Senior Project Manager, eCOA
About the role
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The Sr. Project Manager will work with other members of the eCOA team to develop processes and work according to these processes to effectively provide eCOA services to our clients. The management of third party eCOA vendors will be an integral part. This role will also represent the eCOA practice within ICON, our external clients and the industry.
This is a Home-Based position and can be located anywhere in UK.
Overall Responsibilities include:
- Manage eCOA projects within ILPOR and ICON´s cross-divisional eCOA market.
- Contribute to and manage the development and customization of new products to accommodate the ILPOR and ICON cross-Divisional eCOA market.
- Contribute to the selection process of partners (3rd parties) for eCOA and related technologies.
- Work with ITG and other ICON departments to develop processes, pricing tools and collaterals (e.g. brochures) to develop and grow eCOA business.
- Support Business Development (various groups in ICON) to grow the business for eCOA by providing consulting services i.e. on modality selection, system selection and processes for design and implementation of eCOA systems.
- Function as Subject Matter Expert (SME) advising internal and external clients on best practices in eCOA design to ensure regulatory compliance.
- Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
- As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
- Provide project management for interdisciplinary, interdepartmental and cross- Divisional teams to adapt or develop new e-clinical, specifically eCOA systems for ICON projects.
Qualifications include:
- Minimum of 5 years work experience in clinical research.
- Minimum 3 years’ experience in the development and/or delivery of eClinical or Data management tools and services, preferable in CROs
- A good understanding of the overall clinical development process
- Project management experience, required
- Basic understanding of the current landscape of eCOA validation requirements.
- Understanding of the current competitive landscape for eCOA
- Experience in Proposal Development of eClinical systems and services
- Experience in presenting at client meetings (Bid defense, Project Kick-off, Investigator Meeting)
- Training in GCP and other regulations and official Guidance to Industry affecting conduct of clinical trials and implementation of information systems supporting clinical trials, preferred
- Training in system development lifecycle methodology and other disciplines relevant to eCOA system design, such as statistics, economics and validation of clinical data gathering instruments, preferred
- Bachelor´s degree or Diploma or equivalent, required
- PMP certification, preferred
- MS Project experience, preferred
- Travel (approximately 30%) domestic and/or international. Valid driver's license, required
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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