CR.NA.Study Setup Project Manager

ProClinical is currently seeking a Study Setup Project Manager for a global laboratory located in New York. Successful candidate will work collaboratively with CT clients, Project Managers and key stakeholders to manage the process of designing and launching clinical trial studies.

Job Responsibilities

• Providing exceptional service through a consistent customer centric approach, focusing on precision delivery and flexibility to meet customer expectations.
• Maintaining positive working relationships with CT clients, Business Development Directors, Clinical Trials Study Management and key stakeholders.
• Completing all necessary study setup documentation/forms, priming systems, and coordinating setups with other departments for multiple, multi-region complex and non-complex clinical trials studies at one time.
• Developing the database design requirements and developing and maintaining client design standards as applicable.
• Identifying and resolving issues/requests in a timely manner per service and metric guidelines; following Standard Operating Procedures for escalations, changing control and communication.
• Delivering accurate and timely study data during execution by reviewing and implementing approved study amendments.
• Performing successful study closure by providing study setup documents.
• Maintaining a general working knowledge of FDA, MHRA, NYSDOH, GCP, ICH and other pertinent regulations.
• Assisting in process improvement within the Clinical Trials Project Management team by developing methods to improve productivity, service, quality, cost savings, policies & procedures.
• Participating in Clinical Trial meetings and task forces to develop standardization in the set-up process across protocols and departments.
• Participating in training to maintain relevant working knowledge of Clinical Trials.
• Performing other duties as assigned.

Skills and Requirements

• AS/AA required; BS/BA preferred.
• 2 years of experience supporting clinical trials, labs or health care setting required.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Nicole Aganon at (+1) 347-293-1161 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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