Clinical Data Manager in Durham, NC at Apex Life Sciences

Date Posted: 7/11/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Durham, NC
  • Job Type:
    Management
  • Experience:
    Not Specified
  • Date Posted:
    7/11/2018
  • Job ID:
    866224

Job Description


Apex Life Sciences is looking for a Clinical Data Manager!

The Clinical Data Manager is 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. This position coordinates activities with the DM Contract Research Organization (CRO), internal and external BioStats, laboratory vendors, database programming and trial operations to define and implement data management requirements. 

Responsibilities

  • 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
  • Flags findings during ongoing study to clinical management and may develop materials and present to CRAs, sites to ensure consistent, quality data capture
  • Facilitates and leads all data cleaning including issuing queries along with guidance on issuance and acceptable closure of queries on an ongoing basis
  • Demonstrates a strong understanding of the assigned study protocol(s), critical tasks, and associated milestones
  • Ensures 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
  • Works 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 main relevant report metrics to share with overall study team and upper management. The ability to note and monitor trends across regions will be key
  • Ability to support the clinical team with additional ad-hoc tasks such as newsletter preparation, CRA training
  • Support study-level audit and inspection readiness activities, as needed

Requirements

  • 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

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.