Codera

Research Analyst

•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

Operations

• Develop and execute CMC strategies and activities
• Manage contract manufacturing organizations (CMOs) responsible for drug substance and drug product manufacturing, analytical testing, labeling and packaging
• Ensure that drug substance and drug product control strategies and specifications are appropriate to meet relevant regulations
• Design, conduct and report results for drug substance and drug product characterization
• Develop, validate and continuously improve analytical methods
• Collaborate with regulatory to assure accurate and complete CMC regulatory filings
• Collaborate with quality assurance on vendor qualification and maintenance processes
• Develop and implement appropriate metrics to measure manufacturing goals and objectives, including production cost and quality benchmarks

Associate Director, CMC and Technical Operations

Director

• Provide statistical expertise and input to clinical development programs
• Author detailed statistical analysis plans including the evaluation of study objectives/endpoints, the structure and content of analysis datasets, derivation of variables and sample size/power calculation
• Plan the contents and format of tables, listings and figures (TLFs) to be programmed for the clinical study report (CSR)
• Review CDISC datasets and associated documentation/metadata
• Review Data Management associated documentation and setup of databases
• Support the generation of posters and publications
• Develop statistical programs for data review including detailed listings to identify data issues and vendor reconciliation
• Conduct statistical programming as needed to support quality control of analyses and the success of clinical development programs
• Review and provide input on project related clinical documents from a statistical perspective including protocols, development safety update reports, investigator brochures, and CSRs
• Assist with development of SOPs and quality procedures for biostatistics

Senior Manager – Biostatistics

• 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

Associate Director – Data Management

Compliance

• Provide regulatory strategy advice and support the development and execution of regulatory strategies and plans
• Ensure regulatory milestones are met to support approval strategies and overall business goals of the company
• Plan, prepare and/or review submissions to regulatory authorities including FDA, EMA and other regulatory authorities to support the conduct of clinical trials and approval of marketing applications (e.g., IND, CTA, NDA/BLA, MAA)
• Plan, author and/or review nonclinical and clinical study documents, including but not limited to: Clinical Study Protocols, Clinical Study Reports (CSRs), Investigator’s Brochures (IBs), nonclinical and clinical summaries and scientific publications
• Plan, author and/or review chemistry, manufacturing and controls (CMC) documents, including but not limited to: CMC sections of regulatory applications as well as supporting records summarizing manufacturing process development and validation, analytical method development and validation, comparability study protocols and reports, stability study protocols and reports and justification of shelf-life/expiry dating
• Ensure that regulatory documents are accurate, complete and verifiable and confirm compliance with regulatory requirements and conformance to the company quality standards
• Track progress of regulatory deliverables against timelines, proactively communicate progress and issues to key stakeholders and support development of proactive mitigation plans for identified risks
• Collaborate with vendors who support regulatory operations-related tasks
• Assist with developing and maintaining regulatory document processing and regulatory submission publishing standards and procedures
• Identify and communicate regulatory system enhancement needs or technical issues
• Assist with regulatory inspection activities, as necessary.

Director, Regulatory Affairs

• 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