INTRODUCTION
Do you have a Life Science degree? Do you have experience in a diagnostic laboratory or clinical trial field? Are you looking for full-time job?
If you are, read on, we have a great opportunity for you to support one of the world’s most prestigious pharma companies. You will be part of a multicultural team helping validate data and performing data acquisition activities. Your role is key for clinical data management activities. You can develop your career in a global environment while contributing to health and safety of the patients.
FUNCTION
- Performs a wide range of Data Acquisition activities ensuring that the non CRF data is collected as per data collection standards.
- Lead the collection of non-crf data during study set-up, conduct and close out activities across multiple studies, contributing to fit for quality.
- Responsible for data acquisition, specification, loading and delivery of non crf data across different vendors.
- Provide input during protocol review to ensure clarity of data collection requirement.
- Identify non-CRF data collection requirement from protocol. Create and Maintain
- Data Handling Strategy (DHS) document after consulting with clientstake holders
- Create and finalize File Format Specifications document in alignment with GDSR standards for non CRF data collection
- Collaborate with client to agree with vendor expectations for non CRF data collection andd data transfer
- Responsible for obtaining relevant signatures on finalized FFS, uploading finalized FFS, PDF document in eTMF, uploading DHS and FFS in Touch point area
- Raise tickets within clientsystems for approval of non-crf data collection requirements that are not covered in global standards.
- Manage CDM non crf deliverables, identify risks and coordinate cross functional tasks with adequate understanding of upstream and downstream processes, as applicable
- Perform eTMF review to check completeness and compliance of FFS upload.
REQUIREMENTS
- Good knowledge of MS Office with an emphasis on Excel
- Good interpersonal and communication skills
- Knowledge of Medical/ Bio sciences is desirable.
- Good knowledge of CDM applications and/or programming skills
- Ability to prioritize, schedule and organize
- Basic Knowledge of Clinical Trials and Pharmaceutical Industry
- Ability to work across scientific and technical discipline
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