Specialist I, Clinical Operations/ Sample Management
2 days left
- Full Time
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.
Under moderate supervision in a fast-moving team-based environment, the Specialist I will provide biomarker specimen and clinical trial support across multiple studies in oncology and inflammation/immunology, execute on biospecimen operations logistics and provide biospecimen processing training. As part of the Translational Development (TD) Operations department, the specialist will gain exposure to the planning of clinical trial and biomarker specimen operations across a variety of platforms. The ideal candidate is a team-player who is detail-oriented; can successfully multi-task, supporting several projects simultaneously; understands the broader context and impact of the support that he/she provides; knows how to identify/recognize issues and propose solutions with moderate guidance.
Responsibilities will include, but are not limited to, the following:
The Specialist I will be expected to be an active participant of the internal work group and will often be expected to go beyond assigned tasks that support the department’s mission. The primary responsibilities of the TD Operations Specialist I are to support TD and clinical teams in the implementation and maintenance of a biospecimen management system for global clinical studies in each of the following areas under moderate supervision:
1. TD Operations : Maintain knowledge/status of assigned clinical protocols and be able to follow good clinical practices (GCP), standard operating procedures (SOPs) and working procedures (WPs). Assist manager with various delegated responsibilities that pertain to clinical trial and biomarker operations support.
2. Biospecimen management : Utilize software tools to track biospecimens, identify discrepancies, verify and document consent, and ensure compliant utilization of biospecimens by following written procedures. Follow up and resolve discrepancies through communication with study team, sites or CROs/vendors within specified timeframes.
3. Clinical study teams : Under direction of supervisor, work with clinical development teams to help plan/design biospecimen handling logistics and review biomarker-related clinical documents for successful study start-up i.e. clinical protocols, ICFs, CRFs. Create and maintain biospecimen laboratory manuals and provide hands-on biospecimen processing training at clinical sites. Work with clinical and/or CRO to review supporting biospecimen documentation, labels, requisition forms and manifests to ensure documented chain-of-custody and rapid reconciliation of biospecimens.
4. CROs and Vendors : Under direction of supervisor, assist clinical development teams to plan/design biospecimen handling logistics with preferred vendors on the manufacture of sample collection kits and execution of associated logistics; work with manager and scientists with analytical laboratories on work order requests and logistics pertaining to specimen deployment.
Bachelors Degree preferably in a life sciences or healthcare related field with 4+ years related professional experience in an academic clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment OR
Masters Degree preferably in a life sciences or healthcare related field and 3+ years related professional experience in an academic clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment
Skills/Knowledge Required :
Demonstrated knowledge and mastery of basic skills are required in each of the following areas:
Clinical Trials : Basic knowledge and awareness of FDA regulatory requirements and GCP; have a demonstrated, intuitive understanding of clinical trials. Hands-On experience in Clinical Operations is a plus.
Scientific/Laboratory Skills : Basic knowledge of relevant therapeutic and technical areas; demonstrated understanding of basic laboratory techniques in the life sciences; demonstrated understanding of basic principles in clinical research and clinical procedures involving blood/biopsy collection, handling and processing.
Biobanking : Awareness of global biobanking issues; basic biospecimen management experience in working in organizations adhering to quality standards and procedures; awareness of regulations pertaining to general biospecimen transportation requirements.
Drug Development : Basic understanding of the drug development process.
Professional inter-personal skills and excellent oral/written communication. Must be comfortable presenting in front of internal and external audience
Leadership skills in conflict management, facilitation and negotiation a plus.
Basic computer skills in Microsoft Office.
Experience with databases and intermediate-level Excel a plus.
Up to 15% travel to clinical sites to train sites on biospecimen procedures.
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.