Clinical Operations Manager
hace 2 días
We are seeking a highly skilled Clinical Operations Manager to join our team at Thermo Fisher Scientific. As a Clinical Operations Manager, you will be responsible for managing all clinical operational and quality aspects of allocated studies, ensuring compliance with ICH GCP and project-specific requirements.
Key Responsibilities- Develop and implement clinical tools, such as Monitoring Plans and Monitoring Guidelines, in conjunction with the Data Quality Plan.
- Contribute to the development of the Master Action Plan (MAP) for providing clinical-related documents.
- Ensure timely set up, organization, content, and quality of the relevant sections of the Trial Master File (local and central).
- Participate in the design and development of CRFs, CRF guidelines, patient informed consent templates, and other protocol-specific documents as required.
- Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
- Collaborate with the clinical team and other departments as needed to meet deliverables of the project.
- Regularly communicate with the team and lead team meetings to ensure that timelines, resources, interactions, and quality are maintained.
- Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies.
- Responsible for the timely archiving of documents and study materials for the department.
- Ensure achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution.
- Continuously monitor or co-monitor clinical trials to assess performance and ensure contractual obligations are met. In smaller regions, may routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.
- May communicate with study sites regarding issues such as protocol, patient participation, case report form completion, and other study-related issues.
- May coordinate all start-up activities and ensures that timely ethics committee and regulatory submissions (if appropriate) are addressed.
- Ensures that essential document quality meets the expectation of Regulatory Compliance Review.
- Reviews and follows up on all questions raised by the ethics committees.
- May provide input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities, and identification of additional resource requirements.
- Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years).
- In some cases, an equivalency, consisting of a combination of appropriate education, training, and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
At Thermo Fisher Scientific, we offer a dynamic and supportive work environment that fosters growth and development. As a Clinical Operations Manager, you will have the opportunity to work on a variety of projects, develop your skills and expertise, and contribute to the success of our team.
We value diversity, equity, and inclusion and are committed to creating a workplace that is welcoming and inclusive for all employees. We offer a competitive salary and benefits package, as well as opportunities for professional development and growth.
If you are a motivated and experienced Clinical Operations Manager looking for a new challenge, we encourage you to apply for this exciting opportunity.
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