Clinical Trial Manager - Hybrid

Job description

Harbor Clinical, a certified women owned clinical service firm is seeking a Clinical Trial Manager to support leading, planning, execution and reporting of clinical trials within budget and in compliance with company processes and regulatory requirements. The contract role requires interface with vendors and partners as needed, directing CRO management and oversight of outsourced clinical activities. The successful candidate will be a reliable team player that has the ability to work well with many different functional areas including regulatory affairs, compliance, program management, medical/clinical sciences, data management and drug supply.

This particular project is in the rare disease therapeutic area. Responsible for the overall operational planning and activities for the implementation and conduct of clinical trials. This position does require office attendance 2 to 3 days per week and remote the other days.

• Manage the supervision of contracted clinical research organizations, clinical laboratory vendors, and other outsourced work – these vendors are exclusively in the US.
• Responsible for or contribute to vendor selection and management including issue escalation
• Lead both an internal and external/CRO trial management team, to ensure the successful conduct in accordance with State and Federal regulations, GCP regulations, ICH guidelines, and internal SOPs
• Contribute to development of proactive strategy and corrective action plan to address trial issues in collaboration with cross functional team
• Ensure Clinical Operations team and external partner receive trial specific training
• Report key trial performance information, including start-up metrics, enrollment, data collection timeliness/quality
• Author and review as needed clinical trial documents (Informed Consent Forms, Clinical Trial Plans, Case Report Forms, Statistical Analysis Plan, etc.). Review and contribute as needed to Investigator’s Brochure and other supportive regulatory documents
• Responsible for managing assigned aspects of the budget, timelines, and risk mitigation processes with input from key stakeholders
• Supports the development and application of standardized operational processes, methodologies, appropriate quality and performance metrics and tools to systematize continuous process improvement and impart best practices across clinical operations to maximize its effectiveness
• Responsible for supporting the management, oversight (CRO) and maintenance of the Trial Master File (TMF)
• Ensure inspection readiness at all times

Qualifications:

• Bachelor’s degree required
• Minimum of 5 years of progressively increasing clinical research experience with direct experience with pharmaceutical, biotech, and CROs
• Neuroscience experience strongly preferred
• Knowledge of drug development and FDA GCP/ICH regulatory guidelines
• Proficiency with and ability to utilize software applications that support Clinical Operations: Microsoft Word, Excel, PowerPoint; Adobe Acrobat, EDC systems, etc. Clinical trial management system (CTMS) background is a plus
• Demonstrated communication skills with the ability to communicate in a clear, open and effective manner
• Ability to influence and collaborate successfully with colleagues and partners; ability to work effectively in a fast paced environment
• Demonstrated organizational and time management skills
• Demonstrated ability to prepare and deliver verbal presentations which are clear, focused and concise
• Demonstrated experience in clinical trial management with thorough knowledge of drug development regulations
• Experience cultivating and maintaining relationships with internal and external colleagues and partners
• Experience in trial resource planning, budgeting, and timeline setting to meet the company needs
• Experience contributing cross-functionally to improve operational efficiency in clinical development
• Experience anticipating and addressing key technical and operational problems in clinical research that could impact the broader process or team