Job Description

We are seeking an IRT PROJECT MANAGER, who will be responsible for managing Clinical IRT Systems as an expert resource in supply for multiple global clinical trials and the Systems Analyst, collaborating with Clinical Operations, Clinical Supplies, Information Technologies and Quality Systems in the selection, implementation and maintenance of IRT systems. This role is responsible for hands-on management of setting up the IRT systems and daily/routine IRT management. This position will report to the ASSOCIATE DIRECTOR, IRT- CLINICAL SUPPLY CHAIN and located in the Waltham, MA office.

ESSENTIAL AREAS OF RESPONSIBILITY:

• Collaborate with Clinical Supply and Clinical Operations to understand study design, dosing and initial and resupply clinical supply requirements
• Lead URS and UAT set-up in conjunction with IRT Vendor, Clinical Supply and Clinical Operations
• Work with IRT Vendor, Biostats, Clinical Operations and/or CRO to obtain randomization input into system if applicable and or unit serialization for open-label studies
• Assist in IRT day to day operations, including but not limited to depot setup, supply strategies, country and lot input/releases, manual shipments, expiry date management, and inventory levels
• Maintain blind of the clinical supplies
• Work with IRT vendor to troubleshoot issues and provide timely resolution during the conduct of the clinical studies
• Assist with vendor performance evaluation and relationship(s) at the clinical study level. Responsibilities may include performing root cause analysis and identifying corrective/preventative actions while serving as a point of escalation for vendor issues
• Work with relevant stakeholders in the development of data transfers from IRT to supporting systems (EDC, ERP, Clinical Analytics, etc.)
• Set up vendor scorecard and help establish KPIs
• Assist in Forecast / Demand Planning

REQUIREMENTS:

• AD/BA in Scientific or related field or equivalent with 3+ years of IRT management experience including systems such as EDC and eTMF experience.
• Working knowledge of FDA regulations related to New Drug Applications, Good Manufacturing Practices as well as Microsoft Office, Word, Excel and PowerPoint required.
• Prior experience working with multiple Clinical Information Systems simultaneously along with general knowledge of FDA and other global clinical trial regulations, as well as detailed knowledge of ICH and FDA GCP guidelines.

Qualifications

• High attention to detail and demonstrated ability to manage multiple critical path projects concurrently
• Demonstrates flexibility through adapting to external environment influences through development of new strategies and tactics
• Excellent communication and influencing skills, strong collaboration skills
• Good organization and project management skills with a demonstrated ability to work independently, take initiative, complete tasks to deadlines.
• Ability to communicate effectively with external vendors, including issue escalation, and responding to inquiries and concerns
• Must be able to work in a fast-paced environment with demonstrated ability to prioritize multiple competing task

Additional Information

WHAT DECIPHERA WILL BRING:

Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes the following:

• Summer vacation bonus
• Global, company-wide summer and winter shutdowns
• An annual lifestyle allowance
• Internal rewards and recognition program

Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered in Waltham, Massachusetts. Our state-of-the-art research facility is located in Lawrence, Kansas and our European operations are run out of Switzerland.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially.  Our commitment to increasing diversity in our candidate pool does not affect our commitment to equal employment opportunity, including our ongoing commitment to make all hiring and other employment decisions solely on a nondiscriminatory basis.