Interactive Response Technology (irt) Manager

Company Overview

Boston Pharmaceuticals is a clinical-stage biopharmaceutical company. We are developing highly engineered targeted therapies for patients with serious liver diseases. Our lead investigational program, BOS-580, is a long-acting once-monthly FGF21 analogue being studied in a Phase 2 clinical trial for metabolic dysfunction-associated steatohepatitis (MASH), also known as non-alcoholic steatohepatitis (NASH). 

Position Summary:

The IRT Manager will be the internal point person and subject matter expert for all things related to Interactive Response Technology and will lead the IRT operations for all Boston Pharmaceuticals clinical trials. The IRT Manager will work cross-functionally with Clinical Operations, Data Management, CMC, and Clinical Supply operations to design, build, test, deploy, maintain, and close out an IRT system over the lifespan of clinical trials.

Roles & Responsibilities:

• Liaise with various internal and external stakeholders to build our strategy for, operationalize, and manage Boston Pharmaceuticals’ Interactive Response Technology, evolving to suit the requirements for difference phases of development

• Project manage and drive the IRT process across multiple studies to stay within timeline and budget

• Work with third party vendors (CROs, IRT providers, etc.) to design, build, manage, and maintain the system; closely manage vendors to generate and track performance against expectations

• Assist in IRT vendor selection, audit, and qualification when required

• Manage, administer, and facilitate a regular cadence of IRT meetings

• Generate and facilitate IRT site training as needed

• Maintain a list of IRT users and sites as required

• Monitor site and depot level supply in conjunction with Clinical Supply team

• Update Lots in system for expiry date extensions

• Manage data change requests for sites with vendors

• Operate with a user experience mindset, ensuring ease of use for site staff, clinical supply management, and lot management personnel

• Anticipates and communicates resource and quality challenges that could impact results or timelines

• Formulates proposals that will enable process improvements and operational efficiencies

Qualifications:

• Bachelor’s degree required.
• 7-10 years IRT experience; IRT experience on the sponsor side required; IRT on the vendor side desired but not required.
• Experience building, designing, and maintaining an IRT system
• Flexible and adaptable mindset; incumbent must have both strategic and tactical skills and be willing to operate in either sphere
• Experience with IRT integration with depots and EDC systems
• Clinical Supply packaging/labeling experience strongly desired
• Excellent oral and written communication skills; ability to communicate complex information to non-experts
• Ability to work independently and with flexibility to handle workflow in a fast-paced environment
• Strong collaboration skills; ability to build effective relationships internally and externally, especially with program team members and CROs
• Embraces and embodies Boston Pharmaceuticals’ corporate values: Commitment to Patients, Decisive Innovation, Purposeful Urgency, Passion for Excellence, One Team

Related search terms: IXRS, RTSM

Ideal candidate will be based within commuting distance to Cambridge, MA; remote candidates will be considered