Project Manager - Clinical Trials
Work schedulePermanent, full time
Start dateAs soon as possible
With unrivaled expertise in immunology, and operating sites in North America (East and West Coast) and Europe, Nexelis is a leading provider of assay development and advanced laboratory testing services in the infectious diseases, metabolic diseases, and oncology fields. Our versatile team of scientists, working with our advanced technology platforms, were instrumental in the development, qualification, validation, and large-scale sample testing of assays that supported the FDA filing of almost 100 new molecular entities, including blockbuster vaccines, anti-viral drugs, and immunotherapy, gene and cell therapy products.
Our Seattle office focuses on Bioanalytical Services (PK, Immunogenicity ADA Assays, & Fit-for-Purpose Biomarkers), in addition to offering an extensive Biomarker Menu.
As Project Manager, you’ll take a leading role in communicating with clients, acting as liaison with the lab, and ensuring deliverables are met with a top emphasis on customer service and delivering high-quality projects on time and on budget.
If you are interested in working in a dynamic biotechnology environment that is challenging, rewarding and a source of personal pride and growth, we’re interested in hearing from you! Nexelis is located in Seattle, surrounded by mountains, forests and waterways of the Pacific Northwest.
- Responsible for setup and monitoring of progress, documentation, quality assurance, and logistics support to clinical trial projects for assigned clients that may include pharmaceutical sponsors, central laboratories, or diagnostic manufacturers
- Serve as the control point for communications and problem solving with clients having multiple projects and ensure that document trails comply with regulations and client preferences
- Communicate the needs of the client or study to the appropriate Nexelis department and serve as liaison between client and Nexelis
- Serve as the PM representative on the Client Team, along with business development and scientist counterparts, to support the company’s major clients
- Prepare study plans, lab manuals and sample analysis reports as applicable
- Project and monitor study revenue and other study metrics
Experience and Qualifications
- A minimum of 3 years of experience in clinical trial management or coordination, preferably in the biotech/pharmaceutical industry or other medical/scientific field; 10 years of overall work experience preferred
- Specific experience required includes laboratory/phlebotomy procedures and clinical trials (preferable phase I-III)
- The ability to manage multiple studies for a client, assess overall study requirements, ensure studies are properly managed through the study life cycle, and serve as a principle liaison with departments
- Familiarity with clinical trial operations required; experience in a clinical or research laboratory
- Familiarity with Laboratory Information Systems (LIS/LIMS)
- Working experience with a GXP regulated environment (GCP/GLP/GMP)
- Must be extremely detail-oriented, well-organized and committed to maintaining rigorous documentation standards
- Bachelor’s degree required; life or medical sciences preferred
- Certification in project management and clinical trials would be a plus