Senior Clinical Trial Manager

This is a fully remote position, open to applicants in California.

📋 Description

• Cultivate and sustain positive relationships with clinical sites and investigators, including conducting and/or supporting informational calls.

• Assist in the planning and execution of investigator meetings, when applicable.

• Review and/or authorize IP release packages.

• Evaluate monitoring reports for adherence to study protocols, regulations, and ICH/GCP standards. Track and manage monitoring report metrics, and if necessary, act as a backup monitor for the monitoring team.

• Generate and leverage metric reporting (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports) to guarantee that the study follows planned protocols and communicates issues to the Director and CRAs as needed.

• Ensure precise reporting of Protocol Deviations and collaborate with the monitoring team on any subsequent re-SDV and closure of PDs if required.

• Provide support with findings from Protocol Deviation Review Team meetings and share relevant information with the CRA team.

• Conduct monitoring meetings, preparing agendas and minutes, which may encompass: monitoring team training, report quality concerns, site-level issues/trends in data, and EDC metrics reporting.

• Aid in organizing study-specific training or re-training for the internal study team, the internal monitoring team, and site staff as appropriate.

• Responsible for the continuous development and upkeep of the Trial Master File and Investigator Site Files in Veeva Vault, including quarterly eTMF reviews. Support CRAs in ensuring eTMF completeness, audit findings, and resolutions.

• Oversee and/or assist with vendor management for central laboratory, central IRB, central imaging, patient concierge services, and site payment systems, which includes but is not limited to: managing portal access for sites and internal teams, reviewing reports, tracking samples, examining metrics, conducting document reviews, and participating in meetings.

• Facilitate EDC and IRT access requests for site teams.

• Enable CRA team access to internal Ascendis systems such as TMF, EDC, and vendor systems (e.g., IRT).

• Assist in managing CRA transition meetings, which may involve creating and/or reviewing transition documentation.

• Organize Study Team Meetings, providing agendas and meeting minutes.

• Review site information/informed consents and complete associated checklists according to Ascendis SOPs.

• Support central and site IRB/IEC and regulatory submissions, as needed.

• Accountable for assisting sites, internal staff, and CRAs in preparing for GCP audits.

• Maintain CTMS, including but not limited to: site and site staff contact information, study-level and site-level milestones, and regulatory submissions and approvals at both study and site levels.

• Escalate relevant CRA performance and site compliance issues when necessary.

• Collaborate with the 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 management.

• May review and authorize Vendor Data Clarification Forms.

• Prioritize and escalate issues as needed.

• May develop or assist in creating 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 oversee the management of clinical vendors (e.g., labs, IP, patient diary, home health care) in collaboration with the Associate Director.

• May be responsible for the development, review, and/or implementation of vendor documentation.

• May perform clinical data reviews of patient profiles, data listings, and summary tables, including query generation.

• May meet regularly with the Associate Director of Clinical Operations to report on deliverables, timelines, and employee development.

⛳️ Requirements

• Bachelor’s or master’s degree in natural or health sciences (biology, pharmacology, pharmaceutical sciences, or equivalent).

• Demonstrates comprehensive knowledge of ICH-GCP, relevant Ascendis SOPs and Work Instructions, and regulatory guidance, along with the ability to implement them.

• Familiarity with clinical management techniques and tools.

• Direct work experience in a cross-functional environment.

• Over 7 years of combined experience in managing/monitoring Phase 1, 2, or 3 clinical trials.

• High proficiency in English with strong communication and presentation abilities.

• Experience managing and overseeing vendor relationships.

• Experience conducting clinical site monitoring visits, including remote visits.

• Ability to prioritize tasks and work independently, manage timelines, and clearly present ideas to sites/stakeholders.

• High proficiency with Veeva Systems (Clinical Vault eTMF, Veeva EDC), CTMS, Endpoint IRT, and Microsoft Office (Outlook, Word, Excel, PowerPoint).

• Willingness to travel up to 20% of the time domestically for investigator meetings, meetings with remote employees, and co-monitoring, if necessary.

🏝️ 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 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.