CLIENT SUMMARY

A global leader in research-based drug development, this CRO builds strong strategic partnerships with select Sponsors to advance the most efficient and cost-effective path to drug approval. As a therapeutically-focused Clinical Research Organization (CRO), it is viewed as a steward of drugs, leveraging extensive medical and regulatory expertise to deliver additional input, strategy, and efficiencies to each and every phase of the clinical trial. From custom solutions addressing the needs of small and midsize biotechnology companies to full-service offerings for global pharmaceutical companies, the company has the breadth, depth, and flexibility to deliver a superior result, specific to client needs, on six continents.

JOB SUMMARY

Individual will manage projects independently for one or more major clients.  The individual will demonstrate a thorough understanding of clinical operations activities and prioritize effectively. The CTM will interact with internal and external project team members and will have direct supervision of staff designated to the client.

KEY JOB RESPONSIBILITIES

Coordinate project start-up, project maintenance and project close-out activities.  Maintain ongoing Sponsor contact for the project specific issues by serving as the primary contact for the Sponsor and all project team members.  Track study status including patient status, CRF status, safety issues, timelines, etc.  Provide oversight for the project team.  Interpret contract related issues and coordinate activities according to current scope.

IDEAL CANDIDATES’ QUALIFICATIONS AND EXPERIENCE

Bachelor's degree and 4 years of related pharmaceutical industry experience (clinical monitoring or study management) or Masters/Ph.D with 2 years of related pharmaceutical industry experience (clinical monitoring or study management) or Bachelor's degree or Masters/Ph.D. and 1 year of clinical trial management.

Broad knowledge of medical terminology, clinical patient management, and clinical research methodology.  Ability to understand and present relevant clinical data and handle protocol related questions.  Knowledge of pharmaceutical research, GCP and local regulations regarding clinical studies and the conduct of studies.  Basic knowledge of drug therapy techniques and clinical research methodologies as well as the ability to understand and present relevant clinical data.