Clinical Research Manager

1 week ago

Selangor, Malaysia Fortrea Full time

Essential Job Duties:
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

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit


Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea 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, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our

Privacy Statement

.

  • Clinical Research Administrator

    2 months ago

    Selangor, Malaysia Bright Prospect Full time

    Full Time _Selangor_ January 22, 2024 - May 21, 2024 Admin & Office Support - Healthcare & Life Science **Job Overview**: - **Salary **RM4,500-RM6,000 **Location**: _Petaling Jaya, Selangor_ **Job Descriptions**: - Supports in organizing and managing clinical studies throughout the initiation, execution, and conclusion phases. - Participates in creating...

  • Clinical Research Administrator

    24 hours ago

    Selangor, Malaysia Bright Prospect Full time

    Full Time _Selangor_ January 22, 2024 - May 21, 2024 Admin & Office Support - Healthcare & Life Science **Job Overview**: - **Salary **RM4,500-RM6,000 **Location**: _Petaling Jaya, Selangor_ **Job Descriptions**: - Supports in organizing and managing clinical studies throughout the initiation, execution, and conclusion phases. - Participates in creating...

  • Study Coordinator

    3 weeks ago

    Selangor, Malaysia Clinical Research Malaysia Full time

    **主要責任** 研究協調員的任務； - 向副區域經理報告。 - 從醫院和衛星站點更新研究者資料庫、研究者 GCP 清單和可行性日誌。 - 管理和協調從可行性團隊收到的可行性研究，包括會見有興趣的新的和潛在的調查員。支持並追蹤可行性問卷在時限內的完成情況。 -...

  • Country Clinical Quality Manager

    2 weeks ago

    Selangor, Malaysia Fortrea Full time

    Responsibility for the annual country specific QC plan, monitoring, and coordinating the implementation, and execution of QC plan in the respective country/US region according to the Client Standard Operating Procedures and ICH Guidelines and GCP. - Responsibility for the management of the Client Corrective and Preventive actions (CAPA) of GCP audits and...

  • Clinical Trial Associate

    2 months ago

    Selangor, Malaysia Bright Prospect Full time

    Full Time _Selangor_ April 9, 2024 Others **Job Overview**: - **Salary **RM4,000 - RM6,000 **Location**: _Petaling Jaya, Selangor_ **Job Descriptions**: - To collect and submit regulatory documents to the Ethics Review Board and Competent Authority, communicate and negotiate budgets and contracts with site. - Track and ensure site compliance to required...

  • Clinical Trial Associate

    24 hours ago

    Selangor, Malaysia Bright Prospect Full time

    Full Time _Selangor_ April 9, 2024 Others **Job Overview**: - **Salary **RM4,000 - RM6,000 **Location**: _Petaling Jaya, Selangor_ **Job Descriptions**: - To collect and submit regulatory documents to the Ethics Review Board and Competent Authority, communicate and negotiate budgets and contracts with site. - Track and ensure site compliance to required...

  • Clinical Team Lead

    2 weeks ago

    Selangor, Malaysia Fortrea Full time

    The Clinical Team Lead (CTL) is responsible and accountable for the driving the delivery of the clinical deliverables, acting within the Clinical Project Management (CPM) role within the Core Team or supporting the CPM, as assigned. The CTL is responsible for working cross functionally, within a matrix environment, to ensure successful execution of the trial...

  • Clinic Supervisor

    4 weeks ago

    Hulu Selangor, Malaysia Prevent Plus Sdn Bhd Full time

    **URGENT HIRING!!! URGENT HIRING!!! URGENT HIRING!!!** **Job Title: Clinic Supervisor/Clinic Assistant** **Industry: Healthcare** **Years of Working Experience: Preferred 1 year of experience in any related field.** We are seeking a motivated and detail-oriented individual to join our healthcare team as a Clinic Supervisor/Clinic Assistant. You will be...

  • Clinic Supervisor

    2 weeks ago

    Hulu Selangor, Malaysia Prevent Plus Sdn Bhd Full time

    URGENT HIRING URGENT HIRING URGENT HIRINGJob Title: Clinic Supervisor/Clinic AssistantIndustry: HealthcareYears of Working Experience: Preferred 1 year of experience in any related field.We are seeking a motivated and detail-oriented individual to join our healthcare team as a Clinic Supervisor/Clinic Assistant. You will be responsible for overseeing the...

  • Research & Development Manager

    3 weeks ago

    Selangor, Malaysia Ambition Full time

    **Job details**: Posted 19 February 2024 SalaryNegotiable LocationSelangor Job type Permanent DisciplineEngineering Reference268886_1708337343 This semiconductor company in Klang Valley is seeking a Process & Packaging Development Manager. **Key Responsibilities**: - To plan, lead and manage package and process improvement and development...

  • Research & Development Chemist

    3 weeks ago

    Selangor, Malaysia Ambition Full time

    **Job details**: Posted 25 January 2024 SalaryNegotiable LocationSelangor Job type Permanent DisciplineEngineering Reference270690_1706178240 Our client is a leading organization specializing in innovative surface enhancement solutions who operates within the Chemical industry. Due to rapid expansion, they are seeking a Research & Development...

  • Clinical Specialist

    2 months ago

    Selangor, Malaysia Embecta Full time

    embecta is one of the largest pure-play diabetes care companies in the world, leveraging its nearly 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of approximately 2,000 employees around the globe. For more information, visit or follow our social channels...

  • Clinical Specialist

    24 hours ago

    Selangor, Malaysia Embecta Full time

    embecta is one of the largest pure-play diabetes care companies in the world, leveraging its nearly 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of approximately 2,000 employees around the globe. For more information, visit or follow our social channels...

  • User Researcher

    1 week ago

    Selangor, Malaysia Netizen Experience Full time

    UX & Data Specialist, the new breed of ‘Market Researcher’ in this digital era. Think of the digital products that you use everyday like Facebook, Twitter or an e-commerce site, UX & Data Specialist applies both quantitative and qualitative research method to study your behaviour and improve your experience in using the products. Fresh Graduates are...

  • Staff Nurse

    2 months ago

    Hulu Selangor, Malaysia Careclinics Healthcare Services Sdn Bhd Full time

    **Primary Purpose and Scope** - Assist doctors and nurses in basic clinical tasks to ensure a high level of operational efficiency - Patient registration, prescriptions preparation, dispensing medicines - Coordinate patient care at the clinic. - Order and keep stock of medication and manage clinic tasks - Manage daily clinic operations, filing system, and...

  • Staff Nurse

    24 hours ago

    Hulu Selangor, Malaysia Careclinics Healthcare Services Sdn Bhd Full time

    **Primary Purpose and Scope** - Assist doctors and nurses in basic clinical tasks to ensure a high level of operational efficiency - Patient registration, prescriptions preparation, dispensing medicines - Coordinate patient care at the clinic. - Order and keep stock of medication and manage clinic tasks - Manage daily clinic operations, filing system, and...

  • Trial Capabilities Associate

    2 months ago

    Selangor, Malaysia Bright Prospect Full time

    Full Time _Selangor_ January 11, 2024 - February 23, 2024 Healthcare & Life Science **Job Overview**: - **Salary **RM5000-RM7000 **Location**: Petaling Jaya **Job Descriptions**: - To collect and submit regulatory documents to the Ethics Review Board and Competent Authority, communicate and negotiate budgets and contracts with site - Track and ensure...

  • Trial Capabilities Associate

    24 hours ago

    Selangor, Malaysia Bright Prospect Full time

    Full Time _Selangor_ January 11, 2024 - February 23, 2024 Healthcare & Life Science **Job Overview**: - **Salary **RM5000-RM7000 **Location**: Petaling Jaya **Job Descriptions**: - To collect and submit regulatory documents to the Ethics Review Board and Competent Authority, communicate and negotiate budgets and contracts with site - Track and ensure...

  • Executive, medical affairs

    4 weeks ago

    Selangor, Malaysia Dksh Full time

    Job Summary Medical and product training on disease management and updating sales force team with latest medical insight with clinical findings , conducting CME/RTD and participating in scientific meetings as well as attending medical enquiries and meeting KOLs to follow up on enquiries when required. General Responsibilities Medical & Product Training –...

  • Executive, medical affairs

    1 month ago

    Selangor, Malaysia Dksh Full time

    Job Summary Medical and product training on disease management and updating sales force team with latest medical insight with clinical findings , conducting CME/RTD and participating in scientific meetings as well as attending medical enquiries and meeting KOLs to follow up on enquiries when required. General Responsibilities Medical & Product Training –...