Serves as the lead project or program data manager on Thrive development projects and in collaboration with external vendors with responsibility for managing the design, implementation, and maintenance of electronic case report forms, and electronic edit checks for new and ongoing clinical research studies.Additionally, responsibilities may include the design, development, implementation, and execution of data review plans to ensure the quality of collected clinical data, including oversight of multi-functional data review teams, management of electronic data received from specialty vendors (e.g., clinical laboratory, central image review), and the development of technical study documents and reports such as data transfer plans, annotated case report forms and database/data quality metrics.
Essential Duties and Responsibilities
include but are not limited to the following:
Serve as lead Data Management (DM) contact, and an active Study Team member, for assigned clinical studies.
Provide leadership and direction in management of third-party vendors such as CROs in support of timelines and data-related deliverables, and adherence to overall Thrive standards for consistency and efficiency.
Identify and troubleshoot operational problems, issues, obstacles, and barriers for study success based on metrics data, audit reports, and input from project team members and other stakeholders.
Regularly review clinical trial data within Veeva or Medidata Rave EDC to confirm data quality. Develop and execute internal procedures for data quality review and data acceptance prior to data analyses and/or database lock.
Work within and across functions to manage and optimize timelines and ensure that clinical data management deadlines are met and in high quality.
Work with database builders to develop EDC databases, Case Report Forms, edit checks, and reports, listings, and visualizations in support of protocol execution and study analyses. Conduct testing according to the UAT Plan.
Orchestrate seamless integration and functionality of additional data management technologies as needed, including randomization, trial supply management, e-consent, and patient facing clinical outcome assessment tools.
Review and provide feedback on draft protocols, Statistical Analysis Plans, CSRs and other clinical trial documents as required.
Train personnel on EDC, as needed.
Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
Support and comply with the company's Quality Management System policies and procedures.
Regular and reliable attendance.
Bachelor's degree or equivalent in a health-related field.
5+ years of experience in clinical data management in the pharmaceutical, biotechnology, and/or diagnostics industry in an FDA-regulated environment.
Proficiency in the area of clinical data collection, cleaning, and analysis.
Demonstrated excellence working in cross-functional, team-oriented environments.
Strong project management skills.
Extensive experience managing CROs and/or other data vendors.
Understanding of ICH and regulatory environment as it pertains to data management.
Proficiency working in Veeva or Medidata Rave EDC systems; experience using other integrated Veeva or Medidata products a plus.
Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
Authorization to work in the United States without sponsorship.
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company's affirmative action program are available to any applicant or employee for inspection upon request.