INTRODUCTION

FUNCTION

• 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

REQUIREMENTS

• 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

OFFER

• 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.

CONTACT INFO

Dr. Noemi Farkas-Hussey
Email address: noemi.farkashussey@tcs.com