Clinical Program Manager

JOB TITLE: Manager of Clinical ProgramsMUST HAVE HANDS ON CLINICAL EXPERIENCE!LOCATION: Rochester, New YorkRELOCATION BENEFITS: YesSTARTING BASE SALARY RANGE: $83,000 to $97,000
BONUS PROGRAM: Yes, 15%BENEFIT PACKAGE: YesADVANCEMENT OPPORTUNITY: YesENVIRONMENT: Bio-Tech, Medical Devices, PharmaceuticalTRAVEL REQUIRED: Up to 25%
EDUCATIONAL REQUIREMENTS: 4 year degree
MINIMUM EXPERIENCE LEVEL RANGE: 10 + years<|B>
REQUIREMENTS
Candidate Must Have :
BA/BS degree
10+ years related experience in clinical trials (including monitoring)
2+ years experience managing clinical trials personnel
Budgeting, timeline and scheduling experience
Formalized medical training (such as a RN, MD, etc)BRIEF JOB DESCRIPTION:
The Clinical Project Manager will be responsible for managing the overall conduct of domestic and international medical device field clinical trials, including management of CROs and all operational aspects of such trials in accordance with FDA regulations, ICH and GCP guidelines and company SOPs.
Individual will effectively translate the company policy and goals to the clinical team to ensure that staff works in support of company objectives; provides technical advice and assist with problem resolution; and works effectively with project teams.Manage all clinical trial project timelines.
Supervise all activities of study managers, CRAs, and Study Assistants, as well as contract monitors assigned to relevant projects.
Identify and evaluate issues related to the project and implement resolutions.
Provide input on departmental decisions related to process and procedures.
Participate in design and development of protocols, CRFs, project planning, budgeting and expense analysis.
Participate in Investigator recruitment and provide final recommendation.
Supervise the activities of study managers, CRAs, and Study Assistants, as well as contract monitors.
Prepare and manage clinical trials budgets and expenses, and review/approve study design and study conduct logistics.
Prepare and manage clinical trial schedules and deliverables.Assist in the identification and evaluation of investigator sites.
Review and approve monitor reports.
Identify and provide direction for the resolution of subject enrollment and other clinical trial issues.
Provide input and make decisions related to policies and procedures.