PRAHS Project Manager (Lab) - Lenexa, KS in United States
The Project Management department is accountable for preparation, execution, timely reporting and archiving of bioanalytical studies (e.g. method development and validation or sample analysis studies) within agreed timelines and according to PRA’s Quality Management System and international regulations (e.g. GLP, FDA, EMA). The department maintains relationships with clients and ensures an optimal match between client needs and opportunities within PRA. In addition, the department is responsible for the budget of each project and supports the proposal, contracting and financial department.
Managing bioanalytical projects (e.g. method development, validation and bioanalysis) with the following responsibilities:
Acting as Project Manager for non-GLP studies and Study Director for single-site GLP studies or PI for multi-site GLP studies; responsible for writing of Study/Phase Plans, monitoring the progress of studies/study phases, writing of (phase) reports and archiving of the studies/study phases.
Timely delivery of projects. Internal coordination with different departments (Business Support, Sample Registration Office, Operations, Analytical Writing and Quality Assurance) to adhere to agree timelines. External coordination with Sponsor to investigate the expectations and requirements.
Maintaining high quality of projects that comply with applicable international regulations (GLP, FDA, EMA) and PRA’s Quality Management System.
Performing projects within the agreed budget.
Customer satisfaction, responsible for a large account (>1 million revenue per year).
Participating in client visits and audits.
Training/Mentoring Level 1 and 2 project managers.
Supervising complex/challenging projects and/or methods.
At least three years of experience in project management and bioanalysis
Read, write and speak fluent English; fluent in host country language required.
M.Sc. level education in (medical) biology, (analytical) chemistry or pharmacy or equivalent preferred
PhD degree in (medical) biology, (analytical) chemistry or Pharmacy preferred
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans, and individuals with disabilities
External Company Name: Pharmaceutical Research Associates, Inc
External Company URL: http://prahs.com/