YOUR NEW COMPANY!

At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you’re a recent college graduate or seeking your next career opportunity, it’s time to discover your future at Altasciences.
We are better together and together We Are Altasciences.

ABOUT THE ROLE

The SEND Data Specialist I 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.

WHAT YOU’LL DO HERE

• Ensure preparation of SEND datasets are submission ready, including the harmonization of study data from multiple data sources, including such as sponsors, Provantis, LIMS, test sites, and/or other testing facilities
• Perform a quality control review on the resulting SEND dataset to ensure the data is equivalent to that presented in the study report
• Resolve system errors, disruptions, and concerns as they relate to protocol management (in conjunction with IT staff, as applicable) and communicates resolutions to the appropriate departments
• Develop and utilizes written standard operating procedures based on information security guidelines, regulatory requirements, and industry best practices
• Maintain 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