Responsible for developing and managing all aspects of the global clinical study data management process from start-up to database lock and regulatory submission support
Project Details:
Coordinate activities with the internal and external BioStats, laboratory vendors, database programming and trial operations to define and implement data management requirements
Ability to develop and own processes related to data compilation, tracking, maintenance, cleaning, and finalization including the ability to develop, run, review, and maintain data listings for laboratory and database data
Flag findings during ongoing study to clinical management and may develop materials and present to CRAs, sites to ensure consistent, quality data capture
Facilitate and lead all data cleaning including issuing queries along with guidance on issuance and acceptable closure of queries on an ongoing basis
Demonstrate a strong understanding of the assigned study protocol(s), critical tasks, and associated milestones
Ensure completeness, correctness and consistency of routine clinical data and its structure
Weekly reconciliation with multiple vendors to ensure timely and quality data entry, lab completion and resulting, and eDiary data entry and compliance
Work closely with DM CRO to ensure all eCRFs, CCGs, Edit Checks, SOPs and DMPs meet study requirements and assist with updates as required
Assistance with any required updates to the EDC system and associated UAT, and updated documentation
Work collaboratively with both internal team members and associated CROs / vendors to meet project deliverables and timelines for clinical data acquisition, quality review, clinical study reports, documents required for regulatory submission and assistance as needed
Close collaboration with Stats and Clinical teams to manage frequent DMC meetings including timeline development, data cleaning, management of EDC and lab data transfers, and more
Aid study manager in managing and tracking database interim review and lock timelines and ensure CDM project milestones are met in coordination with the project team
Develop and maintain relevant report metrics to share with overall study team and upper management
The ability to note and monitor trends across regions will be key
Support study-level audit and inspection readiness activities, as needed
Job Experience:
Minimum of 5 years DM experience with at least two years at a Sponsor company
Experience and familiarity with global Phase 2 and 3 trials
Experience and familiarity with interim analyses, and freezing and locking databases
Excellent communication and time management skills
Ability to prioritize study load and associated tasks
Chosen candidate must be autonomous, independent and must take initiative to manage, own, and lead all aspects of DM while contributing to overall study team
Oxford is an Equal Employment Opportunity Employer. All qualified applications will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Oxford will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. Oxford provides supplemental medical (we do not offer major medical), dental, vision, life, and disability benefit plans along with a 401(k) Retirement Savings Plan. Paid holidays based on eligibility and paid sick leave for applicable jurisdiction, as required. Oxford is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please email oxfordbenefitsgroup@oxfordcorp.com. We will make a determination on your request for reasonable accommodation on a case-by-case basis.
