Senior Clinical Trial Manager

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🏄 California – Remote

🏄 California – Remote

💵 $160k - $170k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Ascendis Pharma

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2006

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Ascendis Pharma is a pharmaceutical company focused on developing innovative therapies to address unmet medical needs, particularly in the areas of endocrinology and oncology. The company utilizes its proprietary TransCon technology platform to develop best-in-class therapies, with a strong emphasis on patient care, scientific innovation, and sustainability. Ascendis Pharma's pipeline includes TransCon PTH and TransCon CNP for endocrinology rare diseases, as well as oncology candidates such as TransCon TLR7/8 Agonist. Committed to making a meaningful difference in the lives of patients, caregivers, physicians, and employees, Ascendis Pharma is guided by its core values and driven by its mission to impact patient lives worldwide.

📋 Description

• Foster and maintain favorable clinical site and investigator relationships, including informational calls. • Support planning and conducting investigator meetings. • Review and/or approve IP release packages. • Review monitoring reports for protocol, regulatory, and ICH/GCP compliance; track monitoring-report metrics. • Generate and use CTMS, DM query-trend, and outstanding-monitoring-report metrics to ensure study execution and communicate issues. • Ensure accurate protocol-deviation reporting and follow-up, including re-SDV and closeout where applicable. • Support Protocol Deviation Review Team findings and disseminate information to CRAs. • Conduct monitoring meetings, including agendas, minutes, training tracking, report-quality issues, site trends, and EDC metrics. • Coordinate study-specific training and retraining for study teams, monitors, and site staff. • Develop and maintain Trial Master Files and Investigator Site Files in Veeva Vault, including quarterly eTMF reviews. • Support clinical vendor management for laboratories, central IRB, imaging, patient concierge, and site payment systems. • Facilitate EDC, IRT, TMF, and vendor-system access for site, CRA, and internal teams. • Assist with CRA transition meetings and documentation. • Run study team meetings, including agendas and minutes. • Review site information and informed consents and complete SOP checklists. • Support central and site IRB/IEC and regulatory submissions. • Assist sites, staff, and CRAs with GCP audit preparation. • Maintain CTMS site, staff, milestone, submission, and approval information. • Escalate CRA performance and site-compliance issues. • Collaborate with Clinical Operations, data management, and CRAs to ensure data quality and cleaning timelines. • Assist with supply, sample, and IMP shipment tracking and management. • Review and approve Vendor Data Clarification Forms when applicable. • Prioritize and escalate issues. • Develop or support clinical documents, forms, manuals, trackers, slides, and training materials. • Manage clinical vendors and vendor documentation when assigned. • Perform clinical data review, including patient profiles, listings, summary tables, and query generation. • Report deliverables, timelines, and employee development to the Associate Director, Clinical Operations.

🎯 Requirements

• Bachelor’s degree or master’s degree in natural or health sciences preferred, or equivalent work experience. • Mastery of ICH-GCP, Ascendis SOPs and Work Instructions, and regulatory guidance, with ability to implement them. • Working knowledge of clinical management techniques and tools. • Direct experience working in a cross-functional environment. • 7+ years of combined experience managing/monitoring Phase 1, 2, or 3 clinical trials. • High proficiency in English with strong communication and presentation skills. • Experience managing and overseeing vendors. • Experience performing clinical site monitoring visits, including remote visits. • Ability to prioritize, work independently, manage timelines, and present ideas clearly to sites and stakeholders. • High proficiency with Veeva Clinical Vault eTMF, Veeva EDC, CTMS, Endpoint IRT, and Microsoft Office. • Ability to travel domestically up to 20% for investigator meetings, remote-employee meetings, co-monitoring, if needed.

🏖️ Benefits

• 401(k) plan with company match • Medical, dental, and vision plans • Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance • Company-provided short and long-term disability benefits • Pet Insurance and Legal Insurance • Employee Assistance Program • Employee Discounts • Professional Development • Health Saving Account (HSA) • Flexible Spending Accounts • Various incentive compensation plans • Accident, Critical Illness, and Hospital Indemnity Insurance • Mental Health resources • Paid leave benefits for new parents • Discretionary annual bonus or incentive compensation plan eligibility • Discretionary stock-based long-term incentives • Paid time off • Comprehensive benefits package