Clinical Research Project Manager – Diagnostic
Los Angeles, CA
Clinical Trials Division
Employment Type: Full Time – Onsite in Los Angeles, CA
Reports to: SVP of Operations
Pay Rate: Based on experience
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.
Essential Tasks~Operate and maintain loaders.~Responsible for the efficient working conditions of the loaders. This includes: performing... ....~Load trucks.~Assist with maintenance around the asphalt plant.~Check fuel supplies at sites to ensure adequate availability....
...you passionate about making a difference in the world? Look no further! The Borgen Project ( is an international organization that works at the political level to improve living conditions for people impacted by war, famine and poverty. With 20 years of experience...
Are you looking for a new job? My name is Caroline and I'm a healthcare recruiter - I'm here to help! A great 250-bed full-service, acute care hospital is looking for candidates for their RN Residency Program! This is a yearlong residency which begins with a 10-16 week...
...STAND-UP FORKLIFT OPERATORS 1st and 2nd shift $17.00-$19.50/ 752411st shift Mon-Fri 6am-2:30pm $17.00-$17.502nd shift Mon-Thurs 4:30pm-3am $19.00- $19.50 REACH TRUCK AND ELECTRIC PALLET OPERATORS The driver locates, pulls, and stages customer materials for shipment...
Description:: Medical Can range from specialized medical appointments to general medicine Location: Columbus, OH Date: Dates... ...jobs. We also look forward to retaining your services as an interpreter for all future jobs we will have in your area. If you are not...