Manager, Clinical Trials Project Management

Rochester General Health System Rochester , NY 14618

Posted 2 months ago

Job ID REQ_93206 FACILITY Rochester Regional Health Laboratories LOCATION Rochester, New York

SUMMARY

The primary role of the Manager, Project Management is to liaise with ACM Global Central Laboratory clients, representing the laboratory aspects of conducting the clinical trial. The Manager is responsible for all aspects of the their assigned clinical trials, from the set up stage, throughout the maintenance period and to study close out, facilitating and coordinating the required functions.

STATUS: Full Time

LOCATION: Rochester Tech Park

DEPARTMENT: Project Management

SCHEDULE: Days

ATTRIBUTES

  • Bachelor's degree required; health care or scientific concentration preferred.

  • Global/international experience preferred.

  • Five years of Clinical Trials Project Manager experience OR a minimum of five years of project management experience in similar field required.

  • Clinical operation experience with metrics reporting strongly preferred.

RESPONSIBILITIES

  • Staff Management. Oversee and be accountable for the daily activities of project team members to initiate new clinical trial protocols and support existing trials in accordance with client requirements.

    Hire, monitor, train, and supervise staff to ensure compliance with corporate policies, department policies and procedures, current guidelines for Good Clinical Practices, any state, federal or national regulations and any other legislation or regulation that is relevant to the activities of the post. Develop standard operating procedures for project team functions and processes as needed. Manage the overall performance of employees under their responsibility.

    Ensure effective training and mentoring. Prepare and delivers annual and interim performance evaluations and makes salary recommendations accordingly

  • Liaison. Collaborate with the department director or head in the development of departmental policies and procedures ensuring compliance with corporate, state, federal, OSHA (or any other national health and safety requirements for their location) and client specifications. Perform duties in compliance with company policies and procedures as well as with a general working knowledge of FDA, NYSDOH, GCP, ICH and other pertinent regulations, as pertains to central laboratory functions and patient/client confidentiality

  • Client Support. Communicate with client to negotiate and document project scope and requirements.

    Assist the business development team in procuring new business and participated in client meeting and bid defense meetings as needed. Participate in the investigation of errors or non-conformances, the preparation of corrective and preventive action plans (CAPSs) and communication of the same with clients as needed. Assist and supports the hosting of client or regulatory audits as needed

Rochester Regional Health is an Equal Opportunity / Affirmative Action Employer. Minority/Female/Disability/Veteran



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Manager, Clinical Trials Project Management

Rochester General Health System