Celgene Specialist II Biospecimen Operations in Seattle, Washington
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
At Celgene Corporation, we’re committed to changing the course of human health through bold pursuits in science, life-enhancing therapies and a promise to always put patients first. The Clinical Operations team is made up of highly skilled and collaborative individuals who are fueled by the impact they make on the world through our work.
To help us achieve our mission, we are hiring a Biospecimen Operations Specialist II to join our team.
What great looks like in this role
Our ideal candidate is detail oriented, collaborative and energized by a fast-paced environment where we are required to work across multiple projects and adjust to change quickly. You’re a creative problem solver with the ability to identify potential risks and issues before they arise and then providing the necessary directions and change so that issues are avoided. Additionally, you’re a leader who enjoys coaching and mentoring others helping them to achieve personal and team success. This is a great opportunity to join a growing team with opportunity to innovate and make a positive impact.
Objectives of this Role
Provide biospecimen and clinical trial support, including assessing quality support from the process improvement perspective, identifying gaps and needs, and proposing and
driving solutions across multiple, often complex, studies in oncology and inflammation and immunology (I&I).
Serve as the lead trainer on biospecimen logistics and represent biospecimen operations at national and international clinical site initiations and investigator meetings.
Act as a mentor to teammates, providing support with issue analysis and solutions, helping to escalate and resolve issues as appropriate, lead and facilitate effective meetings and
manage conflict with minimal guidance.
Stay informed on changes and evolutions within the industry, remaining a subject matter expert for the team and the company, internally and externally.
Daily and Monthly Responsibilities
Maintain knowledge and status of assigned clinical protocols and be able to follow good clinical practices (GCP), standard operating procedures (SOPs) and working procedures (WPs).
Play a key role in planning and designing clinical trial and biospecimen operations support internally and externally.
Utilize software tools such as Labmatrix to track biospecimens, identify discrepancies, verify and document consent, and ensure compliant utilization of biospecimens by following written procedures.
Maintain regular metrics of biospecimen activities for studies supported. Follow up and resolve discrepancies through communication with study team, sites or CROs/vendors within specified timeframes.
Plan and design biospecimen handling logistics and review biomarker-related clinical documents clinical protocols, ICFs, CRFs for successful study start-up.
Create and maintain biospecimen laboratory manuals and provide hands-on biospecimen processing training at clinical sites.
Support clinical and CRO to review supporting biospecimen documentation, labels, requisition forms and manifests to ensure documented biospecimen chain-of-custody and the rapid reconciliation of biospecimens.
Work with manager and clinical development teams to plan and design biospecimen handling logistics with preferred vendors on the manufacture of sample collection kits and execution of associated logistics; will be expected to take on a primary role in working with scientists and analytical laboratories on generating work order requests, work specifications and logistics.
Knowledge and skills required
Master’s or bachelors’ degree in a life sciences or healthcare related field with at least 5 years’ relevant experience for those with a master’s degree and at least 6 years’ relevant experience for those with a bachelor’s degree. Relevant professional experience includes: academic clinical research setting or clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment.
Demonstrated application in the context of clinical trials and biospecimen management.
Proficient knowledge of FDA regulatory requirements and GCP; have a demonstrated, intuitive understanding of clinical trials.
Proficient knowledge of relevant therapeutic and technical areas; demonstrated understanding of laboratory techniques in the life sciences; demonstrated understanding of principles in clinical research and clinical procedures involving blood/biopsy collection, handling and processing.
Understanding of global biobanking issues; proficient experience working in organizations adhering to quality standards and working with regulations pertaining to general biospecimen transportation requirements.
Proficient understanding of the drug development process.
Experienced in presenting logistics and processing instructions, including basic scientific and clinical content, to internal and external audiences.
Basic leadership skills in conflict management, facilitation and negotiation.
Up to 20% travel to clinical sites to train sites on biospecimen procedures.
- Experience with databases and intermediate-level Excel a plus.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.