Senior Clinical Data Associate
The Senior Clinical Data Associate is responsible for leading Data Management aspects of a clinical study with minimal support and oversight and will ensure that study level deliverables are completed on time, with high quality, and in accordance with corporate and regulatory requirements. The Senior CDA has thorough knowledge of FDA regulations and industry standards, strong technical skills, and is capable of leading infrastructure assessment and improvement.
- Lead all data management aspects of a clinical study, including study start-up activities, and guide the study team through change orders and protocol amendments
- 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. Utilize templates and standard guidelines to initiate documents, but demonstrate critical thinking, alignment-building and discretion to tailor documents to study needs
- Independently lead data cleaning activites such as, but not limited to, study team data reviews, Non-system Edit Check Output review, SAE reconciliation, and non-CRF data reconciliation. Gather cross-functional input to drive creation of custom data review plans. Evaluate options and exercise discretion to choose efficient and effective issues resolution paths
- Independently manage data deliverables processes and database locks, with high quality and efficiency
- Foster collaboration and relationship-building with all study team representatives (e.g. Biostatisticians, Statistical Programmers, Medical Monitors, Clinical Project Managers, Clinical Trial Managers, CRAs, Clinical Pharmacologists, Biomarker/Bioinformatics scientists, Medical Writers, Regulatory representatives, etc.)
- DM Project Management: Understand critical tasks and milestones; ensure data management deliverables are met per study timelines. Utilize experience and appropriate tools to efficiently lead and coordinate data management activities. Ensure 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
- 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)
- Run SAS programs, review SAS logs, troubleshoot errors, 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
- Evaluate CDM processes and applications for improvements; participate in working groups to develop and implement new processes and applications
- Coordinate and delegate work performed by junior CDAs, as needed; assist in mentoring of junior CDAs and/or contractors
- Utilize experience and leadership skills to provide guidance to other team members; take ownership of process resources available to team
- Years of experience: 5-10 years
- 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
- Demonstrated project management, risk assessment and time management skills
- Previous relevant EDC experience
- Detail oriented; performs quality and accurate work
- Can identify opportunities for efficiency improvements and simplification, recognizes appropriate resources for deliverables, has effective organizational skills
- Interpersonal skills; encourages collaboration, is a team player and is cooperative, builds constructive and effective relationships, is approachable, communicates effectively
- 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
- Prior experience writing specification documents and/or work instructions
- Previous vendor/CRO management
- Previous experience with RTSM/IWRS and ePRO systems
- Database development experience
- SAS programming experience
- Oncology experience
- BA/BS in relevant field. Years of experience may substitute for education
As the leading employer in our industry in the Pacific Northwest, Seagen 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 Seagen, please visit www.seagen.com.
Seagen 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.