Clinical Systems Manager

The Manager, Clinical Systems (IRT) will work with a cross-functional team of internal stakeholders (including but not limited to : Clinical Study Management, Supply Chain and Data Management functions) and technology suppliers to support the implementation and maintenance of interactive response technology (IRT) solutions to support a clinical trial.

The Manager, Clinical Systems (IRT) will provide technical oversight to ensure that IRT solutions adhere to the study protocol, industry regulations / best practices as well as company policies, procedures and guidelines.

Responsibilities :

Serve as the champion and consultant for most efficient and effective IRT design as needed per study protocol

Lead and facilitate system requirements gathering meetings with clinical study teams and IRT supplier contacts

Design and oversee the development of study-specific IRT technical documents

Document issues and risks, and implement mitigation plans in partnership with study team and technology supplier PM

Identify and track study-related technical issues to resolution

Closely manage project-related timelines and associated activities

Basic Qualifications

Doctorate Degree OR

Master's Degree and 2 years of IRT experience OR

Bachelor's Degree and 4-5 years of IRT experience, clinical experience OR

Associate's degree and 10 years of IRT experience OR

High school diploma / GED and 12 years of IRT experience

Preferred Qualifications :

5+ years focused on IRT experience

Bachelor’s Degree in life science, computer science, engineering, business or related discipline

4+ years of experience in clinical operations, clinical supply chain or clinical systems management

Experience implementing clinical systems, such as IRT and eCOA

Working knowledge of Good Clinical Practices and FDA regulations governing clinical trial execution

Detail-oriented and able to manage many projects simultaneously

Excellent documentation and communication skills

Meeting management and facilitation skills

Vendor management experience

Excellent time management and organization skills in a timeline-driven environment

Sound problem resolution, judgment, and decision-making abilities

Work well in a team-based environment with minimal supervision