Manager of Clinical Operations

Rockville, Maryland
May 21, 2023
Jun 20, 2023
Full Time
Manager of Clinical Operations

US Remote Worker

The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients' success by sharing ideas openly and honestly.

Primary Purpose

Operational leadership role with a focus on the oversight of budget management, resourcing, training, and managing a successful clinical operations team. Critical contributor to overall success and future growth by providing key oversight, operational efficiencies, and strategic contributions to execute and deliver Casimir studies on time and within budget.

Primary Responsibilities
  • Supervise, manage, train and mentor functional group leads (Clinical Research Management, Data Monitoring and Clinical Research Coordinator) across the clinical operations team
  • Provide strategic direction to meet project timelines and enrollment goals, sponsor objectives, and contractual obligations
  • Proactively identify department resourcing and project operations risks as well as the mitigation strategies to minimize or avoid the risks. Communicate risks to senior leadership in a timely manner
  • Work with clinical operations team to assure corporate and business unit goals are met
  • Manage resourcing across the clinical operations department
  • Monitor study budgets and timelines and promptly communicate variances and to senior leadership
  • Participate in the creation and review of proposals, statements of work, budgets, and vendor agreements
  • Identify and document lessons learned from study successes and challenges to promote development of best practices and/or Standard Operating Procedures
  • Support the identification and implementation of tools and process integrations that support the efficiency and productivity of clinical operations staff. This may include but is not limited to collaboration with internal stakeholders and vendors to support efficiency and standardization within the department
  • Manage contract research organization (CRO) and vendor performance to ensure adherence to statement of work and budget, while proactively identifying and resolving issues
  • Ensures changes in scope are identified and managed appropriately by Clinical Research Managers
  • Participate in bid defenses and conferences as needed
  • Model and propagate Emmes' commitment to a culture of quality in all aspects of deliverables, utilizing a solution-based, science-driven, value-added approach in collaborating with clients
  • Critically review current clinical operations processes and suggest solutions for efficiencies
  • Ensure technical and professional development of clinical operations team are aligned with projects, company, and client needs
  • Actively promote positive engagement and retention within the clinical operations team
  • Foster an environment of collaboration, critical thinking and problem solving within the clinical operations department
  • Maintain strong, effective relationships within and across all departments to ensure successful project execution
  • Ensure clinical operations teams perform work high quality work according to the protocol, study plans and work instructions to assure defined deliverables are met
  • Oversee creation, review, and updates of project plans and work instruction templates
  • Establish and update procedures and tools for identifying training and development needs of all personnel in the clinical operations department.

  • Bachelor's degree in science or related field required. Advanced degree strongly preferred
  • Minimum of 7 years of experience with a Bachelor's degree or five (5) years of experience with an advanced degree as integral team support for clinical trials for or within the biotech or pharmaceutical industry, including CRO/vendor management
  • Extensive knowledge of global clinical trial management and operations in fast paced CRO outsourced environment, including interpretation and implementation of Food and Drug Administration (FDA) regulations/International Council for Harmonization (ICH) guidelines is required
  • Medical and scientific knowledge strongly preferred
  • Strong leadership, management, and professional skills, including ability to critically analyze and solve problems
  • Demonstrates strong written and verbal communication skills, with the ability to conduct effective presentations and lead team meetings
  • Excellent planning, prioritization, management, and organizational skills, with strong conceptual thinking and ability to optimize work processes that require a balance of scientific and operational/project management and team leadership expertise
  • Highly proficient in computing and technology skills
  • Excellent organizational and priority management skills with a proven ability to adapt to a rapidly changing work environment
  • Strong interpersonal skills and ability to guide and leverage group dynamics with sensitivity and tact
  • Extensive knowledge of key elements for success in clinical trials.

Emmes requires all US -based Clinical Research Associate new hires to be fully vaccinated before their first day of employment. All new hires may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. Emmes complies with all applicable laws regarding reasonable accommodations or exemptions for religious, medical, or other legally protected reasons.

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

· Unlimited Approved Leave

· Tuition Reimbursement

· 401k Retirement Plan

· Work From Home Anywhere in the US

· Maternal/Paternal Leave

· Casual Dress Code & Work Environment


Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - The Emmes Company, LLC

The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

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