Senior Clinical Trial Manager
New
4
4DMTBiotechnology, clinical trials
Remote, United StatesContractManager
Salary84 - 95 USD per hour
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Job Details
- Experience
- 7+ years of clinical research experience within the biotech industry or a similar combination of experience (biotech, pharma, CRO, etc.)
- Required Skills
- Microsoft Office
Requirements
- Hold a B.A. or B.S. degree.
- Have 7+ years of clinical research experience in biotech, or a similar combination of biotech, pharma, or CRO experience.
- Bring experience developing trial plans, including strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management.
- Have knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trial management.
- Have strong clinical study management skills and experience with vendor management and CRO oversight.
- Bring understanding of the regulatory framework for interactions with HCPs, payers, advocacy groups, and other business partners.
- Have leadership skills to direct protocol execution and meet timeline, budget, and quality metrics.
- Have clinical research knowledge and cross-functional understanding of clinical trial methodology.
- Be proficient with Microsoft Office, including Word, Excel, PowerPoint, and Outlook.
- Have working knowledge of MS Project for developing and updating clinical study timelines.
- Be able to manage a high volume of complex tasks within timelines and collaborate with study teams and external partners.
- Be available for 20% travel.
- Ophthalmology experience is strongly desired.
Responsibilities
- Manage protocol execution and oversee the CRO, study service providers, and consultants.
- Track study milestones, metrics, and timelines, and report study status to leadership.
- Ensure trials comply with ICH GCP, regulations, the protocol, and company SOPs.
- Prepare and review clinical trial documents, including protocols, consent forms, monitoring plans, and study reports.
- Support Trial Master File management and keep clinical documentation inspection- and audit-ready.
- Identify, mitigate, and manage study risks, issues, and protocol deviations.
- Support CRO and site selection, staff training, study start-up, and site documentation.
- Assist with database lock, clinical data analyses, and preparation of clinical study reports.
- Oversee outsourced monitoring and review monitoring reports and site-related issues.
- Oversee clinical supply forecasting and support investigator meetings and study team meetings.
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