Clinical Data Manager/Senior Clinical Data Manager

Theradex Oncology•Princeton, NJ

13d•$80,000 - $145,000•Remote

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.

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

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