Job Description


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Clinical Research Manager

  • Ref: 285202
  • Type: Option-to-Hire
  • Location: Pennington, NJ
  • Industry: Pharmaceuticals
  • Job Level: Associate
  • Pay: Negotiable

Opportunity Description

Global Pharmaceutical Company is seeking a Clinical Research Manager with strong CRO experience. Applicant will need a Bachelor's Degree to qualify for position. 

Job Duties

  • Support the Clinical Operations team in the execution of clinical trials by functioning as a monitor and site manager.
  • Some support may require managing smaller aspect of trials, on an as needed basis.
  • Experience managing clinical trial investigational site.
  • Conduct site feasibility assessments, participating in or managing site selection process, analyzing patient recruitment and retention rates.
  • Conduct ongoing statue verifications.
  • Organize and perform site initiation activities and site training.
  • Verify biological sample collection, storage, and shipping procedures at the site.
  • Verify laboratory data is reviewed by the investigator, properly captured in the case report form, and if necessary, is being reconciled properly within the CRF.
  • Organize and monitor investigator study files.
  • Prepare and organize local institutional review board(IRB)/ethics committee (EC) submissions in collaboration with the site(s).
  • Prepare and organizee central IRB/EC submissions Function as the primary point of contact with the site.
  • Oversee the management of multiple US-based investigational sites across multiple trials.
  • Assist and, in some cases, spearhead the develop and/or revision of SOPs as they pertain to clinical operations.
  • Maintain databases for publication material and investigative sites.
  • Perform background research on potential investigators, and in some cases, prospective vendors.
  • There will be extensive domestic travel.
  • Negotiate and develop clinical trial agreements with investigational sites.


  • Minimum of Bachelor’s Degree.

Experience & Skills Required

  • At least 3 years as a full-time regional monitor working for a sponsor or Contract Research Organization (CRO).
  • Experience managing CRAs either for the sponsor or at CROs is a plus.
  • Experience managing aspects of CRO functions is a plus.
  • Extensive experience collaborating/interacting with counterparts at sponsor and other CROs/vendors (laboratories, drug depots, etc.). Trial Master File maintenance, auditing, and reconciliation experience.
  • TMF readiness experience.
  • A keen understanding of the regulatory requirements in the United States, as they pertain to the conduct and oversight of clinical trials as well as to the development of SOPs.