Senior Clinical Trial Manager
2 months ago
One of our innovative biotech clients focused on creating gene therapies for cardiovascular diseases is seeking a dedicated Senior Clinical Trial Manager (SCTM) to lead the planning, coordination, and management of clinical trials from study start-up through to clinical study reports. If you have a passion for clinical research and a strong background in global trial execution, we want to hear from you
Key Responsibilities:
- Lead the development of study-specific documents, tools, plans, and procedures, including communication, monitoring, risk management, and vendor management.
- Manage a cross-functional study team, ensuring timely information exchange and continuous assessment of operational performance.
- Ensure trials are conducted in accordance with study protocols, SOPs, and regulatory requirements (ICH/GCP, country-specific regulations).
- Perform quality control reviews of central clinical files and trial master files as needed.
- Provide operational oversight to prioritize activities, monitor performance against timelines, and develop contingency plans.
- Identify potential issues and risks, recommend solutions, and escalate concerns to the VP of Clinical Operations when necessary.
- Oversee CROs and vendors to ensure adherence to quality standards and established study documents, timelines, and budgets.
- Build strong relationships with investigators, KOLs, site staff, and CRO partners.
- Champion continuous quality improvement by evaluating processes and recommending enhancements.
- Participate in RFP/bid defense and selection of CRO/third-party vendors.
- Support risk management and audit/inspection activities as needed.
- Maintain trial postings on clinicaltrials.gov.
Qualifications:
- BA/BS in health/life sciences or a related field.
- 3+ years of drug development experience, especially in clinical trial management; experience in small biotech, cardiovascular, or gene therapy preferred.
- Proven experience in developing global clinical operations strategies, including site monitoring and risk mitigation plans.
- Prior global experience managing CROs, vendors, and consultants.
- Strong knowledge of FDA/EMA regulations and ICH/GCP guidelines in clinical trials.
- Leadership experience across all stages of clinical trial delivery (feasibility, start-up, enrollment, data collection, database lock, and close-out).
- Ability to manage multiple competing priorities in a fast-paced environment.
- Results-oriented with strong initiative and problem-solving skills.
- Exceptional communication and interpersonal skills.
- Proficiency in Microsoft Office Suite (Word, Outlook, Excel, Project), OneDrive, and SharePoint.
Special Considerations:
- Some travel required to sites, vendors, and study-related meetings (approximately 40%).
If you’re ready to make a meaningful impact in clinical research and advance your career in a dynamic environment, apply today
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