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The Clinical Trial Manager (CTM) is responsible for effective conduct of Ascendis global and regional clinical trials. As a key member of the cross-functional team driving 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 is based in Palo Alto, CA or may be remote and reports to the Associate Director of Clinical Operations, Oncology.

This role requires working across programs, and taking on key responsibilities across programs

Key Responsibilities

• Responsible for the daily management of assigned operational aspects, such as CRO/vendor management, drug supply management, oversight of clinical sites, etc.

• Manage and oversee contracted vendors; manage budgets, review accrual reports, identify potential risks and resolve issues with CROs; establish vendor management plans and review quality metrics.
• Manage and oversee Central Labs.
• Maintain and report metrics for trial tracking and clinical site performance, including patient recruitment and retention.
• Support safety reporting.
• Review protocol deviations and data listings.
• Lead/manage internal clinical trial teams with representation from relevant functional areas.
• Contribute to clinical trial protocols in collaboration with the Medical Monitor or Clinical Scientist.
• Coordinate and drive identification, assessment, and selection of relevant CROs and vendors; for example, central and special laboratories and imaging service providers.
• Successfully manage and own clinical site and investigator relationships.
• Review monitoring reports for compliance to study protocols and GCP.
• Manage, track and oversee clinical site budgets/payments in relation to conduct of a clinical trial.
• Participate in identification, qualification, initiation and close-out of clinical trial sites.
• Develop or provide input to trial plans, such as Project Management Plan, Enrollment Plan, Monitoring Plan, Protocol Deviation Plan, etc.
• Provide input to patient information/consent, eCRF forms and completion guidelines, site instructions for specimen collections, study drug order forms, etc.
• Plan and participate in Monitor and Investigator Meetings.
• Support IRB/IEC and regulatory submissions, as needed.
• Communicate directly with trial site staff and investigators to support the relationship between the sponsor, CRO, and site, including co-monitoring or monitoring / Sponsor oversight visits.
• Participate in project core team meetings as appropriate.

• Contribute to Ascendis Clinical Quality Management System by authoring or contributing to clinical SOPs.
• Contribute to data review, and preparation of data cuts for meetings, interim analysis and other requirements

Requirements

• Bachelors degree or masters degree preferably in natural or health sciences (biology, pharmacology, pharmaceutical sciences or equivalent)
• Ability to work across global time zones (including EU, APAC)
• High proficiency in English with strong communication and presentation skills
• Possibility to travel up to 20-30% of the time domestically & internationally

• Working knowledge of FDA, and ICH Good Clinical Practice guidelines
• 5 years of industry experience, including a minimum of 2 years of oncology clinical trial experience. Global clinical trial experience preferred.

• Experience working in a cross-functional matrix environment, CRO management and oversight, and managing and overseeing vendors
• Experience in performing monitoring oversight
• Ability to prioritize and to work independently on assigned tasks, manage timelines, and to present ideas to sites / stakeholders clearly and effectively
• Computer skills: Excel, PowerPoint, MS Word, Medidata RAVE
• New hires based in the US will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law
• Estimated salary $140-155K/year

Benefits

• Medical insurance
• Vision insurance
• Dental insurance
• 401(k)
• Paid maternity leave
• Paid paternity leave
• Commuter benefits
• Disability insurance