Senior Clinical Trial Manager

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

📋 Description

• Effectively conduct global and regional clinical trials, ensuring they reach completion within established timelines and quality standards.

• Build and nurture relationships with clinical sites and investigators.

• Facilitate or assist in informational calls for sites and investigators.

• Aid in the planning and execution of investigator meetings.

• Review and authorize investigational product release packages.

• Examine monitoring reports for compliance with protocols, regulatory requirements, and ICH/GCP standards.

• Monitor report metrics and act as a backup monitor when necessary.

• Utilize CTMS, DM query trends, and outstanding monitoring report metrics effectively.

• Relay study-related issues to the Director and CRAs.

• Ensure precise reporting of protocol deviations and follow up on re-SDV and closure of deviations.

• Support findings from the Protocol Deviation Review Team and share relevant information with CRAs.

• Conduct monitoring meetings and create agendas and minutes.

• Organize study-specific training and retraining for internal teams, monitors, and site personnel.

• Develop and maintain Trial Master Files and Investigator Site Files in Veeva Vault, including quarterly eTMF reviews.

• Assist CRAs with eTMF completeness, audit findings, and their resolutions.

• Oversee or support vendor management, including central laboratories, IRBs, imaging services, patient concierge services, and site payment systems.

• Manage EDC and IRT access requests for site teams.

• Facilitate CRA access to Ascendis systems and vendor systems.

• Organize CRA transition meetings and handle related documentation.

• Conduct study team meetings and prepare agendas and minutes.

• Review site information and informed consents, completing relevant checklists.

• Support submissions to central and site IRB/IEC and regulatory bodies.

• Assist sites, internal staff, and CRAs in preparing for GCP audits.

• Maintain CTMS information regarding sites, staff, milestones, submissions, and approvals.

• Escalate issues related to CRA performance and site compliance.

• Collaborate with Clinical Operations, data management, and CRAs to ensure data quality and adhere to cleaning timelines.

• Assist in tracking and managing supply, sample, and investigational product shipments.

• Review and authorize Vendor Data Clarification Forms as necessary.

• Prioritize and escalate issues effectively.

• Develop or assist in creating clinical plans, informed consent templates, study forms, manuals, CRF completion guidelines, trackers, presentation slides, and training materials.

• Manage clinical vendors and their documentation when assigned.

• Conduct clinical data reviews, including assessments of patient profiles, listings, summary tables, and query generation.

• Report on deliverables, timelines, and employee development to the Associate Director of Clinical Operations.

⛳️ Requirements

• Preferred bachelor’s or master’s degree in natural or health sciences, or equivalent professional experience.

• Extensive knowledge of ICH-GCP, relevant Ascendis SOPs and Work Instructions, and regulatory guidelines.

• Practical understanding of clinical management techniques and tools.

• Direct experience working in a cross-functional environment.

• Over 7 years of combined experience in managing or monitoring Phase 1, 2, or 3 clinical trials.

• High proficiency in English with strong communication and presentation capabilities.

• Experience in managing and supervising vendors.

• Proven experience conducting clinical site monitoring visits, including remote visits.

• Ability to prioritize tasks, work autonomously, manage timelines, and communicate ideas clearly and effectively.

• High proficiency in Veeva Systems (Clinical Vault eTMF, Veeva EDC), CTMS, Endpoint IRT, and Microsoft Office (Outlook, Word, Excel, PowerPoint).

• Willingness to travel up to 20% domestically for investigator meetings, remote employee meetings, and co-monitoring activities.

🏝️ Benefits

• 401(k) plan with company matching.

• Medical, dental, and vision insurance plans.

• Company-sponsored Life and Accidental Death & Dismemberment (AD&D) insurance.

• Short and long-term disability benefits provided by the company.

• Pet Insurance and Legal Insurance options available.

• Employee Assistance Program offered.

• Discounts for employees.

• Opportunities for Professional Development.

• Health Savings Account (HSA) available.

• Flexible Spending Accounts provided.

• Various incentive compensation plans.

• Accident, Critical Illness, and Hospital Indemnity Insurance options.

• Mental health resources accessible.

• Paid leave benefits for new parents.

• Eligibility for discretionary annual bonuses or incentive compensation plans.

• Access to discretionary stock-based long-term incentives.

• Paid time off offered.

• Comprehensive benefits package provided.

• Option for remote work or a Palo Alto-based work setup.

• Up to 20% domestic travel as part of the role.