What are the responsibilities and job description for the Clinical Trial Manager position at Barrington James?
Barrington James is recruiting for a Manager of Clinical Trials for a leading provider of radiopharmaceutical therapy (RPT). This is a unique opportunity to join a dynamic and innovative company that is revolutionizing clinical trials in the field of oncology.
What You'll Do:
- Play a pivotal role in orchestrating the operational aspects of sponsored studies.
- Set up and manage clinical trial processes, including implementing the Clinical Trial Management System (CTMS) and overseeing quality management systems.
- Ensure regulatory compliance by handling deviation management, communicating with IRBs and sponsors, and coaching the clinical trial staff.
- Prepare content for auditable training systems, establish regulatory document management and risk management programs, and implement an internal audit-readiness program.
- Foster collaborative relationships with contract resource organizations (CROs), vendors, sponsors, healthcare providers, and patients.
What You'll Need:
- Bachelor's degree in life sciences, healthcare, or a related field (B.A./B.S.) required.
- 5 years of site-level leadership experience in Regulatory aspects of clinical trials.
- 3 years' experience with the Food and Drug Administration (FDA), Bioresearch Monitoring (BIMO), and third-party audits, with a proven track record of handling 483 reports.
- Proficient in clinical trial regulations, including 21 CFR, ICH, and GCP.
- Knowledgeable in Clinical Trial Quality Management, including document management and training logs.
- Extensive experience with establishment of quality improvement plans.
- In-depth knowledge of the clinical trial environment.
- Proficient in Project Management.
- Detail-oriented and skilled in building and optimizing systems.
- Fluency in reading oncology protocols.
- Outstanding communication and interpersonal skills.
- Mastery in operation design.
- Possess strong coaching skills.
- Ability to travel.
- Flexibility to work outside standard business hours when necessary.
What We Offer:
- Competitive salaries based on experience.
- Medical, dental, and vision insurance.
- Opportunity for professional growth and development within a dynamic and innovative company.
