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13 days old

Clinical Project Manager (CPM)

Kelly Services
Boston, MA 02133
**Clinical Program/Project Manager:**


Kelly Science & Clinical is seeking Clinical Project Manager (CPM) professionals who are eager to bring the latest scientific discoveries to life in order to create a brighter, safer and healthier future for all. If youre passionate about shaping the world we live in and ready for a new challenge, this may be the perfect opportunity for you.


The Clinical Project Manager (CPM) is responsible for the management of all aspects of Clinical Trial Team activities for assigned project(s). The CPM, in concert with the Clinical Program Director, is accountable for achieving successful delivery of clinical team activities at the project level by meeting company and regulatory requirements according to time, quality/scope and budget constraints.


**Responsibilities:**


+ Proactively manage project level operational aspects of Clinical Trial Team (CTT) including management of trial timeline, budget, resources and vendors.

+ Provide efficient updates on trial progress to the Clinical Program Director (CPD) and/or Senior Director of Clinical Operations (DCO), with respect to vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation.

+ Lead sponsor study startup process, including but not limited to conduct of the Trial Kick-off meeting, the set-up of trial master file (TMF), site selection and finalization of site and vendor Clinical Trial.

+ Agreements and budgets.

+ Ensure effective project plans are in place and operational for each trial and work proactively with the Clinical Trial Team (CTT) to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.

+ Ensure potential study risks are escalated to the attention of the CDP when appropriate.

+ Chair CTT working group and vendor status update meetings and ensure meeting minutes are completed, distributed to team members and filed in the Trial Master File (TMF) in a timely manner.

+ Review and approve site visit reports; ensure tracking, follow up and resolution of site issues have been completed in a timely manner.

+ Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team.


**Minimum Qualifications:**


+ Bachelors degree in Life Sciences, Nursing Licensure or Pharmacy, at minimum.

+ Four or more years of clinical operations experience for CPM; with increasing levels of responsibility, in the Pharmaceutical, Biotechnology, Medical Device or CRO industry is required.

+ Five or more years of clinical project management experience at a sponsor or CRO company is preferred for CPM.

+ Therapeutic experience in oncology and/or rare disease.

+ Experience in early phase trials (Phase I-II) and First-In-Man trials.

+ Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and data management methods.

+ Travel to sites when necessary.


\#TJP2021_SPEC


\#TJP2021_SCT


**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: 2021-09-06 Expires: 2021-10-07

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Clinical Project Manager (CPM)

Kelly Services
Boston, MA 02133

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