Senior Clinical Study Manager for Global Clinical Trials
Há 5 dias
Unlock your potential as a Senior Clinical Study Manager at Mygwork - LGBTQ+ Business Community, where diversity and inclusion thrive. We are seeking an experienced professional to lead clinical trials with moderate complexity, providing quality oversight and driving decision-making.
Job Summary
As a Senior Clinical Study Manager, you will be responsible for leading the execution of clinical trials from start-up to close, ensuring timely delivery of quality study data. You will work closely with our client's team and PPD colleagues to deliver innovative clinical support.
Key Responsibilities:
- Lead and coordinate the execution of clinical trials, including study start-up, monitoring, and close-out.
- Provide quality oversight and ensure compliance with Good Clinical Practices (GCP).
- Work closely with Contract Research Organizations (CROs) to resolve issues and drive decision-making.
- Develop and implement detailed study startup and monitoring plans, as well as study delivery strategies.
- Conduct country-level feasibility assessments, review Pre-trial Assessment outputs, and assess site activation plans.
- Coordinate study/protocol training & investigator meetings, develop and provide key inputs to Clinical Trial Budget.
- Lead inspection readiness activities related to study management and site readiness.
Requirements:
- MS/PhD – minimum of 3 years of proven experience in global clinical trial/study management.
- BS/Nurse – minimum of 5 years of proven experience in global clinical trial/study management.
- Extensive global clinical trial/study management experience, with knowledge of GCP, monitoring, clinical, and regulatory operations.
- Demonstrated study management / leadership experience, demonstrated oversight of CROs, and experience in managing Per Subject Costs, vendor & ancillary, and monitoring costs projections & spend.
- Fluent in English, excellent communication skills, both written and verbal, and keen problem-solving skills.
What We Offer:
- An estimated salary of $90,000 - $120,000 per year, based on experience.
- A competitive benefits package, including health insurance, retirement plan, and paid time off.
- The opportunity to work with a diverse team of professionals who share your passion for innovation and excellence.
About Us:
Mygwork - LGBTQ+ Business Community is a member of the largest global platform for the LGBTQ+ business community. We value diversity and inclusion, and we are committed to creating a workplace that is welcoming and inclusive for all employees.
#ThermoFisherScientific #ClinicalStudyManager #GlobalClinicalTrials #LGBTQPlusBusinessCommunity
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