Job DescriptionOur client is a boutique CRO which offers specialized services supporting drug development for the pharmaceutical and biotechnology industry who are looking for a skilled home based Project Manager.
The Clinical Project Manager is responsible for performing activities associated with Clinical Project Management including evaluation, initiation, monitoring and close out of clinical trials to ensure the trial is conducted in accordance with the protocol; company Standard Operating Procedures (SOPs), ICH GCP guidelines and other applicable regulatory requirements.
About the role:
- Autonomously manage clinical projects from commencement to completion.
- Develop and review study protocols and other study related documents.
- Conduct clinical trial feasibilities and site selections.
- Review study budgets and clinical trial agreements.
- Assist with project-specific invoicing, and payment tracking.
- Prepare or review documents for Ethics submissions.
- Submit studies to Regulatory Authorities.
- Register, or supervise the registration of, studies on an appropriate publicly accessible database.
- Ordinary degree in the appropriate discipline or appropriate industry experience.
- Previous management experience in pharmaceutical or Contract Research Organisation (CRO) industry
- Minimum 5 - 7 years’ experience in the pharmaceutical industry / CRO working in a GCP environment.
- Formal Clinical Research Associate (CRA) and ICH GCP training.
- Phase 1 experience highly regarded
- Commercial links with pharmaceutical and biotech industry
Please get in touch for more information.