- Manage clinical trials from initiation to close-out, ensuring timely delivery of internal and external deliverables within budget constraints.
- Coordinate with cross-functional clinical teams to facilitate the exchange of information and materials necessary for trial delivery.
- Develop and oversee clinical trial project timelines, identifying and addressing risks and challenges, and monitoring metrics to ensure accuracy and comprehensiveness.
- Proactively manage outsourced partners, including risk identification, to ensure trial deliverables and performance goals are met.
- Maintain day-to-day contact with counterpart at Contract Research Organizations (CROs), conducting daily reviews and identifying potential issues or problems with trial sites, and escalating as necessary.
- Collaborate with CROs to ensure the accuracy and currency of the clinical study database.
- Proactively manage and track project scope and change orders for clinical trial operations.
- Perform additional duties and responsibilities as required.
- Bachelor's degree in a life science or allied health field (e.g., nursing, medical or laboratory technology).
- Minimum of 5 years' experience in trial operations, primarily within the industry.
- Strong attention to detail and a focus on quality.
- Excellent written and oral communication skills.
- Thorough understanding of Good Clinical Practice (GCP), International Conference on Harmonisation (ICH), and other applicable regulations/guidelines.
- Good organizational and prioritization skills with strong attention to detail.
- Proficiency with Microsoft Office Suite: Outlook, Word, Excel, PowerPoint, MS Project, and SharePoint.
- Ability to work collaboratively with cross-functional teams and external partners.
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Biotech Company Boston, United StatesSr Clinical Trial Manager – Hybrid, MUST BE onsite 3 days , Boston, Massachusetts · Position pays around $160,000 to $175,000 base (depending on experience) plus 15% bonus , stock and full coverage on health benefits. Full Relocation provided if need be. · Summary: · We currentl ...
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Clinical Trial Manager - Boston, United States - Green Key Resources
Description
We are seeking a dedicated Clinical Trials Manager to oversee all aspects of clinical trials, ensuring adherence to timelines, budgets, and quality standards. The incumbent will facilitate collaboration across functional areas and manage relationships with external partners to ensure the successful execution of trials.
Key Responsibilities:
Qualifications:
Join us in our mission to advance medical research and improve patient outcomes through the successful management of clinical trials.
