Skip to main content

This job has expired

Clinical Research Leader - Belgium - L

Employer
ClinChoice
Location
Belgium
Salary
Competitive
Start date
13 May 2021
Closing date
11 Jun 2021

View more

Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Description:
For our client, located in Diegem, we are looking for a Clinical Research Leader for a long term project in the area of medical devices.

This Clinical Research Leader will be responsible for leading and supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.

Position Duties & Responsibilities:
  • Serve as a Clinical Research Leader within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones
  • Oversight/execution of feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures
  • May serve as the primary contact for clinical trial sites (e.g. site management);
  • Develop clinical trial documents with minimal supervision
  • Ensure applicable trial registration from study initiation through posting of results and support publications as needed (e.g. on www.clinicaltrials.gov )
  • Management/oversight of ordering, tracking, and accountability of investigational products and trial materials
  • Oversee the development and execution of Investigator agreements and trial payments
  • Responsible for clinical data review to prepare data for statistical analyses and publications
  • If applicable, may perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need
  • May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS) within the assigned projects
  • If applicable, as part of a clinical trial, may provide on-site procedural protocol compliance and data collection support to the center
  • Contribute to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated
  • Responsible for delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs)
  • Responsible for communicating business related issues or opportunities to next management level.
  • Track and manage assigned project budgets to ensure adherence to business plans
  • Support clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy
  • Develop a strong understanding of the pipeline, product portfolio and business needs
  • May serve as the clinical representative on a New Product Development team
  • May be responsible for development of Post-Market Clinical Follow-up (PMCF) Plans and Reports
  • May conduct review of promotional materials to ensure fair-balance, accuracy in clinical claims and messaging
  • Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures
  • Manage resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency


Education, Experience and Skills:
  • Minimum of a Bachelor's Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required
  • BS with at least 6 years, MS with at least 5 years, PhD with at least 3 years of relevant experience preferred
  • Previous experience in clinical research or equivalent is required
  • Experience working well with cross-functional teams is required
  • Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…)
  • Clinical/medical background a plus
  • Experience managing projects a plus
  • Medical device experience highly preferred
  • Good understanding of clinical research science and processes along with an understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations
  • Ability to provide scientifically strategic and scientific clinical research input across New Product Development (NPD) and Life-Cycle Management (LCM) projects
  • Proven track record in delivering clinical projects within clinical/ surgical research setting, on time, within budget and in compliance to SOPs and regulations
  • Strong presentation and technical writing skills
  • Behave and lead in a professional and ethical manner
  • Advanced technical writing skills
  • Advanced project management skills with ability to handle multiple projects


Our benefits when working in Belgium
  • Competitive Salary
  • Group and hospitalisation insurance
  • Electronic meal vouchers
  • Internet reimbursement
  • Company Car with fuel card depending on the function
  • Dedicated Line Manager
  • Regular face-to-face or phone meetings with line manager
  • Full annual performance review process
  • Ad-hoc team events and end of year party
  • Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
  • Employee satisfaction survey - your feedback is important for continuous improvement


Who will you be working for?

About CROMSOURCE

CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our Company Ethos

Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.

About TalentSource Life Sciences

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00002553

or please contact Vanessa.Verdickt@cromsource.com for more information.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Keywords: Clinical Research Lead, Medical Devices, Contract Research Organisation, CRO
Skills: Clinical Research Organisation, CRO, Medical Devices Location: Belgium Share:

LinkedIn Facebook Twitter Email

Company

ClinChoice

ClinChoice is a recognized and highly respected mid-size, global, full-service contract research organization (CRO) specializing in clinical development, post-marketing, and functional service support. We provide comprehensive end-to-end solutions, taking products from early clinical development to post-approval lifecycle management. We are committed to fostering innovation in the pharmaceutical, biotechnology, medical device & diagnostics, consumer health, cosmetics, and nutraceuticals industries. Since our establishment in 1995, we have consistently delivered high-quality services and solutions throughout the entire development lifecycle of our clients’ products. We serve a wide-ranging clientele that encompasses six of the top ten pharmaceutical companies, leading medical device companies, preeminent biotechnology companies, the largest consumer health and cosmetics companies, and numerous small-to-mid-sized innovator companies. With over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific, we are positioned to fulfil our clients’ needs locally and globally.

 

We’re on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.

 

Company info
Website
Telephone
+44 1628 566121
Location
Suite G48
268 Bath Road
Slough
Berkshire
SL1 4DX
United Kingdom

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert