Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do.  A dynamic, global company founded in 1995, we bring together more than 2,000 driven, dedicated and passionate individuals.  We work on the front-line of medical science, changing lives, and bringing new medicines to those who need them.

If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.

Job Description

The official title for this role will be Regional Project Lead.

The Regional Project Lead manages and coordinates activities of project teams in designated countries and ensures consistency of Clinical Operations processes across regions. They ensure meeting study milestones are met by the project team on a country and regional level.

Ensures planning, implementation, and management of projects in compliance with industry regulations, ICH-GCP, essential study documents, and applicable controlled documents (e.g., PSI QSDs or Sponsor QMS documents)Acts as primary or secondary project management contact for the project team and PSI support services in designated countriesPerforms study status review and progress reporting (if delegated by the Project Manager)Collects and reports project status updates for designated regions, both internally and externallyDevelops and updates project planning documents, essential study documents and project manuals/ instructionsManages and reports on Key Performance Indicators (KPIs) for designated countries and clinical project team membersEnsures that the project timelines and subject enrollment targets are met in designated countriesCoordinates maintenance of study-specific and corporate tracking systemsCoordinates site contractual startup and budget negotiationsEstablishes communication lines within the project team and supervises clinical project team members’ performanceIdentifies, escalates and resolves resourcing and performance issuesConducts and supervises therapeutic area training of the project team (if delegated by the Project Manager)Prepares presentations and conducts training of InvestigatorsEnsures team compliance with project-specific training matrixPerforms field training of Monitors tailored to the project needsSupervises preparation, conduct and reporting of site selection, site initiation, routine monitoring and closeout visitsOversees investigator and site payments, as well as CRF data retrieval/ upload and monitoring and the query resolution processSupervises project team preparation for study audits/ inspections and resolution of audit/ inspection findingsCoordinates conduct of supervised monitoring visitsReviews site visit reports and ensures monitoring and reporting standards are met Coordinates preparation of initial and follow-up Regulatory and Ethics Committee submissions and notificationsOversees the safety information flow and participates in feasibility researchReviews/ approves project related expenses and timesheets (if delegated by the Project Manager)

QualificationsCollege/University degree in Life Sciences or an equivalent combination of education, training & experienceAt least 4 years of experience in Clinical Research and site monitoring activitiesAt least 2 years of expereince as a Study Manager or Lead with the ability to supervise project activities as a Regional Lead or equivalentExperience in Oncology is preferred. Full working proficiency in EnglishProficiency in MS Office applications, including MS ProjectCommunication, presentation and customer-service skillsAbility to negotiate and build relationships at all levelsTeam-building, leadership and organizational skills

Additional Information

Advance your career in clinical research and lead challenging full-service projects on the country/regional level while growing with a rapid company, that puts its people first! You will get hands-on involvement in every aspect of the study.