Position at Seagen
Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines.
As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells.
Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission.
By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world.
Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!
A Sr. CRA may also have the role of Associate CTM which is primarily responsible for management of some Seagen clinical trial sites.
This role focuses on performing all activities required to evaluate, initiate, monitor and close clinical trial sites.
Principal Responsibilities :
Provide operational / clinical trial site management input to the key study documents including the protocol, informed consent, CRFs, Statistical Analysis Plan, and Clinical Study Report as assigned.
Participate in the Clinical Protocol Committee as appropriate. Create and maintain clinical trial start up documents such as the Clinical Monitoring Plan.
investigational drug supply plan, research specimen plan, CRF Completion Guidelines and other plans and processes as appropriate.
Participate in the identification, evaluation and selection of clinical trial investigators / sites Manage clinical trial site monitoring team metrics (i.
e. monitoring frequency and trip report completion, CRFs expected / outstanding, Source Document Verification (SDV) progress, query aging, monitoring resource requirements, etc) to ensure performance maximizes efficiency, quality, ICH / GCP adherence, and meets clinical trial and corporate goals.
Provide support to field CRAs and may assist in the initiating, monitoring and coordinating day-to-day operations of clinical trial sites.
May conduct monitoring visits including pre study, initiation, interim monitoring and close visits as needed. If any portion of the clinical monitoring function is conducted by a CRO, ensure performance meets expectations, as outlined in the CRO oversight plan and / or other applicable plans, and requirements of the trial.
Facilitate information flow between clinical trial sites, clinical project team members and other members of the clinical operations team, external CRO or contracted members, clinical field team, vendors, and other personnel as appropriate.
Oversee research specimen collection, including accountability, monitoring, reconciliation, and shipment as needed. Ensure completeness of clinical trial management system (CTMS) and Trial Master File (TMF) for assigned studies May assist in the preparation and follow-up of in-house and on-site Seattle Genetics sponsored quality audits, as well as, regulatory authority inspections,
Advanced degree preferred.
As a leading employer in our industry, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families.