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Local Trial Manager

10.09.2019 REF: O190084 Brussels area

Organization

A Local affiliate of an International Medical Devicel company

Description of the Position

OVERALL RESPONSIBILITIES:
This individual will be responsible for activities related to site activation (Coordinate EC submission, coordinate CTA execution, Site initiations) for one or several clinical trials within the Clinical Department, as well as fostering strong, productive relationships with colleagues across the organization.

POSITION DUTIES & RESPONSIBILITIES:
• Serve as a Clinical Trials Leader within the group to execute company sponsored clinical trials for the Medical Device Franchises
• Serves as a member of the clinical trial/study core team
• May serve as the primary contact for clinical trial sites
• Manage operational activities of assigned clinical studies within the Clinical group
• Solves problems with support from Clinical Management arising during clinical trial execution, and will seek guidance for more complex problems, as needed
• Provide internal communication of important clinical data and events. Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders
• May be involved in other tasks to support Clinical as needed
• Track assigned projects budgets to ensure adherence to business plans
• Support the implementation of new clinical systems/processes, and provide support for publications, as needed.
• Interface and collaborate with site personnel, IRBs/ECs, Competent Authorities/MoH, contractors/vendors, and company personnel
• Ensure personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety, and Environmental compliance

People Leadership Responsibilities:
• Ensure that all Human Resource related activities, and decisions embody the values
• Provide leadership within a clinical trial, ensuring that each team member has a well-defined set of activities and objectives specific to their role and responsibilities within the context of their business focus.
• Ensure efficient use of resources within the clinical study/program to provide high quality deliverables.

Business Leadership Responsibilities:
• Accountable for quality, compliance with regulations and company procedures, timelines, and budgets for assigned clinical trials.
• May assist with the management of large regulated or complex trials under supervision of CTM.
• Identify and ensure strategies, resources, and accountabilities are in place to achieve rapid, high quality execution of assigned clinical trials under his/her responsibilities.

Demands of the Position

• Minimum of a Bachelor’s/University Degree or equivalent required; preferably in Life Science, Physical Science, Nursing, or Biological Science.
Experience
• 2-4 years of relevant experience (or equivalent) required.
• Previous experience in clinical trial management or equivalent is required.
• Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
• Clinical/medical background required.
• Medical device experience a plus.

Terms of Employment

The contract will initially be a contract with The Clinical Company, you will first be outsourced to our client with the possibility of a direct contract after a period of time. Within The Clinical Company you will be part of a Benelux team of about 60 enthusiastic clinical professionals under the support of 2 dedicated Clinical Team Managers. Motivated, well trained and happy employees is essential to us in order to build a long lasting successful cooperation with our employees and clients. We therefore offer all the personal support you need, focus on your career development and make sure it’s fun to work for us!
Interested in this challenge and want to apply directly?! Please use the apply button below. For more information, feel free to contact Nick Dufour at 0032 (0)475 87 02 36 or n.dufour@theclinicalcompany.com

Nick for Belgium

Didn’t find the right job on our website yet? Interested in an introduction of our company and what we can do to your career? Please feel free to contact me!

+32 475 87 02 36n.dufour@theclinicalcompany.com

Simone for the Netherlands

Didn’t find the right job on our website yet? Interested in an introduction of our company and what we can do to your career? Please feel free to contact me!

+316 12996359simone.polman@theclinicalcompany.com

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