111481 - Lead Clinical Data Manager
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#111481 Lead Clinical Data ManagerFiling Deadline: Thu 9/23/2021
For the safety and well-being of the entire university community, the University of California requires, with few exceptions, that all students, faculty and staff be vaccinated against the COVID-19 virus before they will be allowed on campus or in a facility or office. For more information visit: https://ucnet.universityofcalifornia.edu/news/2021/07/ucs-covid-19-vaccine-policy.html
Special Selection Applicants: Apply by 9/23/21. Eligible Special Selection clients should contact their Disability Counselor for assistance.
The Alzheimer’s Disease Cooperative Study (ADCS) is a growing, progressive, multi-center clinical trials consortium created to provide an operational framework for large scale Alzheimer’s disease research projects and consists of 7 cores, 22 committees, 35 research sites that are members of the consortium/Steering Committee, and an additional 40 or more research sites located across the U.S. and Canada that participate in one or more trials coordinated by the ADCS. The ADCS is funded by federal and private grants, contracts, and gift support.The ADCS is a unique center (ARO) at UCSD, which collaborates with internal and external stakeholders to forward its mission to discover, develop, and test, new drugs to treat patients with AD. Annual funding for the ADCS grant is approximately $10 million, with additional funding through industry partnerships totaling over $30 million.
Lead Data Manager oversees data operations tasks for a team of data managers/analysts from study start-up to database lock, to produce a clean and analyzable database.
Serves as the Data Management (DM) lead for internal/client team meetings and communication. Meet with DM team members on a regular basis to ensure milestones meet timelines and quality deliverables. Provides training of other DM staff on project specific processes. Assists with the validation of the EDC system (CRF content & edit checks), reports using EDC reporting and ad-hoc query tools, and associated change control. Creates the data review plan for studies and develops standards. Oversees the issuing of queries and review query responses with the highest level of quality based upon the data review plan. Drafts the eCRF design, edit check specification and DM listings. Ensures all database modifications are communicated with team and implemented effectively.
Creates and maintains documentation for studies/programs/departmental standards including data management plan (along with supporting DM documents), CRF completion guidelines, trial design document, edit specifications, reconciliation guidelines and report specifications.
Receives assignments in the form of objectives with goals and the process by which to meet goals. Provides direction to staff according to established policies and management guidance. Administers policies that directly affect subordinate staff. Recommends changes to department policies and practices. Identifies risks and responds accordingly. Provide priority setting and work flow analysis.
Nine years of related experience, education/training, OR a Bachelor’s degree in related area plus five years of related experience/training.
Three years of clinical data management experience in pharmaceutical industry, contract research organization and/or academic research organization.
Demonstrated extensive data management skills and thorough knowledge of the data management process (e.g., therapeutic area, deep understanding in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology)
Requires critical thinking, persuasion / negotiation, mentoring, leadership / management, problem solving, human resources policies and procedures relating to management responsibilities, verbal and written communication, quantitative abilities, analytical, strong technical database systems skills.
Demonstrated skill in managing technical staff. Ability to lead Data Management team members and work well with technical and clinical team members.
Knowledge of data management systems, practices and standards.
Requires knowledge of database management systems.
Experience with SDTM/CDASH.
Ability to collaborate with entire clinical team (Clinical Operations, CRAs, Safety, Biostatisticians, etc.) and answer questions related to specific data collection concerns.
Proficiency in computer programs or project management tools (Excel, Word, JIRA, MS Project, Confluence etc.)
Must have knowledge of location and system protocols and procedures for budget and account management.
Knowledge of relevant rules and regulations.
Excellent oral and written communication skills.
Excellent organizational and analytical skills.
Ability to facilitate team meetings.
Comprehensive understanding of clinical drug development process.
Understanding of ICH and regulatory environment as it pertains to data management.
- Experience with OmniComm TrialMaster preferred.
- Well-versed in EDC Systems; preferred proficiency in OmniComm TrialMaster.
- Strong project management; expertise in metrics analysis and reporting methodologies.
- Employment is subject to a criminal background check.
- Must be able to work various hours and locations based on business needs.
Job offer is contingent on successful engagement in the UC COVID-19 Vaccination program (fully vaccinated with documented proof or approved exception/deferral).
UC San Diego Health is the only academic health system in the San Diego region, providing leading-edge care in patient care, biomedical research, education, and community service. Our facilities include two university hospitals, a National Cancer Institute-designated Comprehensive Cancer Center, Shiley Eye Institute, Sulpizio Cardiovascular Center, and several outpatient clinics. UC San Diego Medical Center in Hillcrest is a designated Level I Trauma Center and has the only Burn Center in the county. We invite you to join our dynamic team!
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UC San Diego Health is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, age, protected veteran status, gender identity or sexual orientation. For the complete University of California nondiscrimination and affirmative action policy see: http://www-hr.ucsd.edu/saa/nondiscr.html
UC San Diego is a smoke and tobacco free environment. Please visit smokefree.ucsd.edu for more information.