Clinical Project Manager (Option for Remote Work) - NIH

Kelly Services

Washington District of Columbia

United States

Healthcare - Physician
(No Timezone Provided)

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 experienced individual to work as a Clinical Project Manager at the National Institutes of Health in Rockville, MD with the option for a remote working arrangement.
 
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 paid federal holidays and 401K plan.  
- Access to NIH’s unparalleled resources and niche scientific initiatives

TASKS/SERVICES. The contractor shall: 
(1) Lead the creation and implementation of an overall operational plan for one or more COVID-19 treatment studies, including timeline, key milestones, resources needed and budget. The ACTIV 2 study is the U.S. Government’s premier effort to develop data on promising therapies for outpatients suffering from COVID-19 disease. The study is a complex platform study, capable of testing multiple investigational products simultaneously with an adaptive design that spans traditional phase 2 and phase 3 of clinical development. 
(2) Assess the operational feasibility and resource considerations of new entrants to the trial and create/oversee the execution of a study risk management plan
(3) Work through established contract resource organizations and with the sponsor and network
(4) Create a global site/country strategy and oversee the execution of that strategy including site selection including feasibility, qualification and pre-study assessment 
(5) Oversee site activation including the provision of investigational product, non-IP clinical supplies and laboratory materials as well as the completion of required regulatory documentation 
(6) Coordinate efforts to recruit participants into the trial including global trial and site-specific recruitment plans, media and outreach programs and vendor programs. 
(7) Oversee the execution of the study monitoring and oversight plan. Ensure site productivity and quality issues are actively managed. 
(8) Oversee the execution of the data management plan to ensure that queries are resolved and database closure occurs on time. 
(9) Oversee the study close-out plan. 
(10) Lead team meetings and report study status to key stakeholders at NIH, NIAID, and/or Operation Warp Speed

REQUIREMENTS. The contractor must have: 
(1) B.S./B.A. degree in a related field; advanced degree may also be considered
(2) Minimum of ten (10) years of related clinical trial/clinical research experience
(3) Experience working with CROs and/or infectious diseases research is a plus

Please Note: Vaccination against COVID-19 is a requirement for all job opportunities offered through Kelly Government Solutions, in accordance with the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors.

PLEASE APPLY ONLINE
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. 

Due to the high volume of inquiries, we regret that we cannot accept phone calls. Even if you aren’t 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, Kelly’s Talent Promise confirms our commitment to those in search of a better way to work and live and to help discover what’s 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.

#ACRP



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. It’s just another way we make the job search work for you.

You should know: Vaccination against COVID-19 is a requirement for all job opportunities offered through Kelly Government Solutions, in accordance with the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re 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.

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Clinical Project Manager (Option for Remote Work) - NIH

Kelly Services

Washington District of Columbia

United States

Healthcare - Physician

(No Timezone Provided)

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 experienced individual to work as a Clinical Project Manager at the National Institutes of Health in Rockville, MD with the option for a remote working arrangement.
 
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 paid federal holidays and 401K plan.  
- Access to NIH’s unparalleled resources and niche scientific initiatives

TASKS/SERVICES. The contractor shall: 
(1) Lead the creation and implementation of an overall operational plan for one or more COVID-19 treatment studies, including timeline, key milestones, resources needed and budget. The ACTIV 2 study is the U.S. Government’s premier effort to develop data on promising therapies for outpatients suffering from COVID-19 disease. The study is a complex platform study, capable of testing multiple investigational products simultaneously with an adaptive design that spans traditional phase 2 and phase 3 of clinical development. 
(2) Assess the operational feasibility and resource considerations of new entrants to the trial and create/oversee the execution of a study risk management plan
(3) Work through established contract resource organizations and with the sponsor and network
(4) Create a global site/country strategy and oversee the execution of that strategy including site selection including feasibility, qualification and pre-study assessment 
(5) Oversee site activation including the provision of investigational product, non-IP clinical supplies and laboratory materials as well as the completion of required regulatory documentation 
(6) Coordinate efforts to recruit participants into the trial including global trial and site-specific recruitment plans, media and outreach programs and vendor programs. 
(7) Oversee the execution of the study monitoring and oversight plan. Ensure site productivity and quality issues are actively managed. 
(8) Oversee the execution of the data management plan to ensure that queries are resolved and database closure occurs on time. 
(9) Oversee the study close-out plan. 
(10) Lead team meetings and report study status to key stakeholders at NIH, NIAID, and/or Operation Warp Speed

REQUIREMENTS. The contractor must have: 
(1) B.S./B.A. degree in a related field; advanced degree may also be considered
(2) Minimum of ten (10) years of related clinical trial/clinical research experience
(3) Experience working with CROs and/or infectious diseases research is a plus

Please Note: Vaccination against COVID-19 is a requirement for all job opportunities offered through Kelly Government Solutions, in accordance with the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors.

PLEASE APPLY ONLINE
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. 

Due to the high volume of inquiries, we regret that we cannot accept phone calls. Even if you aren’t 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, Kelly’s Talent Promise confirms our commitment to those in search of a better way to work and live and to help discover what’s 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.

#ACRP



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. It’s just another way we make the job search work for you.

You should know: Vaccination against COVID-19 is a requirement for all job opportunities offered through Kelly Government Solutions, in accordance with the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re 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.

]]