What are the responsibilities and job description for the Vice President Clinical Operations position at Barrington James?
The Vice President of Clinical Operations will be responsible for overseeing the entire clinical operations function, including the planning, execution, and delivery of clinical trials. This senior leadership role will involve managing teams across various functions, ensuring operational efficiency, and maintaining compliance with regulatory requirements. The VP of Clinical Operations will collaborate closely with senior executives and cross-functional teams to ensure the strategic objectives of the clinical development programs are met.
- Lead and oversee the clinical operations department, including clinical trial management, site management, monitoring, and regulatory compliance.
- Develop and implement strategies for the efficient and effective execution of global clinical trials, ensuring timelines and budget goals are met.
- Establish and maintain clinical trial processes and best practices to optimize study execution, improve patient recruitment, and enhance data quality.
- Collaborate with senior management to define clinical development goals, ensuring alignment with organizational priorities and strategies.
- Provide leadership and mentorship to clinical operations teams, fostering a culture of collaboration, continuous improvement, and accountability.
- Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, FDA regulations, and other applicable global regulatory standards.
- Establish strong relationships with external vendors, including CROs, clinical sites, and suppliers, to ensure the smooth operation of trials.
- Monitor and manage the clinical operations budget, resources, and personnel to ensure cost-effective execution of clinical programs.
- Identify, assess, and mitigate risks associated with clinical trials to ensure high-quality and compliant trial operations.
- Represent clinical operations in interactions with regulatory agencies, investors, and other key stakeholders.
Qualifications
- A minimum of 15 years of experience in clinical operations, with at least 7 years in a leadership role.
- Proven track record of managing complex, global clinical trials across various therapeutic areas.
- In-depth knowledge of clinical trial design, implementation, and regulatory requirements.
- Strong understanding of GCP, ICH guidelines, FDA, EMA, and other relevant regulatory standards.
- Experience with budgeting, resource allocation, and vendor management in clinical operations.
- Exceptional leadership and communication skills, with a demonstrated ability to lead, mentor, and develop high-performing teams.
- Ability to navigate and lead in a fast-paced, rapidly evolving environment.
Send your resume to rmoseley@barringtonjames.com if you're interested in applying!
