Central Monitor Consultant (US)
King of Prussia,
CluePoints is the premier provider of Risk-Based Quality Management (RBQM) and Data Quality Oversight solutions for Sponsors and CROs. Our products enable both risk planning and operational monitoring and utilize advanced statistical algorithms to determine the quality of clinical trial data both during and following study execution. CluePoints is seeking outstanding candidates with strong data analytics aptitude and a passion for delivery excellence, to help drive customer success and broad adoption of the CluePoints solution.
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 follow-up 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 on-site, 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 cross-study and cross-organization learning.
Participate in the continuous improvement and development of our product solutions and operational processes.
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 multi-task and provide expertise on multiple projects concurrently.
Ability to thrive in a fast-moving environment, under time and resource constraints
Bachelor’s degree or above of equivalent experience in a scientific or business-related discipline required.
Minimum 5+ years working experience in clinical research industry
1-2 years experience in RBQM/Central Monitoring
Previous experience as clinical research associate is a plus
Reasons to work with Us
A challenging and rewarding job in an ambitious and fast-paced technology scale-up that has received many national and international awards including “Scale-Up of the year 2019”!
An opportunity to work in an internationally focused, fast-growing, multi-disciplinary company
On top of that, we offer a competitive salary, a Geek & Start-up atmosphere, some perks such as: free drinks, cookies and fruits - if you want to go the healthy road
A flat hierarchy