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8 days old

Remote/Hybrid - Clinical Project Manager

Kelly Services
Van Nuys, CA 91401
**Kelly Science** is looking for a great individual to manage In-Vitro Diagnostic Clinical Trials. In this role will primarily initiate, and coordinate in vitro diagnostic studies to collect data to support regulatory submissions for use in future product development.


**Clinical Project Manager** - **Direct Hire - Remote or Hybrid**


**In-Vitro Diagnostic clinical trials - sample collection**


+ Responsible for the planning, implementation, and management of the sample collection clinical trials and will have broad responsibilities in project management and site management.


**Responsibilities:**


+ Take responsibility of ensuring the execution of clinical studies with the goal of adhering to target timelines, budget and quality

+ Manage clinical studies, which may include protocol development including risk rationales and study design, CRF development, investigational product supply management, budget/contract negotiation and regulatory document management

+ Conduct and/or assist clinical teammates with on-site visits, including qualifications through close-outs; training clinical sites on implementation and conduct of study protocols

+ Monitor conduct/compliance of clinical studies as related to GCP, SOPs, and regulatory requirements, utilizing knowledge of the diagnostic area sufficient to perform source data verification; occasional handling of biological samples may be required, based upon project need

+ Assist clinical sites with IRB submission/documentation, as needed

+ Proactively anticipate and identifying issues; implement solutions, propose corrective actions in areas relevant to the role

+ Evaluate and communicate the impact of risks, develops project quality and risk management plans for performance.

+ Manage staff and overcome challenges to ensure proper monitoring of studies and completion of project deliverables in accordance with project plan

+ Manage cross-functional project team including protocol development team, regulatory team, physicians/investigators, study coordinators, study nurses, study recruiters, clinical research managers, and research associates.

+ Develop and manage key relationships with multiple sponsors, investigative sites, labs, vendors, and Institutional Review Boards IRB.

+ Assist in identification, evaluation, and selection of investigative sites

+ Provide leadership to develop new study-related documents, including protocols and SOPs, Informed Consents, and programming of eCRF

+ Communicate the status of the projects on a regular basis to the sponsors, principal investigator and stakeholder teams using graphic illustrations and concise reports

+ Ensure the scientific integrity of clinical studies and oversee clinical and research laboratory data QA/QC processes at the clinical trial sites


**Qualifications:**


+ A minimum of 5 years of work experience and a minimum of 2 years in clinical trials CCRA certification with ACRP or SoCRA

+ Knowledge of accepted good clinical research practice GCP and procedures.

+ Experience with in vitro diagnostics and/or medical device industry

+ Excellent organizational, time management, budget management, and problem-solving


**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: 2022-05-13 Expires: 2022-06-13

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Remote/Hybrid - Clinical Project Manager

Kelly Services
Van Nuys, CA 91401

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