Kelly Government is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Kelly Government offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with one of the most prestigious research organizations in the world. We are currently seeking a Quality Program Manager to work onsite with the National Institutes of Health in Bethesda, MD.
This is a long-term contract position which offers:
- Competitive salary with comprehensive benefit package
- Opportunity to work at NIH, the world's foremost medical research center
- Learn more about what Kelly can do for you at www.kellygovernmentsolutions.com
TASKS: The contractor shall:
- Oversee the VRC CTP's Quality Management System, including leading a Quality Management team of subject matter experts, to ensure quality throughout all stages of the clinical trial process.
- Ensure staff and program compliance with CTP's quality procedures and regulatory requirements.
- Assess GCP compliance risk areas and develop and implement risk mitigation measures, including facilitating Root Cause Analyses (RCAs) and instituting Corrective and Preventive Actions (CAPAs).
- Provide expertise and guidance on governmental regulations, agency guidelines, and internal policies to assure GCP compliance.
- Plan and lead GCP sponsor audits of international and domestic clinical sites, contract clinical laboratories, and Contract Research Organizations (CROs) to verify and document compliance status and identify any compliance risks.
- Conduct Trial Master File (TMF) audits.
- Facilitate and track GCP training of functional areas and develop appropriate training for personnel involved in the execution of clinical trials and nonclinical studies.
- Participate as a Subject Matter Expert in the evaluation and selection of CROs and other clinical and nonclinical service providers supporting CTP activities.
- Develop and implement SOPs, policies and work instructions for GCP regulatory compliance.
- Identify and seek appropriate resources for the functioning and improvement of the QMS.
- Work with CTP leadership team and personnel on issues that require resolution or escalation.
REQUIREMENTS: The contractor must have:
- Master's Degree preferred but not required.
- Minimum 5-7 years' experience in clinical research within Government, Biotech, Pharma and/or CRO and at least 5+ years' experience in Quality Systems related to GCP.
- Certified quality auditor preferred, but not required.
- Experience auditing clinical CRO's, clinical sites and investigator sites.
- Strong understanding of domestic and international quality and regulatory requirements, regulatory agencies, and ICH/GCP.
- Outstanding communication skills (interpersonal, verbal, and written).
- Strong leadership skills and experience independently managing complex projects.
- Experience managing staff or overseeing a team.
- Ability to work independently and as part of a team.
- Excellent analytical, organizational, and time management skills.
- Experience with Microsoft Office programs (Word, Excel, PowerPoint).
PLEASE APPLY ONLINE
Note that the phone number for our NIH branch is not listed. Due to the high volume of inquiries, we regret that we cannot accept phone calls. All qualified candidates will be contacted.
Looking to connect with premier government agencies or the top 25 federal government contractors? Kelly® Government offers a variety of full-time, project (SOW), seasonal, and surge support opportunities in science, engineering, technical, professional, and administrative support roles. Our experts will find you the opportunity that fits your schedule and interests and handle the details of transferring and processing all levels of security clearances. It's just another way we make the job search work for you.About Kelly®
Kelly connects talented people to companies in need of their skills in areas including Science, Engineering, Education, Office, Contact Center, Light Industrial, and more. We're always thinking about what's next in the evolving world of work, and we help people ditch the script on old ways of thinking and embrace the value of all workstyles in the workplace. We directly employ nearly 500,000 people around the world, and we connect thousands more with work through our global network of talent suppliers and partners in our outsourcing and consulting practice.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity Equal Employment Opportunity is The Law.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
Apply on company website