- Oversee the planning, implementation, and management of immuno-oncology clinical trials from initiation to completion.
- Ensure trials are conducted with the highest quality, adherence to timelines, and in compliance with regulatory requirements.
- Manage and collaborate with Contract Research Organizations (CROs), central labs, and other vendors to optimize trial processes and ensure efficient resource utilization.
- Contribute to the development of clinical trial protocols, informed consent forms, and other study-related documents.
- Develop and manage clinical trial budgets, ensuring cost-effective trial conduct while maintaining high quality.
- Work closely with investigative sites to ensure proper trial conduct, including site initiation, training, and monitoring activities.
- Bachelor's degree in a scientific discipline; advanced degree preferred.
- Must have recent experience in the biotech/pharmaceutical industry.
- Must have a minimum of 5 years of experience in clinical trial management within the biotech/pharmaceutical industry.
- Must be able to go onsite 2 days a week.
- Proven experience managing Oncology and/ or Rare Disease clinical trials.
- Strong understanding of ICH/GCP guidelines and regulatory requirements.
- Ability to deal with time demands, incomplete information, or unexpected events.
- Excellent communication and interpersonal skills.
- Ability to work independently and collaboratively in a fast-paced environment.
- Competitive pay (salary, bonus and stock options)
- Paid time off (PTO)
- Comprehensive medical coverage (PPO, dental, vision)
- Notable leadership and growth opportunities.
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Meet Boston, United StatesAre you an experienced Clinical Operations professional looking to advance your career in a dynamic and innovative environment? Do you thrive in a fast-paced setting and excel at managing clinical trials from start to finish? If so, we have an exciting opportunity for you to join ...
Senior Clinical Trial Manager - Boston, United States - EPM Scientific
Description
Senior Clinical Trial Manager (Hybrid in Boston, MA)
Salary: $160,000-$185,000
A dynamic and rapidly growing biotech in the heart of Boston, Massachusetts is seeking a highly skilled and motivated Senior Clinical Trial Manager to lead and drive the successful execution of their groundbreaking gene therapy programs used to treat rare diseases and cancer. This is a unique opportunity to contribute to cutting-edge advancements in mRNA and make a meaningful impact on patients' lives. If you are passionate about advancing Oncology and Rare Disease therapies and have a proven track record in clinical trial management, this is the perfect opportunity for you
Position Overview:
The Senior Clinical Trial Manager will play a crucial role in overseeing and managing Phase 1-3 clinical trials related pertaining to mRNA therapies targeting cancer and rare disease. Their responsibilities are diverse and encompass various aspects of trial planning, execution, and management. The successful candidate will collaborate with investigators, study coordinators, and site staff to ensure the smooth execution of clinical trials and accurate data collection while contributing to the company's mission of advancing the science.
Key Responsibilities:
Qualifications:
Benefits:
Note: This is a confidential search. All inquiries and applications will be handled with discretion