Clinical Research Diagnostic Project Manager - Military Veterans
at Kelly
Clinical Research Project Manager – Diagnostic
• Clinical Trials Division
• Employment Type: Full Time – Onsite in Los Angeles, CA
• Reports to: SVP of Operations
• Pay Rate: Based on experience (90-130K)
Our client, who is a biobank and laboratory CRO, supports the largest In Vitro Diagnostic companies in the industry. They are hiring a permanent Project Manager to work onsite in Los Angeles California. In this role, you will design and execute IVD sample collection trials to ensure that agreed upon services are delivered on time and on budget, using a network of physicians and labs to achieve client satisfaction. The Project Manager will perform all job functions in accordance with the CRO standard operating procedures and policies, Good Clinical Practice guidelines and all applicable regulatory requirements.
Responsibilities
• Design and document a project plan with details for each site and any labs including details for (sites selected, # kits per site, detailed CTMS setup in Salesforce, lab coordination, shipping, etc.)
• Responsible for evaluating and communicating the impact of any risks and developing plans to mitigate these risks
• Manage Clinical studies as Project Owner for all assigned studies, as outlined in the Clinical Studies process, with accountabilities/authorities specified in the process map including ensuring protocol and study design are feasible, develop and train team on the project plan, risk mitigation plans, CRF development, kit design with service getting from kit making team, support budget/contract negotiation with sites and service from Site Network Manager, regulatory document management, and maintaining and suggesting improvements to Clinical studies process documentation
• Design protocols to be approved by the IRB quickly that meet client requirements, prevent unnecessary deviations, and allow for internal and client flexibility
• Define and recommend top priorities for all projects on a rolling weekly basis
• Ensure team members supporting study activities are working on these priorities, escalating any issues or prioritization question with service providers to manager
• Design and ensure case report forms can capture client requested data, allow them to audit, and are clear for doctors to avoid doctor errors and minimize the number of queries
• Provide options to clients for kit materials and design
• Develop SIV training materials to clearly define the steps of the study and how it is conducted
• Conduct or ensure training for all relevant site staff
• Conduct and/or ensure clinical "visits" including site qualification, clinical training/SIV, and site close outs
• Ensure all clinical studies and sites receive IRB approval within two weeks for new submissions
• Proactively monitor project status and address issues, potential risks, and client inquiries/requests in a timely manner, which may occasionally require a flexible work schedule/working outside of normal business hours
• Keep track and resolve client requests as study progresses
• Host/attend client calls on time/early especially when hosting
• Host/support client visits and audits/inspections
• Review each project, balancing requirements with current workload, and recommending additional resources including time or reprioritization that will help enable new studies
• Ensure CRA are generating site payments and client invoices monthly
• Review/approve site payments prior to submission to doctors
• Ensure successful execution of data management activities (eCRF, manifest, test file)
• Review shipping manifests and contents of shipping containers
Skills & Requirements
• A minimum of 5 years of industry experience and a minimum of 2 years clinical study management.
• Knowledge of accepted good clinical research practice (GCP) and procedures.
• Experience with in vitro diagnostics and/or medical device industry for diagnostic devices.
• Excellent organizational, time management, budget management, and problem-solving skills.
• Hustle: Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.
• This is an onsite position with little to no travel
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
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Los Angeles, CA
Why Kelly - Since 2011 we have placed over 16,000 Veterans
Need More?
Kelly applies targeted recruiting initiatives to the Veterans population (in all stages of transition) by aligning customer defined requirements with military skills and experience. The transition from military to civilian life can be stressful and complex for veterans, and our staff is trained to assist in this transition. Unlike our competition, Kelly places these resources without geographic or industry constraints, offering our customers and our employees greater flexibility. Kelly has a wide variety of local opportunities, for Veterans and their spouses, within our workforce solutions as well as national recruiting programs on behalf of our customers. Kelly’s leading placement opportunities for Veterans are within Information Technology, Engineering, Science, Light Industrial and Call Center.
Our specially trained Veteran recruiters are armed with a number of tools to help Veterans obtain roles that match their potential including skill translation tools, leading Veteran- centric job boards and Veteran/spouse social media networks, among others.
Through Kelly’s vast branch network, we are closely located to the majority of major military installations across the United States. Kelly recruiters participate in onsite and virtual military career fairs as well as advertise through local and national Veteran job boards. In recent years, over 150 Kelly branches have worked directly with their local military installations to recruit spouses and transitioning personnel. These teams not only engages with transitioning talent from local bases, but also have a strong focus on Veterans in areas where the military has identified high Veteran unemployment. This approach ensures that military talent is engaged and shared across the centralized military recruiting team and documented in a centralized database, so that other Kelly locations can benefit from hiring or relocating this valuable pool of talent.
Our focus on military recruiting is a win on multiple levels. Kelly gains top talent with the skills needed to excel; our clients receive the benefit of that talent to help them compete in an ever challenging business landscape; and Veterans receive gainful employment in line with their skills and abilities to ease the transition to the next phase of their lives.
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