Looking to be the heartbeat of clinical research? Join our client in this project management position and assist in turning innovative science into life-changing care!
R&D Partners is seeking Clinical Project Manager to oversee the day-to-day operations of gene therapy clinical trials. You will play a pivotal role in managing study timelines, budgets, and compliance, ensuring trials are delivered efficiently and to the highest standards. The position requires close collaboration with internal departments, vendors, and stakeholders to achieve successful study outcomes.
Please note that to be considered for this role you must have the right to work in this location.
Responsibilities:
- Manage day-to-day operations of clinical trials from start to finish.
- Ensure trials are completed on schedule, within budget, and meet quality standards.
- Oversee trial start-up activities, including site selection, contracts, budgets, and regulatory submissions.
- Manage relationships with service providers, vendors, and clinical sites.
- Monitor study budgets and ensure financial compliance.
- Lead team meetings, track progress, and resolve action items.
- Maintain accurate and timely reporting of trial data.
- Ensure proper setup and maintenance of trial documentation for inspection readiness.
- Identify risks, implement mitigation strategies, and address challenges proactively.
- Support the development of study documents such as protocols and consent forms.
- Collaborate with investigators, key opinion leaders, and external consultants.
- Contribute to the development and improvement of clinical quality management systems.
- Participate in audits and inspections as needed.
Key Skills and Requirements:
- Strong understanding of clinical trial processes and regulations, particularly in the USA, UK, and EU.
- Knowledge of ICH-GCP guidelines and general data privacy regulations (e.g., GDPR).
- Proficiency in tools like Word, Excel, PowerPoint, and eTMF systems (Veeva Vault experience preferred).
- Ability to manage multiple stakeholders, including CROs, clinical sites, and vendors.
- Experience in managing clinical trials across all phases, especially Phase 1 (First-in-Human) trials.
- Background in biological sciences or a related field is preferred.
- Strong organizational, communication, and problem-solving skills.
- Provide leadership and mentorship to Clinical Trial Managers and/or Clinical Trial Administrators.
For more information, please contact Giovanni Esposito.
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Clinical Project Manager employer: R&D Partners
R&D Partners is an exceptional employer, offering a dynamic remote work environment that fosters collaboration and innovation in the pharmaceutical and biotech sectors. With a strong emphasis on employee growth, we provide ample opportunities for professional development and career advancement, all while supporting a culture of teamwork and excellence. Join us to be part of a forward-thinking organisation that values your contributions and prioritises your well-being.
