Clinical Project Manager - Spain (Homebased)
- Experience Level
Upsilon Global are working in a mid-size global CRO, who specialize in oncology studies within solid tumours and onco-immnunology studies in Phases I-III. Over the last 3 years we have supported our partner CRO in the growth within Europe and they have grown by 300%.
The CRO is now continuing to grow within Europe and are looking to find a Clinical Project Manger to join their management team working on European studies.
They are looking for an ethusiastic, motivated team member with a minimum 3 years experience managing studies in oncology.
- Management and operational delivery of the clinical elements within a trial including site selection, start-up, enrolment management, site engagement and support, monitoring planning and execution, data cleaning activities and close-out
- Successful execution of assigned trials and ensuring completion of trial deliverables
- Ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned trial(s) by working in close collaboration with other functional team members
- Mentoring and training of team members
- Identify challenges to study timelines/deliverables and offer creative action plans to the team/sponsor
- Lead CRAs as they establish relationships with their sites for high quality oversight of monitoring, regulatory, IP, site payment and overall site correspondence activities
- Maintain team focus on study priorities through efficient cross-functional partnerships and effective communication to achieve the highest level of client satisfaction
- Sr Clinical Trial Managers are responsible for the independent clinical project delivery for small studies without an allocated Project Manager.
Qualifications, Experience and Skills
- Bachelor’s degree or equivalent combination of education/experience in science or health-related field, including at least two (2) years in oncology
- 2+ years clinical trial monitoring experience
- Clinical trial experience in pharmaceutical, biotech or CRO and/or healthcare setting; 3+ years for Clinical Trial Managers and 5+ years experience for Senior Clinical Trial Managers
- Working knowledge of GCP/ICH guidelines and the clinical development process
- Availability for domestic and international travel including overnight stays
- Demonstrated computer skills (MS Office, MS Project, PowerPoint) and software experience (CTMS, eTMF, EDC, IXRS)
- Demonstrated ability to develop positive working relationships with internal and external organizations
- Demonstrates core understanding of medical terminology and clinical trial activities as it relates to the execution of a clinical development plan
- Demonstrates mastery knowledge of ICH-GCP, meaningful Precision SOPs, and regulatory guidance, as well as the ability to implement