Company: Barrington James Clinical
Closing Date: 12 Feb 17
Salary (£): Competitive
I am currently partnering an exciting Medical Device company on a retained search basis that is looking to expand their Clinical Operations function in Belgium. They have recently upgraded there office to a plush, modern environment which is extremely attractive! This company have huge goals to achieve, in which they are keen to bring someone on board who also wants to learn, grow and develop with the company.
For more than 80 years, my clients name has been associated with high-quality, innovative medical devices. From the founding in the 1900’s as a manufacturer of clinical thermometers, my client has grown worldwide to a position of leadership in such areas within Medical Devices The high-quality products are used in more than 160 countries worldwide!
Salay + Package: Competitive
Reporting Into: Head of Clinical Operations EU
Management of Clinical Trials
Management of the clinical trials assigned to his/her responsibility
Plan, establish and guard study time-lines, required resources and protocol specific milestones
Assign study team in collaboration with Head of Clinical affairs
Participate in selection of research locations & CROs
Responsible for the set-up and maintenance of the administrative structure of the project(s)
Coordinate with the project team:
Preparation of the materials for clinical trials (Investigational plan, Investigators brochure, Patient information, monitoring and study guidelines ...)
Preparation of files for the submission to Ethics committees, Competent Authorities and other bodies if needed
Preparation of files for Clinical trial insurance
Follow-up of agreements with hospitals and investigators
Establish appropriate committees (CEC, DMC) and organize meetings according to schedule
Coordination of payments to clinical sites according to contract milestones
Follow-up of enrolment and milestone follow-ups and develop actions to optimize it
Writing monitoring Manual
Ensure proper clinical trial monitoring
Regular communication with the study sites and CRO
Regular reporting of project status to management and business units
General administration related to the clinical trials
Oversee clinical trial documentation filing and ensure compliance with regulations
Closely follow relevant regulatory requirements related to conduct of clinical trials in different countries and regions
SOP preparation and update
Ensure project documents are compliant with regulations and internal SOPs
Clinical data analysis
Writing clinical trial reports
Coordinate with Medical Scientific team to ensure data availability on specified milestones
Act as a representative of the company.
Interact closely with administrative departments and commercial organisation of the company.
Assume all other responsibilities and authorities this function may require regarding new opportunities.
Reporting to the Clinical Program Manager(s) for the assigned therapeutic areas.
Contributing to society through healthcare
Master Life sciences degree or equivalent by experience
Minimum 5 years’ experience in Clinical trials
Good knowledge of project management and regulatory requirements
Well-developed computer skills, communication skills, and presentation skills.
Analytical with well-developed scientific rigor
Strong problem solving skills
Team player, working with others to reach results/resolution
Advanced organizational skills with an ability to plan, organise, monitor and execute the project
Must be able to work in an international environment
Fluent in English, and preferably one other European language
Ability to motivate in a dynamic environment
Ability to function in a self-directed manner with a high degree of independence
Strong personal integrity, capable to motivate others
For more information, please do reach out to me directly! (Relocation is accepted!)
+44 1293 77 66 44
PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.