R

Rho

Comprehensive CRO for regulatory drug approvals

Clinical Team Lead

Clinical Research OperationsUpdated on Nov 12
Full-timeRemote in USA$130k - $165k /yr

About the Job

Requirements

  • At least 8 years of clinical research experience within the CRO, pharmaceutical, or biotechnology industry, including 1–2 years leading the clinical operations function within clinical trials and at least 2 years of on-site monitoring experience.
  • A Bachelor of Arts or Bachelor of Science degree; a degree in life science, nursing, pharmacy, or a related field is preferred.
  • Demonstrated understanding of medical and therapeutic area knowledge and medical terminology.
  • Strong written, verbal, and presentation skills.
  • Ability to travel as needed, possibly up to 25%.

Responsibilities

  • Independently manage and maintain ownership of the clinical operations portion of assigned projects.
  • Provide direction and training to CRAs assigned to projects, and oversee planning and monitoring of CRA and site performance to ensure compliance with study protocols, ICH/GCP guidelines, and federal regulations.
  • Drive project success by working with cross-functional study leadership to develop and implement operational strategies.
  • Identify and mitigate clinical risks and contribute to development of the quality risk management plan.
  • Review study protocols and other study materials, including CRFs.
  • Develop and manage clinical operations timelines, metrics, resourcing, budgets, and activities.
  • Develop monitoring tools and plans.
  • Oversee operational planning and site performance in accordance with departmental productivity expectations.
  • Create and conduct training sessions, including investigator meetings, conferences, and team trainings.
  • Determine and drive study start-up, track and report progress, review data, and ensure sites are selected and supplies provided in accordance with study expectations.
  • Provide status updates to project management and sponsors.
  • Lead regular clinical team teleconferences.
  • Work with site staff as needed and serve as an escalation point for CRAs when issues arise.
  • Manage clinical site communications and documentation of decisions, including mass correspondence to sites about study updates.
  • Participate in the request for proposal process, including internal and external business development meetings.
  • Review monitoring visit reports and ensure they are finalized within contractual timelines.
  • Assist Project Managers with project management tasks as assigned.
  • Support the management and development of in-house CRAs and CRAs.

Desired Qualifications

  • Therapeutic experience in neurology and pain.

About the Company

Rho

Comprehensive CRO for regulatory drug approvals

Rho is a contract research organization that provides end-to-end services for developing and gaining regulatory approval for drugs, biologics, and medical devices. It supports planning and executing clinical development, regulatory strategy, and marketing submissions, guiding projects from program strategy through NDAs, BLAs, and MAAs. An integrated team handles decentralized clinical trials and has infectious-disease programs, combining trial design, data management, and regulatory insight to move products toward approval. Its goal is to help clients bring products to market efficiently by navigating regulatory requirements and streamlining development and submission processes.

Company size
501-1,000
Company stage
Not listed
Total funding
Not listed
Headquarters
Durham, NC
Founded
1984

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