Codera

Medical Director

• Responsible for the successful start-up, monitoring and execution of Phase I-IV studies at assigned clinical sites
• Perform clinical site management and monitoring activities in compliance with principles of ICH-GCP guidelines, SOPs, local laws and regulations, study protocol(s), applicable study plans and working guidelines
• Serve as primary point of contact for clinical sites through all phases from start-up to close-out of clinical studies
• Arrange for monitoring availability and ensure data entry timelines are maintained at assigned sites
• Perform required monitoring, including required source data verification, and ensure site activities are conducted in established timelines
• Develop and cultivate strong site relationships and ensure continuity of site relationships
• Communicate with investigators and site staff on issues related to protocol conduct, recruitment, protocol deviations, inspection readiness and overall site performance
• Identify, assess, escalate and resolve site performance or quality issues in a timely manner
• Complete feasibility and site identification activities for new clinical studies
• Conduct start-up and maintenance activities for designated sites including preparation and collection of essential documents required for regulatory and IRB/EC submission (initial and amendments)
• Facilitate communication with appropriate site staff involved in start-up and IRB/EC submissions
• Facilitate site budget and site contract negotiations and ensure timely finalization of the required clinical trial agreements for designated sites in collaboration with clinical program management and finance
• Responsible for the development of site specific recruitment, retention and follow-up plans
• Facilitate and support investigator site audits and/or inspection activities as needed
• Perform remote data review and query resolution for designated sites
• Contribute to overall clinical operations team knowledge by sharing best practices and participating in improvement initiatives
• Coach and mentor colleagues as needed
• Contribute to the review of Codera’s systems and procedures as needed
• May be involved, when needed, in other areas of study management and staff training
• Execute other duties as assigned

Clinical Research Associate – Site Director

• Support the planning and execution of clinical development programs, ensuring alignment with overall program strategy and timelines
• Contribute to the evaluation and refinement of development strategies to mitigate risks and advance clinical assets efficiently
• Participate in the planning, delivery and cross-functional coordination of clinical trials from early to late phases
• Assist in the development, review and refinement of clinical trial protocols, ensuring scientific rigor, ethical conduct and regulatory compliance
• Provide medical and clinical input throughout the clinical trial lifecycle, including safety monitoring, data interpretation and risk management
• Partner with biometrics and medical writing to ensure clinical and nonclinical studies are designed, analyzed and summarized appropriately in accordance with timelines, good quality practices and applicable regulatory requirements
• Collaborate with regulatory affairs and other departments to support regulatory strategies, clinical trial submissions and responses to health authorities
• Support data analysis and reporting activities, contributing strategic insights to inform decision-making and regulatory submissions

Director – Clinical Development

• Lead end-to-end clinical supply chain operations for assigned international studies
• Serve as the primary clinical supply chain contact for assigned studies
• Provide study- and site-level operational support, including resupply requests facilitation, returns and destruction oversight, and temperature excursion management
• Develop and execute global inventory supply plans in coordination with Technical Operations, Clinical Operations and Quality Assurance
• Lead label development efforts for assigned studies, including booklet label development for international studies
• Manage manual and IRT-enabled drug supply shipments
• Facilitate and oversee storage, returns, reconciliation and destruction
• Monitor inventory levels, drug product expirations and resupplies
• Oversee import/export licenses and customs forms
• Ensure batch release dates are properly prioritized for key study timelines
• Review and approve packaging and labeling documents and batch records
• Prepare and manage clinical supply projections
• Maintain budget for supply chain operations for assigned studies and review and track monthly invoices from vendors against budget
• Ensure clinical supply documentation is organized and filed to the Trial Master File (TMF), per SOPs
• Participate in inspection readiness efforts, ensuring clinical supply chain is prepared for qualifications

Associate Director – Clinical Supply Chain

Program Manager

• 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

Associate Director, Clinical Program Management

Director

• Support the Data Management (DM) department and all clinical development programs
• Responsible for Electronic Data Capture (EDC) vendor oversight, project timeline management, clinical database setup through closeout, creation of data management documents, data metrics reporting, and data cleaning activities
• Act as the data management lead for one or more clinical studies including responsibility for all data management and back-end activities from database start-up through database lock
• Establish and oversee partnerships with DM vendors and other external partners
• Ensure clinical databases and external data files are designed in a standard, accurate, complete, and consistent format to produce datasets that are conducive to analysis and regulatory submission
• Oversee data management vendors with respect to key performance indicators, metrics, program level deliverables, and timelines
• Review and provide feedback to the clinical team on study documents, including clinical monitoring plans, statistical analysis plans and vendor specifications
• Review protocols for all data management activities to ensure data is properly captured via CRF design and data requirements
• Coordinate and participate in the review of clinical data, tables/listings/figures (TLF) analysis, and patient profiles for data consistency and accuracy
• Ensure that all clinical trials have complete and accurate data and supporting documentation for regulatory submission and data analysis, including raw datasets and annotated CRFs
• Ensure data management project documentation is in an audit-ready format
• Oversee the building, validation, and maintenance of clinical trial databases in accordance with ICH/GCP guidelines and current regulatory requirements
• Oversee the generation of key documents such as data validation specifications, manual data review guidelines, data management plans, data cut plans, CRF completion guidelines, data access plan, data transfer agreements, etc.
• Work closely with statistics and programming to ensure high-quality data output including data cleaning/validation, SAS listings review, TLF dry runs, etc.
• Develop, track, analyze, and report internal data management performance metrics
• Lead computer system development initiatives including database integration, data sharing, access, and storage
• Support the setup of other systems such as the safety database and IRT
• Contribute to budget/resource planning, re-forecasting and program milestones
• Provide leadership, training, and support to data managers
• Communicate and escalate project issues involving processes, timelines, resourcing, performance, etc. and establish appropriate courses of action with senior management
• Assist in the preparation and support of clinical documentation for IND and NDA submissions as appropriate
• Assist with directing the activities of the data management team to complete project deliverables on schedule and per quality standards and requirements from study start-up through archival
• Assist with the development of SOPs and specific quality processes and procedures for data management
• Ensure data management activities are conducted in accordance with GCP, internal SOPs, and all regulatory requirements
• Assist with departmental performance evaluations, goal setting, career development, and growth
• Ensure all study specific training is kept up to date and documented for the department

Clinical Research Associate – Site Director

Director – Clinical Development

Associate Director – Clinical Supply Chain

Associate Director, Clinical Program Management

Associate Director – Data Management