Associate Director, Clinical Operations
Location: Palo Alto
Posted on: September 16, 2022
Yoh is seeking an Associate Director, Clinical Operations -
Oncology for our Biopharmaceutical client on the San Francisco
Peninsula. The AD will be responsible for effective conduct of
global and regional clinical trials. As a key member of the
cross-functional team driving clinical trials to completion, the AD
contributes directly to the focus on making a meaningful difference
in patients' lives. Title: Associate Director, Clinical Operations
- Oncology Location: San Francisco Bay Area Type: Permanent
Industry: Biopharma Pay: Competitive 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:
- Bachelor's degree or master's degree in natural or health
sciences (biology, pharmacology, pharmaceutical sciences or
- 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
- 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 &
internationally -Yoh, a Day & Zimmermann company, is an Equal
Opportunity Employer. All qualified applicants will receive
consideration for employment without regard to race, color,
religion, sex, sexual orientation, gender identity, national
origin, disability, or status as a protected veteran.Visit -to
contact us if you are an individual with a disability and require
accommodation in the application process.
Keywords: Yoh, Palo Alto , Associate Director, Clinical Operations, Healthcare , Palo Alto, California
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