Senior Clinical Trial Manager - Job ID: 2020

About the role

Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Here at Ascendis, we are advancing programs in Endocrinology, Rare Disease, and Oncology. Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark.

Responsibilities

• Foster and maintain favorable clinical site and investigator relationships.
• 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.
• 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 of any subsequent re-SDVs 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.
• 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.
• Performs clinical data review of patient profiles, data listings and summary tables, including query generation.
• Meets 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.
• 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

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 include:

• 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
• Variety of incentive compensation plans
• Accident, Critical Illness, and Hospital Indemnity Insurance
• Mental Health resources
• Paid leave benefits for new parents