Seattle Genetics

Principal Clinical Data Associate

Description

Seattle Genetics is an emerging global multi-product biotechnology company that develops and commercializes innovative antibody-based therapies for the treatment of cancer. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. In addition to one marketed product, we are advancing a strong product pipeline of novel therapies for solid tumors and blood-related cancers designed to address significant unmet medical needs and improve treatment outcomes for patients.

Summary

The Principal CDA is a Management-level CDA capable of leading Data Management aspects of a clinical study with minimal support and oversight. The Principal CDA has thorough knowledge of FDA regulations and industry standards, strong technical skills, and is capable of leading infrastructure assessment and improvement. This position may manage vendor/CRO relationships.

Responsibilities:

• Manage/coordinate work performed by vendors/CROs as appropriate to ensure quality of product. Assist in the selection of vendors/CROs (e.g. review RFPs, attend site audits).
• Independently develop DM documents including but not limited to DMPs, CRFs, CRF Completion Guidelines, Edit Checks, UAT specifications, centralized monitoring plans, data flow and integrity plans, blinding plans, and data review plans.
• Ability to run SAS programs, review SAS logs, and generate output. Program SAS Non System Edit Checks (NSECs) and/or SAS Data Listings as appropriate for SAS skill level. Mentor less proficient SAS users as appropriate.
• Independently lead data cleaning activities such as but not limited to Study Team data reviews, Non-system Edit Check Output review, SAE reconciliation, and non-CRF data reconciliation.
• Independently manage the database lock process in an efficient and timely manner.
• DM Project Management: Understands critical tasks and milestones; ensures data management deliverables are met per study timelines. Utilizes experience and appropriate tools to efficiently lead and coordinate data management activities. Ensures study team members understand and deliver components affecting data to ensure successful execution of deliverables. Provide solutions for data management issues that arise during study conduct. Assists DM Management in coordinating and/or supervising data management activities across studies.
• Perform medical coding utilizing MedDRA and WHO-DRUG, as appropriate.
• Ability to research, evaluate and lead departmental initiatives and new technologies/innovations to improve CDM processes; represent CDM through working groups (internal and external) and initiatives where thorough knowledge of CDM practices/processes are required.
• Coordinate and delegate work performed by junior CDAs, as needed; assist in mentoring of junior CDAs and/or contractors; may manage CDAs.
• Utilizes experience and leadership skills to provide guidance to other team members.
• Takes ownership of procedures and resources available to team.
• Independently and collaboratively performs ongoing evaluation of procedures for efficiency and scalability.

Qualifications:

• BA/BS in relevant field and 10+ years experience. Years of experience may substitute for education.
• Requires effective organizational and communication skills.
• Technologically savvy; quickly picks-up new information, standards, regulations, tools, methods or software as it relates to position and profession.
• Detail oriented; performs quality and accurate work.
• Thorough knowledge of FDA regulations, ICH GCP guidelines, SDTM, CDISC, database development, UAT, medical coding, the drug development process.
• Knowledge and understanding of DM Lifecycle associated with P1-P3 studies, including pivotal, blinded, and randomized trials.
• Previous relevant EDC experience required.
• Previous vendor/CRO management required.

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, color, religion, sex, national origin, protected veteran status, or disability status.

Apply:

Seattle Genetics

Seattle Genetics is an Equal Opportunity Employer

Submitted: 11/30/2018