Clinical Project Manager

Location
Rockville, Maryland
Posted
Jan 24, 2022
Ref
2021-11038
Hotbed
BioCapital
Required Education
Doctorate/PHD/MD
Position Type
Full time

We are currently searching for a Clinical Project Manager support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC, and it is on-site in Rockville, MD.

 

Duties & Responsibilities
  • 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.
  • Serve as the lead Clinical Project Manager and coordinate the activities of other Clinical Project Managers.
  • Assess the operational feasibility and resource considerations of new entrants to the trial.
  • Working through established contract resource organizations and with the sponsor and networks:
    • Create a global site/country strategy Oversee the execution of that strategy including site selection including feasibility, qualifications, and pre-study assessment.
    • Oversee site activation including, the provision of investigational product, non-IP clinical supplies and laboratory materials; the completion of required regulatory documentation and the granting of needed systems access.
    • Coordinate efforts to recruit participants into the trial including global trial and site-specific recruitment plans, media and outreach programs and vendor programs. d. Oversee the execution of the study monitoring and oversight plan. Ensure site productivity and quality issues are actively managed.
    • Oversee the executions of the data management plan. Ensure that queries are resolved, and database closure occurs on time.
    • Oversee the study close-out plan.
    • Create and oversee the execution of a study risk management plan. Proactively resolve risks to operational delivery.
    • Lead team meetings.
    • Support meeting documentation and follow-up action items.
    • Facilitate reporting of study status to key stakeholders in NIH.
Requirements
  • B.S./B.A. degree in a related field.
  • PMP certification is preferred.
  • Minimum of ten (10) years of related experience in operational project/program management. Experience supporting clinical trial studies, preferred.
  • Experience executing program strategy for clinical site selections and pre-study assessments, helpful.

#LI-GH1

Due to our contractual requirements and federal orders, including an Executive Order from the White House and an emergency regulation from the Centers for Medicare & Medicaid Services (CMS), the position for which you are applying requires that you provide proof of your vaccination status. If you are unable to receive the COVID-19 vaccine for medical reasons or because of a sincerely held religious belief, you may request an exemption from the vaccination requirement which shall be reviewed after the submission of requested documentation. If an accommodation is granted, the conditions may include weekly testing and masking. All Guidehouse employees also agree to follow any additional health and safety mitigation policies that may be required in the workplace.

 

Company Description

Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) was acquired in October 2021.

 

Guidehouse is a leading global provider of consulting services to the public sector and commercial markets, with broad capabilities in management, technology, and risk consulting. By combining our public and private sector expertise, we help clients address their most complex challenges and navigate significant regulatory pressures focusing on transformational change, business resiliency, and technology-driven innovation. Across a range of advisory, consulting, outsourcing, and digital services, we create scalable, innovative solutions that help our clients outwit complexity and position them for future growth and success. The company has more than 12,000 professionals in over 50 locations globally. Guidehouse is a Veritas Capital portfolio company, led by seasoned professionals with proven and diverse expertise in traditional and emerging technologies, markets, and agenda-setting issues driving national and global economies.

 

Guidehouse is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation.

 

Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance, including the Fair Chance Ordinance of Los Angeles and San Francisco.

 

If you have visited our website for information about employment opportunities or to apply for a position, and you require accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at RecruitingAccommodation@guidehouse.com. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.

 

Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse, and Guidehouse will not be obligated to pay a placement fee.