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Clinical Trial Project Manager

Job Description:

Criterium brings a high level of expertise and technology in the management of clinical trials for new drug and medical devices. We provide quality solutions by customizing the clinical research process to each client’s specific needs. Our proprietary technologies enable us to accomplish “traditional” monitoring tasks, register and randomize patients and develop patient diaries, as well as managing clinical trial materials (CTM), at reduced costs. With the use of our proprietary tools, (IVR, EDC, ePro), our staff is able to speed up the process of managing and coordinating clients, sites and patients.

Position Summary:

Responsible for tactical management, administration and leadership of project teams in order to ensure the project proceeds on time and within budget parameters. The Project Manager ensures that Criterium Inc. meets all regulatory requirements, establishes and maintains positive relationships with vendors, sites, consortia members, sponsors and clinical trial staff. Throughout the study, the PM organizes and provides information regarding study operations and project status in the form of project management trackers and related reports, to evaluate performance and financial status of the study. Project Managers report directly to the President.

Essential Duties and Responsibilities:

Develop and maintain study-specific plans and project reporting documents. Acts as the primary liaison between the study team and sponsor. Submits project management reports to the President. Is responsible for the management and study-related training of all relevant personnel. Will assist the finance department with necessary information for project invoicing and is responsible for site budgets and approval of site payments. Periodic review of study budgets for deviations or change of scope scenarios. Ensures those in direct reporting relationship follow relevant Criterium Inc. SOPs and policies, as well as relevant sponsor and study specific guidelines. Provides quality management through reporting of deviations and CAPAs, as required. Review and adhere to study protocol and assess problem/risk management. Oversee and manage the study-monitoring calendar and conduct regular calls with project CRAs. May function as a CRA when required. Will facilitate client visits and audits when applicable. Prepares sites for SIVs and works in conjunction with staff members in sending the required materials to sites. Facilitates training to sites in the use of IWRS and EDC as needed, if study applicable. Reviews all study site and staff expenses to ensure payment is in line with budgets.

To ensure CRF 21 Part 11 compliance:

The Project Manager will follow Criterium Inc.’s GCP/ICH compliance processes. Work with the Quality Assurance Officer to plan, coordinate and control continuous improvement processes and systems for all staff members working on the study. Manage or assist in activities of Internal Quality Audits, CAPA, review and assist in client and vendor audits and assist in managing Contract Research Associates (CRAs). Assist in review of investigator sites, documents, Trial Master Files and internal processes. Ensure that studies are conducted in accordance with client protocols, GCP guidelines and agency regulations.

Qualifications:

Bachelor’s degree required; A minimum of 5 years of experience in project management. Must have broad knowledge of GCP (FDA and ICH) and 21CFR Part 11; Experience with all phases of clinical trials and inspection readiness activities resulting in successful FDA inspection. This position summary is not intended to be all inclusive. Criterium Inc. has the discretion to hire personnel with any combination of listed requirements. Criterium Inc. is an equal opportunity employer and qualified applicants will be considered for employment without regard to race, color, religion, sex, national origin or any other characteristic protected by law.

Contact Us:

Please mail your resume to:
Criterium Inc.
Attn: Human Resources
358 Broadway, Suite 201
Saratoga Springs, NY 12866

Or send via fax with cover letter(518) 583-0394
Or send via email:

We are Expanding – Currently Interviewing for:

  • Business Development Associate
  • Clinical Data Liaison (CDL)
  • Clinical Research Associates (CRA)
  • Clinical Trial Assistants (CTA)
  • Contract & Budget Specialists
  • Finance Accounts Associate
  • Financial Analyst
  • Human Resources Associate
  • Medical Writers
  • Programmers
  • Project Managers
  • QA Associate