We are the leading oncology CRO, developing novel treatments for patients that need them most. Our team is fully dedicated to oncology – it is all we do – combining innovation and expertise to quickly move medicines from preclinical development into clinical trials. Adaptive and forward-thinking – we guide our client's therapy through the most critical development milestones from the lab to planning their regulatory and clinical strategy. Our ultimate goal? To help patients.
This position is responsible for coordinating activities associated with the data management process throughout a clinical trial and overall quality and integrity of data input and output. This position reports to the Head of
- Reviews clinical study data with 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), Data Review and Quality Specifications (DRQS), eCRF Completion Guidelines and Data Validation Specification (DVS). Submits manuals and plans to the Data Manager for final review and approval
- Performs database User Acceptance Testing, including script writing and execution
- Maintains and tracks monthly clinical research project data metrics to adequately analyze, identify and report data and trends
- Assists Data Manager with data coding and maintaining appropriate WHODrug and MedDRA licenses
- Assists Data Manager with data reconciliation, including adverse event (AE), serious adverse event (SAE) and external lab data reconciliation.
- Assists in performing bi-annual reviews of database users in collaboration with TD2 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
- Assists with writing controlled documents and department training modules related to the Data Management function
- Participates in training clinical team members
- Performs other related duties as assigned
- This position requires at least an Associate's degree with preference to degrees in a health science, statistics, or data management field. Must have at least 3 years of data coordination or data management experience in a biotechnology/pharmaceutical, academic or contract research organization setting.
Required Specialized/Technical Skills:
- 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
TD2 is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, creed, disability, veteran’s status, gender, sexual orientation, gender identity, or gender expression.