Clin Research Data Mgr

GENERAL PURPOSE

The Sr. Clinical Research Data Analyst Manager, under the direction of the Executive Director and URCC NCORP Research Base MPIs and with latitude for independent judgement, responsible for all aspects of day-to-day data management operations for a portfolio of large, multi-site, cancer control and cancer care delivery clinical trials in a national network of over 600 community oncology practices and overseeing high quality data from hundreds of clinical research coordinators and data managers nationwide. URCC's clinical trial portfolio includes prospective, cohort, longitudinal as well as Phase II - III randomized clinical trials.

The Sr. Clinical Research Data Analyst Manager oversees a team of approximately 6 data coordinators and will delegate their work assignments and will manage employee performance. Sr. Clinical Research Data Analyst Manager works as an integral part of the cross-functional team throughout the lifecycle of the research study from study development through database lock, final analysis, and study closeout. The Sr. Clinical Research Data Analyst Manager is responsible for the completeness and accuracy of the study data in the electronic database and serves as primary point of contact with internal and external project teams on all aspects of data collection to ensure high quality data for URCC NCORP Research Base in network studies.

JOB DUTIES AND RESPONSIBILITIES:

Management of Data Management Team

• Orientation, training, documentation of core competencies, certi¿cation mandates, safety/responsible conduct of research education and performance evaluations, including the following tasks:

• Manages the day-to-day operations, issue resolution, and supervision of assigned sta¿.

• Completes annual performance evaluation process; ensures fair and accurate evaluation following standards of performance. Provides counseling and constructive feedback for employee development.

• Addresses disciplinary issues.

• Carries out all actions as to hiring, transfers, promotions, and terminations of clinical research data sta¿.

• Performs QA and supervision of team, clinical trial project timelines, adherence to procedures, and all other activities.

• Participates in sta¿ recruitment and retention initiatives. Participates in Research Base wide team building and training activities.

Oversight of Data Management Operations as sponsor/coordinating center for national, multi-site clinical trials from development to close-out.

• Collaborates with cross-functional teams and facilitates the design, documentation, testing, and implementation of clinical data collection studies.

• Interfaces with Study Chairs, biostatisticians, IT and Project Management to create and/or reviews study-specific Case Report Forms (CRFs) using prior knowledge, protocol-specific information, and URCC NCORP Research Base standards; works efficiently to incorporate core clinical team input and produce CRFs in a timely manner.

• Determines data collection requirements based on the study protocol and system knowledge; makes recommendations based on previous experience.

• Proactively identifies potential data management issues/risks and recommends/implements solutions.

• Manages data collection and data validation at participating clinical sites.

• Manages training documentation and provides oversight of system user access; may serve as a resource for troubleshooting system issues.

• Creates and/or reviews study data management documents according to instructions (e.g., Data Management Handbook, Data Management Plan, Data Validation Plan, URCC REDCap Users Guide)

• Independently monitors own activities and project status for successful project deliverables according to timelines.

• Manages the development of the data validation plan and ensures associated data checks are completed in accordance with project timelines.

• Oversees data review and query identification/resolution; manages data quality metrics for a protocol or project; may conduct or review data quality checks.

• Mentors staff on URCC and project-specific clinical data management processes; provides data management expertise.

Primary Liaison representing Data Management to URCC NCORP Research Base Leadership, Study Chairs, Scientific Collaborators (internal and external), NCI, NCORP community partners.

• Manages data reports and creates data summaries or presentations to ensure URCC Leadership and Study Chairs are kept updated on data collection and quality status for all research studies.

• Assumes leadership in protocol data timelines, keeping all key stakeholders appraised of study progress.

• Attends and contributes to project and department meetings; serves as

• Data Management representative on external calls as required.

• Leads URCC Data Management as the subject matter expert for clinical research data collection, processing, QA, storage, security and sharing per institutional policies, GCP, and all applicable federal regulations.

Professional Development

• Maintain working knowledge of the specialty as well as the current regulations, industry standards and good clinical practices for conducting individual protocols.

• Attend meetings and pertinent seminars in academic settings.

Other projects and duties as assigned.

QUALIFICATIONS:

• Bachelor's Degree in relevant field, (e.g. Data Science, Biostatistics, computer sciences, information technology) required

• Master preferred in relevant field (e.g. Data Science, Biostatistics, computer sciences, information technology) required

• 5 years clinical research or relevant work experience or equivalent combination of education and experience required

• 1 year leadership experience preferred

• Fluent English language skills (oral and written) required.

• Knowledge of GCP and applicable regulatory guidelines required

• Experience in clinical electronic data capture (EDC) systems required

• Proficient use of Microsoft Office suite required

• Proven data management skills required

• Excellent verbal and written communication skills required

• Self-motivated and proactive required

• Strong attention to detail, adaptable, and flexible required

• Reliable and collaborative team member required

• Demonstrated leadership skills and competency. Ability to effectively manage complex research protocols/procedures required.

• Pro¿ciency in medical terminology, the clinical research process and applicable regulatory guidelines and standards required.

• Pro¿ciency in managing multiple and competing priorities/demands required.

• Clinical Research Certification by the Association of Clinical Research

• Professionals (ACRP) or Society of Clinical Research Associates (SOCRA) or other applicable preferred

The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University's mission to Learn, Discover, Heal, Create - and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.

How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

Pay Range

Pay Range: $62,200 - $93,300 Annually

The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

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