Overview

Atreo, a revolutionary start up SaaS RTSM company, is committed to modernizing and simplifying the Clinical Trials process through our revolutionary RTSM technology.  Our mission is to create the ‘go to’ RTSM platform for the Pharmaceutical / Biotech industries, offering numerous advantages and efficiencies to both clients and internal team members, creating a solid foundation for clinical trial success in partnership with our clients.

As a Product Delivery Manager your focus will be on designing and configuring clinical trials. Using your years of expertise, you will partner closely with Atreo customers, guiding them through the process and navigating study protocols to create robust and sustainable clinical trials.

Responsibilities

• Expert implementation of client RTSM applications to enable client goals
• Primary sponsor contact during RTSM system design, responsible for the health of the client relationship working with clinical study teams to establish RTSM specifications and deliver state-of-the-art RTSM systems.
• Work with product development and QC to ensure study level applications are designed, configured, customized and tested to deliver a high quality, validated system to clients.
• Expert in Atreo’s Studio tool; identifying sponsor specific requirements, configuring study, overseeing customization and validation process of SDLC, facilitating sponsor review and approval as per Atreo SOPs.
• Conduct risk assessments on study designs per Atreo SOPs.
• Prepare the client systems for UAT and Production.
• Coordinate efforts towards system integration with 3rd parties such as CTMS, EDCs, CROs/shippers, etc.
• Work with client clinical supplies leads and provide expert consultation in establishing their initial supply settings.
• Primary support to Project Management (PM) during the study maintenance phase, including troubleshooting production issues and system change management.
• Identify operational business needs and collaborate with product development to influence RTSM product feature development, prioritization and strategy to ensure that the product meets client capability needs, improve the system’s efficiency and user-friendliness.

Required Experience:

• The position requires a minimum of 5 years (10 for senior) in experience in the clinical research field, particularly clinical supplies operations, RTSM delivery.
• Knowledge of US FDA Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) GCP regulations, Electronic Records; Electronic Signatures regulation (21 CFR Part 11) and EU Annex 11, and associated regulatory guidance documents.

Education and/or Certification Requirements:

• BS in a related field. Equivalent experience with at least 5 years in a related field may be considered.

Other Skills / Requirements:

• Industry experience of key product functionality (randomization, drug supply management, forecasting, natural language processing) is an asset.
• Leadership Competencies; Client focused, solutions focused, proactive, responsive, organized, highest quality deliverables. Excellent verbal and written communication skills.
• Up to 25% business travel, namely for on-site client visits in support of sales opportunities, client specification development, client User Acceptance Testing and industry conferences.

Location:

East Coast, USA

Compensation Range:

$100k-$150k dependent on experience

+equity

Overview

Atreo is committed to modernizing and simplifying the Clinical Trials process through our revolutionary RTSM technology.  Our mission is to create the ‘go to’ RTSM platform for the Pharmaceutical / Biotech industry, offering advantages and efficiencies to both clients and internal team members, creating a solid foundation for clinical trial success in partnership with our Clients.

The Project Manager is the principal client advocate between Atreo and our partners.

Responsibilities

• Primary client contact for day to day operations in support of RTSM applications starting at User Acceptance Testing (UAT).
• Develop, implement and oversee sponsor communication plans, including service level agreements data management and support procedures, per Atreo SOPs.
• Coordinate efforts towards data uploads (users, sites, randomization lists etc.) in the different environments.
• Oversee client system UAT and system go live.
• Consult with client clinical supplies and operations leads to support system usage.
• Customer Support point of escalation for any system or support issues where required; develop training materials and train Customer Support staff on study application support procedures and client standards.
• Develop client and site system training manuals and deliver study training for clinical team
• Monitor study issues for trends to enhancement opportunities or additional training needs
• Participate in client audits
• Responsible for the health of the client relationships and tracking client Health Scores

Required Experience:

• Professional technical support experience
• Strong communication skills

Education and/or Certification Requirements:

• The candidate must possess at minimum a bachelor’s degree in a life sciences, supply chain management, or information technology field, or equivalent experience.

Other Skills / Requirements:

• Clinical management experience is highly desired.
• Supply chain experience is a plus.
• Experience with RTSM is a plus.
• Leadership Competencies; Client focused, solutions focused, proactive, responsive, organized, highest quality deliverables. Excellent verbal and written communication skills.
• Up to 25% business travel, namely for on-site client visits in support of sales opportunities, client User Acceptance Testing, client training and industry conferences.

Location:

East Coast, USA

Compensation Range:

$75-$100k dependent on experience