Clinical Data Manager
Clinical Development | San Francisco, Ca | Full Time
Overview of the Role
Key to the success of this effort will be the conduct of single- and multi-center clinical trials. The Parker Institute will conduct early phase investigator-initiated trials as well as partner with biotech and pharmaceutical companies on industry-sponsored trials. The Clinical Data Manager (CDM) is responsible for working closely with scientists at member institutions as well as external stakeholders, vendors, and PICI staff to plan, staff, implement, and evaluate collaborative clinical trials across the consortium.
The CDM is responsible and accountable for managing all aspects of clinical data, establishing and maintaining policies and procedures for gathering, analyzing, and reporting clinical data. Working within a matrix environment, the CDM works closely with functional groups to ensure work for individual trials is uniform, complete, and successfully delivered. The CDM must be experienced in all phases of the clinical research project lifecycle and possess a thorough understanding of cross-functional research processes impacting clinical data management.
Reporting Structure and Team
The Clinical Data Manager reports to the Sr. Clinical Data Manager and is a key member of the Clinical Development team. This role requires an on-site presence.
Essential Job Functions
- Coordinate the centralized data review activities in support of monitoring, working closely with CRAs to ensure data entry and query resolution timelines are met
- Works closely with Informatics team to generate data retrievals and summaries, including query reports
- Accountable for overseeing data integrity, quality, and consistency at database lock
- Review case report forms for completeness and consistency
- Develop database clinical trial specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations
- Reconcile electronic data transfers from vendors to PICI
- Coordinate user acceptance testing (UAT) and eCRF build and validation documents, including but not limited to, edit check document, issue logs and UAT summary report
- Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and/or final database lock, including but not limited to, data reconciliation and /or coding
- Assist in defining and/or creating data listings, summary table validations, data specifications and/or process data transfers in preparation for statistical review and/or data management audit
- Coordinate the archiving of study databases and related documents
- Perform close-out audits, as specified, for closing out trials in EDC or other clinical data management databases
- Assist in reconciling AE/SAE data in safety databases
- Participate in the preparation and presentation of data, when applicable
- Ensure data system compliance by following the established guidelines of national regulatory authorities
- Participate in conference calls and/or meetings with vendors
- Consult with team members to solve operational or data problems
Knowledge, Skills, and Experience
- The CDM position Bachelor’s degree preferred and at least 3 years of relevant work experience in clinical research operations, project management, study start up, data collection and review or related field
- Oncology experience is a must
- Early Phase I/II experience preferred
- Proven ability to perform all commonly applicable functions for this position
- Proficiency utilizing EDC systems (Medidata preferred) and/or Clinical Trial Management systems to capture study data
- Knowledge of clinical data management practices and ability to apply knowledge and skills to recommend improvements in methodology
- Working knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical Research, Clinical Trial processes and related regulatory requirements and terminology
- Advanced ability to effectively manage and support one or more projects with competing timelines to meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities.
- In depth, critical thinking skills to evaluate issues and identify a potential solution. Ability to creatively address complex or new problems.
- Advanced communication skills; includes verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Clear and concise communicator.
- In depth ability to work collaboratively with other cross-functional teams. In depth ability to interface, collaborate and influence / persuade other members of an extended study team.
- Excellent written and verbal communication skills
- Solid organizational skills including attention to detail and multi-tasking skills
- Clinical Research certification is a plus