Clinical Research and Development Specialist

1 day ago

Manila, National Capital Region, Philippines Private Advertiser Full time $40,000 - $60,000 per year

Key Responsibilities

  • Design and implement clinical trial protocols and study plans.
  • Coordinate site selection, initiation, monitoring, and close-out activities.
  • Ensure compliance with Good Clinical Practice (GCP), FDA, and ICH guidelines.
  • Monitor trial progress, data integrity, and subject safety.
  • Prepare and review regulatory documents, informed consent forms, and case report forms.
  • Collaborate with investigators, site staff, and internal teams to resolve issues and maintain timelines.
  • Analyze clinical data and contribute to study reports and publications.

Qualifications

  • Bachelor's or Master's degree in Life Sciences, Nursing, Pharmacy, or related field.
  • 2–5 years of experience in clinical research or clinical trial management.
  • Strong knowledge of GCP, clinical trial methodologies, and regulatory requirements.
  • Experience with clinical trial management systems (CTMS) and electronic data capture (EDC).
  • Certification from ACRP, SOCRA, or equivalent is a plus.

Technical Skills

  • Proficiency in Microsoft Office Suite and clinical data management tools.
  • Familiarity with statistical software (e.g., SAS, R) is an advantage.
  • Ability to interpret complex clinical data and generate insights.

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