Clinical Affairs, Senior (Study Operations) Transplant Diagnostic
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Job Location:
Fishers, IN - USA
Monthly Salary:
Not Disclosed
Posted on:
03-10-2025
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
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 managment 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:
- Bachelors 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).
Required Experience:
Senior IC
Key Skills
- Heavy Bus Driving
- Jdbc
- Event Marketing
- Labouring
- ACCA
- Arabic
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
