AgreeYa is a global Systems Integrator and is seeking a Senior Project Manager.
- IRT - Interactive response technologies
- Pharma or Biotech or supplier experience required
- Must have clinical trial experience
- The candidate will be we working remote - Ideally PST - open to US Time Zone
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.
- 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
- 5+ years of IRT experience and / or a clinical supply chain discipline (supply chain management, distribution, packaging, labeling, etc.)
- 4+ years of experience in clinical operations 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
- Bachelors Degree in life science, computer science, engineering, business or related discipline
- Detail-oriented and able to manage many projects simultaneously
- Excellent documentation and communication skills
- Meeting management and facilitation skills
- Supplier 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.
AgreeYa is a global systems integrator delivering competitive advantage for its customers through software, solutions, and services. Established in 1999, AgreeYa is headquartered in Folsom, California, with a global footprint and a team of more than 1,850 staff across offices. AgreeYa works with 500+ organizations ranging from Fortune 100 firms to small and large businesses across industries such as Telecom, Banking, Financial Services & Insurance, Healthcare, Utility & Energy, Technology, Public sector, Pharma & Biotech, and others. Please visit us at for more information.
AgreeYa is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, gender identity, sexual orientation, national origin, disability, veteran status or other protected characteristics. Visit our website to learn about our Career & Culture .- provided by Dice