Project Manager
2 months ago
(ID: 2024-5928)
**Benefits**:
- 100% Medical, Dental & Vision Coverage for Employees
- Paid Time Off (Including Holidays)
- Employee Referral Bonus
- 401K Match
- Tuition reimbursement and professional development opportunities
- Flexible Spending Accounts:
- Healthcare (FSA)
- Parking Reimbursement Account (PRK)
- Dependent Care Assistant Program (DCAP)
- Transportation Reimbursement Account (TRN)
**Overview**:
Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented **Project Manager** to join our vibrant team to provide services in support of the overall functions of the Office of Director (OD), Division of Intramural Research (DIR).
**Technical Requirements**:
- Conduct or review on-site inspections at DIR international sites to assess adherence to study protocols, ensure compliance with regulatory requirements and guidelines and quality control and assurance procedures, adherence to laboratory procedures, review progress, study protocols, good clinical practices (GCP), good laboratory practices (GLP), good manufacturing practices (GMP), and the College of American Pathologists (CAP) or CAP-equivalent standards, as appropriate.
- Assist with establishing and monitoring quality assurance (QA)/quality control (QC) programs at DIR international sites.
- Collaborate directly with operating entities to make certain that inspections and audits of DIR international sites are conducted on a continuing basis as specified to enforce mandated requirements and meet specifications.
- Provide expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance.
- Responsible for preparing and submitting detailed reports of site visits to cite specific improvement and implementation recommendations.
- Develop recommendations for improving the safety, regulatory compliance, and efficiency of laboratory operations and provide critical feedback to the Federal Task Leader, technical support staff, and investigators.
**Specific Qualifications**:
- BS degree or 5 years of work experience is equivalent to BS degree and is required.
- 5 years of work experience is required.
- Effective and clear communication skills and the ability to work in a high-stress environment.
The diversity of Axle's employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.
**Disclaimer**:The above description is meant to illustrate the general nature of work and level of effort being performed by individual's assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.
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