Address
Form of work Responsibilities:
- Mentor junior DMs and other project team members on areas related to data management; train site personnel on EDC system, eCRF, and additional tools such as ePRO when needed.
- Make strategic decisions and recommendations related to the data that benefit the project.
- Ensure compliance with standard operating procedures.
- Manage database design, development, testing and system validation for new studies.
- Lead design of eCRF and review with study team to ensure design is robust and minimizes risk; work particularly closely with the lead statistician to translate study outcomes, protocol guidelines and prior build experience into eCRF design; lead electronic data capture (EDC) system design and validation, including oversight of all database specifications (eCRF design, edit checks, external data transfers, IWRS integration, etc.).
- Create and implement data management plans (DMPs), data validation plans (DVPs), and other study documents; ensure that the project team is trained and has a shared understanding of how data will be cleaned and each person's role in the process.
- Review and approve creation of edit checks, including validation of simple univariate and multivariate edit checks, programming of complex multivariate validation checks, and UAT of system edit checks.
- Create and maintain data transfer agreements with external vendors and leads external data cleaning activities.
- Review recommended data management tools and select the best tools for the study, leveraging study metadata and automation to minimize manual error and facilitate deeper understanding of study data.
- BA/BS degree along with at least 5 years of Clinical Data management experience which includes 3 years in a DM lead role and 1-2 years of experience in developing clinical trials databases in a commercially available EDC system (e.g. RAVE, Medrio, Red Cap, Veeva); Medidata RAVE build certification 5.6.4 a plus.
- Strong analytical skills with a demonstrated ability to identify trends in data and use insights to manage risks and drive decisions; strong technical acumen, with experience selecting, customizing, and using various tools for data base build and data cleaning; demonstrated programming skills, particularly experience in SAS or Business Objects IX, is a plus.
- Strong Communicator: Demonstrate written, verbal and presentation skills to help showcase the successes of your work and Rho's.
- Committed to Quality: Every job at Rho requires an attention to detail, a deep understanding of our high-quality scientific standards, and an ability to care about every outcome.
- High-Character: Contribute to our collaborative culture with honesty and integrity. At Rho, we value a strong team spirit highlighted by loyalty, accountability, and mutual trust. We work smart together, we work hard together, and we laugh together. We take responsibility for our actions, forgive honest mistakes and respect one another.
