Clinical Data Manager

100% Remote
CONTRACT
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
Requirements
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
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.
If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/
Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.
If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/
Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.\"

Work arrangement
Yes