- Support and act as a backup in the execution of study set-up/conduct/close-out activities in accordance with the defined process guidelines and study requirements
- Support the creation and update of study-specific documents applicable for set-up/conduct/close-out
- Maintain a full understanding of study documentation in order to perform proper execution of Clinical Data Management activities
- Perform day-to-day data management activities e.g. data cleaning, metric creation, and risk identification activities as defined and agreed upon in the study data management plan/quality review plan
- Perform timely archival of study documentation in client defined repository
- Responsible for execution of data listing strategies as per defined study guidelines and review for the patient data consistency, quality, and completeness
- Update and upload the relevant documents on the shared client portal on completion of the tasks.
- Ensure adherence to study project plans and agreed timelines/SLAs deliver data management activities
- Utilize appropriate data management tools to monitor the quality and timeliness of data flow
- Ensure delivery of error-free, quality data for all study-defined milestones
- Identify and suggest process improvements
- Works closely with the study data lead and provides solutions for the new requirements
- Perform quality control procedures for relevant activities.
- Develop and maintain good communication and working relationships with the CDM team
- Review the protocol and any other customer specifications for implementing any client-specific process
- Attend telephone conferences/meetings and support in drafting the minutes
- Adherence to SOPs/Regulatory requirements/project-specific guidelines
- Escalate any issues/unresolved queries
- Provide inputs/status reports on study-defined frequency during the life cycle of the study
- Proactively propose process improvements in the client/TCS partnership when identified
- Knowledge transfer & sharing experience/lessons learned
- Act as a mentor to peer data managers/New Data managers as and when required
- Life science degree
- Minimum 1 year of experience in study data management
- Medidata Rave is required
- General knowledge of Clinical Trials and the Pharmaceutical Industry
- English on a business level
- TCS has been delivering services from Hungary since 2001, making us a perfect choice if you’re looking for stability.
- We provide a wide range of benefits, including a market leading comprehensive private health care package.
- We offer extensive self-development opportunities: our colleagues have a multitude of training possibilities for personal and professional growth.
- At TCS Hungary there are both vertical and horizontal career options for those who like to challenge themselves and try out different areas and positions.
- You will be part of a global and diverse working environment with relaxation areas, terraces, and a friendly atmosphere.
- You can seize the day with us at our company events, hobby clubs, and sporting initiatives.
- An attractive compensation package.
Dr. Noemi Farkas-Hussey
Email address: email@example.com