Company: STADA Vietnam/STADA Pymepharco
Location: HCMC - Viettel Tower
Position: Clinical Research Executive
Reporting line: Medical Affair & Clinical Affairs Manager (MACA)
Contact term: Till 31/12/2027 (chance to extend) | Expected onboard: from 10/2026
Open for candidate who has 2-5 years experience as clinical research/coordinator role for bioequivalence studies (GCP standard), good command of English and open to contract till end of 2027
Benefit:
- 100% SHUI contribution on probation time
- 15 days annual leave/year
- Healthcare Insurance covered for 2 dependents
- Birthday, Tet, holidays...bonus
- Friendly, open and comfortable MNC working environment
- Other benefits following current labor law
Job Purpose:
Clinical Research Executive plays a critical role in executing, and overseeing bioequivalence studies aimed at assessing the interchangeability and safety of generic drug formulations with their brand-name counterparts. This role requires a blend of project management expertise, regulatory knowledge, and scientific understanding to ensure the successful completion of studies that impact pharmaceutical product development and patient safety
Main Responsibilities:
Regulatory Compliance (10%) | Project Management (20%) | Study Execution (40%) | Communication, Risk Management, Improvement (30%)
Regulatory Compliance: Stay current with global regulatory guidelines related to bioequivalence studies (e.g., FDA, EMA, ASEAN) and ensure adherence throughout the project.
Project Management: Monitor and manage project timelines, milestones, and budgets.
Study Execution:
- Collaborate with internal and external stakeholders to prepare the investigational medicinal products for in-vitro and in-vivo studies in compliance with applicable regulations.
- Oversee the recruitment of study participants, ensuring adherence to inclusion and exclusion criteria.
- Coordinate sample collection and analysis, including pharmacokinetic assessments.
- Implement quality control measures to maintain data integrity and compliance with Good Clinical Practice (GCP) standards.
Communication and Collaboration:
- Maintain clear and effective communication with internal teams, external partners, clinical investigators, and regulatory agencies.
- Act as a liaison between project stakeholders, ensuring alignment with project goals.
Risk Management:
- Identify potential risks and develop mitigation strategies to address study challenges.
- Proactively manage and resolve issues that may impact study progress.
Continuous Improvement:
- Stay informed about advances in bioequivalence study methodologies and recommend improvements to enhance study efficiency and quality.
- Conduct post-study reviews to identify lessons learned and opportunities for optimization.
Requirements
- A bachelor's or master's degree in a relevant scientific field (Pharmacy, Pharmacology, Life Sciences, etc.)
- From 2-5 years experience as clinical research/coordinator role for bioequivalence studies (e.g., FDA, EMA, ASEAN)
- Willing to sign contract till end of 2027 (chance to extend)
- Good command of English (verbal & non-verbal)
- Good understanding about Good Clinical Practice (GCP) standards
- Such an open person who strong at task management, ability to manage cross-functional teams
- Proven experience in conducting bioequivalence studies or clinical trials
- Strong knowledge of regulatory requirements and guidelines related to bioequivalence studies
- Excellent project management skills, including the ability to manage multiple projects simultaneously
- Attention to detail, problem-solving abilities, and a commitment to data integrity and patient safety
*Note: By clicking the Submit Application button, you agree to allow STADA Pymepharco to collect and process your personal data for recruitment purpose.
