Job: SEND Data Specialist, Altasciences Preclinical Services, Everett, WA

General Information

Job title:
SEND Data Specialist
Job location:
Everett, WA 98203 United States

Requisition code:
Date posted:
Job type:

Career path:

Scientific Discipline:

Job Description

Everett, WA, USA Req #1272

Altasciences is a mid-size contract research organization with a unique focus on supporting drug development from lead candidate selection to proof of concept. With over 25 years of industry experience, we provide preclinical and clinical solutions to an international customer base of biopharmaceutical companies. Our full-service offering in this critical stage of drug development includes program management, preclinical safety testing, clinical pharmacology services, manufacturing and analytical services, medical writing, biostatistics, data management, and bioanalysis services tailored to specific research requirements. Altasciences has facilities in Montreal, QC; Kansas City, KS,Seattle, WA and Philadelphia, PA.

Our team is made up of over 1,300 professionals from the medical and scientific fields who work together to achieve a common goal: to contribute to the advancement of life sciences. Bring your talents and forward-thinking approach to Altasciences and help us develop medicines for those who need them, faster.

The SEND Data Specialist plays an active role in the company's SEND program. SEND is an FDA required electronic format for nonclinical study data to accompany submission of study reports.

The SEND Data Specialist performs business analysis and administration functions that include: continuous process improvement efforts to maximize the business value of our SEND system, assisting study set-up, scheduling, execution, and reporting; providing Helpdesk support for SEND issues; helping to develop processes that are associated with SEND; validation and testing; training; and maintaining the SEND system through change management procedures.


• Works with operational stakeholders to gather requirements, map processes, and document workflows using standard methodologies for the purpose of building functional requirements for implementation of business processes in SEND and/or other systems integration and development projects
• Configures SEND system modules in support of these functional requirements and interfaces to other systems
• Participates in other IT integration activities as the SEND Subject Matter Expert (SME). In conjunction with operational departments, ensures preparation of SEND datasets are submission ready. This may include the harmonization of study data from multiple data sources, including but not limited to: Sponsors, Provantis, LIMS, test sites, and/or other testing facilities
• Performs quality control review on the resulting SEND dataset to ensure the data is equivalent to that presented in the study report
• Resolves system errors, disruptions, and concerns as they relate to protocol management (in conjunction with Information Technology staff, as applicable) and communicates resolutions to the appropriate departments
• Develops and utilizes written standard operating procedures based on information security guidelines, regulatory requirements, and industry best practices
• Maintains technical documentation in support of all these duties
• Respond to internal/external audit findings and contribute to corrective actions as needed
• Assist in providing SEND system training and maintaining a robust system training program
• Utilize diagramming software to assist in the creation of dataflow and system diagrams


• B.S./M.S. degree, preferably in scientific or technical discipline or equivalent combination of education, related experience and/or certified training
• 1 plus years of experience with SEND in a GLP pre-clinical environment preferred
• Experience in a global role in a global healthcare services company a plus
• Proficient in the use of MS Office (Word, Excel, Visio, PowerPoint) and project management tools
• The language skills required include, but are not limited to: the ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals; the ability to write routine reports and correspondence; excellent oral and written communications and teamwork skills; demonstrates excellent written and oral communications skills for interaction with a multidisciplinary project team; and the ability to speak effectively before groups of customers or employees of the organization
• The math skills required include, but are not limited to: a working knowledge of applied mathematics used in the life sciences industry, advanced algebra, regression analysis, and statistics
• Training needs for this position may include computer software, networking, and security. Continual GLP, Part 11, Program Management and scheduling training
• Diagnosing, tracking and solving system problems; prioritizes tasks, demonstrates strong support for customers and team members, carefully follows verbal and written instruction and contributes independently or as team member; positive customer service orientation, with a quality oriented work ethic. Development and utilization of written procedures checklists and test plans is required
• Preferred skills include strong computer and writing skills, attention to detail, excellent interpersonal and organizational skills, and the ability to communicate effectively at several levels of the organization. Candidate must have the ability to interact effectively with people with diverse personalities and cultural backgrounds
• May enter areas where biological or chemical hazards are present
• Wears appropriate PPE in accordance with policies and procedures. PPE may include, but is not limited to: N-95 respirator, face mask, safety glasses, goggles, face shield, gloves, lab coat, scrubs, shoe covers, and hair bouffant
Other details

• Job Family Valide Positions
• Pay Type Salary
• Required Education Bachelor's Degree
• Job Start Date Monday, December 14, 2020

Altasciences is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race,
color, religion, sex, sexual orientation, gender identity, or national origin, and protected veteran status, or disability status.

Altasciences uses E-Verify to confirm the employment eligibility of all newly hired employees.
To learn more about E-Verify, including your rights and responsibilities, please visit

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Job Requirements

(see job description above)

(Job number: 3967737)