Clinical Operations

CANSINO BIOLOGICS (HONG KONG) LIMITED; Hong Kong; Vor Ort; HKD 600.000 - 900.000; Vollzeit

Zusammenfassung

CANSINO BIOLOGICS (HONG KONG) LIMITED is seeking a clinical research professional to lead development strategies for biological products. You will finalize study designs with rigorous statistics, align resources with key opinion leaders, and draft clinical study reports for regulatory reviews.

The role requires robust project planning and cross-functional collaboration, with emphasis on quality, compliance, and effective communication with investigators and regulatory bodies.

Qualifikationen

• Master's degree or above in Preventive Medicine, Public Health, Clinical Medicine, Statistics, Life Sciences, Biopharmaceuticals, or related subjects.
• Three years of relevant work experience in clinical research, drug development, clinical trial management, or related fields is preferred.
• Strong capabilities in project planning, management, operations, and coordination with a strong sense of responsibility.
• Excellent communication and teamwork skills with the ability to collaborate across departments.
• Rigorous work attitude with attention to detail and strict compliance in execution processes.
• Forward-thinking mindset with the ability to contribute to protocol development and optimization.

Aufgaben

• Conduct research to create clinical development strategy and plans for biological products and finalize study designs.
• Assess study feasibility across target countries and clinical centers and establish feasible trial designs.
• Prepare and review clinical trial documents for ethics committees and regulators to secure approvals.
• Develop standardized trial operations, protocols and trainings, and manage trial resources and supply.

Kenntnisse

Project planning

Management

Operations

Coordination

Ausbildung

Master's degree or above in related life sciences

Jobbeschreibung

• Conduct research to create clinical development strategy and plans for biological products, finalize study designs including statistics, endpointsand key operations, align resources with key opinion leaders and principal investigators, and draft or review clinical study reports.
• Conduct research onstudy feasibilityacross target countries and clinical centers, evaluate study site infrastructure, local regulatory readiness, patient pool availability, etc. Establish scientific and feasible designs for clinical trials.
• Prepare and review clinical trial documents for ethics committees and national regulatory authorities, address scientific queries to secure trial approvaland maintain communication with regulatory bodies.
• Develop and implementstandardizedtrial operations, protocol, and trainings. Manage critical trial resources, recruitment and retention strategies, investigational drug supply, and biological sample logistics, develop new assays and analytical methodologies for novel investigational product's immunogenicity or efficacy analysis.
• Conduct audit and quality control visits to ensure laboratories and third parties compliance with quality standards and global GCP rules.Requiements1. Master's degree or above in Preventive Medicine, Public Health, Clinical Medicine, Statistics, Life Sciences, or Biopharmaceuticals, or related subjects.2. Three years of relevant work experience in clinical research, drug development, clinical trial management, or related fields is preferred.3. Strong capabilities inproject planning, management, operations, and coordination skills, with a strong sense of responsibility.4. Excellent communication and teamwork skills, with the ability to collaborate effectively with team members and other departments.5. Rigorous work attitude, with attention to detail and compliance in execution processes.6. Outstanding forward-thinking mindset and awareness, with the ability to continuously contribute to the development and optimization of protocols.