[Hiring] Senior Clinical Trial Manager @Ascendis Pharma

Role Description

The Sr. Clinical Trial Manager (Sr CTM) is responsible for effective conduct of Ascendis’ global and regional clinical trials. As a key member of the cross-functional team driving one or more Ascendis’ clinical trials to completion according to agreed timelines and quality, the Sr. CTM contributes directly to Ascendis’ focus on making a meaningful difference in patients’ lives and is part of a global organization with locations in US, Germany and Denmark. The role will be based in Palo Alto, CA or be remote and reports to the Director, Clinical Operations.

Key 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 that the study is conducted per plans and communicate issues to Director and CRAs as appropriate.
• Ensure accurate reporting of Protocol Deviations and follow up with 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, creating agendas and 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.
• 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, including 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 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.

Qualifications

• 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

• 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.