INTRODUCTION

Are you a Lifescience professional with experience in clinical research? Do you have experience in clinical data management? Looking for a new professional challenge?

If you are, read on, we have a great opportunity for you to support one of the world’s most prestigious pharma companies. As a Study Data Lead, you will be part of a multicultural team proving support in clinical data management activities. You will have the opportunity to manage clinical studies and coordinate with programming and clinical data review teams. You can develop your career in a global environment while contributing to health and safety of the patients.

FUNCTION

• Overall in-charge of all Data Management activities for a study/ies including Study Set up, Conduct and Close Out.
• Providing support and training on the Clinical data management activities to TCS Data Managers for the relevant functional processes/work statements/projects – be trained and perform as back up where required
• Maintaining & building awareness of internal and external clinical Data Management practices to enhance domain expertise
• Single point of contact for client Study Data Manager / designee
• Monitor and evaluate overall study progress, identify the potential risk / challenges faced during the course of the study
• Conduct regular team meetings for study updates and provide guidance on study related issues to client as well TCS internal teams
• Monitor, maintain & report  KPI / SLAs /metrics on the study
• Ensure adequate resource for the Study throughout its lifecycle in collaboration with group leader and inform client contact of any changes in staff
• Keep the Group Lead & Project Manager fully informed about the need for the resources so the resource requests can be finalized with client AM and TCS PM
• Set priorities and targets of the study within the CP, DM, CCS, DAS teams
• Responsible for recruitment, selection, training of team members & managing attrition

Additional Responsibilities

• Provide regular status reports to TCS Group Lead and client Study Data Manager (SDM) and proactively communicate/escalate any identified unresolved issues or challenges.
• Identify training needs for team members and maintains documents of staff training assessments including updates.
• Responsible for ongoing monitoring & development of study team at a functional level
• Responsible for assessing the performance of Data Managers and reporting the progress to TCS Group Lead
• Ability to work on multiple database set-up, locks, data review, cleaning, coding, SAE reconciliation, and some CRO or vendor interface

Quality Related Job Accountabilities

• Follow regulations and company policies, and complies with all client Standard Operating Procedures
• Demonstrate a continuous improvement mindset by identifying and recommending opportunities to streamline or improve processes
• Provide support as needed for internal and external audits/inspections

REQUIREMENTS

• Experience in Clinical Data Management
• Good knowledge of MS Office
• Excellent Technical skills, start-up knowledge
• Excellent verbal and written skills, good organizational, interpersonal, and team skills
• Project management skills
• Strong knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology
• Knowledge of PL/SQL is not required, but will serve as a recommendation
• Ability to work across scientific and technical disciplines

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

Balint Timar
Email address: balint.timar@tcs.com