Ecocareers · 3 months ago
Senior Clinical Data Manager
Boston, MA
Full-time
Onsite
Senior Level
7+ years expEcocareers is a company seeking a Senior Clinical Data Manager to oversee data management activities throughout the lifecycle of clinical studies. The role involves ensuring data quality, developing key documentation, and collaborating with various stakeholders to meet study timelines and deliverables.
Staffing & Recruiting
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
Preferred
Experience in ophthalmology therapeutic areas
Familiarity with Case Report Form and Edit Check Specification development
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase