Job Details

Role : Clinical Data Manager
Location: San Francisco, CA

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 reportsAccountable for overseeing data integrity, quality, and consistency at database lock.
Review case report forms for completeness and consistencyDevelop database clinical trial specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations.Reconcile electronic data transfers from vendors to PICICoordinate 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 codingAssist 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 auditCoordinate 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 databasesAssist in reconciling AE/SAE data in safety databasesParticipate in the preparation and presentation of data, when applicableEnsure data system compliance by following the established guidelines of national regulatory authorities.Participate in conference calls and/or meetings with vendorsConsult 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 mustEarly Phase I/II experience preferredProven 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 dataKnowledge of clinical data management practices and ability to apply knowledge and skills to recommend improvements in methodologyWorking 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 skillsSolid organizational skills including attention to detail and multi-tasking skillsClinical Research certification is a plus