Lead Clinical Data Manager – UCSD Health Jobs

Job Description:

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.

Job Responsibilities:

• 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.

Job Requirements:

• Ability to facilitate team meetings.
• Comprehensive understanding of clinical drug development process.
• Understanding of ICH and regulatory environment as it pertains to data management.
• Three years of clinical data management experience in pharmaceutical industry, contract research organization and/or academic research organization.

Qualification & Experience:

• Bachelor’s degree in related area and/or equivalent experience/training.
• Five or more years of clinical data management experience.
• 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.

Job Details:

Company: University of California San Diego

Vacancy Type:  Full Time

Job Location:  San Diego, CA, US

Application Deadline: N/A

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