Alira Health

Project Manager

• Manages clinical research studies to ensure studies are conducted in accordance with approved scope of work/budget, ICH GCP guidelines, and FDA regulations and within established timelines
• Serves as study lead and primary contact for sponsors
• Manages clinical study functions, which may include investigational supply, IWRS/IXRS, data management, biostatistics, pharmacovigilance, and central laboratory
• Generates and presents frequent study status updates and reports to sponsor
• Supervises and provides support to the Clinical team, including Clinical Assistants, In-house Clinical Research Associates, and Clinical Research Associates
• Supervises and trains Associate PMs
• Creates and reviews clinical study documents, including protocols, ICF templates, study budgets, site log/form templates, study manuals and plans, site binders, etc
• Drives and facilitates clinical teamwork and communications to ensure timely attainment of trial milestones
• Ensures accuracy of reports and material work product
• Provides monthly billing information to finance team
• Presents at project meetings such as investigator meetings and new client meetings
• Updates management accurately and regularly through frequent communication
• Identifies issues and develops problem-solving strategies to ensure study timelines are met
• Manages subject accrual, retention, and compliance
• Assists in TMF management and manages TMF reviews as needed
• Prepares for and participates in third-party audits and FDA inspections
• Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company SOPs
• Participates in internal, client/sponsor, scientific, and other meetings as required
• Performs additional duties as assigned.

Data Scientist

• Ensure DM tasks for the assigned studies are performed on time and within budget
• Partner with Sponsors, clinical and statistics to develop the data collection specification from all data sources
• Manage in-stream data flow activities and deliver a quality database in accordance with the project plan
• Lead and drive the DM team and act as the reference point for the Sponsor
• 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

Senior Data Manager

Software Engineer

• Contribute to develop the clinical database to collect the clinical data provided on paper or electronic CRFs on Medrio
• Program the computerized checks or SAS checks to ensure clean, accurate and complete clinical data
• Act as the reference point for the Lead Data Manager from the Database Programming perspective
• Make recommendations for process improvement
• Bridge scientific or medical knowledge into database programming processes
• Accountable for achieving project milestones from study setup through to delivery of database
• Create the annotated CRF using company standards
• Build the clinical database
• Develop the computerized checks
• Communicate the database setup status to the Lead DM
• Create and validate import programs of electronic data received from external vendors
• Educate/train on use of study specific data collection tools

Project Manager

Senior Data Manager

Senior Database Programmer