Position Summary
The position is responsible for coordinating activities associated with the data management process throughout a clinical trial and the overall quality and integrity of data input and output. This position reports to management within the Data Management department.
Essential Functions
Independently reviews clinical study data entered in the EDC systems, generates queries as needed and works with site data entry staff and site Clinical Research Associates (CRAs) to ensure that data collected is accurately reported.
Drafts data-related manuals and plans, including but not limited to the Data Management Plan (DMP), eCRF Completion Guidelines (CCGs), Database Specification, and Data Validation Specification (DVS). Submits near-final manuals and plans to the Clinical Data Manager (CDM) for limited final review and approval.
Performs database User Acceptance Testing, including high-level script writing and execution.
Maintains and tracks monthly clinical research project data metrics. Reviews metrics to assist the CDM in analyzing, identifying and reporting data and trends.
Works with the CDM on data coding and maintaining appropriate WHODrug and MedDRA licenses.
Works with the CDM on data reconciliation, including serious adverse events (SAE) and external lab data reconciliation.
Performs database user administration tasks including granting, modifying, and revoking access rights.
Performs bi-annual reviews of database users in collaboration with NK Clinical Project Managers.
Represents the Clinical Data Management department in Sponsor meetings, audits and project team meetings.
Maintains established timelines for assigned projects.
Works extensively with project leaders, clinical team members and Sponsors in managing their clinical data needs.
Encourages collaborations and builds working relationships with functional groups that are contributing to the project plan.
Liaises with clinical, safety and regulatory organizations for coordination of clinical trial activities.
Writes controlled documents and department training modules related to the Data Management function for review and approval by management.
Participates in training clinical team members.
Performs other related duties as assigned.
Job Requirements
Associate's Degree with preference to degrees in a health science, statistics, or data management field.
Must have at least 4 years of data coordination or data management experience in a biotechnology/pharmaceutical, academic or contract research organization setting.
Required specialized/technical skills include:
Experience with clinical data management, clinical study database design and implementation and generation of data reports and listings
Experience with hands-on management and testing of clinical databases
Experience utilizing programs to code medical terms and medications
Experience with commercial electronic data capture systems (EDC) such as Medidata Rave and Oracle Inform
Strong computer skills with proficiency in Microsoft Office applications
Possess strategic thinking, contingency planning and problem-solving skills
Strong interpersonal and communication skills, both oral and written
Ability to work collaboratively with cross-functional teams
Excellent planning and organizational skills
Strong knowledge of the clinical drug development process
Demonstrated skill with establishing and documenting standard processes by which project tracking data is collected, updated and reported to the project team