Associate Director, Clinical Program Management

About CoderaCodera is a Tang Capital company that provides in-house end-to-end drug development for its portfolio companies. Founded in 2002, Tang Capital is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products.Position SummaryThe 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 ResponsibilitiesSupport CPM Leads with operational tasks and overall conduct of clinical studiesManage study operational plan, including project timelines, budget, and quality of deliverables, throughout the duration of the assigned clinical studiesPartner 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 plansParticipate in the selection of study vendorsResponsible for vendor set up from selection through study close-outManagement of site and vendor-related issues to resolutionResponsible for vendor engagement and oversight, maintaining frequent contact and oversight of applicable vendors to assess performance and provide guidance as neededParticipate in the selection of investigational sitesOversee protocol deviation and risk management reviewsManage study-specific team training per study plans and proceduresProvide input in the development of department processes, procedures, and guidelines, as requiredMay provide or facilitate training of clinical study teams on assigned protocol specific topicsLiaise with all internal and external team members and stakeholders to facilitate achievement of study goalsContribute 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 necessaryProvide ongoing assessment of subject enrollment/discontinuations to inform accurate forecasting and planningEnsure the submission of trial-related and essential documents to the Trial Master File (TMF)Support submission activities, as necessaryDevelop 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 appropriateSupport with alliance management, as neededServe as a resource to facilitate audit/inspections, as applicableQualificationsBachelor’s degree in nursing, Life Science or related field required; Advanced degree preferredMinimum 4-5 years of clinical trial conduct experience with at least 3-4 years of experience at a CRO or biopharmaceutical organization requiredPrior Clinical Research Associate (CRA) experience preferredDetailed understanding of all aspects of clinical protocol design and implementation as well as understanding of overall drug development requiredThorough understanding of FDA, ICH and GCP guidelinesPrevious experience negotiating vendor/site contracts and managing budgets preferredMust be self-motivated, well-organized, detail-oriented and have excellent written and verbal communication skillsResults-driven and capable of managing competing high-priority assignments with a proven track record of achieving deliverables within specified timelinesAbility to establish collaborative working relationships with internal and external stakeholdersProven leadership abilities in a highly complex and dynamic environmentAbility to inspire a collaborative team environmentAbility to work in a dynamic environment with a high degree of flexibilityAbility to interpret study level metrics data and identify risksAbility to proactively identify and mitigate risks through study lifecycleProven experience leading meetings and discussions with internal and external stakeholdersAttendance at all Investigator Meetings, Aurinia all company meetings, as well as occasional travel to sitesMust be willing and able to travel domestically up to and/or internationally up to 15%The job description is not designed to cover or contain a comprehensive list of activities, duties or responsibilities that are required. They may change, or new ones may be assigned at any time with or without notice.The estimated annual base salary for this position is $160,000 - $230,000, commensurate with experience and skills.Codera provides a comprehensive benefits package designed to support employees’ physical, mental and financial health and includes employer sponsored insurance plans including medical, dental and vision coverage; generous paid time off; retirement plan options and additional wellness and professional development programs.Codera provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Codera participate in E‑Verify. All newly hired employees are required to complete the E‑Verify process as part of their employment eligibility verification.