Ipsen

Senior Clinical Project Manager

Ipsen

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Salary

💰 $143,250 - $210,100 per year

Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • Senior Clinical Project Manager responsible for execution and oversight of global clinical trials outsourced to CROs, ensuring timelines, quality, budgets, and study goals. Collaborate with Clinical Development Program Directors, Medical Development Directors, and Ipsen team members. Endorse CRO project plans, ensure GCP, local regulations, and SOP compliance. Manage study budgets and tracking systems. Lead cross-functional Clinical Study Team and external partners (CROs, service providers). Identify process/technology improvements and participate in continuous improvement initiatives. Oversee study team management and communication, set-up study team, contribute to protocol development. Develop and control planning and study timelines, support RFPs and CRO selection. Accountable for budget development, management, and tracking; ensure oversight of CROs and vendors. Supervise country feasibility, site selection, and provide oversight for CTAs and Clinical Monitoring Leads. Work with CROs and other teams on recruitment strategy and communications. Ensure regulatory, safety and data requirements are met; participate in CRO meetings and escalate issues. Travel as needed; ensure CAPA implementation post audits and assist with inspections. Contribute to SOP updates, training, systems implementation and continuous improvement. Comply with EHS regulations and contribute to environmental impact reduction.

Requirements

  • 10+ years working in clinical research with management of clinical activities for the set up and running of international registrational studies, for at least 8 years. Relevant experience of pharmaceutical drug development. Experience in managing and developing relationships with Contract Research Organizations (CROs/SPs). Experience in working with multidisciplinary groups (internal & external), flexibility, adaptability, and ability skills to work within a matrix environment. Ability to work in a strong regulated environment within a quality management system (QMS). Advanced proficiency in digital tools and software applications including Microsoft Office, Adobe Reader, etc. Proven leadership and collaboration skills, with the ability to work effectively in multidisciplinary teams. Basic Financial Knowledge- must be able to work with financial tracking tools. Knowledge of Pharmaceutical Industry R&D. Strong understanding of FDA, EMEA and ICH GCP guidelines. Good understanding of the drug development process and knowledge of the pharmaceutical industry environment. Good knowledge of the Good Clinical Practices (GCP) or other clinical study regulations. Intimate knowledge of regulatory requirement (ICH, E6, GCP, EU Directive). Strong organizational and management skills, with the ability to delegate effectively, and set and prioritize tasks. Demonstrate flexible and creative leadership and able to build a network. Strong verbal and written communication skills (English). Experience in outlining clinical study operational strategies and managing de-centralized studies. Experience with risk-based quality management (RBQM). Aesthetics Experience strongly preferred. Bachelor’s degree in a relevant life sciences discipline is required. Medical degree or equivalent advanced qualification(s) is preferred. Fluent in English. Background screening, reference checks, and drug testing as part of pre-employment screening.