The Senior 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. 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- Bachelor's degree or master's degree in natural or health sciences (biology, pharmacology, pharmaceutical sciences or equivalent) preferred, or equivalent work experience.
- 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.
The estimated salary range for this position is $160-170K DOE. Actual salary determination is dependent on a variety of factors some of which include: experience, qualifications, and geographic location. This position may be eligible for a discretionary annual bonus or an incentive compensation plan (eligibility varies based on role and position level), discretionary stock-based long-term incentives, paid time off, and a comprehensive benefits package.
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
