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Clinical Trial Manager

Clinical Trial Manager

Job Title: Clinical Trial Manager
Contract Type: Permanent
Location: Noord-Brabant
Industry:
Salary: To be discussed on application
Start Date: 2020-09-07
Reference: V-46365
Contact Name: Alex Butcher
Contact Email: alex.butcher@nextphaserecruitment.com
Job Published: September 08, 2020 16:10

Job Description

An exciting opportunity has arisen with a Netherlands based Stem Cell company. Their patented protected technology is based on the expansion and differentiation of stem cells. They have several assets, all focused on oncology, with two moving into phase II stage and four at pre-clinical stage. Due to growth within the company they are seeking a Clinical Trial Manager.

The Opportunity
You will be responsible for delivering and executing the clinical development strategy for assigned cell therapy projects.

This is a fantastic opportunity to join a growing biotech company whose products bring many benefits to cancer patients. 

This position offers remote working, with a requirement for office attendance once a week.

Responsibilities Include:
• Execution of clinical trial strategies in close coordination with the Medical Director.
• Ensuring projects are conducted in compliance with relevant regulatory requirements and standards.
• Ensuring projects are conducted according to defined scope, quality, budget and timelines.
• Oversight of clinical trials sponsored by our client and Investigator Initiated Trials.
• Oversight of Contract Research Organizations (CROs) and other vendors 
• Coordination of investigational medicinal product shipment to clinical sites.
• Co-monitoring of investigational sites.
• Participation in Investigator Meetings and key scientific meetings/conferences.
• Participation in the interpretation of clinical trial data.
• Maintenance and archiving of the clinical trial documents, including Trial Master Files.

Experience:
• 3+ years’ work experience as a CTM or equivalent for pharmaceutical/biotechnology company or CRO.
• Experience in oncology, immunotherapy and/or cell therapy is highly desired.
• Experience in phases I-III is highly desired
• Outstanding communication skills, both verbal and written in English.
• Effective time management and organization skills and meticulous attention to detail.
• Demonstrated ability to work within small teams in a fast-paced environment.
• Experience managing CROs and other vendors.
• Problem-solving skills.
• Available to travel for a limited number of clinical investigator meetings and site co-monitoring visits with CRO.