We are seeking an experienced Clinical Data Manager! This is a fully remote role and begins on an initial 12-month contract with opportunity for extension. (Note: W-2 candidates only).
PRINCIPAL ROLES / RESPONSIBILITES:
ยท Represent data management in study team meetings.
ยท Manages data management timelines to coordinate and synchronize deliverables with the overall study timelines.
ยท 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.
ยท 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.).
ยท Executes and distributes data management metrics, listings, and reports, as required.
ยท May have oversight of data management CRO/service providers.
ยท Monitors the progress of all data management activities to ensure study timelines are met.
ยท Provide training on the CRF completion guidelines and EDC system at Investigator meetings and to internal or external team members, as needed.
ยท Participate in the development, review and implementation of departmental SOPs, templates and processes.
ยท Proactively identifies potential study issues/risks and recommends/implements solutions.
ยท Responsible for the accuracy, quality and completeness of the clinical data collected during a clinical trial, able to work independently towards the assigned goal.
ยท Assist with EDC user account management.
REQUIREMENTS:
ยท Requires solid knowledge of clinical data management principles, clinical trials process and regulatory requirements.
ยท Excellent verbal, written and interpersonal skills required for working successfully in a cross-functional team environment.
ยท Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHODrug.
ยท Strong working knowledge of industry standards (CDISC, SDTM, CDASH) and applicable ICH, FDA, and GCP regulations and guidelines.
ยท 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.
