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Clinical Trial Manager- Job Id: 1172
Company | Ascendis Pharma |
Address | Palo Alto, CA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Technology, Information and Internet |
Expires | 2023-08-07 |
Posted at | 10 months ago |
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.
- 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.
- Support IRB/IEC and regulatory submissions, as needed.
- Provide input to patient information/consent, eCRF forms and completion guidelines, site instructions for specimen collections, study drug order forms, etc.
- 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.
- Develop or provide input to trial plans, such as Project Management Plan, Enrollment Plan, Monitoring Plan, Protocol Deviation Plan, etc.
- Contribute to data review, and preparation of data cuts for meetings, interim analysis and other requirements
- Participate in identification, qualification, initiation and close-out of clinical trial sites.
- Responsible for the daily management of assigned operational aspects, such as CRO/vendor management, drug supply management, oversight of clinical sites, etc.
- Support safety reporting.
- Review monitoring reports for compliance to study protocols and GCP.
- Participate in project core team meetings as appropriate.
- 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.
- Contribute to Ascendis’ Clinical Quality Management System by authoring or contributing to clinical SOPs.
- Manage and oversee Central Labs.
- Manage, track and oversee clinical site budgets/payments in relation to conduct of a clinical trial.
- Review protocol deviations and data listings.
- Plan and participate in Monitor and Investigator Meetings.
- Maintain and report metrics for trial tracking and clinical site performance, including patient recruitment and retention.
- 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.
- Ability to work across global time zones (including EU, APAC)
- High proficiency in English with strong communication and presentation skills
- Bachelor’s degree or master’s degree preferably in natural or health sciences (biology, pharmacology, pharmaceutical sciences or equivalent)
- Computer skills: Excel, PowerPoint, MS Word, Medidata RAVE
- Estimated salary $140-155K/year
- 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
- Possibility to travel up to 20-30% of the time domestically & internationally
- 5 years of industry experience, including a minimum of 2 years of oncology clinical trial experience. Global clinical trial experience preferred.
- 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
- Working knowledge of FDA, and ICH Good Clinical Practice guidelines
- Commuter benefits
- Dental insurance
- Paid paternity leave
- Paid maternity leave
- 401(k)
- Medical insurance
- Disability insurance
- Vision insurance
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