SOLTI is an academic research group that performs clinical trials of excellence in oncology. Currently, SOLTI is comprised of over 550 renowned research professionals distributed over a broad network of more than 100 leading hospitals in Spain, Portugal, France and Ireland.
SOLTI focuses its efforts on developing cutting‑edge clinical trials with novel targeted therapeutics including innovative translational research, fostering participation in international networks and promoting excellence in the management of cancer among its members.
Currently we’re looking for a Clinical Project Manager to join our Clinical Operations Team.
Responsibilities
- Responsible for planning, coordinating, and leading all activities and stakeholders involved in a clinical trial to ensure the delivery of project objectives within the agreed timelines, maintaining high-quality data and adhering to the study budget.
- Coordinate operational activities and communication with the Sponsor, Collaborative Groups, and other third parties (e.g., CRO) involved in the projects under your responsibility.
- Participate in the development and negotiation of the clinical trial budget.
- Manage the study budget throughout the trial and ensure timely billing of achieved milestones.
- Perform project setup in the CTMS and ensure it is kept updated by all project team members.
- Develop, maintain, and ensure compliance with SOPs and regulations for all study plans.
- Ensure the availability and maintenance of all essential documents in accordance with ICH GCP throughout the study.
- Support and assist CRAs with project-specific matters. Ensure all study stakeholders receive proper training throughout the study.
- Perform vendor selection and management.
- Collaborate in the evaluation and selection of study sites.
- Review Protocol, ICF and other patient facing documents.
- Review and approve monitoring reports.
- Coordinate regulatory submissions and site activations across multiple count
