Ref #: 36936

Employment type: Permanent - Full-Time

Location: Poland

Posted: 13-May-2022

Description

We are looking to recruit an experienced Study Managers / Project Leaders to join our ICON FSP team and work for a global and prestigious pharmaceutical company.



Overview

As a CTM you will be a member if the Global Trial Management and Study Oversight Team led by a Global Project Manager. You will ensure regional or global clinical operations deliverables progress. You will supports the Global PM in leading related CRO, country, and site activities, including global vendors involved in site facing activities.



Requirements

• Life science degree (preferable)

• 2-6 years of regional or global clinical trial management experience from start- up to database lock in the pharmaceutical industry or CRO

• Cross-country experience working in Clinical Operations (If you managed studies in multiple countries in EMEA this is also acceptable.)

• Experience with supervision of CROs/vendors is a must

• Strong decision-making and communication/collaboration skills

• Effective leadership skills



Key Responsibilities

• Lead the Study Management Team including providing updates to all trial team members on deliverable status.

• Act as primary contact for Country and Regional staff

• Collaborate with the Global PM to execute and oversee central activities from planning, trial start up, through the life of trial to close-out.

• Ensure issue escalation and drive issue resolution.

• Work closely with Trial Team to ensure CAPAs are resolved timely.

• Demonstrate deep knowledge of protocol and procedures and adequate therapeutic area knowledge.

• Ensure compliance with Health Authority regulations and guidelines and internal standard operating procedures and processes.

• Participate in preparation for Health Authority inspections and internal audits.

• Coordinate data cleaning with some supervision towards a timely and successful database lock.

• Provide central documents required for HA/EC/IRB submission.

• Ensures creation of appropriate trial-specific training materials and requirements, making them available to the regional/site/CRO staff and delivering training as needed.



How to apply?

This is an exceptional opportunity within a global organization who offers rewarding careers. If you want to be a part of this exciting opportunity who offers a competitive salary, excellent benefits package, please contact Dariusz Sternlicht, Recruitment Consultant at ICON Strategic Solutions and email your up-to-date CV to: dariusz.sternlicht@docsglobal.com



Keywords:

Study Leader, Global Clinical Trial Manager, CTM, CSM, Project Leader, Clinical Trials, Clinical Studies, Pharmaceutical, CRO, Pharma, Contract Research Organization, Biotech, Health, Poland