Clinical Trial Manager

Clinical Ops (600) · Seattle, Washington
Department Clinical Ops (600)
Employment Type Full-Time
Minimum Experience Mid-level

Company:

 

Chinook Therapeutics is a clinical-stage biotechnology company developing precision medicines for patients with kidney diseases. We apply our proprietary research platform to discover and develop therapies with novel mechanisms of action in key kidney disease pathways. Our development focus is on rare, serious disorders with clear unmet medical needs and well-defined clinical development opportunities. Our lead program, atrasentan, is a potent and selective, small molecule inhibitor of the endothelin A receptor that is planned to move into a phase 3 registrational trial for IgA nephropathy and a phase 2 basket trial for glomerular diseases, in 2021. We are advancing BION-1301, an anti-APRIL monoclonal antibody, in an ongoing phase 1b trial for IgA nephropathy, and CHK-336, an oral small molecule LDHA inhibitor for primary hyperoxaluria, towards trial initiation in 2021. Our pipeline also includes several additional preclinical programs at the validation and lead optimization stages, and we continue to actively evaluate business development opportunities around early and late-stage clinical assets in kidney disease. 

 

Chinook completed the third quarter of 2020 with over $290 million in operating capital and trades on Nasdaq under the ticker symbol, “KDNY.”  The company has locations in Vancouver, BC, Seattle, WA and Berkeley, CA.


Position:


The Clinical Trial Manager (CTM) is a key member of the Clinical Operations Team, supporting the successful execution of clinical trials. The CTM has primary responsibility for implementing studies across clinical trial sites and quality oversight of site management and monitoring activities across both early and late-stage clinical trials.  This position reports to the Director of Clinical Trial Management.

 

 Responsibilities include:

  • Support clinical trial management efforts on global, late-stage clinical trials and/or serve as lead CTM on early phase clinical trials.
  • Partner with investigative site personnel, CROs, and other study vendors to drive key study activities.
  • Ensure conduct of clinical trial activities in accordance with Standard Operating Procedures and all applicable regulations governing the conduct of clinical trials.
  • Lead the identification, evaluation, selection, and oversight of clinical trial sites.
  • Contribute to the design and review of clinical trial protocols, CRFs, and Clinical Study Reports in collaboration with cross-functional study team members.
  • Develop informed consent forms and other patient-facing materials.
  • Contribute to the development and maintenance of study plans and documents, including but not limited to Study Start-up Plans, Clinical Monitoring Plans, Site Instructions, Forms, and Binders.
  • Contribute to development of study timelines and milestone setting.
  • Contribute to study forecasting and tracking of enrollment, investigational drug, and financials.
  • Perform data cleaning activities.
  • Oversee relevant CRO and/or vendor activities.
  • Oversee research specimen collection, including accountability, monitoring, reconciliation, and shipment as needed.
  • Facilitate information flow between clinical trial sites, study team members, CRO’s, and vendors.
  • Ensure completeness of Trial Master File (TMF) and various tracking systems for assigned studies.
  • Participate in the preparation and follow-up of internal process audits, vendor and study site quality audits, as well as regulatory authority inspections.
  • May train and mentor new clinical staff and may contribute to dotted-line management of team members.

 

Education, Experience, and Skills:

  • 8 years of relevant clinical trial management experience
  • BA/BS or equivalent
  • Experience managing and overseeing CROs is strongly preferred
  • Ability and willingness to travel is required (domestic and internationally)
  • Thorough knowledge and understanding of CFR and GCP/ICH requirements, as well as European Clinical Trial Directive is required
  • Strong leadership, communication, and organization skills
  • Exceptional ability to plan, organize and conduct clinical studies with minimum oversight
  • Proficiency in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint) and other electronic systems (CTMS, EDC and eTMF)
  • Consideration given to candidates with therapeutic experience in kidney disease

 

Chinook is an Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind.  We are committed to fostering an environment where ALL people are welcome and supported.  We respect and value different experiences and viewpoints.  We act respectfully toward one another and embrace diversity of people and ideas. Having a diverse workforce made up of team members who bring a wide variety of skills, abilities, experiences, and perspectives is essential to our success. Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect.

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  • Location
    Seattle, Washington
  • Department
    Clinical Ops (600)
  • Employment Type
    Full-Time
  • Minimum Experience
    Mid-level