Clinical Research Project Manager (PM)
Kelly Services - Jacksonville, FL

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Clinical Research Project Manager
Every day, Kelly Scientific Resources (KSR) connects clinical research professionals with opportunities to advance their careers.
We currently have a one year contract opportunity for a Clinical Research Project Manager in Jacksonville, FL .

Job Responsibilities (other duties may be assigned):
Education and experience required
Bachelors degree in a scientific field.
Relevant clinical research experience that includes trial or project management.
For immediate consideration , click the Apply Now! button, or refer a friend by clicking the E-mail this job link provided.
Kelly Scientific Resources has grown into a $270 million global business as the scientific business unit of Kelly Services. Our recruiting consultants place clinical, regulatory and medical affairs, data management and biostatistics professionals to the pharmaceutical, biotechnology, medical device, CRO and university research communities. We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:
Kelly Services is an Equal Opportunity Employer.
Manage the study preparation, conduct, and close out of clinical trials.
May provide support on product approval applications.
Compile information required for the clinical trial project quality plan including project timelines, resourcing, budget management and reconciliation, contract negotiation and finalization, and review and management of scopes of work and change orders.
Develop monitoring plans and compile data management plan, statistical analysis plan, and communication plan as part of the clinical trial project quality plan.
In collaboration with the project team, responsible for preparing and finalizing key clinical documents which at minimum may include the clinical protocol, informed consent, case report form, and investigator?s brochure.
Develop request for proposals for clinical sites and CROs and other vendors as required.
Responsible for the identification and selection process for the clinical sites and Contract Research Organization (CRO).
Support development of Master Services Agreements, Clinical Research Agreements, Scopes of Work and Change Orders.
Manage and oversee CRO delegated responsibilities.
Oversee internal conduct of study specific activities.
Responsible for reviewing final study reports.
Ensure that clinical trials are conducted meeting all applicable Regulations and Guidelines required to gain approval of investigational contact lenses.
Interface and cooperate with Research and Development, Regulatory Affairs, Professional Affairs, Office of Project Management, as well as the Clinical Investigators to ensure that regulatory requirements and company requirements are met.
Define complex issues & develop strategies to address these issues.
Manage departmental/projects day-to-day operations within area of responsibility, and interrelationship between functions.
Act as spokesperson and technical expert for functional area. : .

About Kelly Services ®

Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly ® offers a comprehensive array of outsourcing and consulting services as well as world-class
staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provides employment to more than 560,000 employees annually.
Revenue in 2012 was $5.5 billion.
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