Alimentiv

Manager

• Develop, implement, and continuously refine risk-based CSV strategies for both off-the-shelf and custom-developed software, ensuring alignment with FDA, EMA, GCP, and ICH guidelines.
• Oversee the full lifecycle of validation activities, including planning, execution, documentation, and maintenance, with a focus on integrating CSV into agile software development processes.
• Ensure validation deliverables such as risk assessments, validation plans, protocols, test cases, and traceability matrices are prepared to the highest standards of quality and regulatory compliance.
• Monitor and interpret changes in global regulatory requirements, proactively updating internal policies and procedures to maintain compliance and operational excellence.
• Utilize technology to drive operational efficiencies into the CSV process.
• Serve as the subject matter expert on regulatory requirements for computerized systems supporting clinical research, providing guidance on the practical application of regulations to diverse technology solutions.
• Collaborate closely with Quality to identify, assess, and remediate compliance gaps, ensuring all systems meet GCP and other relevant standards.
• Lead the preparation and submission of documentation for regulatory inspections, audits, and sponsor audits, ensuring timely and accurate responses to findings and observations.
• Act as a strategic partner to corporate IT, Product, software development, Quality, and operational teams, facilitating the integration of CSV requirements into business processes and technology projects.
• Advocate for pragmatic, risk-based approaches that balance regulatory compliance with business agility and innovation.
• Design and deliver training programs to build organizational capability in CSV principles, regulatory requirements, and best practices.
• Lead, mentor, and develop a team of validation specialists, fostering a culture of collaboration, accountability, and continuous improvement.
• Ensure the team is appropriately resourced, trained, and equipped to deliver on validation objectives and support organizational growth.
• Conduct regular performance reviews, set clear goals, and provide constructive feedback to support professional development and high performance.
• Represent the CSV function during internal and external audits, regulatory inspections, and sponsor reviews.
• Coordinate the investigation and resolution of audit findings, ensuring corrective and preventive actions are implemented effectively and sustainably.
• Maintain readiness for audits by ensuring documentation, processes, and systems are consistently compliant and up to date.

Manager, Computer System Validation – CSV

Financial Planning and Analysis

• In collaboration with Manager, Financial Planning & Analysis, support all activities related to financial planning & analysis for all company product lines, including the analysis and forecasting of revenue, profitability, costs, and backlog, expenses etc.
• Act as a liaison between finance and project operational groups to support the development of systems to improve financial related communications and tracking of project financial metrics, including providing support for the collection of data and the identification of cost saving opportunities at the product, department, and project level.

Financial Planning and Analysis Coordinator

Administration

• Collaborates with cross-functional stakeholders to gather, analyze, and translate business needs into actionable requirements & specifications for Vault Clinical applications.
• Configures, validates, and implements Vault Clinical solutions across all applications, including workflows, lifecycles and metadata.
• Coordinates planning & deployment of vendor platform updates, including evaluation of new features & releases, impact analysis, readiness assessments, and production roll-out.
• Identifies and recommends innovative Vault Clinical enhancements aligned with Alimentiv’s strategic direction & roadmap for the platform.
• Collaborates with business and technical stakeholders to execute data migrations and system integrations (e.g., EDC) connected to Veeva Vault.
• Ensures alignment and consistency of configurations across Vault Clinical applications, coordinating with delivery & support staff to maintain a coherent architecture.
• Maintains configuration of Vault Clinical applications (eTMF, CTMS, Study Training, Study Startup, Site Connect) and underlying Vault Platform data architecture (Global Directory).
• Manages system change requests, applying change controls in accordance with internal policies & SOPs and external regulations.
• Manages user accounts & permissions, applying role-based access principles and conducting user access reviews.
• Liaises with vendor support & professional services for issue resolution and escalation when required.
• Oversees data governance of Vault Platform, monitoring data integrity and quality.
• Conducts system risk assessments and develops & applies mitigations to ensure security, integrity and availability of the platform in accordance with GxP regulations (21 CFR Part 11, EMA) and ISO 27001 principles.
• Maintain system documentation, including validation deliverables, SOPs and work instructions, to ensure regulatory compliance and audit readiness.
• Oversee user training and development & maintenance of comprehensive training resources to drive user adoption and support effective system use.
• Provide technical support and guidance to internal and external Vault Clinical users, ensuring timely resolution of system issues and user inquiries.
• Serves as a trusted partner to non-technical users, ensuring clear communication and practical guidance to support adoption and effective use of the platform.
• Develop and maintain reports and dashboards for internal and external users leveraging Vault Clinical data to support operational visibility and decision-making.
• Formally supervise and oversee the work of internal Veeva solution delivery & support staff.
• Assign and prioritize workloads to ensure timelines and quality expectations are met.
• Support recruitment activities, including onboarding and training new team members.
• Set, track, and evaluate performance objectives to align with departmental strategies.
• Conduct performance reviews and support team competency development.
• Provide conflict resolution support and maintain positive team morale.
• Monitor resourcing, capacity, and availability of staff, escalating concerns to Sr leadership as required.

Manager, Veeva Vault Administration

Business Development Rep

• Partner with the Executive Team to define and execute business development and growth strategies, aligned with corporate objectives.
• Lead annual sales planning, forecasting, and execution to achieve aggressive revenue targets.
• Monitor industry trends and competitor activity to inform growth strategies.
• Identify new market segments, partnership models, and strategic opportunities to expand client base and service offerings.
• With Marketing, define and execute cross-promotion strategies with external partners.
• Serve as a trusted advisor to pharma/biotech partners and key stakeholders, fostering long-term strategic client relationships.
• Oversee contract negotiations, pricing and proposals in collaboration with key stakeholders.
• Represent the organization at industry events, strengthening market reputation.
• Drive new business growth and achieve quarterly and annual targets.
• Lead key account planning and build and maintain qualified pipeline.
• Partner with Operations and Leadership to ensure alignment between service delivery and client needs.
• Oversee proposals and budgets to ensure client needs and profitability goals are met.
• Implement efficient business development process, CRM utilization and continuous improvement initiatives.
• Develop and report on performance metrics, forecasts and business analytics to guide data-driven solutions and ensure alignment with strategic objectives.
• Ensure seamless client onboarding and drive high post-sales satisfaction through strong internal collaboration, providing client feedback and proposing action as needed.
• Lead, mentor, and inspire a business development team, fostering accountability and excellence.
• Optimize team effectiveness through coaching, training, goal setting, performance management.
• Responsible for team resource and succession planning.
• Serve as a role model, promoting a culture of engagement, innovation and high-performance.

VP, Business Development

• The Sr. Manager, Study Start-Up is responsible for overseeing and driving all global and regional activities related to clinical study start up, site feasibility, site selection, contract and budget negotiations, and site activation.
• This role ensures timely, high-quality, and compliant study start-up deliverables to support the successful execution of clinical trials across the organization’s portfolio.
• This role will implement the SSU skills development strategy, will build functional expertise across all regions and countries, manage a portfolio of site activation improvement initiatives, drive excellence in execution of site activation and manage external and internal customer’s expectations through the delivery of excellent solutions that ensure all milestones and quality targets are met.

Manager, Computer System Validation – CSV

Financial Planning and Analysis Coordinator

Manager, Veeva Vault Administration

VP, Business Development

Senior Manager, Study Start-Up