Clinical Research Manager

1 week ago

Subang Jaya, Selangor, Malaysia MSD Full time

Clinical Research Manager

Join our team as a Clinical Research Manager and play a key role in the success of our clinical trials. As a member of our team, you will be responsible for the end-to-end performance and project management of assigned protocols in a country, ensuring compliance with ICH/GCP and country regulations, company policies and procedures, quality standards, and adverse event reporting requirements.

Key Responsibilities:

  • Main Point of Contact for assigned protocols and link between Country Operations and clinical trial team.
  • Responsible for project management of the assigned studies: pro-actively plans, drives, and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution, and close out.
  • Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards, and adverse event reporting requirements internally and externally.

Key Performance Indicators:

  • Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
  • Performs Quality control visits as required.

Leadership and Collaboration:

  • Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the CTC, CRAs, and COM).
  • Responsible for creating and executing a local risk management plan for assigned studies.
  • Ensures compliance with CTMS, eTMF, and other key systems in assigned studies.

Requirements:

  • Min Bachelor degree in Science (or comparable)
  • Advanced degree (e.g., Master degree, MD, PhD) advantage
  • 5-6 years of experience in clinical research
  • CRA Experience preferred

Desirable Skills:

  • Knowledge in Project Management and site management.
  • Strong organizational skills with demonstrated success required.
  • Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight, and supervision of the TA Head or CRD.
  • Requires strong understanding of local regulatory environment.
  • Strong scientific and clinical research knowledge is required.
  • Strong understanding of clinical trial planning, management, and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
  • Experience functioning as a key link between Country Operations and Clinical Trial Teams.
  • Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures, and functions.
  • Ability and skills to manage resource allocation, processes (and controls), productivity, quality, and project delivery.
  • Proficiency in written and spoken English and local language.
  • Strategic thinking.
  • Ability to work efficiently in a remote and virtual environment.
  • Understand cultural diversity.

About Us:

Our company is a leading biopharmaceutical company that has been in the business for over 25 years and in AP for over 60 years. We are committed to fostering an inclusive and diverse workplace and encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

Join Our Team:

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time.

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