Sirtex is a global life-sciences company that develops and delivers effective oncology treatments using novel small particle technology. .
The global Sirtex team over the past few years has grown significantly and we now have almost 300 employees located in 20 countries.
Sirtex employees are driven by a passion to help medical professionals worldwide provide real hope for patients and their families.
Achieving this vision is a large and complex task requiring dedication and commitment.
The Role :
Ensures timely and accurate study-related communication to clinical personnel
Assists the Clinical Operations Manager and Clinical Research Managers in tracking of study activities
Works with the clinical sites to collect and file regulatory documentation required for the study
Ensure TMF and ISF set up and maintenance for global clinical studies
Coordinates specified clinical trial meetings (e.g., investigator meetings, Study Management Team meetings CRA and CRO meetings) by arranging logistics, preparing necessary materials and recording and distributing minutes
Sets-up and maintains audit-ready clinical trial documentation and study status
Manages and tracks : regulatory / IRB / EC / REB documentationsafety Letter distribution,confidentiality Disclosure Agreementsclinical trial insurance certificatesother clinical trial documents
Assists with quality assurance audits and resolution of audit findings
Sources clinical trial supplies through external vendors (such as Case Report Forms, Study Manuals, Lab Kits, )
Assists in developing of Investigator and Institution contracts and budget template, negotiates budgets with sites and arranges site payments
Coordinate site contracts negotiation and organize the investigator payments to sites
Bachelor’s degree or equivalent
Minimum of 4 years of clinical trial experience and previous CTA experience
Understanding of GCPs, ISO, ICH guidelines and regulatory requirements
Study coordinator, data management, site monitoring and / or nursing experience
Excellent communication skills and the ability to build effective relationships with trial centre staff and colleagues
Fluent English and good German language knowledge
Numeracy and an eye for detail
Good organizational, IT and administrative skills
Ability to travel up to 20% of the time within EMEA
What you can expect from Sirtex :
If you have the right skills and experience and want to work for a company making a real difference to the quality of people’s lives, Sirtex will offer the right candidate :
Diverse and flexible employment and working arrangements to achieve the optimum balance between work and personal responsibilities and objectives
A working culture of respect, diversity and performance to help facilitate an inclusive culture
Attractive compensation and benefit packages which are practical, robust, fair and equitable
A place to grow through training opportunities
To apply, please email your cover letter and resume and all relevant certificates in English to Ecaterina Chislari, HR Generalist EMEA at recruitment sirtex-europe.com.
Unfortunately, applications send via post cannot be returned