Clinical Operations Manager

Location
Rockville, Maryland
Posted
Apr 24, 2022
Ref
2022-11374
Hotbed
BioCapital
Required Education
Masters Degree/MBA
Position Type
Full time

We are currently searching for a Clinical Operations Manager to provide 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
  • Serve as an advisor to the Director and Deputy Director on administrative and operational issues.
  • Collaborate with Program staff to plan and coordinate programmatic activities for high priority science (i.e. HIV and HIV-associated coinfections and comorbidities).
  • Participate in the review, planning, and implementation of clinical trials under program purview.
  • Track all planned and ongoing clinical trials and provides the framework and tools for trial documentation.
  • Coordinate clinical review activities/meetings for the program portfolio, including support for the Clinical Science Review Committee and pre-review activities for the Data Safety and Monitoring Boards.
  • Serve as the liaison to clinical trial-related working groups led by NIH programs.
  • Stay abreast of new clinical research policies being developed and ensures program is aware and provides input, as appropriate, for draft policies and procedures.
  • Work closely with the Regulatory Affairs Branch on regulatory and protocol registration issues as appropriate for clinical trials.
  • Coordinate internal audit preparation and responses; Communicates audit responses with other scientific programs and offices within NIH.
  • Conduct internal program evaluations for the Quality Management System.
  • Assist with the development of new and/or update of existing policies and procedures, as required.
  • Provide centralized support for NNCTs, including coordinating site activation activities with relevant staff.
  • Assist in the development of risk management plans and mitigation of identified risks.

#LI-DW1

Requirements
  • Minimum of a B.S./B.A. degree and ten (10) years of experience in clinical trial management including budget management.
  • Knowledge of regulations, policies, procedures and guidelines governing clinical research.
  • Knowledge of clinical practices in order to conduct evaluations for quality management, coordinate site-activation activities, and render internal audit preparations.
  • Ability to analyze problems and to make decisions/recommendations for resolving those problems.
  • Knowledge of Microsoft Office Suite (MS Word, Excel, Outlook) and spreadsheet applications.
  • Strong communications skills, both oral and written.
  • Excellent analytical, organizational and time management skills.

 

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.