Phase I Study Manager in Durham, NC at Apex Life Sciences

Date Posted: 7/19/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Durham, NC
  • Job Type:
    Management
  • Experience:
    Not Specified
  • Date Posted:
    7/19/2018
  • Job ID:
    859799

Job Description


Apex Life Sciences is looking for a Phase I Study Manager!

Scope of Project:

  • Lead the start-up, execution, and closeout of multiple Phase 1 studies (US or overseas)
  • Lead or contribute to integrated clinical study team meetings to ensure high scientific, ethical and regulatory standards, and expeditious registration submissions worldwide
  • Works efficiently with internal regulatory, CMC, and clinical trial supplies, project management, and quality personnel to seamlessly meet key study milestones
  • Constructs or reviews study plans and documents (e.g. protocols, Informed Consent Forms, CRFs, Monitoring Plan and associated tools, Patient Information Sheets) and coordinate translations as needed
  • Oversee study related site management and monitoring activities
  • Manage  and help select study vendors including Phase 1 units and bioanalytical laboratories, statistical support and case report forms/data management services
  • Contributes to or provides proactive solutions to study-related issues

Experience Desired:

  • Minimum of 5 years study management responsibility including site/CRA management.
  • BS degree required
  • Experience in vendor management required.
  • Must be able to work independently, adapt to changing priorities, with the ability to take initiative to complete tasks accurately and timely

For more information on this position please send resume or contact:

Vickie Dagit, Recruiter

vdagit@apexlifesciences.com

919-334-0178

#LI-VD1

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.

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.