Manager, Clinical Operations

Role Summary

Manager, Clinical Trial Operations. In this role you will manage all aspects of clinical trial conduct including study start-up, enrollment, study conduct and close-out. The candidate must be knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines.

Responsibilities

• Provides support with project completion according to overall development plan, and in compliance with all regulations, guidance, and health authority expectations.
• Oversees clinical trial conduct including feasibility, study start-up, enrollment, study conduct and close-out.
• Collaborates with the department, cross-functional teams, and external service providers that directly contribute to key study activities and milestones.
• Prepares and reviews study-related and essential clinical study documentation. Provides oversight and guidance if some tasks are delegated to a Clinical Trial Associate.
• Proactively identifies potential study risks and recommends/implements solutions.
• Communicates and escalates issues appropriately.
• Ensures clinical data from sites are of quality and delivered in accordance with expectations.
• Participates in the selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function.
• Ensure the Clinical Trial Management System is complete and up to date for assigned studies.
• Prepares metrics and updates for management, as assigned.
• Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings.
• Serves as a liaison and resource for investigational sites.
• Participates in the review and implementation of departmental SOPs and processes.
• Participates in study-level review to support data quality and integrity.

Qualifications

• Bachelor’s degree required; Masters degree is preferred.
• 4+ years of experience in clinical research in the pharmaceutical/research industry leading complex clinical research deliverables in a multi-disciplinary, cross-functional environment. Experience in more than one therapeutic area is required.
• Working knowledge of legal, compliance, and regulatory guidelines related to conduct of late-phase trials in the US and globally.
• Considers quality and attention to detail as fundamental and necessary attributes of all output and patient safety as an overarching responsibility.
• Strategic problem-solver with ability to identify appropriate solutions.
• Effective written and verbal communication skills.
• Proficient in the use of Microsoft Office Suite.

Skills

• Clinical trial operations
• Regulatory compliance (FDA/ICH)
• Cross-functional collaboration
• Documentation and records management
• Risk assessment and mitigation
• Communication and stakeholder management
• Project management
• Clinical data quality and integrity

Physical Demands

• Domestic travel around 10% will be required for this role.
• Continuous sitting for prolonged periods. Specific vision abilities required: close vision. Manual dexterity to use computers, tablets, and cell phone.