Senior Clinical Operations Manager

Location
Bethesda, MD, United States
Posted
May 24, 2021
Ref
2021-10260
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
Overview

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 it is on-site in Bethesda, MD.

Duties & Responsibilities

  • Create and facilitate implementation of an overall operational plan for the ACTIV 2 family of 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. It is an adaptive design spanning traditional phase 2 and phase 3 of clinical development. It is being conducted under the auspices of the NIH, and the NIH-funded AIDS Clinical Trial Group (ACTG).
  • 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, qualification 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 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, Operation Warp Speed, and the ACTG.

#LI-DW1

Requirements

  • Bachelor's degree in Life Sciences, or a related field.
  • Minimum of ten (10) years of related experience.
  • Experience in management and operations of clinical trials, including developing operational plans, site activation and management, data management, and study close-out.
  • Expertise in leading study-risk initiatives in support of clinical portfolios.
  • Excellent communication skills, both oral and written.


Company Description

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.