Senior Clinical Trial Manager - Job ID: 2013

About the role

Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company advancing programs in Endocrinology Rare Disease and Oncology. Guided by core values of Patients, Science, and Passion, we use our TransCon® drug development platform to develop new and potentially best-in-class therapies addressing unmet medical needs. The Senior Clinical Trial Manager (Sr CTM) is a key member of the cross-functional team driving one or more global and regional clinical trials to completion according to agreed timelines and quality. This role contributes directly to Ascendis' mission of making a meaningful difference in patients' lives and is part of a global organization with locations in the US, Germany, and Denmark.

The role will be based in Palo Alto, CA or be remote and reports to the Director, Clinical Operations.

Responsibilities

• Foster and maintain favorable clinical site and investigator relationships, including conducting and/or supporting informational calls for sites and investigators.
• Support in planning and conducting investigator meetings, if applicable.
• Review and/or approve of IP release packages.
• Review monitoring reports for compliance to study protocols, regulations, and ICH/GCP. Track and manage monitoring report metrics. Serve as a backup monitor to the monitoring team if applicable.
• Generate and utilize metric reporting (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure the study is conducted per plans and communicates issues to Director and CRAs as appropriate.
• Ensure accurate reporting of Protocol Deviations and follow up with the monitoring team on any subsequent re-SDV and close out of PDs if applicable. Provide assistance with findings from Protocol Deviation Review Team meetings and disseminate applicable information to the CRA team.
• Conduct monitoring meetings, create agendas, and prepare meeting minutes which may include monitoring team training and tracking, report quality issues, site-level issues/trends in data, and EDC metrics reporting.
• Assist in coordinating study-specific training or re-training for the internal study team, internal monitoring team, and site staff as appropriate.
• Responsible for the ongoing development and maintenance of Trial Master File and Investigator Site Files in Veeva Vault, including quarterly eTMF reviews. Assist CRAs in ensuring eTMF completeness, eTMF audit findings, and resolutions.
• Manage and/or support vendor management for central laboratory, central IRB, central imaging, patient concierge services, and site payment systems, including portal access management, report review, sample tracking, metrics review, document reviews, and meeting participation.
• Facilitate EDC and IRT access requests for site teams.
• Facilitate CRA team access to internal Ascendis systems such as TMF, EDC, and vendor systems (e.g., IRT).
• Assist and manage CRA transition meetings, which may include creating and/or reviewing transition documentation.
• Run Study Team Meetings including providing agendas and meeting minutes.
• Review site information/informed consents and complete associated checklists as per Ascendis SOPs.
• Support central and site IRB/IEC and regulatory submissions, as needed.
• Accountable to assist sites, internal staff, and CRAs with the preparation for GCP audits.
• Maintain CTMS including site and site staff contact information, study-level and site-level milestones, regulatory submissions, and approvals on both study and site level.
• Escalate pertinent CRA performance and site compliance issues when necessary.
• Collaborate with Director of Clinical Operations, data management, and CRAs to ensure data quality and compliance with data cleaning timelines.
• Assist CRAs and sites with supply shipment/tracking, sample tracking, and IMP shipment tracking and management.
• May review and approve Vendor Data Clarification Forms.
• Prioritize and escalate issues, as needed.
• May develop or assist in developing study-related clinical documents (e.g., clinical plans, Informed Consent Form templates, study-specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides, and other training materials).
• May be responsible for the management of clinical vendors (e.g., labs, IP, patient diary, home health care) in conjunction with Associate Director.
• May be responsible for development, review, and/or implementation of vendor documentation.
• May perform clinical data review of patient profiles, data listings, and summary tables, including query generation.
• May meet with Associate Director, Clinical Operations on a regular basis to report deliverables, timelines, and employee development.

Requirements

• Bachelor's degree or master's degree in natural or health sciences (biology, pharmacology, pharmaceutical sciences or equivalent) preferred, or equivalent work experience.
• Demonstrates mastery knowledge of ICH-GCP, relevant Ascendis SOPs and Work Instructions, and regulatory guidance, as well as the ability to implement.
• Working knowledge of clinical management techniques and tools.
• Direct work experience in a cross-functional environment.
• 7+ years of combined experience in 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 in performing clinical site monitoring visits, including remote visits.
• Ability to prioritize and work independently on assigned tasks, manage timelines, and present ideas to sites/stakeholders 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% of the time domestically for investigator meetings, meetings with remote employees, co-monitoring, if needed.

Pay

The estimated salary range for this position is $160-170K DOE. Actual salary determination is dependent on a variety of factors including experience, qualifications, and geographic location.

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 Savings 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 stock-based long-term incentives