14 days old

Clinical Trials Operations Manager - NIH - Rockville, MD

Kelly Services
Rockville, MD 20851
Kelly Government Solutions 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 Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with the leading medical research center in the world. We are seeking an individual to work as a Clinical Trials Operations Manager at the National Institutes of Health in Rockville, MD

This is a long-term contract position which offers:

+ Competitive compensation and comprehensive benefit package

+ Optional health, vision, and dental plans

+ Vacation leave as well as 10 paid federal holidays and 401K plan.

+ Access to NIHs unparalleled resources and niche scientific initiatives

TASKS/SERVICES. The contractor shall:

+ Effectively provide support to OPCRO OD, branches, and teams in the conduct of sponsor oversight for the ACTIV-2 trials.

+ Proactively manage ACTIV-2 project level operational aspects, including management of timelines, action items, resources, and vendors.

+ Provide efficient updates on trial progress to the Office Director with respect to Office-related activities, project plans, trial and project timeline management, quality standards, and risk mitigation.

+ Ensure effective project plans are in place and operational and work proactively with the DAIDS ACTIV-2 team to set priorities in accordance with applicable project plans, DAIDS policies, standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.

+ Assist in tracking activities for ACTIV-2 with respect to protocol implementation and individual assets/investigational products.

+ Support tracking of manufactured agents related to the trial against facets of OPCRO operations.

+ Ensure potential study risks are escalated to the attention of the branch chiefs/team leads and the OPCRO Director, when appropriate.

+ Track and follow up to resolution OPCRO ACTIV-2 issues, ensuring they have been completed in a timely manner.

+ Monitor the quality of vendor deliverables, escalate quality issues to the appropriate team member, and identify opportunities to improve training, execution and quality control across the Office with respect to ACTIV-2.

+ Participate in routine OPCRO meetings to discuss ACTIV-2 quality issues, sponsor oversight activities, and planning for process improvements.

+ Review and approve vendor responses to quality concerns against raised issues for appropriateness, timelines and accordance with DAIDS policies, SOPs, and regulatory requirements.

REQUIREMENTS. The contractor must have:

+ All support positions require a minimum of a BS degree

+ A minimum 10 years relevant experience in the field of clinical trials operations, including vendor oversight, leadership, and management of clinical trials.


When you apply, please know a Kelly Government Solutions Recruiter will review your resume and will contact you directly, if your skills and experience match the requirements of this position; a full job description can be made available at that time.

Due to the high volume of inquiries, we regret that we cannot accept phone calls. Even if you arent contacted for this position, you are still part of our talent network. All Kelly recruiters have access to your profile, which expands your opportunities even further.

As a specialty talent company, Kelly is committed to doing the right thing for our talent and clients.

We stand up for equity, inclusion, fair treatment, and opportunity for all as these build the foundation of our Talent Promise. With a focus on safety, value, well-being, investment, and opportunity, Kellys Talent Promise confirms our commitment to those in search of a better way to work and live and to help discover whats next.

It is obvious things are different than they were just a few months ago. Kelly is at the forefront of ensuring the safety of our employees in this new working environment. Be well and stay strong.

**Why Kelly** **** **?**

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. Its just another way we make the job search work for you.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

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. (
Posted: 2021-09-10 Expires: 2021-10-11

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Clinical Trials Operations Manager - NIH - Rockville, MD

Kelly Services
Rockville, MD 20851

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