ThermoFisher Scientific
Clinical Affairs, Senior (Study Operations) - Transplant Diagnostic
ThermoFisher Scientific, Wilmington, North Carolina, United States, 28412
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Clinical Affairs, Senior – Study Operations
In this role, you will have the unique opportunity to lead clinical study operations to include clinical trial budgeting and study management activities. You will collaborate with cross-functional teams to support clinical planning and study execution. Additionally, you will analyze clinical affairs operations, identifying areas for improvement and implementing corrective measures. Responsibilities
Manage overall clinical study budgets; negotiation and management of budgets with clinical sites, vendors, and CROs (e.g. CTAs, PO and invoicing) Support department leadership to determine resource allocation and financial forecasting for clinical studies. Interact with investigative sites, vendors, and other functional areas to ensure successful execution of clinical studies. Coordinate the planning of clinical studies to ensure that deliverables are completed on time and within budget Develop and lead internal clinical project database. Update and/or generate internal Standard Operating Procedures (SOPs) to ensure GCP compliance Support clinical study management activities to include, IRB/EC submission and approval activities and generating clinical site documentation in compliance to trial protocols. Participate on cross functional core project teams to ensure clinical deliverables are aligned with business objectives. Qualifications
Bachelor's degree in Science with at least 5+ years of hands-on involvement in clinical research, demonstrating a strong history of effectively managing budgets for clinical trials. Strong working knowledge of Good Clinical Practices (GCP), FDA and EU regulations, and current industry practices related to the conduct of clinical trials. Excellent communication and interpersonal skills, with the ability to effectively collaborate with multidisciplinary teams Organized and attentive to detail, with a strong commitment to achieving high-quality outcomes Strong analytical and problem-solving abilities Ability to work effectively in a fast-paced and dynamic environment Proficient in applying tools for managing clinical trials (e.g. eTMF, EDC). 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.
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In this role, you will have the unique opportunity to lead clinical study operations to include clinical trial budgeting and study management activities. You will collaborate with cross-functional teams to support clinical planning and study execution. Additionally, you will analyze clinical affairs operations, identifying areas for improvement and implementing corrective measures. Responsibilities
Manage overall clinical study budgets; negotiation and management of budgets with clinical sites, vendors, and CROs (e.g. CTAs, PO and invoicing) Support department leadership to determine resource allocation and financial forecasting for clinical studies. Interact with investigative sites, vendors, and other functional areas to ensure successful execution of clinical studies. Coordinate the planning of clinical studies to ensure that deliverables are completed on time and within budget Develop and lead internal clinical project database. Update and/or generate internal Standard Operating Procedures (SOPs) to ensure GCP compliance Support clinical study management activities to include, IRB/EC submission and approval activities and generating clinical site documentation in compliance to trial protocols. Participate on cross functional core project teams to ensure clinical deliverables are aligned with business objectives. Qualifications
Bachelor's degree in Science with at least 5+ years of hands-on involvement in clinical research, demonstrating a strong history of effectively managing budgets for clinical trials. Strong working knowledge of Good Clinical Practices (GCP), FDA and EU regulations, and current industry practices related to the conduct of clinical trials. Excellent communication and interpersonal skills, with the ability to effectively collaborate with multidisciplinary teams Organized and attentive to detail, with a strong commitment to achieving high-quality outcomes Strong analytical and problem-solving abilities Ability to work effectively in a fast-paced and dynamic environment Proficient in applying tools for managing clinical trials (e.g. eTMF, EDC). 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.
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