Clinical Trial Manager
TKL Research, Inc. - Rochelle Park, NJ

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TKL Research is a full-service, international Clinical Research Organization (CRO) serving the pharmaceutical, biotechnology, medical device and consumer healthcare industries. We provide comprehensive clinical trial management services for Phase 1-4 clinical research studies, including an inpatient Phase 1 facility and outpatient specialized research clinics.

We are seeking a highly motivated Clinical Trial Manager for our growing organization!

At TKL, the Clinical Trial Manager manages multi-center clinical trials under the supervision of the Clinical Project Manager(s) or may conduct a small study with minimal supervision. Takes a leadership role in developing sponsor relationships by reporting critical study metrics, authoring CAPA reports as needed, and in problem resolution or appropriate escalation of issues encountered in conducting clinical studies. Provides appropriate guidance and mentorship to project team members. Works closely with Project Manager(s) to assure that protocol requirements, regulatory guidelines and study timelines are followed. Works closely with the Lead CRA and sites to ensure adherence to the Clinical Monitoring Plan. Assures careful review of study documents and data as required by TKL’s SOPs. Assures that the Sponsor and sites are aware of all critical issues. The Clinical Trial Manager may travel up to 30% to investigative sites, investigator meetings or for other business related reasons.

Min Bachelor’s degree, preferably in the sciences or health related field. Ideal candidate will have at least 5 years of relevant experience with a clinical research organization. At least 1 year of field monitoring (CRA) experience is preferred. Must also possess detailed knowledge of FDA regulations and GCP/ICH guidelines as they apply to the conduct of clinical research. Excellent written and verbal communication skills are a must. Ability and willingness to travel (e.g. Investigators Meetings, monitoring as required per study). Working knowledge of Microsoft Office Suite. We are considering remote-based candidates for this opening. Home/Remote office experience is required.

We offer a competitive compensation package for full time employees, commensurate with your background and experience, including full benefits, 401(k) with match and a profit sharing plan.