About this opportunity
Planet Pharma lists this Associate Director, Clinical Trial Management opportunity in brisbane, California. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Responsibilities include:
Accountable for the oversight and execution of multiple clinical trials including:
Develop, implement, and provide oversight of vendor budgets and contracts
Tracking and reporting of study metrics
Identifyand mitigate risks to study implementation, enrollment, conduct, compliance, and completion
Develop and manage effective working relationships with Investigators and other key clinical opinion leaders
Provides technicalexpertisefor the development of clinical documents (protocols, monitoring plans, clinical trials report, investigator brochures, etc.) and trial conduct
Remains current with therapeutic areas under study, industry practices /trendsand FDA requirements.Applies this knowledgeto current programs
Partners with andmaintainsregular contact with key stakeholders including Regulatory, Clinical Development, Legal, Finance, and others as necessary
Leads the team in the selection of Contract Research Organizations (CROs) for both large budget and small budget
AttendsCRO or other vendor meetings such as project kick-off and investigator meetings, quarterly face-to-face meetings, and others as necessary to assure alignment and achievement of study goals
Contributes to definition, development, and implementation of Clinical Operations functional initiatives for role clarity and institution of best practices
Travel may be required to 30% in support of clinical study activities
Education, Experience, and Skills:
Required:
BS/BA degree in related discipline or equivalent combination of education and experience
10+ years of experience leading clinical trial operations including multinational/multisite clinical studies with experience in ophthalmology, neurology, rare diseases, and overall drug development. Strong leadership skills with ability to be hands-on and lead/ manage the clinical team. Experience with direct line-management of clinical operations staff.
Has a thorough knowledge of the clinical development process, FDA, EMA and other regulatory requirements that may impact global clinical studies as well as ICH and GCP guidelines
Has demonstrated success identifying, negotiating and overseeing outsourced clinical operations services and vendors
Experience with financial budgeting or reporting
Ability to interact with investigators, vendors, and individuals at all levels of the organization
Base $175-200K based on experience level
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Worksite address
brisbane, CA, 94005, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.