Alira Health

Research Analyst

• Conduct site monitoring responsibilities for clinical trials
• Provide oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality
• Review monitoring visit reports, conduct co-monitoring and evaluation visits as needed
• Ensure appropriate and timely investigator site visits
• Coordinate with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues
• Assist in development of study-specific Monitoring Plans and training presentations as required
• Manage study budget and act as referent for the sponsor
• Prepare consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status
• Maintain regular contact with study sites to ensure protocol/GCP compliance, assess patient accrual rates, and respond to sponsor requests
• Comply with and ensure team compliance with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs
• Conduct audit preparation at study sites as needed

Senior Clinical Research Associate

Project Manager

• Directs and manages projects from initiation to closure.
• Serves as primary contact for clients.
• Responsible for monitoring and managing a project to ensure it meets Alira Health ’s and the Sponsor’s or other organization’s requirements.
• Responsible for the overall planning and oversight of the projects, from inception to completion.
• Coaches/mentors Senior/Junior Project Managers and supports Project Management Director with process improvement initiatives.

Principal Project Manager

Software Engineer

• Lead and drive the DBP team, acting as mentor and coach
• Contribute to develop the clinical database to collect clinical data provided on paper or electronic CRFs
• Program computerized checks and SAS checks to ensure clean, accurate and complete clinical data
• Act as reference for Lead Data Manager and Project Manager on Database Programming perspective
• Create annotated CRF (aCRF) using company or sponsor naming conventions
• Build clinical database: create variables, codelists, forms and visits per aCRF
• Develop computerized checks and SAS checks according to Data Validation Plan
• Implement mid-study changes to production eCRF and communicate database setup status
• Create and validate import programs for electronic data from external vendors
• Program and validate listings, tracking/metric reports and coding reports
• Plan, prioritise own work; contribute to training and apply SOPs/ICH/GCP; recommend process improvements

Principal Database Programmer

Data Scientist

• The Principal Data Manager leads and drives the DM team, acting as mentor and coach and as the reference point for the Sponsor and the appointed person responsible for the project from the Data Management perspective, to develop the data collection specification from all data sources
• The Principal Data Manager manages in-stream data flow activities and deliver a quality database in accordance with the project plan, ensure DM tasks for the assigned studies are performed on time and within budget, make recommendations for process improvement and/or new standards development
• The Principal Data Manager is an effective input into strategic planning across the department and bridges scientific or medical knowledge to data management processes to ensure sound data collection tools, validations and integration to fit for purpose clinical datasets
• KEY RESPONSIBILITIES: Accountable for driving achievement of project milestones from study start up through to delivery of database
• Provide Data Management input into the protocol Design the Case Record Form and guide process for CRF approval
• Define and develop the Data Management Plan, Data Validation Plan and their annexes (e.g. Reconciliation Plan), with input from the study team
• Validation of the database and computerized checks, including SAS listings or SAS checks
• For EDC studies, define the User Acceptance Test Plan (UAT) and execute the test activities in the test environment to ensure quality eCRF
• For EDC studies, timely response to issues identified by the eCRF Helpdesk
• Prepare CRF completion guidelines
• Prepare study specific data-entry guidelines and train data-entry staff
• Perform term coding for clinical studies, raise manual queries for uncoded terms as required
• Query management: review discrepancies, review answered queries, resolve and close where appropriate, manage the data cleaning process including manual checks and Medical Review listings
• Create and test import programs for electronic data received from external vendors
• Perform timely data integration of CRF and non CRF data (data import from external sources)
• Perform reconciliation of external data (e.g. SAE, Central Labs, ECGs etc )
• Run and monitor study data progress reports including query management and take appropriate actions ( e.g. escalation, re-training, etc ), escalate any study issues within study team
• Define and executive QC plan, lead and execute database release and database freeze activities
• Lead the DM team, coordinate other DM staff providing direction regarding work assignment, scheduling and proritising
• Input into and monitor progress against study project plan and escalate issues to resolution at the appropriate level
• Proven ability to analyse data capture problems/opportunities and a track record of developing and delivering high quality solutions
• Demonstrate broad and integrated knowledge of all aspects of Data Management providing consultancy to other groups outside CDM
• Educate/train on use of study specific data collection tool(s) and query management process
• Effectively contribute in formal training for new starters
• Make recommendations for process improvements and development of new standards
• Maintain continuous and appropriate communication with sponsors and share with them critical and general issues
• Effective relationship management with vendors and customers in order to meet expectations and achieve results
• Effectively represents Data Management in internal or external meetings ( e.g. Investigator’s Meetings)
• Conducts other activities as required

Senior Clinical Research Associate

Principal Project Manager

Principal Database Programmer

Principal, Data Manager - Consultant