Associate Director, Clinical Trial Management

Responsibilities

• 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
• Identify and 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 technical expertise for 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 / trends and FDA requirements; applies this knowledge to current programs
• Partners with and maintains regular 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
• Attends CRO 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 up to 30% in support of clinical study activities

Education

BS/BA degree in related discipline or equivalent combination of education and experience.

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 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.

Skills

• 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.

Pay

Base $175-200K based on experience level.