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 regulatory requirements.
Key Responsibilities- Manage clinical operational and quality aspects of allocated studies
- Ensure compliance with ICH GCP and regulatory requirements
- Develop clinical tools, such as Monitoring Plans and Monitoring Guidelines
- 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
- 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 ensure 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)
- Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams
- Good planning and organizational skills to enable effective prioritization of workload
- Solid interpersonal and problem-solving skills to enable working in a multicultural matrix organization
- Capable of working effectively in a changing environment with complex/ambiguous situations
- Familiarity with the practices, processes, and requirements of clinical monitoring
- Good judgment and decision-making skills
- Effective oral and written communication skills, including English language proficiency
- Capable of evaluating workload against project budget and adjusting resources accordingly
- Sound financial acumen and knowledge of budgeting, forecasting, and fiscal management
- Strong attention to detail
- Solid understanding of relevant regulations, e.g., ICH/GCP, FDA guidelines, etc.
- Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
Thermo Fisher Scientific is an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. We value the health and wellbeing of our employees and support individuals to create a healthy and balanced environment where they can thrive.
We are committed to accelerating research, solving complex scientific challenges, driving technological innovation, and supporting patients in need. Our Mission is to enable our customers to make the world healthier, cleaner, and safer.
As one team of 100,000+ colleagues, we share a common set of values – Integrity, Intensity, Innovation, and Involvement – working together to achieve our goals.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.
Accessibility/Disability Access Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process.
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