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 inspections in the country/US region at the Client level according to the Client Standard Operating Procedures and ICH Guidelines and GCP
- Responsibility for the annual country specific quality plan, monitoring, and coordinating the implementation and execution of QC in the respective country/region
- Responsibility to manage and/or co-lead key Client initiative charged with executing the continuous improvement.
- CCQM identifies local as well as global process improvement opportunities and training needs, and will be the local point of contact for all stakeholders ensuring appropriate training is implemented
- The role requires the ability to follow current processes and procedures of the Client but also the ability to improve processes and procedures
- This position has a significant impact on the ability to conduct clinical trials in accordance with external and internal regulations and guidelines of the Client

On the Client level:

- ICH Guidance and GCP Regulations, Country Client SOPs: Is an expert at local level.
- Local Lead for Management of the Client Country Standard Operation Procedures (CSOP).
- In cooperation with country functional area heads: ensures the Client CSOPs are checked/updated regularly; signs/authorizes CSOP deviations along with process owner.
- Responsible for all aspects of the quality site management as prescribed in the project plans
- Local Quality and Process Improvement and training contact person
- identifies local training demand, initiate local training needs and activities.
- Defines an annual country QC plan with collaboration to regional CQM
- With mutual agreement with the functional areas will perform quality control (QC) activities and visits. Support on resolution of quality issues
- Responsible for management and support audit preparation activities. In cooperation with country functional area person initiate state of the art root cause analysis for audit and inspection findings
- Responsible for country trend analysis and impact assessments of audits and/or inspection findings

**Experience**:

- Minimum Required:_
- Minimum of six-eight (6-8) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits)
- Deep knowledge and understanding of Clinical Trial processes and quality management tools
- Demonstrated experience leading cross-functional teams of business professional
- Ability to proficiently interact with all levels of clinical research management and exert influence to achieve results
- Excellent site monitoring skills
- Excellent study site management skills
- Ability to work with mínimal supervision
- Good planning and organization skills
- Good computer skills with good working knowledge of a range of computer packages
- Excellent verbal and written communication skills
- Ability to train and supervise junior staff
- Ability to resolve project-related problems and prioritizes workload for self and team
- Ability to work within a project team
- Works efficiently and effectively in a matrix environment

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 identi

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