We are seeking a fully remote, part-time (20 hours/week) Clinical Data Manager who will be responsible for all aspects of the data management process from system set-up, UAT through database lock.
PRINCIPAL ROLES / RESPONSIBILITES:
· Represent data management in study team meetings.
· Manages data management timelines to coordinate and synchronize deliverables with the overall study timelines.
· Leads the CRF and EDC build process, working with the study team and EDC Builder to meet study protocol requirements. Perform UAT of the EDC system.
· Generates, reviews, and approves study documents (e.g., Data Management Plans, Case Report Forms, Data Transfer Specifications, SAE and/or external data reconciliation plans, coding conventions, study protocols, etc.).
· Executes and distributes data management metrics, listings, and reports, as required.
· May have oversight of data management CRO/service providers.
· Monitors the progress of all data management activities to ensure study timelines are met.
· Provide training on the CRF completion guidelines and EDC system at Investigator meetings and to internal or external team members, as needed.
· Participate in the development, review and implementation of departmental SOPs, templates and processes.
· Proactively identifies potential study issues/risks and recommends/implements solutions.
· Responsible for the accuracy, quality and completeness of the clinical data collected during a clinical trial, able to work independently towards the assigned goal.
· Assist with EDC user account management.
· Requires solid knowledge of clinical data management principles, clinical trials process and regulatory requirements.
· Excellent verbal, written and interpersonal skills required for working successfully in a cross-functional team environment.
· Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHODrug.
· Strong working knowledge of industry standards (CDISC, SDTM, CDASH) and applicable ICH, FDA, and GCP regulations and guidelines.
· Ability to initiate and lead departmental or interdepartmental initiatives.
EDUCATION / TRAINING:
- Bachelor's degree in Life Sciences, Computer Sciences, Mathematics, or related field; Master's degree preferred.
-Minimum of 4+ years of data management experience in the pharmaceutical or biotechnology industry
-Prior oncology/hematology experience is highly desirable.