R

Rho

Comprehensive CRO for regulatory drug approvals

Study Start-Up Lead

Clinical Research OperationsPosted on Nov 11
Full-timeRemote in USA$75k - $95k /yrRemote

About the Job

Requirements

  • A Bachelor's degree and at least 4 years of clinical research experience, including 3 years of clinical study start-up experience.
  • A sound understanding of applicable international and local Regulatory and IRB/IEC requirements and guidelines, including ICH, GCP, and/or EU directives, and good knowledge of Regulatory and IRB/IEC submission processes for assigned countries.
  • Strategic and creative risk management and contingency-planning skills.
  • Strong written, verbal communication, and presentation skills, including the ability to express complex ideas to study personnel and internal and Sponsor team members.
  • Strong organizational skills and the ability to manage priorities across multiple studies.
  • Strategic, tactical, and critical-thinking skills with a client-focused, action-oriented approach to work.
  • Proficiency with computers and the internet, including working knowledge of Microsoft Outlook, Word, and Excel.

Responsibilities

  • Lead and manage regional study start-up efforts and develop start-up plans for country and site activation on studies of moderate scope and complexity.
  • Participate in Sponsor meetings regarding study start-up, including endorsing operational targets and mitigating delivery risks, establishing client expectations for delivery, communication, reporting, and metrics, with oversight from a higher-level SSU Lead when necessary.
  • Partner with Functional Leads and SSU team members to identify and resolve study start-up issues proactively.
  • Oversee country and site feasibility activities, ensuring timely collection and evaluation of site capabilities, Regulatory and IRB/IEC considerations, and study-specific requirements; review and interpret site feasibility data to identify risks or barriers to site selection and activation.
  • Coordinate with internal teams to confirm site recommendations and ensure alignment with study strategy.
  • Drive regional Regulatory and IRB/IEC submission and approval strategy and manage country-level Regulatory and IRB/IEC submission and approval timelines.
  • Participate in and coordinate country-level Regulatory and IRB/IEC submission preparation and approval activities, ensuring compliance with regional requirements.
  • Coordinate cross-functional input from Regulatory, Medical, Legal, and Clinical Operations to prepare complete and accurate Regulatory and IRB/IEC submission packages.
  • Coordinate Informed Consent Form development, country adaptation, review, negotiation, and approval, with senior SSU support as needed.
  • Manage Site Essential Document requirements, templates, collection, review, approval, and second-level quality checks.
  • Drive site budget and contract negotiations, obtain approval from the Sponsor and Rho Legal, and file completed documents.
  • Collaborate with applicable departments, the client, and stakeholders to obtain site budget and contract templates and negotiation tools and trackers.
  • Update the Sponsor and internal team regarding negotiation progress and anticipated timelines.
  • Maintain relevant SSU systems and keep them up to date to analyze study start-up progress metrics against targets and timelines.
  • Ensure accurate documentation and timely handoffs to the Sponsor and internal project team.
  • Serve as the point of contact for client matters related to study start-up.
  • Partner with Clinical Team Leads, CRAs, and the client to develop strategy and timing for the Site Initiation Visit and site activation.
  • Support business development with proposal and bid-defense efforts, including representing Rho in proposal meetings, as needed.
  • Provide operational oversight, guidance, and constructive feedback to SSU Associates on assigned projects.
  • Oversee the work quality of SSU Associates by providing clear expectations, timely feedback, and performance coaching.
  • Lead components of project team meetings, delegate tasks appropriately, and ensure clarity of responsibilities.

Desired Qualifications

  • Global study start-up experience is preferred.

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

Recently Posted Jobs

Explore more opportunities at Rho

See more jobs