Quality Assurance Manager

vor 2 Wochen

Basel, Schweiz Barrington James Vollzeit

Basel
- 22-05-2023
- JOB TYPE
- Permanent
- EMP TYPE
- Full-Time
- EXPERTISE
- Quality Assurance
- SALARY TYPE
- Annually
- SALARY
- Negotiable

Position Overview:
As the Clinical Operations Manager, you will play a crucial role in overseeing and coordinating all aspects of our clinical trials and studies. You will work closely with cross-functional teams, including clinical research associates, investigators, and vendors, to ensure the successful execution of clinical trials from initiation to completion. Your exceptional organizational skills, attention to detail, and strong leadership abilities will contribute to the advancement of our clinical development programs.

**Responsibilities**:
Manage and oversee the planning, implementation, and execution of clinical trials and studies, adhering to applicable regulations and guidelines.

Develop and maintain detailed project plans, timelines, and budgets to ensure successful trial execution.

Collaborate with cross-functional teams, including clinical research associates, data management, and regulatory affairs, to ensure alignment and effective communication throughout the trial process.

Identify and select appropriate investigational sites and investigators, ensuring they meet the study requirements and standards.

Manage relationships with external vendors and CROs, providing oversight and ensuring compliance with study protocols, regulatory requirements, and quality standards.

Monitor the progress of clinical trials, identify potential issues or risks, and implement mitigation strategies to ensure study timelines and objectives are achieved.

Prepare and review study-related documents, including protocols, informed consent forms, case report forms, and study reports.

Ensure compliance with regulatory and ethical standards, including GCP guidelines and applicable local and international regulations.

Coordinate and participate in site initiation visits, monitoring visits, and study close-out activities.

Provide leadership and guidance to the clinical operations team, fostering a culture of collaboration, accountability, and continuous improvement.

Stay abreast of industry trends, best practices, and emerging technologies in clinical operations, and implement innovative approaches to optimize trial processes.

Qualifications:
Bachelor's or Master's degree in a scientific or healthcare-related field (e.g., Life Sciences, Biotechnology, Nursing, Pharmacy).

Minimum 10 years of experience in clinical operations within the biotechnology, pharmaceutical, or CRO industry.

Strong knowledge of clinical trial management, including study start-up, monitoring, data management, and regulatory compliance.

Thorough understanding of GCP guidelines and relevant regulatory requirements (e.g., FDA, EMA) governing clinical trials.

Proven experience in managing multiple clinical trials simultaneously, from initiation to completion.

Excellent organizational skills, with the ability to prioritize tasks, manage timelines, and work effectively in a fast-paced environment.

Strong leadership abilities, with the capacity to motivate and guide cross-functional teams to achieve study objectives.

Exceptional communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders.

Proficient in utilizing clinical trial management systems (CTMS) and electronic data capture (EDC) platforms.

Detail-oriented mindset with a strong focus on quality and compliance.

Certifications such as Certified Clinical Research Professional (CCRP) or Certified Clinical Research Associate (CCRA) are preferred.

Consultant
- Felix Brunner
- +41417695000

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