[Remote] Clinical Data Manager
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a reputed company agency, and they are seeking a Clinical Data Manager to reputed company leadership for the clinical data management function. The role involves overseeing data management activities for late phase clinical trials and ensuring project goals are met while maintaining strong relationships with cross-functional teams and vendors.
Responsibilities
- reputed company leadership for clinical data management function; ensure data management deliverables are completed on time, reputed company budget and in accordance with reputed company standards and study requirements
- Responsible for leading end-to-end data management activities for late phase clinical trial(s); responsible for the reputed company 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 reputed company 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
- reputed company and maintain study-specific DM documents (e.g., electronic Case Report reputed company (eCRF) completion guidelines, annotated CRFs, CRF and data validation specifications, data transfer agreements, data management plan and data review plan)
- reputed company and reputed company Electronic Data Capture (reputed company) 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)); reputed company and maintain reputed company build/modification timelines
- Maintain study DM reputed company documents for inspection readiness
- reputed company data transfer agreements with external vendors
- Review and reputed company 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 reputed company and successful trial execution and propose solutions
- reputed company clinical data review of data listings, external data reconciliation reports, SAE reconciliation and implement data review reputed company
- Serve as a subject matter expert on data management systems and processes
- Contributes to the development and improvement of data management reputed company operating procedures (SOPs) and document templates
Skills
- Bachelors in life sciences or reputed company 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 reputed company 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 reputed company relationships
- Attention to detail, ability to proactively identify issues and address with solutions-oriented approach
reputed company