Posted to MedZilla on 11/21/2017

TechData Services

US-NJ, Clinical Project Manager


Driven by oncology-dominated innovative product portfolio and international growth strategy, we are looking for a Clinical Project Manager (CPM) to manage clinical studies to be conducted in US. As a full time employee, the CPM will be responsible for, but not limited to, the following activities:

· Select and manage CRO and other vendors

· Select investigators and develop working relationships with site staff

· Develop study execution plan, timelines and budgets

· Conduct site monitoring visits to ensure quality and resolution of site-related issues

· Coordinate regulatory or ethics committee activities

· Review clinical study data

· Oversee trial conduct by coordinating internal and external activities

· Ensure compliance with regulations, GCP guidelines and SOPs

· Participate in quality assurance activities and coordinate resolution of audit findings

· Ensure audit-ready condition of clinical trial documentation including TMFs

The requirements for the position include:

  • Bachelor’s degree or higher in science or health-related field required
  • Minimum of 10 years of trial management experience with a proven track record for delivering clinical projects within time, budget and quality expectations.
  • Extensive clinical study management skills.
  • Excellent communication o build relationships within and between the organizations
  • Strong organizational skills with problem solving and team building skills.
  • Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management;
  • Ability to handle a high volume of tasks within a given timeline.

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