Clinical Trial Manager
2 weeks ago
- Specialize in internal radiation therapy for oncologic diseases, providing safe outpatient care.
- Offer advanced theranostics, combining therapy and diagnostics, to target and treat cancer cells effectively.
- Treat thyroid cancer, metastatic prostate cancer, and metastatic neuroendocrine cancer.
- Collaborate closely with oncologists, endocrinologists, urologists, and other providers for comprehensive patient care.
- Utilize PET scans for tumor visualization, SPECT scans for therapy monitoring, and radiopharmaceuticals for cancer treatment.
- Manage Clinical Trial Sites: Oversee and manage clinical trial operations at various sites, ensuring adherence to protocols, timelines, and regulatory requirements.
- Process Management: Develop and implement efficient processes and workflows for the execution of clinical trials, optimizing resource allocation and productivity.
- Task Coordination: Coordinate tasks and activities among cross-functional teams, including research coordinators, investigators, vendors, and other stakeholders, to ensure smooth execution of clinical trials.
- Leadership: Provide leadership and guidance to the clinical trial team, fostering a collaborative and results-driven work environment.
- Communication: Facilitate effective communication between internal team members and external stakeholders, including investigators, study coordinators, regulatory agencies, and sponsors.
- Systems Engineering: Utilize IT expertise to leverage technology solutions for data management, analysis, and reporting throughout the clinical trial lifecycle.
- Project Management: Act as a project manager for clinical trials, overseeing the collection, analysis, and reporting of data to support regulatory submissions and advance to the next phase of clinical development.
- Regulatory Compliance: Ensure compliance with applicable regulations, guidelines, and SOPs governing clinical research, including FDA regulations and ICH-GCP guidelines.
Required Experience and Qualifications:
- Bachelor's degree in a relevant scientific or technical field
- Minimum of 10 years of experience in clinical trial management within CROs, pharmaceutical companies, or hospital settings.
- Proven track record of successfully managing clinical trials from initiation to closeout
- Strong leadership and team management skills, with experience supervising research coordinators and leading cross-functional teams.
- Excellent communication skills, both verbal and written, with the ability to effectively communicate with stakeholders at all levels.
- Proficiency in project management methodologies and tools, with the ability to prioritize tasks and manage competing priorities effectively.
- Solid understanding of regulatory requirements for clinical research, including FDA regulations and ICH-GCP guidelines.
- IT background with experience in leveraging technology solutions for data management and analysis in clinical trials.
- Ability to travel as needed to clinical trial sites and attend relevant conferences and meetings.
- Advanced degree (e.g., MS, MBA, PhD) preferred.
- Focus on oncology or molecular diagnostics preferred.
Compensation $120k-$150k, Health Insurance, 401k, Paid Vacation #J-18808-Ljbffr
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