Clinical Trials Regional Project Lead

PSI is a leading Contract Research Organization with more than 27 years in the industry offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

Only CVs in English will be considered

In this position, you will be responsible for coordinating activities of project teams ensuring milestones are met and ensuring consistency of Clinical Operations processes across regions. This function holds project managerial responsibilities under supervision.

Responsibilities will include:

• Coordinating project team work, supervising the clinical project team members’ performance,
• Implementation and management of projects in compliance with industry regulations, ICH-GCP, essential study documents, and applicable controlled documents,
• Acting as a point of contact for the project team, PSI support services, and contractors,
• Collecting and reporting project status updates,
• Developing and updating project planning documents, essential study documents, and project manuals/instructions,
• Conducting and supervising therapeutic area training of the project team and Investigators,
• Supervising preparation, conduct, and reporting of site selection, site initiation, routine monitoring, and closeout visits and reviewing site visit reports,
• Overseeing investigator and site payments,
• Supervising project team preparation for study audits/inspections and resolution of audit/inspection findings,
• Coordinating preparation of initial and follow-up Regulatory and Ethics Committee submissions and notifications,
• Performing other project management tasks in agreement with the responsible Clinical Operations Manager following adequate and documented training, and formal delegation of tasks.

Qualifications

• College/University degree in Life Sciences or an equivalent combination of education, training & experience,
• Full working proficiency in English,
• At least 4 years’ experience in a health care or clinical environment,
• Minimum 4 years’ site monitoring experience and at least 2 years’ experience as Lead Monitor or equivalent,
• Availability to travel,
• Proficiency in MS Office applications,
• Ability to plan and work in a dynamic team environment,
• Communication, collaboration, and problem-solving skills.

Additional Information

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.