Clinical Research Manager

2 weeks ago

Petaling Jaya, Malaysia Labcorp Full time

The CRM is accountable for execution and oversight of local operational clinical trial activities and has ownership, oversight and impact on local regulatory and financial compliance, at a country operations level at the client in compliance with ICH GCP and country regulations.

The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during the study.

**Essential Job Duties**:
On the Client level:

- These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties.
- PERFORMANCE: Accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally.
- MANAGEMENT: POC for assigned protocols. Pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments for assigned protocols. Strong collaboration with local CO roles. Forecasts country resource needs. Serves local business needs (signs contracts, manages budgets as delegated).
- QUALITY OVERSIGHT: Responsible for quality and compliance in assigned protocols in country. Oversees CRAs and CTCs on assigned projects. Oversees training compliance. Performs quality control visits. Reviews Monitoring Visits Reports and escalates performance issues and training needs to functional vendor and internal management as needed. Oversees associate CRMs assigned to the Client and work on training needs in collaboration with functional vendor.
- EXTERNAL CUSTOMER FACING: Responsible for collaboration with functional outsourcing vendors, investigators, other external partners. Oversees country and site validations, site selection and recruitment in assigned protocols. Responsible for clinical trial education to sites. Country POC for programmatically outsourced trials for assigned protocols.
- INTERNAL COLLABORATION & STRATEGY: Collaborates internally with local PV, Regulatory, GMA/GHH to align on key decisions in countries. Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD and Regional Operations.

**Experience**:

- Minimum Required: _
- Good organizational and time management skills
- Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project team and investigative sites preferred.
- Excellent communication skills, oral and written.
- Self-motivation with the ability to work under pressure to meet deadlines
- Works well independently as well as in team environment.
- Detail and process oriented
- Positive attitude and approach
- Interact with internal and external customers with high degree of professionalism and discretion
- Multi-tasking capability.
- Good computer skills with good working knowledge of a range of computer packages
- Ability to lead and develop junior staff
- Flexible and adaptable to a developing work environment
- Minimum of six-eight (6-8) years of clinical research experience

**Education/Qualifications**
- Minimum Required: _
- University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
- Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
- Thorough understanding of the drug development process
- Fluent in local office language and in English, both written and verbal

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

**Did you know?**

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information,

  • Clinical Research Coordinator

    4 weeks ago

    Petaling Jaya, Malaysia Beacon Hospital Sdn Bhd Full time

    1. Primary point of contact to Sponsors and Contract Research Organisations (CRO) on enquiries related to clinical research. 2. Prepare site and inform & remind team on any pre-qualification visit by Sponsor / CRO. 3. Assist Investigators / Sub Investigators in preparation of required documents for ethics submission to Clinical Research Associate (CRA from...

  • Clinical Research Associate

    1 month ago

    Petaling Jaya, Malaysia MSD Full time

    Job DescriptionClinical Research Associate (CRA) Based in Malaysia, named one of the Best Companies to Work for in 2019 by HR AsiaWe were awarded ‘Sponsor of the Year’ in 2019, 2020 and 2022 from Clinical Research Malaysia for the highest number of studies and total study value recorded in the country!We have a proud legacy of turning breakthrough...

  • Clinical Research Associate

    4 weeks ago

    Petaling Jaya, Malaysia MSD Full time

    Job DescriptionClinical Research Associate (CRA) Based in Malaysia, named one of the Best Companies to Work for in 2019 by HR AsiaWe were awarded ‘Sponsor of the Year’ in 2019, 2020 and 2022 from Clinical Research Malaysia for the highest number of studies and total study value recorded in the country!We have a proud legacy of turning breakthrough...

  • Trial Capabilities Associate

    2 weeks ago

    Petaling Jaya, Malaysia Manpower Group Malaysia Full time

    Minimum Qualification Requirements - At least Bachelor’s degree preferably in a scientific or health related field, postgraduate degree is also welcomed - 1-4 years clinical research experience or relevant experience preferred Understanding of the overall clinical development paradigm and the importance of efficient site activation - Applied knowledge of...

  • Clinical Research Analyst

    2 weeks ago

    Petaling Jaya, Malaysia Beacon Hospital Sdn Bhd Full time

    1. Plan and managing the types of information collected from patients, healthcare providers and medical researchers from Beacon Hospital 2. Provide support to the clinical research department on analytics execution 3. Manage and processing the raw datasets and conducted statistical analysis. Data sources include medical and pharmacy claims data, hospital...

  • Senior Clinical Research Associate

    6 days ago

    Petaling Jaya, Malaysia MSD Full time

    Job DescriptionThe role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements...

  • Clinical research coordinator

    2 months ago

    Subang Jaya, Selangor, Malaysia Beacon Hospital Sdn Bhd Full time

    1. Primary point of contact to Sponsors and Contract Research Organisations (CRO) on enquiries related to clinical research.2. Prepare site and inform & remind team on any pre-qualification visit by Sponsor / CRO.3. Assist Investigators / Sub Investigators in preparation of required documents for ethics submission to Clinical Research Associate (CRA from...

  • Clinical research coordinator

    4 weeks ago

    Subang Jaya, Selangor, Malaysia Beacon Hospital Sdn Bhd Full time

    1. Primary point of contact to Sponsors and Contract Research Organisations (CRO) on enquiries related to clinical research.2. Prepare site and inform & remind team on any pre-qualification visit by Sponsor / CRO.3. Assist Investigators / Sub Investigators in preparation of required documents for ethics submission to Clinical Research Associate (CRA from...

  • Research Executive

    1 week ago

    Petaling Jaya, Malaysia Cardas Research & Consulting Sdn Bhd Full time

    **Responsibility** - Assist in consumer / industry project implementation - Conduct research using primary & secondary research and anaysis - Support research / mystery shopping life cycle from recruitment efforts, scheduling, communication, team communications and streamlining the research operations - Assist in project management and team...

  • Clinical Operations Manager

    2 months ago

    Petaling Jaya, Malaysia IQVIA Full time

    **Job Overview** Manage a team of clinical staff working in support of clinical studies to ensure projects are appropriately resourced and employees are trained and meeting project objectives. **Essential Functions** - Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and...

  • Clinical Research Associate

    1 month ago

    Subang Jaya, Selangor, Malaysia MSD Full time

    Job DescriptionClinical Research Associate (CRA) Based in Malaysia, named one of the Best Companies to Work for in 2019 by HR AsiaWe were awarded 'Sponsor of the Year' in 2019, 2020 and 2022 from Clinical Research Malaysia for the highest number of studies and total study value recorded in the countryWe have a proud legacy of turning breakthrough science...

  • Clinical Research Associate

    2 weeks ago

    Subang Jaya, Selangor, Malaysia MSD Full time

    Job DescriptionClinical Research Associate (CRA) Based in Malaysia, named one of the Best Companies to Work for in 2019 by HR AsiaWe were awarded 'Sponsor of the Year' in 2019, 2020 and 2022 from Clinical Research Malaysia for the highest number of studies and total study value recorded in the countryWe have a proud legacy of turning breakthrough science...

  • Clinical Research Associate

    4 weeks ago

    Subang Jaya, Selangor, Malaysia MSD Full time

    Job DescriptionClinical Research Associate (CRA) Based in Malaysia, named one of the Best Companies to Work for in 2019 by HR AsiaWe were awarded 'Sponsor of the Year' in 2019, 2020 and 2022 from Clinical Research Malaysia for the highest number of studies and total study value recorded in the countryWe have a proud legacy of turning breakthrough science...

  • Clinical Research Coordinator

    2 weeks ago

    Subang Jaya, Selangor, Malaysia Beacon Hospital Sdn Bhd Full time

    1. Primary point of contact to Sponsors and Contract Research Organisations (CRO) on enquiries related to clinical research.Prepare site and inform & remind team on any pre-qualification visit by Sponsor / CRO.Assist Investigators / Sub Investigators in preparation of required documents for ethics submission to Clinical Research Associate (CRA from Sponsor /...

  • Clinical Research Associate

    2 months ago

    Petaling Jaya, Malaysia AstraZeneca Full time

    The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient...

  • Clinical Trials Assistant

    4 weeks ago

    Petaling Jaya, Malaysia IQVIA Full time

    **Responsibilities**: - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines. - Assist the clinical team with the preparation, handling, distribution, filing,...

  • Clinical Trials Assistant

    2 months ago

    Petaling Jaya, Malaysia IQVIA Full time

    **Responsibilities**: - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines. - Assist the clinical team with the preparation, handling, distribution, filing,...

  • Research Scientist/ Clinical Data Scientist

    3 weeks ago

    Petaling Jaya, Malaysia Beacon Hospital Sdn Bhd Full time

    Plan and managing the types of information collected from patients, healthcare providers and medical researchers from Beacon Hospital - Provide support to the clinical research department on analytics execution - Manage and processing the raw datasets and conducted statistical analysis. Data sources include medical and pharmacy claims data, hospital data,...

  • Clinical Research Associate II

    5 days ago

    Petaling Jaya, Malaysia Parexel Full time

    Key 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 with investigators and site staff.Conduct, drive and manage country specific feasibility and/or site pre-qualification and...

  • Associate Director, Clinical Operations

    1 week ago

    Petaling Jaya, Malaysia IQVIA Full time

    Direct a team of clinical professionals to support and deliver clinical research projects in Singapore and Malaysia, ensuring that projects are effectively resourced and that teams are effectively trained and managed to deliver successful outcomes to customers. Work with senior leadership in formulating and executing effective strategic goals and objectives...