Clinical Data Manager
2 days ago
KAYENTIS is a software solutions provider specialized in pharmaceutical clinical trials.
Our core competence is in patient data capture and processing (eCOA) solutions.
With 16 years of global experience in eCOA, Kayentis has supported more than 220 clinical trials in 79 countries with more than 80,000 patients. Its head office is located in Meylan, near Grenoble; Kayentis is also present in Boston.
Joining Kayentis' teams means choosing a fast-growing company committed to improving clinical trials and the well-being of its employees.
KAYENTIS is growing Develop your career with us
Join an international, cohesive and dynamic team and develop new skills
YOUR MISSION:
Manage all data related aspects of clinical trials from setup to closing:
- Serve as the primary data management contact for the sponsor.
- Work on the implementation of the platform and database for clinical data exploitation on client platforms.
- Ensure the high quality of data exported from our platforms to clients.
- Prepare reports as required by clients or for internal purposes.
Contribute to the continuous improvement of methods, tools and procedures related to your area of expertise.
Maintain regular communication with clients (email & meetings).
Proactively monitor key aspects of the study and associated risks, anticipating necessary actions in collaboration with the client.
YOUR RESPONSIBILITIES:
Collaborate closely with Kayentis project managers to support the implementation of Kayentis' internal software for clinical data collection and validation:
- Define project requirements with the project manager and sponsor (data collection, cleaning, monitoring, and transfer).
- Write project documentation specific to Data Management (e.g. Data Management Plan, Data Cleaning Plan, Data transfer agreement) in line with the study protocol and sponsor needs.
- Support internal teams in preparing RFPs and presentations for sponsors.
Ensure quality and adherence to project timelines for data cleaning by:
- Monitoring data cleaning subcontractor.
- Participating to detecting discrepancies, tracking and resolving associated queries, performing data reconciliations.
- Producing and reviewing data listings.
- Performing data quality checks.
- Producing data transfers to clients.
Produce listings for metrics and business intelligence reports:
- As requested by clients.
- For data management activity.
- For internal requests to facilitate study follow-up and ensure high-quality client service.
YOUR PROFILE:
- Master’s degree or equivalent with a strong and successful experience in clinical data management.
- Good knowledge of clinical data, ICH Good Clinical Practices, 21 CFR part 11.
- Strong organizational, planning, and time management skills with the ability to multitask under tight deadlines while maintaining attention to detail.
- Proven ability to adapt to change, work independently, and establish collaborative relationships in a multidisciplinary, remote team environment.
- Excellent verbal and written communication skills.
- Preferably experienced in clinical studies including the use of eCOA questionnaires.
YOUR BENEFITS:
- Flexible working hours
- Performance-based bonuses
- Generous PTO policy
- Health, Dental, Vision insurance
- 401K retirement plan
- Commuter’s benefit
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