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Job Details

Regulatory and Site Services Specialist

Company: Chiltern
Location: Leuven
Reference: RSS - BELG900305
Closing Date: 22 Jun 18
Type: Full Time
Salary (£): On Application
Benefits: Excellent and competitive benefits

Job Summary:

We are looking to recruit a Regulatory and Site Services Specialist - office based in Leuven, Belgium

Requirements:

Job Background

Established in the UK in 1982, Chiltern is leading privately owned global CRO with 4300 employees located around the world. Chiltern has extensive experience in the management of Phase I-IV clinical trials across a broad range of therapeutic areas, functional service provision and contract staffing solutions. Chiltern prides itself as a development partner that offers flexibility, responsiveness and quality delivery. Chiltern is a CRO that starts every project by taking the time to understand each sponsor’s situation. Then we draw on a wide-ranging skill set to craft a customized engagement perfectly matched to those needs from start to finish.

Our successful and dynamic team in Belgium is currently looking to expand. Are you searching for an exciting new role? Do you have any experience in start-up and regulatory affairs in Belgium and/or the Netherlands? Then this is a fantastic opportunity for you!

We are looking to recruit a Regulatory and Site Services Specialist - office based in Leuven, Belgium

About the department: The Regulatory and Site Services (RSS) department provides an efficient, quality-centric approach to study start-up activities with a growing focus on site relationships. RSS perform regulatory and ethics submissions (initial and amendment), document collection and quality control through all phases of the clinical trial, and execution of site level feasibility in coordination with the Feasibility department.  There are opportunities to develop your career, take on more responsibilities and be involved in cutting edge global studies.

What makes us different:

  • Work-life balance is considered
  • We are a supportive community where everyone helps each other to succeed, and you will receive direct coaching from our expert managers
  • Your studies will be “yours” from the beginning until the amendments stage: you will not jump from study to study without previous notice


 

Duties & Responsibilities

1. Perform the preparation, quality control review, and submission of Clinical Trial Application packages including initial submission, amendments and End of Trial Declarations as well as non-substantial notifications, status reports etc. to the Ethics Committee (EC) and to any other country specific authority/body in assigned countries.

 2. Serve as the primary contact with the EC and other applicable country-specific authority/body throughout the study.

3. Development of Informed Consent Forms, labels and other patient facing material in accordance with country-specific requirements.

4. Review translations of study documentation in accordance with the study-specific translation plan and/or relevant SOPs/WIs (e.g. ICFs, patient facing material, correspondence with authorities etc.)

5. Serve as main contact for investigative sites during start-up.

6. Perform the collection and quality review of all required essential documents from sites.

7. Negotiating of site contracts

8. Ensure that Chiltern’s tracking and project management systems are kept up to date and provide status updates on request

9. Maintain accurate, timely knowledge of the directives, regulations and guidelines relating to clinical trial applications in assigned countries. Maintain awareness of any country specific and any applicable multi-country requirements and regulations as required to perform assignments.

10. Provide input to Requests For Information (RFIs), Requests for Proposals (RFPs) and bid defence presentations as required.

Requirements

  • University/College degree (life science preferred), or certification in a related allied health profession (e.g., nursing, medical or laboratory technology)
  • A minimum of 2 years experience in the role
  • Proven working knowledge of Study Start Up activities in Belgium
  • Ethic committee submission experience
  • Competent Authority experience is preferred but not mandatory
  • Experience in Study Start-up activities in the Netherlands is preferred but not mandatory
  • Experience of the clinical research process and terminology
  • Experience using a clinical trial management system
  • The successful candidate will be a strong communicator, who has a great eye for detail and excellent organizational skills. You will have the ability to work independently and as a part of a team.
  • Candidates must be fluent in French, English and Dutch.


Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans.

Salary

On application

Position Type

Permanent
Full Time

Contact

Email Kevin Thomas - kevin.thomas@chiltern.com
+33 01 41 05 73 53

Apply for this job: Regulatory and Site Services Specialist

Contact Information:

Address:  France
37 bis rue de Villiers, 92200 Neuilly sur Seine, France

France
Tel:  +33 1 41 05 73 00
Fax:  +33 1 41 05 73 01
Website:  Visit Our Web Site

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