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26 days old

Clinical Study Manager

Kelly Services
Jacksonville, FL 32232
**Clinical Trial/Study Manager**


**Johnson and Johnson Vision Care**


**Relocation Assistance for Eligible Candidates**


**\#ACRP**


Kelly Science & Clinical is currently seeking a **Clinical Trial/Study Manager** for a long-term engagement with one of our Global Medical Device clients in Jacksonville FL.


This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.


The requirements listed below under the job title are representative of the knowledge, skills, and/or abilities required to perform the duties of this position.


**RESPONSIBILITIES**


+ Lead core study initiation project team and facilitate team's ability to lead extended/complete project team.

+ Ensure effective cross-functional teamwork among study initiation project team members including both internal and external ancillary services.- Serve as escalation point for project issues and resolve conflicts as needed. Monitor study initiation project schedule and scope to ensure both remain on track. Implement and follow pre-approved procedures for any deviations.

+ Proactively engage in both quality assurance and risk management activities to ensure deliverables are met according to client requirements.

+ Actively participate as operational lead in internal Project Review meetings.

+ Manage timelines, resourcing and budget for supporting platform clinical trials.

+ Serve as key client contact for assigned project(s).- Establish working relationships with client project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business.- Prepare and deliver presentations in collaboration with relevant departments for new business as required.

+ Perform feasibility, site identification, site contract negotiation, and other study start up activities, as assigned

+ Prepare, review and submit submissions to CA, EC and other relevant authorities in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct.

+ This includes, but it is not limited to:

+ ethics/regulatory/other relevant authority approvals for clinical trials

+ ethics/regulatory/other relevant authority approvals for trial amendments

+ ethics/regulatory/other relevant authority study notifications

+ authorizations for import/export of investigational products, clinical supplies and biological samples

+ approvals from the national authorities for data protection

+ Advise Sponsor on knowledge content for development of Drug Labels

+ Perform independent quality review of submission package

+ Responsible for the collection and maintenance of the current Regulatory/Competent Authority (CA) and Ethics Committee (EC) submission information, and similar information for other related organizations, for the assigned countries and update relevant information system

+ Perform timely and accurate data entry of regulatory documents, submission status and maintenance of Country/Investigator information in the appropriate clinical trial management system

+ Lead study team and kick-off meetings as required

+ Assemble and distribute study materials to Clinical and Project teams, including materials to study sites and Investigator Meetings (e.g.; investigator binders) and vendors, as appropriate

+ Competent in communication skills for timely follow-up, issue resolution and report updates; as outlined in the communication and escalation plan with timely documentation

+ Mentor/facilitate successful study team behavior.

+ Provide rationale for decisions, present strategies in a clear message and drive clinical study execution with Platform leads.


**QUALIFICATIONS**


+ Optometry experience is a plus

+ Working knowledge of ICH/GCP, FDA, IRB/IEC and other applicable regulations/guidelines

+ Familiarity with investigator start up documents

+ Previous interaction with operational project teams and investigative sites preferred


+ Bachelors Degree or local equivalent and/or appropriate experience from the Medical/science background and/or discipline

+ 8+ years experience and/or understanding of clinical study start up requirements and activities

+ + 5 years Clinical Research Associate or Study Monitor preferred

+ Excellent written and spoken English

+ Advanced computer skills

+ Due to the nature of this position it may be required for the employee to travel. Therefore, dependent on the employees location, the employee may be required to possess a valid Drivers license


Location: Jacksonville, FL 32256


Please send your resumes: erlin.golubski@kellyservices.com


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-04-22 Expires: 2022-05-23

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Clinical Study Manager

Kelly Services
Jacksonville, FL 32232

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