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Consumer Product Testing Company
Fairfield, New Jersey, United States
10 days ago

Description

Senior Director, Clinical Evaluations and Photobiology
CLN400


One of the nation’s largest independent testing facilities, seeks a Senior Director for our Clinical Evaluations division, with a minimum of fifteen (15) years managing a clinical testing facility, or equivalent GCP environment. Our Clinical Evaluations division is a healthy subject site. We conduct approximately 3500 clinical trials per year to ascertain the safety and/or efficacy of products, which are submitted to us by our clients. The ideal candidate must have a minimum of a Ph.D. in a scientific discipline, and working knowledge of testing products in a FDA regulated facility, with the technical ability to understand client requirements, GCP documentation, and be able to generate testing protocols.

Responsibilities include, but are not limited to the following:

• Ensure the overall regulatory and quality compliance of the clinical operation with GCP, GMP, ICH, and other local, state, and federal guidelines and regulations.

• Develop and review protocols for clinical trials consistent with GCP, FDA, local, state and federal laws and regulations. Review and approve protocols for consistency, completeness, accuracy, and compliance with individual client requirements. Provide guidance and assistance in protocol implementation and interpretation of results for bioinstrumentation studies and clinical trials.

• Serve as Principal Investigator and/or primary contact with clients for clinical trials, for activities such as, but not limited to: structure and scheduling of trials, and IRB approvals, for oral and written communications, for hosting, monitoring, and inspections, and for support and follow-up activities.

• Liaise with all board certified medical doctors, and technical consultants, in the performance of clinical trial activities.

• Oversee the physical state of the laboratory to ensure that sanitary conditions are maintained and that GMP compliance of laboratory equipment is maintained.

• Oversee the maintenance of clinical records and other pertinent data for each trial performed.

• Develop and maintain working relationships with worldwide experts and specialists in clinical and scientific disciplines.

• Advise clients and senior management with regard to clinical, scientific, and business issues.

• Maintain and troubleshoot client relationships by promoting exemplary laboratory staff interactions with clients.

• Liaise with Administration and the Quality Assurance Unit in the development and maintenance of all Standard Operating Procedures (SOPs) for the laboratory.

• Administer the CPTC training program in the clinic including the planning, conducting, and documenting of all training sessions.



PHYSICAL REQUIREMENTS
On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch; talk, hear, and smell. Specific vision requirements including reading of written documents, visual inspection of materials, and use of computer monitor screen frequently.
All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age or any other characteristic protected by law.

Apply to: dneumann@cptclabs.com



Job Information

  • Job ID: 58357301
  • Location:
    Fairfield, New Jersey, United States
  • Position Title: Senior Director, Clinical Evaluations and Photobiology CLN400
  • Company Name: Consumer Product Testing Company
  • Job Function: OTHER
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