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 the participation in international networks and promoting excellence in the management of cancer among their members.

Currently we're looking for a Clinical Project Manager to join our Clinical Operations Team.

Main 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 vendors 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 countries, ensuring alignment with local requirements and global study timelines.
Support Risk-Based Quality Management (RBQM) and centralized monitoring activities in collaboration with the clinical operations team.

Requirements and skills:

Minimum 1-2 years of professional experience as PM or CTM/CRM in clinical trials within pharmaceutical industry, CRO or Collaborative Group, preferably including international or multi-country studies. Experience in oncology clinical trials is strongly preferred.
Desirable previous experience as CRA.
Budget management know how.
Advanced understanding of GCPs and clinical trial legislation.
Familiarity with Project Management tools, CTMS and eTMF systems; experience with remote or centralized monitoring tools is an asset.
Advanced English level.

This is a full-time position (38h/week). Primary base in Barcelona (Spain), with hybrid-remote flexibility for candidates within Spain.

What we offer:

Join a team driving investigator-initiated oncology research with real potential to influence clinical practice globally. As a Global Clinical Project Manager at SOLTI, you will lead complex, multi-country trials from setup to close-out - with the autonomy and visibility that only an academic sponsor can offer.

We offer a hybrid work model (up to 3 days remote per week), flexible schedule, a central Barcelona office, access to international conferences and scientific events, a collaborative and expert team environment and a competitive benefits package.

SOLTI is an employer committed to Equal Opportunities regardless of sex, gender, sexual orientation, race, age, origin or disability.

Clinical Project Manager

Empieza con tu correo