Clinical Trial Manager in Summit, NJ at Apex Life Sciences

Date Posted: 5/29/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Summit, NJ
  • Job Type:
    Management
  • Experience:
    Not Specified
  • Date Posted:
    5/29/2018
  • Job ID:
    852439

Job Description


Summary/Scope

The Clinical Trial Manager is responsible for the day-to-day operational management and minimal scientific input for global Phase 1 clinical pharmacology trials, from generation of protocol synopsis through final clinical study reporting.  Excellent organizational, managerial, and interpersonal skills are required.  The candidate must have good project and time management skills to allow aggressive deadlines to be met.  The candidate must be familiar with GCPs and ICH guidelines.  The candidate should have the ability to identify potential rate-limiting issues and to effectively communicate the issues to the appropriate parties.

Responsibilities

  • Contribute to the planning, managing, implementing, monitoring, and reporting of clinical pharmacology studies (US and ex-US) to characterize the safety, tolerance, pharmacokinetics, and pharmacodynamics in healthy volunteers and/or patients.
  • Track progress of assigned studies and report updates to management, identify rate-limiting issues, and propose solutions as needed in a proactive manner.
  • Review budgets of assigned studies and interface with internal department representatives to ensure fiscal accountability.
  • Interact with investigators, internal customers, external customers, etc., to progress studies forward in alignment with departmental and company objectives such as initiation visits, monitoring visits, budget meetings, study team meetings, etc.).
  • Participate in the assessment and selection of external vendors for various aspects of clinical pharmacology studies.
  • Conduct all aspects of study management, from study start-up through report finalization.
  • Participate in the site evaluation visits and on-site monitoring visits in accordance with company SOPs and GCPs, and direct internal and/or external study-assigned monitors (eg, CRAs).
  • Maintain study-related documentation as per Celgene SOPs and GCP requirements.
  • Participate in departmental and company-run initiatives to support continuous business improvements.
  • Participate in authoring and reviewing abstracts/manuscripts, etc., for presentation/publication at internal/external meetings.

Travel required – approximately 10%.

Qualifications

  • Bachelor degree in life sciences or a Master’s Degree (life science preferred).
  • 7 or more years with a bachelor’s degree, or 5 or more years with a master’s degree
  • 3+ years of Clinical pharmacology trial experience preferred but not required

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