Avance Clinical is a leading Contract Research Organization (CRO) specializing in supporting drug development for the pharmaceutical and biotechnology industries. With a strong focus on innovation, Avance Clinical offers world-class clinical trial management and data services to accelerate drug development. The company ensures compliance with regulatory guidelines, maintaining high standards in Good Clinical Practice (GCP) environments.
Responsibilities in Job
As a Clinical Data Associate, you will play a crucial role in the clinical research process by managing and maintaining accurate clinical data. Your responsibilities will include:
- Development and review of Case Report Forms (CRFs) and completion guidelines.
- Preparation of Data Management Plans.
- Assisting in the development of Edit Check Documents under mentorship.
- Generating clean and erroneous dummy data for validation purposes.
- Conducting database validation, including testing data entry screens and edit checks.
- Performing data review and cleaning of clinical trial data.
- Ensuring accurate and timely data entry from handwritten CRFs and Data Clarification Forms (DCFs).
- Assisting in the preparation of DCFs and query resolutions.
- Conducting MedDRA / WHO-DD Coding with support from mentors.
- Performing quality control checks before study data lock.
- Archiving studies, including Medrio documentation.
- Supporting administrative tasks, including CRF reconciliation and tracking.
- Maintaining effective communication with team members and stakeholders.
Qualifications and Skills
To be successful in this role, you should possess the following qualifications and skills:
Qualifications:
- A degree in a relevant discipline (or equivalent experience).
- 2-3 years of experience in the pharmaceutical industry or CRO, working in a GCP environment.
Skills Required:
- Strong knowledge of ICH GCP Guidelines, medical terminology, and clinical trial processes.
- Prior data entry experience with a focus on accuracy and speed.
- Excellent time management and organizational skills.
- Ability to work independently while demonstrating initiative, trust, and reliability.
- Strict adherence to client confidentiality.
- Strong verbal and written communication skills.
- Proficiency in Microsoft Office Suite.
- Team-oriented mindset with a positive and dynamic work culture.
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