Senior Clinical Trial Manager

This is a fully remote position, open to applicants in California.

📋 Description

• Responsible for the overall management of clinical study operations, encompassing CRO and vendor oversight, project planning, budgeting, and resource allocation.

• Spearhead the creation of study operational plans and assist with functional area strategies and processes.

• Supervise CROs, vendors, and clinical sites while ensuring compliance with GCP and regulatory standards.

• Act as a representative of clinical operations within cross-functional teams.

• Develop and oversee study timelines and budgets alongside the Clinical Operations Lead, internal leadership, and CROs.

• Manage clinical study vendors, defining deliverables and key performance indicators.

• Create site-specific training for staff, CRAs, and vendors, and present at Investigator and Kick-off meetings.

• Oversee the submission process and approvals from Competent Authorities and IRB/Ethics Committees.

• Formulate clinical monitoring strategies to adhere to timelines and guarantee quality deliverables.

• Manage and supervise the eTMF structure, plans, and quality control.

• Handle investigator selection, drug supply forecasts, study initiation, participant recruitment and retention, data collection, database locks, drug accountability, and study closure.

• Contribute to the development of clinical trial outlines, protocols, informed consent forms, and clinical study reports.

• Lead or collaborate on project strategies, training, system implementations, CRF designs, and user acceptance testing.

• Identify and address issues and risks in collaboration with cross-functional teams and service providers.

• Work alongside data management and CRAs to ensure data quality and adherence to cleaning timelines.

• Conduct clinical data reviews, including query generation as necessary.

• Contribute to process enhancements, initiatives, and standard operating procedures.

• Provide guidance and mentorship to junior team members.

• Escalate issues related to CRA performance and site compliance.

• May involve line management responsibilities.

⛳️ Requirements

• A Bachelor’s degree is required, preferably in Life Sciences or a related field.

• A minimum of 8-10 years of experience in clinical operations is essential.

• Experience in managing a CRO and a complex study in a previous Clinical Trial Manager or similar role is required.

• Global Clinical Trial experience particularly in Phase I-III is necessary.

• Experience in Rare Disease is required; cardiovascular experience is an added advantage.

• Familiarity with inspection readiness and experience with inspections is a plus.

• Exceptional attention to detail along with strong organizational skills.

• Excellent oral and written communication, analytical, and project management abilities.

• Capacity to develop and sustain strong collaborative relationships with key internal and external stakeholders.

• Ability to manage multiple tasks, navigate conflicts and obstacles, and thrive in a fast-paced environment.

• Quick to learn and utilize technical applications.

• Preferred proficiency in Smartsheet/MS Excel or similar tools.

• Capability to manage budgets and projections effectively.

• Prior auditing experience is preferred.

• Previous experience as a Clinical Research Associate (CRA) is advantageous.

• Comprehensive knowledge of ICH/GCP, regulatory guidelines/directives, drug development, and clinical research processes.

• Experience in team leadership within a cross-functional matrix environment.

• Willingness to travel domestically and internationally for meetings and conferences, approximately 10%-15% of the time.

🏝️ Benefits

• Stock options.

• 401(k) with employer matching.

• Medical insurance coverage.

• Dental insurance coverage.

• Vision insurance coverage.

• Long-term disability coverage.

• Unlimited paid time off, including summer and winter breaks.

• Internally developed training and development programs.

• Job-specific training provided by industry professionals.

• Education reimbursement program.