Clinical Data Manager/Senior Clinical Data Manager
About the position As part of Theradex Oncology, you will have the opportunity to work with one of the largest professional teams focused solely on the development of cancer therapies. Cancer research continues to evolve as new therapies and therapeutic approaches are discovered, as part of the team you will work to support our sponsors in the development of these therapies. Theradex Oncology is an environment for highly motivated individuals who want to make a difference. Opportunity Clinical Data Manager/Sr Clinical Data Manager - dependent upon experience You will play a pivotal role in ensuring the integrity and quality of our clinical trial data. You will collaborate closely with cross-functional teams and manage data management activities for multiple studies.
Responsibilities
- Perform all clinical data management activities in compliance with SOPs and ICH-GCP regulatory requirements
- Work closely and collaboratively with the SAS Programming team, biostatistics team and other data managers
- Act as lead clinical data manager on multiple studies of moderate complexity with minimal supervision
- Serves as the main point of contact for study DM related matters
- Lead DM Study Start-Up Activities
- Conduct EDC User Acceptance Testing and program validations.
- Develop programs in SAS/EXCEL for study data metrics monitoring and clinical data review.
- Perform comprehensive data review of all patient data.
- Perform WHO Drug Dictionary coding and MedDRA coding as necessary
- Support Project Team through: Tracking and provision of project status updates to project managers for monthly project team meetings Close communication with CRA’s to identify and mitigate negative data trends/issues Provision of listings/reports as needed Create ad-hoc reports for special data requests from Sponsor
- Ensure that documentation is maintained in a state of constant audit-readiness and filed in the Trial Master File.
- Coordinate all activities in preparation for study milestones and database lock
- May assist in the mentoring of less experienced employees
- Manage and prioritize project deliverables per established study timelines Requirements
- Bachelor’s degree required / Master’s degree preferred
- 3-5 Years relevant data management experience in the CRO / pharmaceutical industry required
- EDC experience required, RAVE EDC experience preferred
- SQL/SAS programming experience preferred
- Demonstrates knowledge of GCP s and protocol
- Strong understanding of CDISC CDASH and SDTM Standards
- Highly effective ability to anticipate problems relating to projects and to develop and implement solutions
- Excellent interpersonal skills
- Fluent knowledge of written and verbal English
- Highly organized and result-oriented
- Strong communication, comprehension and logic skills
- Ability to work independently with minimal supervision as well as in a team environment
- Proficient in Word and Excel
- Ability to understand high level programming languages
- Strong time management and prioritization skills to meet deadlines among multiple projects Benefits
- medical, dental and vision coverage
- life insurance
- disability insurance (STD/LTD)
- company matched 401(k)
- competitive tuition reimbursement
- generous vacation/sick plans
- flexible work schedules
- employee discounts and other company provided benefits Apply tot his job
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