Note: The job is a remote job and is open to candidates in USA. Thermo Fisher Scientific is a global team focused on scientific excellence, innovation, and collaboration. The IRT Project Manager manages Interactive Response Technology projects for complex clinical trials, serving as the primary IRT contact, coordinating vendors and stakeholders, overseeing testing and audit readiness, and managing study budgets.
Responsibilities
- Serve as the primary IRT contact for sponsors and study team members during the life of the study including understanding the IRT system requirements and functionality and managing the IRT Vendor in all tasks related to the study
- Partner with functional area leads to identify and evaluate fundamental issues on projects
- Gather information regarding potential or actual risks/issues and provide detailed information to management to ensure the risks/issues are surfaced and mitigated. Manage all IRT quality events that may arise for the study
- Ensure the study is always audit ready. Attend and participate in any study audit that requires IRT attendance
- Perform study specific informal testing, review study specific system support guidelines for accuracy and completeness. Manage the UAT testing phase with all appropriate parties
- Prepare, coordinate, and deliver meeting materials and communications per timeline milestones. Attend/facilitate meetings and communications with sponsors, vendors, and cross-functional team members
- Manage the IRT budget for the life of the study. Ensure accurate hours are included for various tasks. Review and approve all vendor invoices. Escalate any discrepancies or adjustments needed in the IRT budget
Skills
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)
- Strong attention to detail and problem solving skills
- Strong comprehensive oral presentation and written communication skills
- Strong proficiency in computer skills with knowledge of Microsoft Word, Excel, email software, various analytics and visualization software; and proficiency with primary software used by the company
- Fundamental understanding of relational database concepts and fundamental familiarity with data manipulation tools (e.g., SQL or MS Access)
- Strong ability to adapt to changing priorities and to work as a member of a multi-disciplinary, global cross-functional team
- Basic knowledge of project management, standards and practices
- Proven ability to develop and deliver services and solutions in a collaborative and cross-functional global environment, with an understanding of the user perspective
- Effective ability to query, compile, enter, track and maintain data in systems supporting department programs and processes
- Basic familiarity of IRT system applications and concepts
- Role is considered home based
- Occasional travel both domestic and international
- Frequently stationary for 6-8 hours per day
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists
- Frequent mobility required
- Occasional crouching, stooping, bending and twisting of upper body and neck
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf
- Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences
- Frequently interacts with others to obtain or relate information to diverse groups
- Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration
- Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task
- Regular and consistent attendance
Benefits
- A choice of national medical and dental plans, and a national vision plan
- A wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Accounts (HSAs) or Health Savings Account (HSA)
- Tax-advantaged savings and spending accounts and commuter benefits
- Employee assistance programs
- At least 120 hours paid time off (PTO)
- 10 paid holidays annually
- Paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave)
- Accident and life insurance
- Short- and long-term disability
- Volunteer time off in accordance with company policy
- Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
- Variable annual bonus based on company, team, and/or individual performance results in accordance with company policy
Company Overview