Senior Clinical Trial Manager

Ascendis Pharma

Senior Clinical Trial Manager at Ascendis Pharma overseeing global clinical trials for rare diseases. Working cross-functionally to manage projects and ensure compliance throughout clinical processes.

Posted 5/14/2026full-timeRemote • California • 🇺🇸 United StatesSenior💰 $160,000 - $170,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud PlatformVault

About the role

Key responsibilities & impact

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. If applicable, serve as a backup monitor to the monitoring team.
Generate and utilize metric reporting (e.g. CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plans and communicates issues to Director and CRAs as appropriate.
Ensure accurate reporting of Protocol Deviations and follows up with monitoring team of any subsequent re-SDV and close out of PDs if applicable.
Provides any assistance with findings from Protocol Deviation Review Team meetings and disseminates any applicable information to the CRA team.
Conducts monitoring meetings, creating agendas and meeting minutes which may include but is not limited to: 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 which includes quarterly eTMF reviews. Assists CRAs in ensuring eTMF completeness, eTMF audit findings and resolutions.
Manages and/or supports vendor management for central laboratory, central IRB, central imaging, patient concierge services, and site payment systems including but not limited to: portal access management for sites and internal teams, 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.
Reviews site information/informed consents and completes 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
Maintains CTMS including but not limited to: 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 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

What you’ll need

Bachelor’s degree or master’s degree in natural or health sciences (biology, pharmacology, pharmaceutical sciences or equivalent)
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 to work independently on assigned tasks, manage timelines, and to 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.

Benefits

Comp & perks

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
Unique offerings of 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

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Hard Skills & Tools

clinical trial managementmonitoring clinical trialsdata quality assuranceclinical data reviewprotocol deviation managementvendor managementmetric reportingclinical document developmentregulatory submissionsGCP compliance

Soft Skills

communication skillspresentation skillsorganizational skillsindependent workprioritizationcollaborationproblem-solvingteam managementtraining coordinationrelationship management