Katalyst CRO · 1 day ago
Senior Clinical Data Manager
San Francisco, CA
Contract
Onsite
Senior Level
7+ years expKatalyst CRO is seeking a Senior Clinical Data Manager to oversee data management activities throughout the study lifecycle. The role involves representing data management in study meetings, managing study timelines, and ensuring data quality from service providers.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Represent Data Management in study team meetings, providing metrics and guidance on data-related issues
Oversee Data Management activities from study start-up to close-out
Develop and manage study timelines and ensure the quality and timeliness of data from service providers (e.g., Central Reading Centers, Labs, Medical Coders)
Author key documents, including Data Management Plans, Data Review Guidelines, eCRF Completion Guidelines, and study timelines
Prepare training materials for Investigator Meetings, internal teams, and site staff
Maintain all Data Management project documentation in an audit-ready manner
Support Lead Clinical Programmers in developing and managing Data Transfer Agreements
Lead regular data review across studies, identifying quality issues, trends, and outliers, and generate queries as needed
Reconcile data from external sources
Assist in creating CRF and Edit Check Specifications
User Acceptance Testing (UAT) of clinical databases, including EDC systems
Manage EDC User Access for all assigned studies
Provide day-to-day support to Clinical Study Teams to ensure data is reviewed and discrepancies are resolved
Collaborate with internal stakeholders to meet study timelines and deliverables
Work with Clinical Programming to produce reports for efficient data review and cleaning
Facilitate cross-functional Data Management meetings with Study Managers, Project Managers, Programming, and Regulatory teams
Review study protocols and provide feedback on data collection methods
Participate in updating Data Management standard operating procedures, work instructions, and templates
Contribute to the development and improvement of departmental processes
Qualification
Required
Bachelor's degree or higher in biological science, nursing, or a related health field preferred
Minimum of 7 years of experience in clinical data management, preferably within the pharmaceutical or medical device industry
Strong understanding of clinical trial processes, FDA/ICH guidelines, and Good Clinical Data Management Practices (GCDMP)
Hands-on experience with Electronic Data Capture (EDC) systems such as MedNet, Rave, and Veeva Vault EDC
Proficiency in data review and use of reporting/analytics tools
Excellent project management and documentation skills, with experience writing Data Management Plans, Data Review Guidelines, and study timelines
Strong verbal and written communication skills
Ability to manage multiple clinical studies and tasks simultaneously
Knowledge of CDISC Standards (CDASH, SDTM)
Problem-solving skills and flexibility in responding to business needs
Ability to identify and mitigate risks to data quality proactively
Experience in ophthalmology therapeutic areas
Familiarity with Case Report Form and Edit Check Specification development
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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