Beacon Hill · 4 hours ago
Clinical Data Manager
United States
Contract
Remote
Senior Level, Lead/Staff
8+ years expBeacon Hill is a staffing agency seeking a Clinical Data Manager for a remote contract position. The role involves leading clinical data management activities for late-phase clinical trials, ensuring compliance with quality standards, and collaborating with cross-functional teams and vendors to meet project goals.
Staffing Agency
Hiring Manager
Shakira Irizarry
Responsibilities
Provide leadership for clinical data management function; ensure data management deliverables are completed on time, within budget and in accordance with quality standards and study requirements
Responsible for leading end-to-end data management activities for late phase clinical trial(s); responsible for the oversight of CRO and/or DM vendors to ensure that project goals are achieved and overseeing adherence to scope of work and service agreements
Represent data management in Study Management Team (SMT) meetings; proactively identify and communicate risks, suggest solutions and provide updates
Establish and maintain strong relationships with cross-functional teams, vendors and key stakeholders for successful execution of clinical trial
Collaborate with study statistician and statistical programmer to support production of clinical trial reports and other study deliverables
Develop and maintain study-specific DM documents (e.g., electronic Case Report Form (eCRF) completion guidelines, annotated CRFs, CRF and data validation specifications, data transfer agreements, data management plan and data review plan)
Lead and oversee Electronic Data Capture (EDC) build, modifications and deployment including creation and execution of User Acceptance Testing (UAT) plans and test scripts, and implementation of data integrations with external vendor data sources (e.g., Interactive Response Technology (IRT)); develop and maintain EDC build/modification timelines
Maintain study DM related documents for inspection readiness
Develop data transfer agreements with external vendors
Review and provide feedback on clinical documents (e.g., clinical protocols, statistical analysis plans, protocol deviation plans, vendor specifications)
Report data management metrics and trends; proactively identify barriers to timely and successful trial execution and propose solutions
Lead clinical data review of data listings, external data reconciliation reports, SAE reconciliation and implement data review strategy
Serve as a subject matter expert on data management systems and processes
Contributes to the development and improvement of data management standard operating procedures (SOPs) and document templates
Qualification
Required
Bachelors in life sciences or related discipline with 8 or more years of experience in clinical data management
Zelta experience Required
Requires extensive knowledge of clinical data management principles, clinical trials process and regulatory requirements
Excellent ability to manage competing priorities in a changing environment
Strong working knowledge of CDISC standards, FDA and ICH/GCP regulations and guidelines
Proficient on EDC configuration and design, testing and validation, data collection and data review process, and data standardization
Self-motivated and takes pride in your work
Results-oriented team player; enjoy working collaboratively with colleagues and building positive relationships
Attention to detail, ability to proactively identify issues and address with solutions-oriented approach
Company
Beacon Hill
Beacon Hill was founded to set a new standard in search, career placement and flexible staffing.
1001-5000 employees
H1B Sponsorship
Beacon Hill 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 (38)
2024 (94)
2023 (76)
2022 (60)
2021 (77)
2020 (86)
Funding
Current Stage
Late StageLeadership Team
Amber Leslie
Executive Assistant to CEO
Amy Van Sicklin
Chief Culture Officer
Recent News
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