Senior Clinical Trial Manager

🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $160k - $170k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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

• Conduct global and regional clinical trials effectively and drive trials to completion according to agreed timelines and quality standards • Foster and maintain clinical site and investigator relationships • Conduct or support informational calls for sites and investigators • Support investigator meeting planning and execution • Review and approve investigational product release packages • Review monitoring reports for protocol, regulatory, and ICH/GCP compliance • Track monitoring report metrics and serve as backup monitor when applicable • Generate and use CTMS, DM query trend, and outstanding monitoring report metrics • Communicate study issues to the Director and CRAs • Ensure accurate protocol deviation reporting and follow up on re-SDV and deviation closure • Support Protocol Deviation Review Team findings and disseminate information to CRAs • Conduct monitoring meetings and prepare agendas and minutes • Coordinate study-specific training and retraining for internal teams, monitors, and site staff • 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 resolutions • Manage or support vendors including central laboratories, IRBs, imaging, patient concierge services, and site payment systems • Facilitate EDC and IRT access requests for site teams • Facilitate CRA access to Ascendis systems and vendor systems • Manage CRA transition meetings and related documentation • Run study team meetings and prepare agendas and minutes • Review site information and informed consents and complete associated checklists • Support central and site IRB/IEC and regulatory submissions • Assist sites, internal 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 on data quality and cleaning timelines • Assist with supply, sample, and investigational product shipment tracking and management • Review and approve Vendor Data Clarification Forms when applicable • Prioritize and escalate issues • Develop or assist with clinical plans, informed consent templates, study forms, manuals, CRF completion guidelines, trackers, presentation 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 knowledge of ICH-GCP, relevant Ascendis SOPs and Work Instructions, and regulatory guidance • Working knowledge of clinical management techniques and tools • Direct work experience 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 and effectively • High proficiency with Veeva Systems (Clinical Vault eTMF, Veeva EDC), CTMS, Endpoint IRT, and Microsoft Office (Outlook, Word, Excel, PowerPoint) • Possibility to travel up to 20% domestically for investigator meetings, meetings with remote employees, and co-monitoring

🏖️ 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 • Remote work option or Palo Alto-based work arrangement • Up to 20% domestic travel as part of the role