Clinical Trials Management Associate - II in Foster City, CA at Apex Life Sciences

Date Posted: 9/14/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    9/14/2018
  • Job ID:
    886249

Job Description


Apex Life Sciences is looking for a highly motivated and experienced Clinical Trial Management Associate to work on site with our client, a leading Bio-pharmaceutical company. 

Description:
  • Must meet all requirements for Clinical Research Associate position and have demonstrated proficiency in all relevant areas.
  • With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required.
  • Assures site compliance with the routine protocol and regulatory requirements and quality of data.
  • Assists in the setting and updating of study timelines.
  • Assists in CRO or vendor selection.
  • With guidance from supervisor coordinates CROs or vendors.
  • Drafts and coordinates review of protocols, informed consents, case report forms, and monitoring plans and other study related documents.
  • Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies.
  • Participates or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams.
  • May participate in abstract presentations, oral presentations and manuscript development.
  • Interfaces with individuals in other functional areas to address routine study issues.
  • May be asked to assist in the training of Clinical Research Associates and Clinical Project Assistants.
  • Under general supervision, participates in two or more departmental or interdepartmental strategic initiatives.
  • Travel is required.
  • Excellent verbal, written, interpersonal and presentation skills are required.
  • Working knowledge and experience with Word, PowerPoint and Excel.
  • Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials.
  • Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures.
  • Ability to develop tools and processes that increase measured efficiencies of the project.
  • Must be able to anticipate obstacles and proactively develop solutions to achieve project goals.
  • Must have a general understanding of functional issues and routine project goals from an organizational perspective.

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 844-463-6178.




886249