Senior Clinical Trial Manager

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

📋 Description

• Establish and nurture positive relationships with clinical sites and investigators, including conducting informational calls.

• Assist in the planning and execution of investigator meetings.

• Review and/or authorize IP release packages.

• Evaluate monitoring reports for compliance with protocols, regulations, and ICH/GCP standards; monitor and track report metrics.

• Generate and utilize CTMS, DM query-trend, and outstanding monitoring report metrics to ensure effective study execution and address issues.

• Ensure precise reporting of protocol deviations and follow-up actions, including re-SDV and closeout as necessary.

• Support the findings of the Protocol Deviation Review Team and share information with CRAs.

• Organize monitoring meetings, covering agendas, minutes, training tracking, report quality issues, site trends, and EDC metrics.

• Coordinate study-specific training and retraining for study teams, monitors, and site personnel.

• Create and maintain Trial Master Files and Investigator Site Files in Veeva Vault, including quarterly eTMF reviews.

• Assist in managing clinical vendors for laboratories, central IRB, imaging, patient concierge, and site payment systems.

• Facilitate access to EDC, IRT, TMF, and vendor systems for sites, CRAs, and internal teams.

• Aid in CRA transition meetings and associated documentation.

• Lead study team meetings, including preparing agendas and minutes.

• Review site information and informed consent documents, completing SOP checklists.

• Support central and site IRB/IEC and regulatory submission processes.

• Assist sites, personnel, and CRAs in preparing for GCP audits.

• Maintain CTMS information related to sites, staff, milestones, submissions, and approvals.

• Escalate issues related to CRA performance and site compliance.

• Collaborate with Clinical Operations, data management, and CRAs to ensure data quality and adhere to cleaning timelines.

• Assist in tracking and managing supply, sample, and IMP shipments.

• Review and approve Vendor Data Clarification Forms as necessary.

• Prioritize and escalate issues effectively.

• Develop or assist in creating clinical documents, forms, manuals, trackers, slides, and training materials.

• Manage assigned clinical vendors and their documentation.

• Conduct clinical data reviews, including patient profiles, listings, summary tables, and query generation.

• Report deliverables, timelines, and employee development progress to the Associate Director of Clinical Operations.

⛳️ Requirements

• Bachelor’s or master’s degree in natural or health sciences preferred, or equivalent professional experience.

• Comprehensive understanding of ICH-GCP, Ascendis SOPs and Work Instructions, and regulatory guidelines, with the ability to implement them effectively.

• Proficient knowledge of clinical management techniques and tools.

• Direct experience in a cross-functional work environment.

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

• High level of proficiency in English, with strong communication and presentation capabilities.

• Experience in managing and overseeing vendors.

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

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

• High proficiency with Veeva Clinical Vault eTMF, Veeva EDC, CTMS, Endpoint IRT, and Microsoft Office applications.

• Willingness to travel domestically up to 20% for investigator meetings, remote employee meetings, and co-monitoring as 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

• Pet Insurance and Legal Insurance

• Employee Assistance Program

• Employee Discounts

• Professional Development opportunities

• 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

• Eligibility for discretionary annual bonus or incentive compensation plans

• Discretionary stock-based long-term incentives

• Paid time off

• Comprehensive benefits package