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Global drug and device development services

Global Clinical Delivery Manager

Clinical Research OperationsConfirmed live in the last 24 hours
Full-time

About the Job

Requirements

  • A bachelor's degree in a scientific or related field is required; an advanced degree is preferred.
  • At least 5 years of experience in clinical research is required.
  • 1–2 years of experience working as an Associate Project Manager within a CRO or pharmaceutical setting is required.
  • Vendor management experience is required.
  • Global experience is required.
  • Experience working closely with cross-functional teams on status updates and deliverables is required.
  • Knowledge of ICH-GCP, clinical study delivery processes, regulations, operational best practices, and industry standards is required.
  • Familiarity with key systems used in clinical trial delivery and experience using an industry-accepted Trial Master File standard are required.
  • Strong project management skills are required, preferably including analytical or financial skills.
  • Good leadership skills are required.
  • Excellent verbal and written communication in English is required.
  • Excellent communication and relationship-building skills, including external service provider management skills, are required.
  • The candidate must have the legal right to work in the country where the role is based.

Responsibilities

  • Contribute to delivering clinical studies on time, within cost, and to quality requirements, and ensure inspection readiness by overseeing study eTMF completeness.
  • Partner with the Study Delivery Lead on end-to-end operational study delivery from study setup through archival, including setting up, maintaining, and ensuring completeness of internal systems, databases, tracking tools, and project plans (CSAP).
  • Work cross-functionally with internal and external partners on clinical study management activities for in-house and outsourced studies across phases and therapeutic areas, following the applicable operating model, regulations, client procedures, policies, best practices, and standards.
  • Monitor study conduct and progress, identify and resolve risks and issues, and escalate issues that may affect quality, timelines, or budget objectives.
  • Review key clinical documents, including protocols and informed consent forms, and lead development of study plans, including monitoring, vendor management, protocol deviation management, risk management, and communication plans.
  • Facilitate and maintain meetings and interactions with internal partners, including regulatory, LOC, quality assurance, and monitors, as well as external partners such as CROs and third-party vendors.
  • Manage vendors and provide CRO oversight as a primary point of contact, overseeing study-specific deliverables and ensuring continued monitoring and timely delivery of delegated activities.

Desired Qualifications

  • An advanced degree is preferred.
  • Analytical or financial skills are preferred as part of project management skills.

About the Company

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Global drug and device development services

This company provides consulting, development, and commercialization support for drugs and medical devices through a global network of offices. Its team across 53 countries offers end-to-end services, from strategy and regulatory work to manufacturing and market access, helping clients shorten development time, lower costs, and raise quality. It differentiates itself with wide geographic reach and a clear focus on reducing time to market and cost while leveraging deep experience across many therapeutic areas. Its goal is to help clients accelerate the development of life-saving products and improve quality of life by delivering reliable information, practical solutions, and solid performance.

Company size
10,001+
Company stage
IPO
Headquarters
Ireland
Founded
1990

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