Senior Clinical Trial Manager

Duties and Responsibilities

• Manage the implementation, on-time execution, and conduct of clinical study(ies), including the development of study plan(s), key milestones, timelines, study costs, and vendor selection while ensuring the highest level of quality and compliance.
• Prepare and deliver accurate and timely study updates, metrics, and reports to senior management.
• Able to identify potential risks that may impact the study(ies), e.g., study data, ethical conduct, and adherence to ICH guidelines, and provide risk mitigation solutions.
• Appropriately manage the various stages of study activities, e.g., start-up, treatment, maintenance, and close-out, to ensure the study is conducted on time and within budget.
• Understand the data requirements of clinical study(ies) to ensure quality and integrity of data during collection, review, cleaning, and monitoring.
• Perform responsibilities with a high degree of independence while effectively partnering with team members to meet deliverables and deadlines.

Requirements and Qualifications

• Effective team player with exceptional written and interpersonal communication skills.
• Demonstrated aptitude for strategic and flexible thinking, with the ability to anticipate challenges, evaluate alternatives, and adjust strategies as needed.
• Prominent ability to manage delegated aspects of clinical trials, leveraging strong planning, organizational, and time-management skills.
• Ability to manage CROs and clinical study vendors.
• Ability to collaborate with cross-functional clinical study teams.
• Strong working knowledge of FDA & ICH/GCP regulations and guidelines, and ability to translate into inspection readiness at all times.
• Proficiency in MS Office, including Word, Excel, PowerPoint, and other applications; demonstrated experience in technical writing.
• Travel Requirements: domestic and/or international up to 25%.
• BS/BA in Life Sciences or related discipline.
• 3-5 years of experience in clinical and drug development.

Desired Skills and Experience

• Clinical trial management, clinical operations, clinical study execution, study planning, milestone and timeline management, study budgeting, vendor selection, CRO management, clinical vendor oversight, study start-up, treatment, maintenance and close-out, clinical data quality and integrity, data review and cleaning, clinical monitoring, risk identification and mitigation, FDA regulations, ICH-GCP compliance, inspection readiness, cross-functional collaboration, study metrics and reporting, technical writing, strategic planning, project management, organizational skills, time management, written and interpersonal communication, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, life sciences, clinical development, drug development