Skill / Ability 5 :

Knowledge of medical and / or laboratory terminology acquired through education, training, or experience.

Preferred Education, Experience and Skills :

Masters in related field; CCDM. Experience with clinical trials in an academic / sponsor / CRO environment, and investigator-initiated and oncology trials.

Intermediate SAS / R programming skills. Experience using patient profile / review software. Microsoft Excel / Project / Visio.

Experience with CDISC standards and medical coding. Experience creating and managing studies in REDCap and other EDC systems.

Weekend Hours Required?

Evening Hours Required?

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.

COVID-19 Vaccine Requirement

The University maintains policies pertaining to COVID-19. All faculty, staff, students, and trainees are required to comply with these policies, which may be found here :

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.