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Clinical Research Manager
2 months ago
Job Title: Clinical Research Manager
Company: Thermo Fisher Scientific
Job Summary:
We are seeking a highly skilled Clinical Research Manager to oversee all aspects of assigned clinical trials involving patient and healthy subject populations in both inpatient and outpatient settings. As a key member of our research team, you will act as a liaison between different functions, including project managers, investigators, and research teams.
Key Responsibilities:
- Oversee all aspects of assigned clinical trials, ensuring compliance with regulatory requirements and company standards.
- Act as a key liaison between project managers, investigators, and research teams, facilitating effective communication and issue resolution.
- Ensure that client requirements and specifications are effectively communicated to the research teams, and that any issues or questions raised by the research team or investigators are communicated back to the project leads and client for resolution.
- Develop and implement strategies to improve clinical trial operations, including process improvements and quality control measures.
- Collaborate with cross-functional teams to ensure seamless execution of clinical trials, including study start-up, conduct, and close-out.
- Provide guidance and support to research teams on clinical trial operations, including protocol development, informed consent, and study monitoring.
- Stay up-to-date with regulatory requirements and industry developments, ensuring that our clinical trials are conducted in compliance with relevant laws and regulations.
- Develop and maintain relationships with key stakeholders, including clients, investigators, and research teams.
- Contribute to the development of business strategies and initiatives to drive growth and improve operational efficiency.
Requirements:
- Bachelor's degree or equivalent with relevant formal academic/vocational qualification.
- 2+ years of previous experience providing the necessary knowledge, skills, and abilities.
- Strong knowledge of Phase I processes and clinical study operations.
- Familiarity with FDA regulations and ICH GCP guidelines.
- Proficiency in Microsoft Office applications.
- Effective time management and multitasking abilities.
- Excellent written and verbal communication skills.
- Organizational and prioritization skills with the flexibility to adapt to changing study needs.
- Consulting skills to facilitate communication between external and internal groups.
- Understanding of budgeting, forecasting, and project planning.
