Offer summary

Qualifications:

University degree in Life Sciences, Pharmacy, or equivalent education and experience., Significant hands-on industry experience in Phase II/III Clinical Trials with full monitoring responsibilities., Fluent in Turkish and English, both spoken and written., Strong communication, organizational, and time-management skills..

Key responsibilities:

Preparation, conduct, and reporting of monitoring visits for clinical research studies.

Site management and administration of clinical research studies in Turkey.

Contact for clinical investigators and vendors regarding study progress and budget negotiations.

Deliver training and prepare presentations for Investigator’s Meetings and audits.

Job description

Company Description

PSI is a leading Swiss Contract Research Organization with 30 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

Preparation, conduct, and reporting of selection, initiation, routine and closeout monitoring visits
Site management, general administration of clinical research studies in Turkey
Contact for clinical investigators, vendors and support services in regard to study progress
Monitoring trial progress and ensuring that the project timelines are met
Facilitation of site budgets and contract negotiations
Effective and open communication within the project team
Delivering training of investigators, site staff and project teams
Preparation and delivering of presentations at Investigator’s Meetings
Preparation for and attendance at company’s audits; resolution of audit findings
Support to Regulatory Affairs in procurement of site regulatory documents
Maintenance of appropriate documentation regarding clinical site management
Participation in query resolution

Qualifications

University degree in Life Sciences, Pharmacy, or an equivalent combination of education, training and experience
Significant hands-on industry experience at a similar position, with full scope of monitoring responsibilities within Phase II/III Clinical Trials
Independent monitoring experience in Turkey and knowledge of the local clinical research environment
Experience in regulatory submissions, contract negotiations, site management and feasibility assessment
Fluent Turkish and English, both spoken and written
Team oriented with excellent communication and interpersonal skills including a positive and professional attitude to tasks and projects
Attention to detail, organizational and time-management skills
Valid driver’s license and ability to travel