Principal Program Manager

3 days ago

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Thermo Fisher Scientific

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Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics

10,000+

Description

• 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. • Facilitates the flow of information between all parties. • Consults and utilizes scientific input of laboratory management and technical staff to assist the client with management of the clinical trial. • Prepares the study specifications documents and follows the preparation according to budgets and contracts. • Maintains an updated study master file with version controls for specs, budgets and contracts. • Ensures compliance with FDA and Good Clinical Practice guidelines. • Serves as chief liaison between sponsor and all PPD internal departments performing the required tasks during all study phases.

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 to include the areas of stability, QC and method development and validation • 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

• We offer competitive remuneration • annual incentive plan bonus • healthcare • a range of employee benefits.