CLINICAL DATA MANAGER
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.
KAYENTIS is a software solutions provider specialized in clinical trials.
Our core competence is in patient data capture and processing solutions (eClinical Outcome Assessments = eCOA) and we are now expanding towards Decentralized Trials functionalities.
With 16 years of global experience in eCOA, Kayentis has supported more than 260 clinical trials in 79 countries with more than 90,000 patients. Its head office is located in Meylan, near Grenoble (France), Kayentis is also present in Boston (USA) and Tokyo (Japan).
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!
For more information about Kayentis, visit our career page, or have a look at our employee satisfaction survey results. Make sure to follow us on the social media platforms below for our latest news and updates:
- 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
Are you interested in this opportunity?
>> Contact us and send us your CV at career@kayentis.com <<
Master’s degree or equivalent, strong clinical data management experience, knowledge of clinical data, ICH GCP, and 21 CFR Part 11, plus organizational, communication, and independent working skills.
Job Details
- Category: Healthcare Services - Allied Health
- Seniority: Senior Level
- Commitment: Full Time
- Workplace: Remote — Boston or Meylan or Tokyo
- Languages: English
About Kayentis
A software solutions provider specializing in clinical trial data capture and processing. — Industry: Information Technology