Project Design Manager
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Job Description
Project Design Manager configuring clinical trial databases, collection flows, kits, and labels for Thermo Fisher’s central laboratory services. Supporting clinical research projects and client deliverables remotely across the US.
Responsibilities:
- Independently review clinical trial protocols and interpret Central Lab responsibilities based on protocol definitions and budgeted services
- Advise Project Managers on procedural and budgetary items and database configuration-related changes
- Review draft laboratory specifications for consistency with protocol and budgeted requirements
- Provide feedback on budget or protocol discrepancies, system design requirements, and concerns
- Ensure database design consistency across sponsors and programs
- Configure Collection Flow Charts based on protocol testing requirements, assay volumes, testing location, sample stability, testing frequency, and related factors
- Determine testing-to-sample allocation based on schedules, processing instructions, sample disposition, and third-party lab requirements
- Configure Kit Specifications and determine ancillary supply requirements
- Configure sample labels based on client needs and collection requirements
- Attend internal and external meetings and teleconferences
- Support Project Managers during client laboratory specification discussions
- Collaborate cross-departmentally to ensure study database designs meet client and internal requirements
- Build study databases and create study deliverables within established timelines
- Support development and implementation of study database design modifications
- Perform database modifications and update Collection Flow Charts, Kit Specifications, and sample labels
- Monitor assignments and adjust priorities and schedules to meet deadlines and deliver high-quality deliverables
- Complete additional tasks supporting project, client, and departmental objectives
- Follow and contribute to departmental and corporate SOPs and working practice documents
Requirements:
- Bachelor's degree or equivalent and relevant formal academic/vocational qualification
- 2+ years of comparable experience
- Equivalent combination of appropriate education, training, and/or directly related experience may be considered
- Familiarity with Clinical Trial Database within a Central Laboratory environment strongly preferred
- Good organizational, project management, and computer skills
- General knowledge of clinical trial processes and programs
- Strong attention to detail and problem-solving skills
- Good written and verbal communication skills
- Ability to conduct oral presentations effectively
- Demonstrated experience identifying and resolving technical problems in a professional environment
- Ability to maintain confidentiality with clinical teams
- Ability to attain, maintain, and apply knowledge of applicable procedural documents
- Ability to work well with others
- Must be legally authorized to work in the United States without sponsorship
- Must be able to pass a comprehensive background check, including drug screening
- Ability to communicate, receive, and understand information and ideas with diverse groups
- Ability to work upright and stationary for typical working hours
- Proficiency with standard office equipment and technology
- Ability to work successfully under pressure while prioritizing and handling multiple projects
- May require travel
Benefits:
- Fully remote work arrangement
- Standard Monday-Friday work schedule
- Accessibility services and accommodations for job seekers with disabilities
- Global organization collaboration and professional growth opportunities
- Continuous development environment
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