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14.09.2016

Clinical Site Manager

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Medical Devices organization, based in Brussel Belgium.

At the Medical department we will consider patients first in all activities to fulfill our mission to maximize the safe and appropriate use of our products by identifying and communicating their medical value. We will succeed in this by becoming the preferred partner of our external customers.

ROLE DESCRIPTION

As Site manager you are responsible for providing support to the implementation of the clinical research operations programme for all appropriate therapeutic areas for Johnson&Johnson Medical Devices in accordance with all applicable regulations for Medical Devices. Plan & implement a programme of monitoring for all international regulatory and post marketing clinical research studies and maintain the highest ethical, clinical and scientific standards ensuring both the safety and well being of all trial participants, and good/rigorous scientific practice.

RESPONSIBILITIES

1.Provide support to Clinical Trial Leader for agreed projects in the EMEA Clinical Research programme for the defined therapeutic area by monitoring and reporting on studies progress in accordance with all Corporate and Statutory requirements to agreed timescales.

2.Maintain the highest ethical, clinical and scientific standards ensuring both the safety and well being of all trial participants and good/rigorous scientific practice.

3.Keep abreast of international legislation and other requirements concerning clinical research. Prepare and submit submissions for the approval of clinical investigations to regulatory authorities and ethics committees.

4.Keep abreast of developments in clinical research and the clinical literature in therapeutic areas of responsibility.

5.Assist in the preparation of consent documentation where required for the proper scientific evaluation of new or existing products in accordance with all ethical and regulatory requirements for Medical Devices in respect of applicable European and International Medical Devices Regulations.

6.Monitor defined clinical studies in accordance with Good Clinical Practice requirements and provide regular feedback to company personnel on the progress of trials.

7.Administer the inventory of Investigational Products and control the issue of investigational products to approved sites where necessary.

8.Participate in project teams and build relationships with investigators, regulatory bodies and appropriate company personnel as required regarding clinical research issues, working as directed by Clinical Trial Leader & monitoring team.

9.Maintain compliance with Company SOPs.

10.Maintain a high standard of housekeeping and filing accuracy.

REQUIREMENTS

a) Knowledge:
1. Minimum Education Requirements:

1st Degree in Life Sciences, Health Sciences or related field to Biomedical Engineering or equivalent combination of education and experience.

2. Minimum Experience Requirements:
4+ years experience of clinical trials monitoring in a medical company preferably with medical devices.

3.Minimum Skill Requirements:
Knowledge of clinical study design and management. Relevant experience in implementation of clinical research studies. Working knowledge of international regulatory requirements applicable to clinical research. Awareness of research ethics. Above average oral, written and communication skills.

4. Equipment or Machines Used:
Personal computer and general office equipment.

b)Problem Solving: Independent judgement is employed in problem solving for project management with supervision.

c) Decision Making: Decisions are made subject to established company, departmental and government policies and regulations with supervision.

d)Degree of Responsibility: Instrumental in meeting departmental objectives. Must be highly responsible and capable of seeing each project to its conclusion.

e)Extent of Confidentiality:Access to and knowledge of technical, clinical, and regulatory data on many products including adverse event data. Limited access to the research programmes, strategy and commercial data of other affiliates and DePuy Inc. Limited contact with competition, Government and Regulatory Bodies in situations where discretion and security are critical. Access to confidential clinical information and medical history of patients entered into clinical research programmes.

f)Interpersonal Contacts:Medical, health care and academic institutions e.g. Consultant surgeons, Senior Nursing staff and Heads of Department together with their teams. Hospital and Regional Ethical Committees. MHRA and other Competent Authority staff. Patients during clinical investigations. Clinical research and regulatory organisations. Competition through professional societies, meetings and conferences.

g) Adverse Work
1. Environmental Conditions:
- Frequent visits to hospitals.
2. Physical
- Frequent travel throughout the Belgium, possibly Europe.

h) Language
- Both Dutch and French

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Rosa Markus.



 
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