Senior Manager of Clinical Research Trials

2 weeks ago

Connecticut, United States Patel Consultants Corporation Full time

Position Overview:

As the Clinical Trial Manager (CTM), you will be responsible for the comprehensive management of the local aspects of clinical trials. Your oversight will ensure that recruitment goals, timelines, budgets, and quality standards are met both internally and externally.

Team Leadership:

You will guide the local trial team to maintain the integrity of trial execution, prioritize patient safety, and ensure that the local and regional components of the trial are executed in compliance with regulatory standards. This role requires effective orchestration of the local trial team and collaboration with various functions throughout the planning, execution, and closure phases of the trial.

Regulatory and Compliance Expertise:

Working within a complex environment governed by Good Clinical Practice (GCP) and regulatory frameworks, you will engage with multidisciplinary, international teams and various stakeholders, including suppliers and investigational sites. Your representation of the company at internal and external meetings, such as those with regulatory agencies, is crucial. The impact of your role is significant, influencing project deliverables, stakeholder perceptions, and regulatory relationships.

Trial Management Responsibilities:

In collaboration with the Site Monitoring Lead and Clinical Research Associates (CRAs), you will serve as the primary contact for CRAs, investigators, and site personnel.

Essential Skills:

We seek a candidate with strong communication abilities within complex, cross-functional matrix environments. You should effectively articulate and align business strategies, ensuring consistency between actions and objectives. Highly developed listening skills and cultural awareness are essential.

Project Management and Leadership:

Your solid project management skills, stakeholder engagement capabilities, and team leadership experience are vital. A thorough understanding of the scientific and technical elements of the clinical development process and relevant regulatory requirements is expected.

Technical Knowledge:

Demonstrating comprehensive knowledge across all facets of clinical trial operations and execution is essential. Familiarity with a relevant therapeutic area is advantageous. You will manage the complexities of trial protocols, subjects, sites, countries, and suppliers while balancing multiple studies across various therapeutic areas.

Strategic and Operational Coordination:

Your ability to navigate complex situations, resolve conflicts, and influence across different levels of the organization will be critical. Embracing cross-functional initiatives and identifying risks for mitigation will be part of your strategic mindset.

Travel Requirements:

Willingness to travel domestically (10-20% of the time) is necessary.

Qualifications:

A Bachelor's degree with a minimum of 6 years of experience in clinical research, preferably within the pharmaceutical sector; or a Master's degree or PharmD with at least 4 years of relevant experience; or a PhD or MD with a minimum of 2 years of experience in clinical research.

Key Competencies:

Experience in Clinical Trial Monitoring, Clinical Operations, and adherence to GCP standards is required.

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