[Hiring] Associate Director, Clinical Program Management @Codera

Role Description

The Associate Director, Clinical Program Management (CPM) is responsible for leading assigned clinical studies to support Aurinia’s clinical development programs. CPM is accountable for the operational delivery of assigned Aurinia clinical studies from concept through reporting, including inspection readiness, regulatory submission(s) and regulatory review(s). The CPM is an expert on the operational delivery of clinical trials and will bring that expertise to the design and conduct of clinical studies. The CPM is accountable for proactive operational risk management for Aurinia’s clinical studies and will collaborate with all Aurinia functional areas to deliver high-quality clinical trials in accordance with planned milestones.

Essential Duties and Responsibilities

• Support CPM Leads with operational tasks and overall conduct of clinical studies
• Manage study operational plan, including project timelines, budget, and quality of deliverables, throughout the duration of the assigned clinical studies
• Partner closely with Aurinia functional areas to ensure delivery of all study and site goals (e.g., start-up, enrollment, data flow, quality, etc.)
• Monitor study progress against plan; develop and implement operational risk management plans
• Participate in the selection of study vendors
• Responsible for vendor set up from selection through study close-out
• Management of site and vendor-related issues to resolution
• Responsible for vendor engagement and oversight, maintaining frequent contact and oversight of applicable vendors to assess performance and provide guidance as needed
• Participate in the selection of investigational sites
• Oversee protocol deviation and risk management reviews
• Manage study-specific team training per study plans and procedures
• Provide input in the development of department processes, procedures, and guidelines, as required
• May provide or facilitate training of clinical study teams on assigned protocol specific topics
• Liaise with all internal and external team members and stakeholders to facilitate achievement of study goals
• Contribute to the creation and finalization of relevant study documentation by providing operational input into protocol design, clinical study reports as well as other operational plans (monitoring plan, data management plan, etc.)
• Work proactively to ensure alignment on data flow and timely delivery of data; may participate in study data review and other review activities as necessary
• Provide ongoing assessment of subject enrollment/discontinuations to inform accurate forecasting and planning
• Ensure the submission of trial-related and essential documents to the Trial Master File (TMF)
• Support submission activities, as necessary
• Develop and provide key input to the Clinical Trial Budget (e.g., per subject costing)
• Review and approve informed consent form (ICF) and study/country/site level ICFs as appropriate
• Support with alliance management, as needed
• Serve as a resource to facilitate audit/inspections, as applicable

Qualifications

• Bachelor’s degree in nursing, Life Science or related field required; Advanced degree preferred
• Minimum 4-5 years of clinical trial conduct experience with at least 3-4 years of experience at a CRO or biopharmaceutical organization required
• Prior Clinical Research Associate (CRA) experience preferred
• Detailed understanding of all aspects of clinical protocol design and implementation as well as understanding of overall drug development required
• Thorough understanding of FDA, ICH and GCP guidelines
• Previous experience negotiating vendor/site contracts and managing budgets preferred
• Must be self-motivated, well-organized, detail-oriented and have excellent written and verbal communication skills
• Results-driven and capable of managing competing high-priority assignments with a proven track record of achieving deliverables within specified timelines
• Ability to establish collaborative working relationships with internal and external stakeholders
• Proven leadership abilities in a highly complex and dynamic environment
• Ability to inspire a collaborative team environment
• Ability to work in a dynamic environment with a high degree of flexibility
• Ability to interpret study level metrics data and identify risks
• Ability to proactively identify and mitigate risks through study lifecycle
• Proven experience leading meetings and discussions with internal and external stakeholders
• Attendance at all Investigator Meetings, Aurinia all company meetings, as well as occasional travel to sites
• Must be willing and able to travel domestically up to and/or internationally up to 15%

Benefits

• Comprehensive benefits package designed to support employees’ physical, mental and financial health
• Employer sponsored insurance plans including medical, dental and vision coverage
• Generous paid time off
• Retirement plan options
• Additional wellness and professional development programs