Opening for Manager - SEND - IS with Xybion

About Us

Headquartered in Princeton, New Jersey, USA, with offices in Canada, India, and Germany, we are a leading publicly traded global SaaS company that helps enterprise life sciences organizations accelerate new drug development into approved medicines that save lives and keep employees safe. Through our intelligently designed low-code software platforms, we digitize drug research and development, laboratory testing, regulatory approvals, and pharmaceutical manufacturing on a single, unified cloud platform that is cost-effective, ready to deploy, and easy to use.

Highly regulated companies choose Xybion to help them become more efficient, reduce costs and manage compliance, regulatory adherence and risk. Since our founding in 1977, we have supported through software, services, and consulting, 100% of the top 20 global life sciences companies.

Serving more than 160 customers in 25 countries, we have the global scale and expertise to bring our employees around the world together to drive innovation, manage complex business processes, improve program administration and client service delivery.

Manager – SEND - IS:

Manager – SEND-IS is part of SEND Intelligence Services business unit, manages the team of SEND IS colleagues and responsible for delivery of SEND datasets to customers contracting these services.

Job Location: Pune / Chennai

Responsibilities:

• Understand pre-clinical SEND dataset deliverables.
• Manage SEND Intelligence Service projects from post-sales project inception through delivery and client acceptance.
• Customer communication on the status and issues involved in SEND projects.
• Translate pre-clinical study protocols to SEND trail design and nSDRG document authoring.
• Design any transformations of incoming data to SEND nomenclature and work with team developers to implement any such transformation scripting.
• Oversee the generation of SEND datasets using Xybion tools.
• Oversee the QC of output datasets and work with the QC team to ensure the highest quality of deliverables.
• Follow Xybion SOPs and ensure all SEND team members follow them as well.
• Suggest SOP improvements and work with the QA Manager to implement any such improvements.
• Suggest SEND tool improvements and work with the development team to implement such improvements through advice and review.
• To identify and have a good working relationship with all stakeholders and business users involved within the project.
• To support and coach team members through the project process.
• Recruiting and hiring for an expanding SEND IS team.
• Support the sales team offering SEND services as requested through meetings, demos and answering RFPs.
• Support other departments in the understanding of preclinical studies and animal management requirements that inform Xybion software and service delivery.
• Planning and resource allocation and reporting of plans and status to Xybion management.
• Defining best practices.
• Other duties as assigned.

Qualifications:

• Bachelor’s degree in Pharma or Biology or the related sciences. Master's degree preferred.
• Minimum 12+ years of experience in Lifesciences data management and/or preclinical study management.
• Experience in understanding preclinical study data.
• In-depth knowledge on CDISC standards (SDTM/SEND) & FDA-sdTCG requirements and its compliances.
• Knowledge on any nonclinical data collection/management systems (Pristima, PDS, Provantis, etc.).
• Real-time experience in team handling, people management and business operations.
• In-depth understanding of FDA GLP regulations and associated requirements for electronic records and Good Documentation Practices.
• Strong written and verbal communication skills including technical writing.

Compensation:

We offer highly competitive compensation, including a performance-linked bonus, along with a comprehensive benefits package.

We thank all applicants for their interest; however, only those selected for an interview will be contacted. For more information about Xybion, please visit https://www.xybion.com/.