Senior Clinical Trial Manager

3 days ago


Kuala Lumpur, Kuala Lumpur, Malaysia PSI CRO AG Full time
Job Overview

We are looking for a skilled Clinical Research Associate to join our team in Malaysia.

The successful candidate will be responsible for managing the clinical aspects of full-service global projects.

Main Responsibilities:

  • Supervise study activities, timelines, milestones, and schedules on the country level.
  • Conduct and report all types of onsite monitoring visits.
  • Be involved in study set-up, including site contract and budget negotiations.
  • Be responsible for site communication and management.
  • Ensure consistency of all study processes and identify country differences.
  • Oversee maintenance of study-specific and corporate tracking systems.
  • Contribute to the development and update of project planning documents, essential documents, and project instructions.
  • Be a point of contact for in-house support services, contractors, global cross-functional teams, and vendors.
  • Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols.
  • Development of local language materials including local language Informed Consents and translations.
  • Works in partnership with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols.

Your Background:

  • Bachelor's degree in Life Sciences, Pharmacy, or Registered Nursing; or an equivalent combination of education, training, and experience. Registered pharmacists are strongly preferred.
  • Minimum of 4-5 years of demonstrable, independent on-site monitoring experience or equivalent expertise.
  • Extensive experience in conducting all types of monitoring visits in Phase II and/or III clinical trials.
  • Proficiency in feasibility assessment and study set-up processes is highly desirable.
  • Specialized experience in Oncology or Hematology therapeutic indications is a significant advantage.
  • Demonstrated ability to plan effectively, multitask efficiently, and thrive in a dynamic team environment.
  • Superior communication, collaboration, and problem-solving skills are essential.
  • Willingness and ability to travel extensively within Malaysia is a prerequisite for this position.


  • Kuala Lumpur, Kuala Lumpur, Malaysia PSI CRO AG Full time

    About the RoleWe're searching for a knowledgeable, team-oriented Senior CRA to manage the clinical aspects of full-service global projects in Malaysia. You will work on the frontline of communication with project stakeholders, ensuring the successful conduct of clinical trials in a variety of therapeutic indications.The successful candidate will maintain the...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Syneos Health, Inc. Full time

    Join Our TeamWe are seeking a highly motivated Clinical Trials Manager to join our team at Syneos Health, Inc. In this role, you will be responsible for coordinating communications between study team stakeholders and global teams of site-facing site contract & budget negotiators.Your Key ResponsibilitiesClinical Study Agreements: Collaborate with global...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Parexel Full time

    In this role, you will play a critical part in the success of our clinical trials.Job DescriptionAs a Clinical Research Associate, you will be responsible for managing clinical trials from start-up to close out.You will work closely with investigators and site staff to ensure that studies are implemented according to protocol.You will assess and ensure...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Fortrea Full time

    Job OverviewThe Clinical Trial Administrator plays a vital role in the execution of clinical research projects. As an essential member of a Clinical Project Team, this individual will be responsible for performing study-related tasks and ensuring timely production of high-quality clinical data.Main Responsibilities:Document and track study activities using...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Fortrea Full time

    Clinical Trial Administrator RoleWe are seeking a highly motivated and organized Clinical Trial Administrator to join our team. This individual will be responsible for coordinating and executing various aspects of clinical trials, including document management, tracking systems, and vendor liaison.


  • Kuala Lumpur, Kuala Lumpur, Malaysia Psi CRO Ag Full time

    We are a mature and experienced Contract Research Organization (CRO) with a strong presence in the global clinical research industry. Our company has grown organically from a handful of countries to a global presence, while maintaining our independence and freedom to operate.Job ResponsibilitiesWe are seeking a skilled Senior Clinical Research Associate to...


  • Kuala Lumpur, Kuala Lumpur, Malaysia PSI CRO AG Full time

    Job OverviewWe are seeking a seasoned Senior Clinical Research Associate to join our team in Malaysia. As a key member of our global clinical operations team, you will be responsible for managing the clinical aspects of full-service global projects.The ideal candidate will have extensive experience in conducting all types of monitoring visits in Phase II...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Fortrea Full time

    About the RoleWe are seeking a highly organized and detail-oriented Clinical Trial Administrator to join our team. As a key member of our Clinical Project Team, this individual will be responsible for coordinating and executing various aspects of clinical trials.


  • Kuala Lumpur, Kuala Lumpur, Malaysia Psi CRO Ag Full time

    We are a dynamic and global Contract Research Organization (CRO) committed to delivering high-quality clinical research services. Our company has grown organically from a handful of countries to a global presence, while maintaining our independence and freedom to operate.Job RequirementsWe are looking for a knowledgeable and team-oriented Senior Clinical...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Psi CRO Ag Full time

    We are a global Contract Research Organization (CRO) dedicated to providing high-quality clinical research services. Our team of experts is passionate about bringing new medicines to market and improving patient outcomes.Job DescriptionWe are seeking a skilled Senior Clinical Research Associate to manage the clinical aspects of full-service global projects...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Syneos Health, Inc. Full time

    About the RoleWe are seeking a highly skilled Senior Clinical Contracts Specialist to join our team at Syneos Health, Inc. In this role, you will be responsible for establishing and maintaining training material for site contracts lead team and site contract negotiators.Your Key ResponsibilitiesNegotiate Clinical Study Agreements (CTAs): Collaborate with...


  • Kuala Lumpur, Kuala Lumpur, Malaysia ICON Full time

    As a key member of our team, you will be responsible for ensuring the highest standards of clinical quality compliance in our organisation. This involves serving as a local expert on ICH-GCP and local regulations, conducting impact assessments to identify areas for improvement, and developing effective solutions to ensure compliance.You will work closely...

  • Trial Operations Lead

    21 hours ago


    Kuala Lumpur, Kuala Lumpur, Malaysia Parexel Full time

    This role requires a high degree of autonomy, with ability to work independently and make decisions in a fast-paced environment.Job DescriptionAs a Clinical Research Associate, you will be responsible for managing clinical trials from start-up to close out.You will work closely with investigators and site staff to ensure that studies are implemented...

  • Senior CRA

    7 days ago


    Kuala Lumpur, Kuala Lumpur, Malaysia PSI CRO AG Full time

    Job SummaryWe're looking for a highly skilled and experienced Senior CRA to join our team in Malaysia. As a key member of our global clinical operations team, you will be responsible for managing the clinical aspects of full-service global projects.The ideal candidate will have a strong background in clinical research and experience in conducting all types...


  • Kuala Lumpur, Kuala Lumpur, Malaysia PSI CRO AG Full time

    Job DescriptionWe're seeking an experienced Senior Clinical Research Associate to manage the clinical aspects of full-service global projects in Malaysia.About the Role:Supervise study activities, timelines, milestones, and schedules on the country level.Conduct and report all types of onsite monitoring visits.Be involved in study set-up, including site...


  • Kuala Lumpur, Kuala Lumpur, Malaysia ICON Full time

    We are seeking an experienced Compliance Lead to join our Clinical Research Operations team. As a key member of our team, you will be responsible for ensuring the highest standards of clinical quality compliance across our global operations. This will involve working closely with local country operations management to develop and implement effective...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Parexel Full time

    Parexel Federal Territory of Kuala Lumpur, MalaysiaClinical Research Associate - FSPParexel Federal Territory of Kuala Lumpur, MalaysiaKey Accountabilities:Start-up (from site identification through pre-initiation):Act as Parexel's direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.Build relationships...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Malaysianbar Full time

    Responsibilities:Manage and assist partners with litigation cause papers, trials, and hearings.Attend court proceedings as necessary.Provide exceptional client service and support on all matters.Perform various ad hoc duties assigned by senior team members.Requirements:Minimum 2-3 years of experience in the Litigation field.A passion for learning and gaining...


  • Kuala Lumpur, Kuala Lumpur, Malaysia PSI CRO AG Full time

    Job OpportunityWe're searching for a qualified Research Associate to oversee the clinical aspects of global projects in Malaysia.About the Position:Manage the clinical aspects of full-service global projects in Malaysia.Supervise study activities, timelines, milestones, and schedules on the country level.Conduct and report all types of onsite monitoring...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Psi CRO Ag Full time

    We are a global Contract Research Organization (CRO) dedicated to delivering high-quality clinical research services. Our team of experts is passionate about bringing new medicines to market and improving patient outcomes.Job SummaryWe are seeking a skilled Senior Clinical Research Associate to join our team in Malaysia. As a Senior CRA at PSI CRO Ag, you...