Эта вакансия в архиве
Посмотреть похожие вакансии ↓обновлено 1 месяц назад
Data Coordinator III (Clinical Research)
Описание вакансии
Текст:
TL;DR
Data Coordinator III (Clinical Research): Managing clinical trial data processes and ensuring data integrity with an accent on CRF/DCF tracking, database audits, and data reconciliation. Focus on developing data specifications, validation plans, and complying with regulatory requirements.
Location: Onsite in Yerevan, Armenia
Company
is a global full-service CRO providing clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.
What you will do
- Follow and comply with company procedures, QMS, ISMS, and PIMS requirements.
- Track Case Report Forms (CRF) and Data Clarification Forms (DCF) and perform data review.
- Develop and maintain Data Management Plans, Validation Plans, Entry Guidelines, and Handling Plans.
- Create Data Transfer Specifications and perform SAE reconciliation.
- Perform database audits and develop test scripts for User Acceptance Testing (UAT).
- Develop clinical trial database specifications, including eCRF design and data validations under supervision.
Requirements
- Bachelor’s degree in clinical, pharmacy, biological, or mathematical sciences or a related field, or a nursing degree with 2 years of clinical experience.
- Working knowledge of Good Clinical Practices (GCP), clinical research, and related regulatory requirements.
- Good understanding of the clinical drug development process.
- Strong communication and coordination skills, with a detail-oriented approach.
- Training on QMS, ISMS, and PIMS requirements.
Culture & Benefits
- Flexible working hours and team events.
- Health insurance.
- Commitment to continuous improvement through employee feedback.
- Emphasis on professional development and a collaborative "one-team" culture.
- Focus on diversity and inclusivity, with continuous training for personnel.