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Merck

Makes medicines, vaccines and animal treatments

Associate Clinical Research Manager

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timePetaling Jaya, Selangor, MalaysiaNo salary listed

About the Job

Requirements

  • Strong knowledge of project management and/or site management.
  • Ability to work independently and make informed decisions within established policies and guidelines.
  • Strong understanding of the local regulatory environment.
  • Scientific and clinical research knowledge.
  • Understanding of clinical trial planning, management, and performance metrics.
  • Ability to manage multiple studies and competing priorities simultaneously.
  • Effective written and spoken English and local-language skills.
  • Ability to work effectively in remote and virtual environments.
  • Proactive identification of risks, issues, and opportunities, with the ability to develop mitigation plans.
  • Bachelor's degree in Science or a related discipline.
  • Minimum 4 years of experience in clinical research.
  • Knowledge of clinical research, clinical site management, clinical trial agreements, clinical trial compliance and documentation, clinical trial management, planning, monitoring and operations, ICH GCP guidelines, knowledge management, outsourcing, patient recruitment, process management, project delivery, project development, project management methodology, project planning, and project scoping.

Responsibilities

  • Serve as the primary point of contact for assigned protocols and liaison between Country Operations and the Clinical Trial Team.
  • Oversee study planning, execution, deliverables, timelines, and performance from feasibility through closeout.
  • Ensure protocol performance and compliance with applicable regulations, policies, procedures, and quality standards.
  • Review Monitoring Visit Reports and escalate performance issues or training needs when required.
  • Conduct Quality Control Visits as needed.
  • Lead and support local study teams by providing protocol expertise, training, and coordination across country functions, including Clinical Trial Coordinators, Clinical Research Associates, and Clinical Operations Managers.
  • Develop and execute local risk management plans for assigned studies.
  • Ensure compliance with clinical trial management systems, electronic trial master files, and other key clinical systems.
  • Escalate study-related challenges and risks to appropriate stakeholders.
  • Identify and share best practices across studies, countries, and regional teams.
  • Collaborate with outsourcing vendors, investigators, and external partners; serve as the country contact for programmatically outsourced trials.
  • Build and maintain relationships with investigators and external stakeholders.
  • Support local business needs, including contract and budget management where delegated.
  • Contribute to local and regional strategy development.
  • Partner with global, regional, and local stakeholders, including Clinical Operations, Pharmacovigilance, and Medical Affairs, to drive study success.
  • Travel up to 30%.

Desired Qualifications

  • Clinical Research Associate experience is preferred.

About the Company

Merck

Makes medicines, vaccines and animal treatments

Merck develops prescription medicines, vaccines and veterinary treatments for patients, health systems and animal owners worldwide. Its vaccine portfolio includes Gardasil 9, which helps prevent cancers and other diseases caused by several types of human papillomavirus. The company takes potential treatments through laboratory research and clinical trials, then manufactures and sells approved products to drug distributors, hospitals, physicians and governments. Its animal health division sells medicines and vaccines to veterinarians, farmers and pet owners, while selected drug partnerships also earn shared profits or royalties. Founded in 1891, Merck is headquartered in Rahway, New Jersey.

Company size
10,001+
Company stage
IPO
Headquarters
Rahway, NJ
Founded
1891

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