Senior Clinical Operations Manager

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

• Lead the creation and implementation of an overall operational plan for the ACTIV 2 family of 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.
• Work 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.
  • 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 closures occur 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.

• B.S./B.A. degree in a related field.
• Minimum of ten (10) years of related experience managing and supporting clinical operations.
• Familiarity with assessing operational feasibility and considerations and overseeing clinical trial execution.
• Familiarity working with clinical trial databases and creating effective data management plans.
• Experience executing risk-management strategies, desired.
• Ability to effectively communicate with NIH stakeholders.

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Due to our contractual requirements, to be eligible for this role, you must be fully vaccinated against COVID-19 at time of hire.  

We are a trusted government partner that blends deep domain expertise with advanced technologies to help our customers solve complex problems that improve, protect, and save lives. As a rapidly growing company, we combine entrepreneurial spirit, customer focus, and an outcomes-based approach to support agency missions in health IT, life sciences, public safety, and grants management.

The Dovel Family of Companies offers employees an opportunity to advance beyond a specific role or contract, we offer a path to develop an enriching career. We believe in empowering a culture of innovation, customer success, and employee growth. 

What you’ll get…

• Time Off! Flexible schedules and company paid holidays allow you to take the time you need.
• Investment in YOU! 401(K) company contributions are yours to keep with no waiting period.
• Choices! Unique healthcare plans to choose from with options like fertility and orthodontia benefits.
• Discovery! With our tuition assistance and training programs, we support your career advancement.
• Tax Savings! Enroll in pre-tax Health or Dependent Care Flexible Spending, HSA with company contributions, parking, and/or transit commuter benefits.
• Support! Working parents and busy professionals – we’ve got you covered with a supportive culture, confidential Employee Assistance Program and a membership to Care.com.
• Perks! Employee discounts, peer recognition programs, company-wide wellness challenges, and fun community events.
• A Voice! A unique culture where you can influence decisions and have your voice heard.

We are an Equal Opportunity Employer with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, disability, or veteran status.