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Job #03226

About our client Our client is the largest clinical diagnostics company in the world. With offices around the globe, they boast a strong pipeline of products and services designed for efficient delivery of patient test results used for diagnosing medical conditions, monitoring patient therapy and providing quality health care. This is an excellent opportunity for the right person to join a fast-paced environment. Position Location Senior Clinical Project Manager Los Angeles, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee project leadership of selected clinical studies 2) Devise/execute strategies for the clinical and non-clinical (analytical) trials for product releases, regulatory filings, product modifications/claim extensions and/or new markers 3) Support the Head of Clinical Affairs and the company in designing/preparing clinical study protocols as well as the designing, initiation, monitoring and close-out of clinical studies for validation of the company's in vitro diagnostic products 4) Provide expert resources to project teams on the requirements and conduct of successful clinical trials in multiple disease-focus or other areas 5) Ensure adherence to GCP and departmental SOPs for conducting in vitro diagnostic device clinical studies 6) Prioritize/focus resources to deliver all projects on-time in keeping with the group’s commitments 7) Supervise directly, two or more employees in the Department of Clinical Affairs 8) Carry out supervisory duties as per the organization's policies and applicable laws including interviewing, hiring/training and reviewing performance of employees and accordingly reward/discipline employees 9) Maintain staff training files and address/resolve complaints/problems 10) Research scientific evidence, appropriate CLSI documents and current clinical use of in vitro assays in preparation for clinical protocol development 11) Design/prepare CRFs, Investigator or site-specific instruction manuals and other related study documentation 12) Monitor proposed regulations/guidance documents that concern clinical trials, ensuring that the Clinical Affairs Group remains compliant with all current/new regulations/requirements for clinical trials and protection of human subjects 13) Assist in responses during regulatory body review of product submissions 14) Communicate (regularly) with study investigators regarding activities in all study phases 15) Oversee all activities associated with the clinical study that include site pre-assessment and selection, contract negotiation, site-approvals (e.g. Internal Review Board/Ethics Committee), training, monitoring (initiation, interim and closeout visits) as well as on-site audits 16) Identify problems/issues early that could affect the results or completion of the study or any protocol deviations as well as problem-solving strategies 17) Interface with Data Management and Statistical staff to manage incoming clinical site data, design/maintain databases and perform statistical analysis 18) Prepare/review clinical study reports and clinical sections of regulatory submissions 19) Prepare (in conjunction with the clinical investigators) scientific abstracts, posters and publications arising from the studies 20) Develop study budgets and ensure that studies are completed within budget 21) Define study timelines and deliverables with the core team Requirements 1) Ph. D. in a health-related field with 5 years of healthcare experience or equivalent or MA/MS in a health-related field with 8 years of healthcare experience or equivalent, or BS in a health-related field with 10 years of healthcare experience 2) Knowledge of clinical microbiology or certification as a Clinical Laboratory Scientist a plus 3) Laboratory experience a plus with demonstrated experience in developing/motivating individuals and a team 4) Knowledge of regulations concerning the conduct of clinical trials and of the in vitro diagnostics industry 5) Good technical background to understand and communicate new technologies, markers and competitive products 6) Excellent communication (written and oral), interpersonal, managerial and negotiation skills 7) Working knowledge of databases (e.g. Excel, Access), database management and statistical applications 8) Ability to manage multiple high-priority projects across multiple sites and demonstrate/convey the company's high-performance culture to co-workers 9) Excellent relationships with a broad base of clinicians, laboratory professionals and CROs, who can perform field/clinical trials and who have clinical populations appropriate for specimen acquisition 10) Ability to work with a variety of individuals outside the organization (investigators, partners) and critical functions within the company including Regulatory Affairs, Marketing, Service and Support, Project Management, R&D and Manufacturing