About the Opportunity
We are currently partnered with a full-service pharmaceutical company that’s currently in need of a Sr/Principal Clinical Data Manager. This role is responsible for all data management activities from start-up through closeout of study, and will represent data management in meetings and providing status updates and metrics as needed. This is a fantastic opportunity to advance your career in the field of oncology with a growing organization.
The annual base salary range is $120,000 to $130,000. Actual compensation offered to the successful candidate may vary from posted hiring range based upon geographic location, work experience, education, and/or skill level, among other things. Details about eligibility for bonus compensation (if applicable) will be finalized at the time of offer.
Job Responsibilities
- Critically review protocols and provide feedback as it pertains to data collection and data management activities
- Contribute to the design of study databases, case report forms (CRFs) and edit checks
- Develop and maintain proper study documentation throughout the lifecycle of a study, to include, but not limited to Data Management Plans, (DMP), eCRF Completion Guidelines, Database Specifications, Edit Check Specifications, and UAT Test Plans
- Create and validate standard, study specific, and ad hoc study reports
- Develop training material and provide electronic data capture (EDC) system training for internal users and site personnel
- Perform serious adverse event (SAE) reconciliation between EDC and safety database
- Perform coding and review auto-coded terms within EDC using MedDRA and WHODrug dictionaries
- Ensure that all data management activities leading to database lock are completed; work with the clinical team as needed to ensure timely database lock
- Perform data transfers from EDC to sponsors
- Interact with third-party vendors, such as central laboratories, to carry out data management tasks
- Communicate project statuses and key issues to CPM and study team as needed
- Participate in cross functional team meetings as requested
Job Requirements
- Bachelor’s Degree in related field
- Minimum of 5+ years of Biopharmaceutical/CRO experience
- Knowledge of industry standards, such as ICH guidelines, CDASH, 21 CFR Part 11, and FDA guidelines
- Experience with clinical databases such as Medrio, OpenClinica, Oracle
