Senior Principal Investigator/Principal Investigator
Job Description
Serve as a key point of contact for new and existing customers.
Manage project flow from project initiation through closeout while monitoring study for contractual adherence.
Be responsible for interface with Business Development to ensure change orders are timely if needed.
Create sample analysis outlines and manages amendments.
Review sample analysis/validation data and reports in support of non-regulated and regulated methods.
Assure the quality of the data and compliance with applicable SOPs and regulatory requirements.
Develop and maintain good working relationships with Sponsors, interfacing with Business Development, and Scientists to communicate and meet Sponsor needs and timelines, while providing technical information and resolving problems.
Provide guidance on analytical issues, project technical requirements, design, and logistics.
Organize resource allocation/scheduling, contribute to company forecasts and revenue recognition based on project specifications and timelines.
Design and improve processes and procedures to increase efficiency, productivity, and quality
Travel as needed to visit Sponsor and attend scientific meetings and workshops.
Arrange specimen and data handling for all services
Transfer reports to customers per agreements
Oversee study records, data and sample storage
Coordinate transfers of hard copy project records to Quality for archiving
Maintain accurate client databases, support client audits, assist with the writing of company SOPs
Qualifications
The ideal candidate:
Knowledge of current United States FDA requirements and guidance on bioanalytical method development and sample analysis, familiarity with OECD and ICH requirements, and current best practices in bioanalysis.
Knowledge of preclinical and clinical drug development, clinical study designs and procedures.
Strong working knowledge of Microsoft Office applications, particularly Word, Excel, Outlook, and PowerPoint; Watson LIMS; required use of IDBS Electronic Laboratory Notebook as core laboratory tool (after training) for all lab activities.
Bachelor's Degree in a science related field desired or equivalent work experience.
2-5 years’ experience in drug development
Experience in a Contract Research Organization preferred
Lean / Six Sigma experience preferred
PM Certification
Additional Information
The position is full-time, Monday-Friday, 8 a.m.- 5 p.m., with overtime as needed. Candidates within a commutable distance of Lenexa, KS are encouraged to apply.
Excellent full time benefits including comprehensive medical coverage, dental, and vision options
Life and disability insurance
401(k) with company match
Paid vacation and holidays
About the Role
Eurofins USA Clinical Trial Solutions is a Disabled and Veteran Equal Employment Opportunity employer.