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17 days old

Clinical Trial Manager - Clinical Operations Supply (direct hire, 100% remote)

Kelly Services
San Diego, CA 92108 Work Remotely
**Clinical Trials Manager Clinical Operations Supply (100% remote, direct hire)**


**Overview:** Kelly Services is seeking a motivated, enthusiastic individual to join our clients team as a Clinical Trial Manager focused on Clinical Operations Supply. This is a direct hire 100% remote position with a publicly traded biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways.


The Clinical Trial Manager, Clinical Operations Supply is responsible for the management and oversight of clinical trial material supply chain activity, ancillary clinical supplies and laboratory management of central and specialty laboratories for Clinical Trials.


This key role is in the clinical operations group and works closely with stake holders including Clinical Operations, Quality Assurance, Regulatory Affairs, CMC, Research, Contract Manufacturing Operations (CMOs), and Contract Research Organizations (CROs) to ensure seamless supply of Clinical Trial Material, ancillary study supplies and laboratory management. Some key areas of management/ oversight include forecasting, packaging, labeling, distribution of clinical trial material, as well as inventory management of ancillary supplies, vendor oversight of laboratories and CROs, and eTMF filing of Clinical CTM, ancillary supply and laboratory documents. A successful candidate will be skilled at understanding the Clinical Supply and laboratory needs and responsibilities, exhibit strong attention to detail, support a collaborative environment, and strong ability to manage workload and meet project timelines.


**PRIMARY RESPONSIBILITIES:**


+ Clinical Trial Material

+ Manage packaging, labeling, and distribution of clinical trial material for global clinical trials.

+ Drive label creation and approval process, including translations and regulatory requirements

+ Support (Interactive Response Technology) IRT development, user acceptance testing (UAT), and system oversight, as well as utilize the system to actively manage clinical trial material.

+ Utilize and support the budget forecasting and planning

+ Partner with Clinical Operations Lead to align on demand assumptions

+ Develop supply strategies to maximize supply efficiency and minimize waste

+ Design and actively manage supply & demand forecasts

+ Identify potential supply risks, and develop risk mitigation plans as necessary

+ Communicate clinical supply requirements to CMC team and ensure seamless coordination of demand and supply

+ Function as the unblinded representative if required

+ Resource to unblinded site and CRO team

+ Oversight of drug accountability and monitoring, review of unblinded monitoring reports

+ Assist with study plans, training and SIVs as needed

+ Support return and destruction of clinical trial material for assigned protocols

+ Ancillary Clinical Trial Supplies

+ Identify and procure ancillary supplies as needed per protocol

+ Comparators

+ Freezers

+ ECGs, pulse oximeters, etc.

+ Laboratory

+ Oversight of central laboratories utilized in clinical trials

+ Assists Clinical Operations Study Lead in the identification, qualification, and selection of laboratory vendors

+ Collaborate with Research and Clinical Science with regard to needs for additional analyses that may be required (PK, PD, ADA, etc).

+ Sample management and long-term sample storage oversight

+ General

+ Assist in SOP review and development

+ Assist in other areas of clinical operations as needed.


**QUALIFICATIONS:**


**Bachelors degree**


**Experience: 5+ years of relevant experience**


**Experience with vendor oversight and global trials**


**Understanding of clinical supply chain activity**


**Experience with IRT systems**


**Strong understanding of FDA, EMEA, GCP and ICH guidelines**


**Ability to utilize MS Office (Excel, PowerPoint, Visio, Project, etc)**


**Demonstrated flexibility to adapt to external environment influences through identifying new strategies and tactics**


**Strong attention to detail**


**Excellent communication, collaboration, and influencing skills**


**Ability to multi-task and manage complex challenges**


**Ability and willingness to travel as needed positive management approach**


**Maximum flexibility to adapt to changing program needs in real time**


**Excellent oral, written, and communication skills required**


**Ability and willingness to travel as needed**


Please note that resumes from third parties will not be accepted. All candidates must be presently authorized to work for any employer in the US.


Apply today for immediate consideration or send your resume directly to


**Marina.Hart@kellyscientific.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: 2021-11-12 Expires: 2021-12-13

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Clinical Trial Manager - Clinical Operations Supply (direct hire, 100% remote)

Kelly Services
San Diego, CA 92108

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