- Facilitating effective communication and collaboration across internal and external stakeholders, including clinical investigators, study coordinators, regulatory authorities, and medical monitors.
- Ensuring adherence to Good Clinical Practice (GCP) guidelines, regulatory requirements, and company SOPs throughout the conduct of clinical trials, maintaining the highest standards of data integrity and patient safety.
- Identifying potential risks and developing mitigation strategies to ensure the successful execution of clinical trials, proactively addressing issues as they arise.
- Coordinating all aspects of trial conduct, including budget management, site monitoring, patient recruitment and enrollment, drug supply management, and data collection.
- Leading the operational planning and initiation of clinical trials, including site selection, investigator meetings, regulatory submissions, and ethics committee approvals.
- Bachelor's degree in life sciences, pharmacy, nursing, or related field (advanced degree preferred).
- Minimum of 3 years of experience in clinical trial management within the pharmaceutical or biotechnology industry, preferably with expertise in rare diseases.
- Strong understanding of clinical trial design, conduct, and regulatory requirements (FDA, EMA, ICH).
- Excellent project management skills, with the ability to prioritize tasks, manage competing priorities, and meet deadlines.
- Effective communication and interpersonal skills, with the ability to build relationships and influence stakeholders at all levels.
- Proven leadership abilities, with a track record of successfully leading cross-functional teams in a matrix organization.
- Competitive pay (salary, bonus and stock options)
- Paid time off (PTO)
- Comprehensive medical coverage (PPO, dental, vision)
- Notable leadership and growth opportunities.
Clinical Trial Manager - Boston, United States - EPM Scientific
Description
Clinical Trial Manger (Hybrid in Boston, MA)
Salary: $150,000-$165,000
This company is a fast growing biotechnology company in Boston, MA dedicated to advancing research, development, and treatments for rare diseases. We are driven by a commitment to innovation and excellence in developing transformative therapies that have the potential to significantly improve the lives of patients and their families.
Position Overview :
The company is looking for a Clinical Trial Manager you will play a pivotal role in the execution of our clinical development programs aimed at advancing novel therapies for rare diseases. Working closely with cross-functional teams, you will oversee the planning, implementation, and management of clinical trials at various stages of development, ensuring compliance with regulatory standards, protocols, and timelines.
Responsibilities:
Experience:
Benefits:
Note: This is a confidential search. All inquiries and applications will be handled with discretion.