Cascadian Therapeutics is a clinical-stage biopharmaceutical company specializing in developing innovative therapeutic product candidates for the treatment of cancer. Our goal is to discover, develop and commercialize novel compounds that have the potential to improve the lives and outcomes of cancer patients. Our most advanced product candidate is tucatinib (ONT-380), an orally active and selective small molecule HER2 inhibitor. We are headquartered in Seattle, Washington. For more information, visit www.cascadianrx.com.
The Clinical Data Associate II/III is responsible for performing data management activities to support new and ongoing clinical studies. May serve as the lead data manager on specific trials or assist the lead data manager on other clinical trial teams.
Key Job Responsibilities:
- Performs Clinical Data Management (CDM) activities and/or assists with CDM activities for outsourced oncology clinical trials, including but not limited to case report form (CRF) development, EDC user acceptance testing (UAT), data review, coordination of team data review activities, data reporting, general study metrics report generation.
- Writes and reviews clinical trial documentation, including data management plans, data transfer plans, data validation plans, database specifications, data review plans and meeting minutes.
- Writes and presents materials for clinical trial team activities such as team meetings, safety committee meetings, investigator meetings, and internal or external clinical department training.
- Independently solves routine study challenges within industry policies and procedures.
- Routinely prioritizes tasks utilizing time management skills and tools.
- Prepares and tracks timelines and coordinates with management and project team members to ensure timelines are met.
- Performs quality control (QC) activities.
- Schedules, organizes, prepares and assists in clinical data reviews.
- Develops systems for organizing data to analyze, identify and report trends.
- Analyzes the interrelationships of data and defines logical aspects of data sets.
- Prepares reports of clinical trial studies for internal validation and cross validation studies. May evaluate and resolve issues regarding contents of reports.
- Assists Biometrics department with other projects as needed.
- Performs filing and archiving activities.
- Prepares ad hoc reports as needed.
- Performs other responsibilities as assigned.
Education / Experience / Professional Requirements:
- Bachelor's Degree in Life Sciences, Mathematics, or related discipline (or equivalent).
- 3-5 years of Clinical Data Management experience within the pharmaceutical industry, preferably with experience as a CDM lead. Prior experience in small pharma/biotech environment is highly desirable.
- Demonstrated working knowledge of: CDM core competencies using EDC applications from study start-up through database lock and archiving of documentation for outsourced trials, GCP, clinical functional roles, and the drug development process.
- Demonstrated proficiency in MS Office applications, including Excel, Word, PowerPoint and Share Point.
- Demonstrated ability to lead CDM activities in a complex environment with changing project priorities, incorporating problem solving skills and requiring limited oversight.
- Exceptional verbal and written communication skills; ability to communicate effectively with all levels, internal and external to the organization, both in-person, via phone, and in writing.
- Detail oriented with strong organizational skills.
- Ability to prioritize and handle multiple tasks and projects simultaneously in a fast-paced environment with little supervision.
- Ability to work independently and in a highly collaborative team environment.
- Dedication to quality and reliability in all work tasks.
- Self-motivated, eagerness to grow professionally and commitment to self-development.
- Requires an ability and willingness for intermittent travel as necessary, consistent with the project needs.
Cascadian Therapeutics offers a comprehensive and highly competitive benefits package including medical, dental, vision care, life insurance, short and long term disability, stock options, ESPP, a matching traditional and ROTH 401(k) plan, and fully subsidized transit pass/parking.
If you are interested in working with our team in a collaborative and professional work environment, please Submit Resume ».
We are an Equal Opportunity Employer