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

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Job Description:
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):
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.

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: www.kellyscientific.com.
Kelly Services is an Equal Opportunity Employer.
Job Code : BHJOB3479_595630

Kelly Scientific Resources - 2 years ago - save job
About this company
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Kelly Services, Inc. (Kelly) is a global temporary staffing provider operating in 36 countries and territories throughout the world. The...