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Country: United States

Specific Location: Seattle, WA

Job Title: Clinical Data Manager

Type of Job: Permanent

Job Description:

Hope. Care. Cure. These three simple words capture what we do at Seattle Children’s – to help every child live the healthiest and most fulfilling life possible. Are you ready to engage with a mission-driven organization that is life-changing to many, and touches the hearts of all? #HOPECARECURE

As one of the nation’s top five pediatric research centers, Seattle Children’s Research Institute is dedicated to providing hope, care, and cures to help every child live the healthiest and most fulfilling life possible.

Our investigators are involved in hundreds of projects that cover every phase of research, from studying how diseases work to improving investigational therapies. They have pioneered groundbreaking cystic fibrosis treatments and cutting-edge cancer therapies that help a child’s immune system defeat cancer, and made other major contributions to pediatric medicine.

Researchers work in close collaboration with one another, their colleagues at partner institutions including the University of Washington and Fred Hutch and our healthcare providers at Seattle Children’s Hospital, one of U.S. News & World Report’s top children’s hospitals. This collaboration is one of our key strengths, allowing our faculty to draw on a variety of disciplines and techniques as they pursue solutions to some of medicine’s most complex problems.

We are committed to not only treating disease but to eliminating it. Help us achieve our vision of being a worldwide leader in pediatric research aimed to improve the health and well-being of children. If you are interested in a challenging career aimed at groundbreaking research, Seattle Children’s Research Institute is the place for you.

The Immunotherapy Integration Hub (IIH) is a department at Seattle Children’s Research Institute bringing together multi-disciplinary researchers from the “bench to bedside” to develop and test novel CAR T cell therapies in pediatric populations. This includes: laboratory-based research to find novel ways to target tumors, development, implementation, and management of clinical trials and correlative laboratory studies to investigate the impact of the therapies on patients and to provide feedback to the research team. We have the most comprehensive CAR T-cell immunotherapy research program for pediatric patients in the nation.

The Immunotherapy Coordinating Center (ICC) is within the IIH and supports the development and implementation of Phase I/II, single and multi-site, pediatric CAR T cell clinical trials at Seattle Children’s Hospital and other children’s hospitals across North America. The ICC spans multiple functional areas, including Biostatistics and Data Management, Clinical Trial Management, Clinical Development, and Regulatory Affairs.

The Clinical Data Manager will be responsible for clinical data management support for early phase single and multi-site, pediatric Immunotherapy clinical trials. Responsibilities will span from study concept development through closure, including creating data specification, coordinating CRF design as per established standards and applicable protocol, database build and testing, data maintenance, monitoring the collection, processing and quality control of study data, authoring CRF completion guidelines and Data management plan, study material development, study closeout activities, project management and vendor management. This role will also be involved in unit infrastructure development, including the development and review of Standard Operating Procedures (SOPs) and Work Instructions (WIs).

*Please note: This position will be on-site in Seattle, WA. We cannot accommodate a remote employment at this time.

Required Education/Experience:
– Bachelor’s Degree in a scientific discipline or related field.
– Minimum of four (4) years experience in clinical study operations, including at least three (3) years of clinical data management.
– Understanding of relational database principles.
– Minimum two (2) years experience creating specifications for all aspects of a database build.

– Master’s Degree in scientific discipline or related field.
– Database build and management experience in Medidata Rave.
– Advanced SQL query skills.
– Applied knowledge of CDISC/CDASH/SDTM.
– Experience with clinical dictionaries; MedDRA and WHO dictionaries.
– Applied knowledge of Medidata Coder.
– Experience in Labkey.

EEO Statement:
Our community welcomes diverse experiences, backgrounds, and thoughts as this is what drives our spirit of inquiry and allows us to better connect with our increasingly diverse patients and families. Our organization recruits, employs, trains, compensates, and promotes without regard to race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. The people who work at Seattle Children’s are members of a community that seeks to respect and celebrate all the qualities that make each of us unique. Each of us is empowered to be ourselves within this community, which cultivates and promotes equity, diversity, and inclusion at all levels.

Seattle Children’s is proud to be an Equal Opportunity Workplace and Affirmative Action Employer.

Closing Date: December 31, 2019

Website/URL for Company Listing: click here

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