Beacon Hill ยท 2 weeks ago
Senior Manager, Clinical Data Management
Newton, MA
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expBeacon Hill Staffing Group is a company focused on providing coordinated staffing solutions with a commitment to innovation and success. The Senior Manager, Clinical Data Management is responsible for leading complex studies and mentoring junior staff, ensuring quality in all clinical data management activities and overseeing multiple aspects of study management.
Staffing Agency
Responsibilities
Effective in identifying potential Out of Scope activities prior to vendor beginning work, modify/update study contracts while staying within budget, with guidance by a Director of CDM as needed
Provide leadership and direction to junior staff and peers, by mentoring, training and guiding a study team to meet study deliverables within the ICH/GCP guidance
Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports and input from project team members
Ability to recognize, evaluate and develop plans to mitigate risk as needed from study initiation to study close-out
Perform all aspects of Clinical Data Management as related to processing and QC of the data, monitor study status, (e.g. Enrollment, eCRFs, Query Aging, etc.) and provide status reports to the team and Director CDM throughout the study
Work in conjunction with external vendors, CRO(s), CDM Team, Clinical Team to Review/Create (electronic) Case Report Forms and annotated Case Report Forms per Protocol for assigned study (s)
Co-create and review DM SOPs and Work Instructions in accordance with current GCP and ICH guidelines
Review eCRF completion guidelines, data management plan (DMP), data validation specifications (DVS, e.g. edit checks), SAE Reconciliation Plan, Data Cleaning Plan and other DM related documentation in conjunction with CRO(s), providing feedback and guidance where necessary
Assist CRO(s) with cleaning data for Interim Analysis, Database lock, and any ad hoc requests
Liaise with external vendors (Central Labs) in support of timelines and data related deliverables; may also liaise with clinical monitoring in the data management function
Develop data transfer agreements and specifications with various vendors
Review validation of database structure (DVS), data capture screens, code lists, edit checks, listings and other functions in EDC (e.g. User Acceptance Testing (UAT))
Review and provide feedback on Protocols, Statistical Analysis Plans and CSRs
Represent CDM on project teams, at Face-to-Face Meetings, Conferences, etc
Work in conjunction with internal and external Clinical Operations, Research, Medical Monitoring, Medical Writing, Clinical Data Management and other operational departments to ensure accurate, efficient, and complete data collection
Use industry standard conventions, tools, references and processes in support of medical coding
Ensures all CDM procedures are executed with high attention to detail, accuracy and timelines
Ability to create, review and approve study timelines
Monitor timelines and ensure that clinical data management timelines are met with quality
Ensure adherence to Data Management standards
Other duties as assigned
Qualification
Required
10-12+ years of experience
Experience in Oncology
Experience in Medidata Rave
Preferred
Experience in elluminate
Benefits
Medical
Dental
Vision
Federal and state leave programs as required by applicable agency regulations
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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