Senior Cra/ Lead Clinical Trial

Petaling Jaya, Selangor, Malaysia

Job Description


My client is looking for a senior CRA Clinical Research Associate or a lead to manage their clinical trials project, independently

  • Oversee initiation of investigator site activities, including regulatory submissions, negotiation of informed consent documents, budget discussions, and contracts execution.
  • Act as a liaison for ethics review boards (ERB) and competent authorities (CA) as required.
  • Collaborate with internal teams and external parties during site activation, maintenance, and close-out phases.
  • Ensure compliance with local regulations, data privacy standards, and submission requirements.
  • Proactively identify, address, and escalate issues, maintaining effective communication with management and quality teams.
  • Manage clinical trial material logistics and oversee translation processes for essential documents.
  • Maintain accurate site performance data in internal systems and ensure thorough population of Trial Master Files.
  • Provide feedback for continuous improvement and adapt to changing project priorities.
  • Ensure adherence to procurement, legal, and financial protocols and support the reinforcement of company policies and GCP guidelines.
Global pharmaceutical MNCFlexible working arrangement
  • Bachelor's degree in a scientific or healthcare-related field.
  • Minimum of FIVE year of clinical research or relevant experience preferred.
  • Understanding of clinical trial workflows and site activation processes.
  • Proficiency in project management and familiarity with compliance-driven environments.
  • Strong problem-solving, negotiation, and communication skills.
  • Ability to manage multiple priorities effectively and adapt to dynamic changes.
  • Proficiency in English and local languages (if applicable), along with strong computer literacy (MS Word, Excel).
My client is an organization that is committed to combining innovation with compassion to enhance lives globally. As a leader in healthcare, we strive to discover and deliver transformative medicines, improve disease management, and contribute to communities through philanthropy and volunteer efforts. With a people-first approach, we seek individuals passionate about making a meaningful impact in healthcare and improving lives worldwide.The company provides:
  • 13th contractual bonus
  • Working Flexibility / Hybrid
  • Chances to represent global pharmaceutical MNC

Michael Page

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Job Detail

  • Job Id
    JD1077579
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    84000 - 132000 per year
  • Employment Status
    Permanent
  • Job Location
    Petaling Jaya, Selangor, Malaysia
  • Education
    Not mentioned