Associate Director, Clinical Operations - Oncology
Company: Ascendis Pharma
Location: Palo Alto
Posted on: September 23, 2022
The Associate Director (AD) 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 AD / 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 Director of
Clinical Operations, Oncology.Key Responsibilities
- Chair 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
- Review monitoring reports for compliance to study protocols and
- 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.
- Manage and oversee contracted CROs and vendors; identify
potential risks and resolve issues with CROs; establish vendor
management plans and review quality metrics.
- Plan and participate in Monitor and Investigator Meetings.
- Review protocol deviations and data listings.
- 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
- Support safety reporting.
- Maintain and report metrics for trial tracking and clinical
site performance, including patient recruitment and retention.
- Participate in project core team meetings as appropriate.
- Contribute to Ascendis Clinical Quality Management System by
authoring or contributing to clinical SOPs.
- Oversee junior team member deliverables as needed.
- Associate Director may perform line management for 1 2 team
members, depending on experience.Requirements
- Bachelors degree or masters degree in natural or health
sciences (biology, pharmacology, pharmaceutical sciences or
- Ability to work across global time zones (including EU,
- High proficiency in English with strong communication and
- Possibility to travel up to 20-30% of the time domestically &
- Associate Director role requires minimum 8-10 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
- Experience in performing monitoring oversight visits, including
remote visits, desired
- 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 lawBenefits
- Medical insurance
- Vision insurance
- Dental insurance
- Paid maternity leave
- Paid paternity leave
- Commuter benefits
- Disability insurance
Keywords: Ascendis Pharma, Palo Alto , Associate Director, Clinical Operations - Oncology, Executive , Palo Alto, California
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