Clinical Trial Manager/Sr. Clinical Research Associate

Location
Bothell, WA, United States
Posted
Oct 26, 2018
Ref
okIO7fwH
Hotbed
BioForest
Required Education
Associate Degree
Position Type
Full time
Summary:

This position focuses on the execution and coordination of all activities required to initiate, manage and complete clinical trials. Serving as Protocol Lead on one or more clinical trials and being the main point of contact for clinical site management and clinical trial site monitoring functions. Participating as a member on assigned cross functional study teams. Assisting with the design and review of clinical trial protocols, informed consent, CRFs, Statistical Analysis Plan, and Clinical Study Report in collaboration with medical monitor, biostatistician, regulatory affairs, senior management and other relevant groups. Facilitating 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. Provide mentorship to less senior members of the Clinical Trial Team

Responsibilities:
  • Lead identification, evaluation and selection of clinical trial investigators/sites
  • Manage clinical trial site monitoring team metrics to ensure performance maximizes efficiency, quality, ICH/GCP adherence, and meet clinical trial and corporate goals
  • Provide support to Field Clinical Research Associates (CRAs) and assisting 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
  • Coordinate and manage vendor processes for the clinical trial site monitoring function of clinical trials including central laboratories and Clinical Research Organizations (CRO)
  • Oversee the process for 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
  • Assist in the preparation and follow-up of in-house and on-site Seattle Genetics sponsored quality audits, as well as, regulatory authority inspections
  • Assume responsibility for development and maintenance of department SOPs or processes
  • Become a subject matter expert for complex processes within the clinical trial management team
  • Ensure assigned team (dotted line or functional) adheres to clinical operations or project-specific quality documents (e.g., SOPs, work practices, training guides)
  • Lead department initiatives that drive process improvement. Manage internal (dotted line or functional) and Field CRAs, and other external clinical trial service vendors as necessary. Providing timely feedback to assigned staff on personal and project-specific performance, and providing guidance on performance improvements as necessary
  • Conduct performance evaluations and provide assigned staff with constructive feedback to enhance performance. Serve as mentor to help assigned staff develop their career paths


Qualifications:
  • BA/BS or equivalent or any relevant and qualifying training, RN or health care professional, with at least 6 years of pharmaceutical clinical development experience or equivalent
  • Experience in Phase I-III trials for Sr. CRA role and at least 8 years for CTM role
  • CRO management is preferred
  • Experience managing clinical trial personnel (direct or dotted line reporting) is preferred.
  • Oncology clinical research experience preferred
  • Ability and willingness to travel (domestic and internationally) less than 20%
  • Thorough knowledge of CFR and GCP/ICH requirements
  • Excellent communication and organization skills
  • Proficiency in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint) and other electronic systems (CTMS, EDC and eTMF)


As the leading employer in our industry in the Pacific Northwest, Seattle Genetics 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. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.