Alimentiv

Accounting Manager

• Responsible for processing, monitoring, maintaining and reporting of corporate and project-related accounts payable, accounts receivable, credit and collections, expense report processing, project payments and/or related financial transactions.
• Liaise with the Sr. Manager, Accounting, Manager, Procurement, and other Finance team members, vendors, sponsors, regulatory authorities and other functional departments to respond to inquiries and investigate discrepancies.
• Assist Finance team members with transaction entry, system testing, and/or ad hoc reporting as needed.
• Generate, review and/or submit invoices, payments, purchase/standing orders, overdue notices, corporate expenses and project pass-throughs and draws.
• Investigate payment/billing queries from staff, project teams, project sites, sponsors and/or external vendors to resolve payment or billing discrepancies.
• Coordinate, monitor and process project site payments and recoverable expenses.
• Respond to payment inquiries from sites, sponsors and project teams.

Accounting Coordinator

Data Scientist

• Responsible for end-to-end delivery of data management services
• Collaborate with internal and external customers
• Ensure staff deliver high quality, timely service and meet all regulatory requirements
• Hire, manage staff performance, utilization, retention, process improvements
• Financial management for assigned projects

Manager, Clinical Data Management

Compliance

• Responsible for the day-to-day activities and delivery of Global Regulatory Affairs support services.
• Role will include management of clinical trial applications to Competent Authorities, Ethics Committees and Regulatory Agencies.
• Research, review and reporting on applicable global regulations and requirements.
• Develop stakeholder tools, process/document regulatory risk assessments.
• Provide support, expertise and represent the unit with other functional units, sponsors, researchers and/or regulatory authorities.
• Ensure high quality, timely service delivery processes are maintained in accordance with corporate, industry and regulatory standards and guidelines.
• May be required to coach peers and/or provide input for staff performance reviews.

Regulatory Affairs Specialist – North America

• Responsible for the day-to-day activities and delivery of Global Regulatory Affairs support services.
• Role will include management of clinical trial applications to Competent Authorities, Ethics Committees and Regulatory Agencies.
• Develop stakeholder tools, process/document regulatory risk assessments, and provide support, expertise and represent the unit with other functional units, sponsors, researchers and/or regulatory authorities.
• Ensure high quality, timely service delivery processes are maintained in accordance with corporate, industry and regulatory standards and guidelines.
• May be required to coach peers and/or provide input for staff performance reviews.

Regulatory Affairs Specialist – LATAM

Manager

• Drive and deliver on the Alimentiv Site Network (ASN) Strategy.
• Manage the identification, outreach, recruitment and onboarding of high quality, high performing sites into the North America ASN.
• Develop strong relationships with high priority sites & partners through virtual or face-to-face meetings and conference attendance (travel required).
• Build a deep understanding of the challenges of clinical research for sites in GI and how these challenges impact recruitment and research operations.
• Maintain and deliver accurate, real-time analytics on our ASN sites.
• Drive site recruitment in new and existing therapeutic areas and geographies.
• Build solutions to establish and grow a pipeline of high potential sites that are starting in, or naïve to, clinical research.
• Develop a holistic site engagement and support model.

Site Network Manager

• Drive the project management, process optimization and growth of the ASN globally through identification, outreach, collaboration with and onboarding of clinical sites with a focus on enhancing clinical trial delivery.
• Develop and drive Key Performance Indicators around the success of ASN.
• Find innovative solutions to existing and emergent challenges of patient recruitment and facilitate enhanced service delivery to sites within the ASN.
• Manage the identification, outreach, recruitment and onboarding of high quality, high performing sites.
• Build strong relationships with high priority sites & partners through virtual or face-to-face meetings and conference attendance.
• Maintain and deliver accurate, real-time analytics on ASN sites.
• Develop processes and workflows to support a scalable and growing ASN platform.

Data Engineer

• Design, build, and operationalize scalable data solutions to support enterprise analytics and AI/ML initiatives.
• Architect end-to-end pipelines using industry-standard tools.
• Drive automation and move solutions effectively into production.
• Ensure compliance with data governance requirements (including GxP and HIPAA/GDPR).
• Build reusable, integrated pipelines and analytical models that promote self-service analytics.
• Provide technical leadership across the team and mentor junior engineers.
• Partner with business stakeholders to align data engineering with organizational objectives.

Senior Data Engineer

General

• Assist in the execution of all Image Services activities ensuring focus on data integrity and reliability in accordance with standard processes, sponsor guidelines, industry best practices and regulatory standards.
• Provide image collection services to stakeholders in areas of data collection and user system operations.
• Contribute to the delivery of high-quality image services support to internal and external customers, clinical sites, and sponsors.
• May require ability to work shifts, statutory holidays and provide on-call support from time to time.

Image Service Coordinator

Clinical Data Coordinator

• Responsible for assisting in carrying out basic clinical data management activities for assigned projects.
• Ensuring focus on data integrity, validity, reliability in accordance with standard processes.
• Support the department and company in achieving objectives and strategic goals.

Associate

• Responsible for the management of the Trial Master File (TMF) content and associated processes during the study life cycle from study set up to transfer/archiving.
• Work in partnership with study teams during periodic file reviews and audits to address findings related to the TMF.
• Manage access and organization of the controlled electronic file repository, in line with the defined file structure and access management framework.
• Work proactively and successfully within a cross-functional team.
• Communicate and promote department and company goals and practices.
• Interact with stakeholders in a way that fosters a positive working atmosphere and encompasses a professional and helpful attitude.

TMF Associate

Statistician

• Responsible for the application of biostatistical methods to support clinical trials and data management, including statistical planning, design, analysis, and reporting throughout the project life cycle in accordance with project, organizational and regulatory standards.
• Act as subject matter expert, providing statistical support to project teams, quality/study auditors, and external stakeholders.
• Participate in the promotion of Alimentiv as a global research organization, by contributing to the development, publishing, and reporting of project data.
• Lead and develop a group of statisticians and SAS Programmers.

Senior Statistician

Research Analyst

• Manage, deliver and/or perform full clinical site monitoring services for one or more projects
• Responsible for the design and oversight of project monitoring services including training, site/patient recruitment, site data/document management
• Monitoring project site budgets and regulatory filings that aligns with SOPs, study guidelines and GCP best practices
• Act as primary liaison between CRAs and project team
• Participate in the development of project plans, protocols, CRFs, communications or other monitoring forms, documents and tools
• Represent the corporation by maintaining collaborative relationships with stakeholders

Senior Clinical Research Associate – Hungary

• Responsible for the day-to-day activities and delivery of Global Regulatory Affairs support services.
• Role will include management of clinical trial applications to Competent Authorities, Ethics Committees and Regulatory Agencies.
• Research, review and report on applicable global regulations and requirements.
• Develop stakeholder tools and process/document regulatory risk assessments.
• Provide support, expertise and represent the unit with other functional units, sponsors, researchers and/or regulatory authorities.
• Ensure high quality, timely service delivery processes are maintained in accordance with corporate, industry and regulatory standards and guidelines.
• May be required to coach peers and/or provide input for staff performance reviews.

Regulatory Affairs Specialist

Accountant

• Responsible for overseeing financial activities, maintaining accurate and timely financial records, and ensuring compliance with accounting standards and industry best practices.
• Competent in financial reporting, strategy and governance, management accounting, internal controls, finance, and tax.
• Supports the Sr. Manager, Accounting in day-to-day activities and projects, and provides guidance to the Accounting team and others.
• Preparation and/or review of general journal entries for all companies.
• Preparation and review of all management level reporting (product line/executive/departmental) including detailed and appropriate analysis of variances (mainly expenses) where required.
• Evaluate and implement appropriate accounting policies and procedures to meet financial reporting needs.
• Prepare and update account reconciliation files on a pre-determined schedule to ensure the accuracy of financial records and prepare appropriate level balance sheet analysis.
• Identify and resolve discrepancies in financial statements.
• Communicate with internal/external stakeholders to ensure any outstanding balances are cleared appropriately
• Preparation of accurate and timely entries relating to payroll transactions.
• Coordinate with tax professionals to prepare and file tax returns by providing data and responses in a timely manner.
• Assess tax requirements for all entities to ensure best practices are implemented and entities are compliant with regulations and guidelines.
• Document and where necessary develop and maintain departmental processes and procedures to ensure up-to-date detailed work instructions.
• Identify operational risks and implement internal controls to minimize risk that aligns with organization’s strategy, mission, vision, and values.
• Working with the Sr. Manager, Accounting, identify and prioritize projects, develop a workplan and monitor through completion.
• Work closely with cross-functional teams to provide financial support and guidance.
• Collaborate with other accounting and finance professionals to maintain consistency and best practices.
• Support various special projects from creation to implementation including software implementation and product line analytical and accounting support where required.

Senior Accountant

• Manage, deliver and/or perform full clinical site monitoring services for one or more projects, which may include multiple services, be complex in nature and/or run on a multinational scale.
• In-house based position, responsible for the design and oversight of project monitoring services including training, site/patient recruitment, site data/document management, monitoring project site budgets and regulatory filings that aligns with SOPs, study guidelines and GCP best practices.
• In the function of Lead CRA, will act as primary liaison between CRAs and project team and may be required to participate in the development of project plans, protocols, CRFs, communications or other monitoring forms, documents and tools.
• Represents the corporation by maintaining collaborative relationships with stakeholders.