Senior Clinical Trial Manager

📋 Description

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

• Aid in the planning and execution of investigator meetings, if necessary.

• Review and/or authorize IP release packages.

• Examine monitoring reports for adherence to study protocols, regulations, and ICH/GCP. Track and oversee monitoring report metrics. Serve as a backup monitor to the monitoring team when applicable.

• Create and utilize metric reporting (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure the study is conducted as planned and communicate issues to the Director and CRAs as needed.

• Guarantee accurate reporting of Protocol Deviations and collaborate with the monitoring team on subsequent re-SDV and closure of PDs if necessary.

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

• Organize monitoring meetings, preparing agendas and minutes that may include: monitoring team training and tracking, reporting quality issues, and site-level data trends and EDC metrics reporting.

• Assist in coordinating study-specific training or retraining for the internal study team, internal monitoring team, and site staff as appropriate.

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

• Manage and/or assist with 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 participation in meetings.

• Facilitate EDC and IRT access requests for site teams.

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

• Help coordinate CRA transition meetings, which may involve creating and/or reviewing transition documentation.

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

• Review site information/informed consents and complete associated checklists in accordance with Ascendis SOPs.

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

• Responsible for assisting sites, internal staff, and CRAs with preparation 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 adherence to 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 clinical vendors (e.g., labs, IP, patient diary, home health care) in collaboration with the Associate Director.

• May be responsible for developing, reviewing, and/or implementing vendor documentation.

• May conduct 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 effectively.

• Working familiarity with clinical management techniques and tools.

• Direct experience in a cross-functional environment.

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

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

• Experience managing and supervising vendors.

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

• Ability to prioritize tasks and work independently on assigned responsibilities, manage timelines, and communicate 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).

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

🏝️ 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 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.