
Portfolio Manager – Clinical Research, GMP
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: Wisconsin • United States
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About the role
- Provides focused program management services to pharmaceutical development programs.
- Acts as primary liaison and client account lead for the sponsor.
- Oversees the coordination and management of projects by monitoring project status, timelines and budgets.
- Works closely with laboratory management to ensure that the project deliverables meet customer expectations and meet PPD financial commitments.
- Provides oversight and coordination of client portfolio for high value or pivotal client account studies.
- Ensures the project requirements are understood, agreed and followed at all times.
- Facilitates the flow of technical and clinical laboratory information to all stakeholders.
- Maintains an updated study master file with version controls for specs, budgets and contracts.
- Ensures sponsors have authorized and signed off most recent versions of all docs.
- Assures compliance with FDA and Good Clinical Practice guidelines.
Requirements
- 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 8+ years’) or equivalent combination of education, training, & experience.
- Knowledge and proficiency in analytical chemistry technologies as well business acumen
- Knowledge and understanding of all aspects of lab study project management
- Excellent problem solving, judgment and decision-making skills
- Strong verbal, written and presentation skills
- Proven organizational and negotiation skills
- Extensive knowledge and proven leadership in project management
- Understanding of basic budgeting and forecasting terms and definitions
- Superior time management, planning, and organizational skills
- Full understanding of laboratory requirements, ICH guidelines, USP requirements and FDA guidance
- Ability to multitask and effectively prioritize workload
- Ability to work effectively with multi-level teams
- Ability to work in a fast-paced undefined environment
- Strong client relationship management skills
Benefits
- competitive remuneration
- annual incentive plan bonus
- healthcare
- range of employee benefits
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
analytical chemistry technologiesproject managementbudgetingforecastingcomplianceGood Clinical PracticeICH guidelinesUSP requirementslaboratory study project managementversion control
Soft Skills
problem solvingjudgmentdecision-makingverbal communicationwritten communicationpresentation skillsorganizational skillsnegotiation skillstime managementmultitasking
Certifications
Bachelor's degree