What are the responsibilities and job description for the Clinical Program Manager position at Pivotal Solutions, Inc.?
Position Overview:
The Clinical Program Manager (CPM) is responsible for the strategic planning, oversight, and execution of clinical programs. The CPM ensures that all clinical trials within the program are conducted in compliance with the highest ethical standards and in accordance with applicable regulatory requirements.
Key Responsibilities:
Strategic Planning and Oversight:
Lead the development and execution of comprehensive clinical development plans.
Collaborate with cross-functional teams to ensure alignment of clinical objectives with company goals.
Monitor and assess the competitive landscape and adjust clinical strategies as necessary.
Clinical Trial Management:
Oversee the design, planning, and implementation of clinical trials within the program.
Ensure that clinical trials are executed on time, within budget, and in compliance with Good Clinical Practice (GCP), regulatory requirements, and company SOPs.
Coordinate with clinical sites, CROs, and other vendors to ensure smooth trial execution.
Stakeholder Management:
Serve as the primary clinical contact for internal teams, investigators, consultants, and regulatory agencies.
Foster strong relationships with key opinion leaders in the therapeutic area.
Data Management and Reporting:
Oversee the collection, analysis, and interpretation of clinical data.
Ensure timely and accurate reporting of clinical trial results to regulatory agencies, as well as internal and external stakeholders.
Budget and Resource Management:
Develop and manage the clinical program budget.
Ensure efficient allocation and utilization of resources across the clinical program.
Risk Management:
Identify potential risks in clinical programs and develop mitigation strategies.
Ensure that all clinical activities adhere to safety and compliance standards.
Continuous Improvement:
Stay updated with the latest clinical research methodologies, regulatory requirements, and industry best practices.
Implement process improvements to enhance the efficiency and quality of clinical programs.
Requirements
Qualifications:
Bachelor’s degree in a related field; advanced degree (e.g., MD, PhD, PharmD) preferred.
Minimum of 7 years of experience in clinical research, with at least 3 years in a program management or leadership role.
Strong knowledge of GCP, ICH guidelines, and relevant regulatory requirements.
Proven track record of successfully managing complex clinical programs.
Excellent interpersonal, communication, and leadership skills.
Ability to work in a fast-paced environment and manage multiple priorities.
Proficiency in clinical trial management systems and related software.
Physical Requirements:
Ability to travel as needed for site visits, investigator meetings, and conferences.