Central Monitor Consultant

il y a 1 semaine


LouvainlaNeuve, Wallonie, Belgique CluePoints Temps plein

_Louvain-La-Neuve__, _
_Belgium__ _****We are looking for a new Central Monitor Consultant to join CluePoints If you are looking for a challenging work experience within a dynamic, internationally focused, fast-growing, multi-disciplinary company, this following position is what you are looking for

What You Will Be Doing

  • Provide Risk-Based Quality Management (RBQM) consultation and related operational support to customers as needed including but not limited to:
  • Coaching study teams in performing Risk Assessment, identify the critical data and processes, the KRIs and QTLs.
  • Coaching CluePoints' data analysts in reviewing CluePoints Central Monitoring Platform outputs, performing an initial investigation of identified risks (e.g., atypical data patterns) to assess their scope and nature in preparation for review with client study teams.
  • Summarize findings and contribute to the communication of results to clients (both written report and oral presentation) and their understanding of impact of findings to their data.
  • Coaching Client's Risk Coordinator in the Signal Management process, in defining appropriate followup actions and in ensuring robust documentation.
  • Support study teams in adopting an approach to clinical trial monitoring which utilizes data and site level information to determine needs for performing onsite, remote and centralized monitoring activities and focuses resources on risks that have the most potential to impact patients' safety and data quality.
  • Ensure lessons learned during the course of each client engagement are documented and shared with the rest of the organization to facilitate crossstudy and crossorganization learning.
  • Participate in the continuous improvement and development of our product solutions and operational processes.

Skills Needed

  • Working knowledge of clinical development process, including study phases and the principles of study design and study execution.
  • Previous experience with and understanding of clinical trials and clinical data across multiple therapeutic areas (including experience reading and interpreting clinical protocols)
  • Previous experience within clinical operations and understanding of key processes including monitoring, data management, (medical) data review and related processes.
  • Aptitude for data analytics and critical thinking skills to determine the signs of risk.
  • High degree of accuracy and attention to detail.
  • Effective English verbal and written communication skills in relating to people both inside and outside the organization in a team environment.
  • Works independently, ability to multitask and provide expertise on multiple projects concurrently.
  • Ability to thrive in a fastmoving environment, under time and resource constraints

Qualifications Needed

  • Bachelor's degree or above of equivalent experience in a scientific or businessrelated discipline required.
  • Minimum 5+ years of experience in clinical research industry
  • 12 years experience in RBQM/Central Monitoring
  • Previous experience as clinical research associate is a plus

Reasons to work with Us

  • Flexibility is part of our DNA
  • If you choose to come to the office, you'll discover a fun atmosphere with kicker, PS5, arcade machine, nerf battles, and our newly added dartboard
  • Many activities are organized during the year, such as soccer, team lunches, happy hours, LAN parties, board games nights We also have running groups, languages lessons, and much more
  • At CluePoints, learning, training and personal growth are part of the game: you'll have access to online training materials, certifications sponsored by the company, personal growth plans, and career paths to explore new opportunities.
  • You'll work with a fastgrowing, multidisciplinary and international team representing over 20 different nationalities, in an Englishspeaking working environment.
  • You'll have a challenging and rewarding job in an ambitious and fastpaced technology scaleup that has received many national and international awards including "Scale-Up of the year 2019"
  • Last but not least, we offer competitive salary and benefits, bonus potential, employee referral program.


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