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



General Information


Job title:
SEND Data Specialist
Job location:
Everett, WA 98201 United States

Requisition code:
Date posted:
10/06/2020
Job type:
Compensation:

Career path:

Scientific Discipline:

Job Description


Everett, WA, USA; Virtual Req #879

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.

We are looking for our next SEND (Standard for Exchange of Nonclinical Data) Data Specialist to join our Safety Assessment team; could that person be you? We are looking for our SEND Data Specialist to play an active role in Altasciences Preclinical Services 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.

Responsibilities:
• Participates in other IT integration activities as the SEND Subject Matter Expert (SME)
• Ensures that preparation of SEND datasets are submission ready, in conjunction with operational departments. 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
• 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
• Performing a quality control review on the resulting SEND dataset to ensure the data are 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
• Available to provide SEND system training on an as needed basis
• Configures SEND system modules in support of these functional requirements and interfaces to other systems
• 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
• Provides on-call support during non-business hours

Job Requirements


Requirements
• B.S./M.S. degree, preferably in scientific or technical discipline or equivalent combination of education, related experience and/or certified training
• 1 ½ to 2 years' experience working with SEND required
• 1 year of experience in a GLP pre-clinical environment preferred
• Key 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
• Training needs for this position may include computer software, networking, security, Continual GLP, Part 11, Program Management and scheduling.
• 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
• Experience in a global role in a global healthcare services company a plus
• CDISC and PHUSE participation is a plus
• 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
• Proficient in the use of MS Office (Word, Excel, Visio, PowerPoint) and project management tools


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 www.E-Verify.gov.

Other details
• Pay Type Hourly
• Required Education Bachelor's Degree
• Job Start Date Monday, June 22, 2020

• Everett, WA, USA
• Virtual




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 www.E-Verify.gov.

Apply Here: http://www.Click2apply.net/wbk63ncwfhgskqw4

PI120765773

(Job number: 3909860)