CROMSOURCE

Senior Clinical Data Manager, Belgium - L

Company
CROMSOURCE
Location
Belgium
Salary
Competitive
Posted
26 Jan 2021
Closes
24 Feb 2021
Ref
HQ00002428
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Description:
TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Senior Clinical Data Manager for one of the most innovative pharmaceutical company in the world.

For our client facing positions, you must be confident, be able to drive the role and to work autonomously. You will have a close relationship with our Line Managers, who will provide you with mentoring and guidance. Most of our roles are permanent positions with CROMSOURCE and you will be working on projects for just one client. We are open, friendly and approachable and aim to support you through the recruitment process every step of the way.

Position Duties & Responsibilities
  • Support CRF design, review and validation of clinical database
  • Have the ability to support a number of moderate complexity / complex trials with minimal supervision
  • Be responsible for creation of data management plans and other data management documentation as needed with minimal oversight
  • Monitor progress and conduct of their respective projects, including all data cleaning and QC activities to ensure all remain on target to project timelines
  • Be responsible for coordinating, facilitating and participating in all data management activities from initiation of protocol through database lock with minimal oversight, partnering as appropriate with Clinical Operations, Franchise and other functions for their respective projects
  • Be responsible for participating in ongoing data review throughout the conduct of the study, including being responsible for the correction of errors and discrepancies management for the life of a project
  • Proactively identify and address issues that may impact the quality of the data, deliverables or timelines
  • Be responsible for handling of non-CRF data, including lab data and image handling
  • Be responsible for coordinating with Medical Affairs organisation to facilitate data coding and safety reviews as needed
  • Contribute towards process improvement, data standards and efficiency gaining initiatives within data management working with data management leadership as needed
  • Be responsible for ensuring all clinical data management documentation is stored and archived in a timely and compliant manner
  • Know and follow all regulations that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times
  • Performs other related duties as required


Education, Experience and Skills
  • Bachelor's Degree or equivalent in the biological sciences, Computer Science or related discipline
  • At least 4 years of clinical data management experience in Medical Device or Pharmaceuticals
  • Experience of supporting trials with minimal supervision
  • Therapeutic area knowledge in at least one of orthopedics, gynecology, cardiovascular, or general surgery preferred
  • Proficient in computer technology used in an office environment (Microsoft Word, Excel, etc)
  • Strong verbal and written communication skills
  • Knowledge of GCP and regulatory requirements regarding clinical data management documentation and software
  • Experience with Electronic Data Capture (EDC), Medidata RAVE preferred
  • Knowledge of medical terminology and use of coding dictionaries (MedDRA, WHO Drug)


The Benefits of Working for TalentSource 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=HQ00002428

or please contact Rocio.EgeaMota@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: Senior Clinical Data Manager
Skills: Cardiovascular, Gynaecologic, Gynaecology, Gynecology, Orthopedics, surgery, Clinical Data Management, EDC, GCP, MedDRA, Medical Devices, Medidata Rave, MS Office, Pharma, Pharmaceutical, Regulatory Location: Belgium Share:

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