Allucent

Research Analyst

• Independently manage all aspects of monitoring for assigned clinical trials across study phases, including site initiation, routine monitoring, and close-out visits.
• Ensure compliance with protocols, GCP, ICH, SOPs, and applicable regulatory requirements.
• Build strong site relationships, acting as a primary point of contact and ensuring high-quality data collection.
• Identify and resolve site issues, escalating as needed to maintain trial integrity and patient safety.
• Mentor and support junior CRAs, sharing knowledge and best practices.

Clinical Research Associate II – Senior Clinical Research Associate

• Independently manage all aspects of monitoring for assigned clinical trials across study phases, including site initiation, routine monitoring, and close-out visits.
• Ensure compliance with protocols, GCP, ICH, SOPs, and applicable regulatory requirements.
• Build strong site relationships, acting as a primary point of contact and ensuring high-quality data collection.
• Identify and resolve site issues, escalating as needed to maintain trial integrity and patient safety.
• Activities around regulatory affairs, site activation and study-startup.

Clinical Research Associate II

Business Development Rep

• Generate and qualify new business leads and set up meetings with potential clients.
• Collaborate with Business Development colleagues to build and execute strategic territory plans.
• Research potential clients using tools such as GlobalData, Zymewire, LinkedIn Navigator, and ZoomInfo.
• Develop and deliver targeted outreach campaigns and messaging to prospective clients.
• Manage the early stages of the sales process by identifying client needs and introducing Allucent’s service offerings.
• Coordinate with Marketing to support conferences, events, and promotional activities.
• Track and report outreach activity in Salesforce, providing insights to drive improvement.
• Support preparation for client meetings.
• Contribute to continuous improvement in Business Development processes and quality systems.

Senior Account Development Manager – Europe

Director

• Provide statistical consulting to sponsors to support clinical program development, protocol development, sample size calculations, endpoint selection, regulatory interactions, exploratory analyses, scientific meetings, and executive decisions
• Provide statistical consulting for complex and/or novel statistical analyses
• Provide statistical consulting to support clinical development strategies, including extensive interface with client executive and leadership teams
• Provide input and support responses to regulatory questions on statistical issues relating to client regulatory submissions, interacting with and attending meetings with regulatory bodies as applicable
• Prepare statistical analysis plans (SAPs) and table, listing, and figure (TLF) mocks for any complexity of study
• Provide senior reviews of statistical documents, data, and outputs for studies of all complexities to ensure quality and integrity
• Execute a statistical analysis of any complexity as specified in a protocol or analysis plan
• Interpret and communicate results for complex statistical analyses and outputs
• Develop and/or review the statistical sections of a study protocol for studies of any complexity level
• Review statistical sections of a clinical study report to ensure accurate descriptions of statistical methods used and results of analyses
• Provide randomization materials including randomization schedules and treatment kit lists per Allucent SOPs and the sponsor-approved specifications
• Develop or review documents for integrated analyses (e.g. ISS/ISE), including integrated SAPs and statistical sections of integrated study reports
• Working knowledge of SAS® for production and validation of datasets and statistical outputs
• Write and review specifications for complex ADaM or analysis datasets · Annotate or review annotations of TLF mocks to assist programming efforts
• Working knowledge of CDISC standards
• Review CRF design to ensure it conforms with the study protocol and analysis needs
• Review data management documents as requested to ensure integrity of study data
• Lead highly complex projects by fulfilling the following responsibilities: communicate with the client and statistical team, set and achieve timelines and milestones, ensure proper execution of the study SAP, monitor programming efforts in collaboration with the lead programmer, and work with management to ensure adequate resourcing
• Function as the lead unblinded statistician for studies and manage unblinded tasks including implementation of interim analyses and participation in DMC/safety review meetings
• Accountable for leading biostatistics and programming activities for a program of studies of high complexity and/or of high value
• Identify high-risk or high-impact deliverables and assign appropriate oversight
• Lead and manage project budgets, support financial reporting for studies, identify of out-of-scope work and provide leadership in change order process
• Collaborate with and verify open communication with other functional areas and business units
• Provide biometrics leadership and coordination across client and other vendor functional areas, including clinical operations, pharmacovigilance, regulatory, and medical writing teams
• Represent Allucent at proposal bid defenses and/or marketing meetings with prospective clients
• Provide key input into project proposals and budgets
• Establish positive relationships with current and future clients
• Identify key accounts and maintain strong long-lasting relationships to win new and repeat business
• Monitor and assure client satisfaction on existing projects for biostatistics and statistical programming
• Contribute to BIOSC, BBU, and corporate marketing activities via blogs, webinars, white papers, and other publications and presentations
• Contribute to other areas of business and assignments as required

Director / Senior Director, Biostatistical Consulting

Medical Director

• At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
• We are looking for a Medical Director to join our A-team (office-based*/remote). The Medical Director works independently to ensure the medical/clinical and safety integrity and quality of trials conducted by Allucent. Serves as the medical monitor contact in trial protocols to investigators and trial sites regarding protocol related questions and safety of the subjects enrolled. Advises investigators, project teams, and clients on safety issues arising from medicinal products, devices and trial designs undertaken by Allucent. Works along with more senior colleagues and internal team members, senior management and business development on issues and questions of any medical /clinical nature. Reviews SAEs, SUSARs and AEs reports and writes safety narratives in accordance with all applicable competent authority regulations and reporting standards. Reviews, if needed with support from more senior colleagues, protocols, investigator’s brochures, clinical trial reports written by Allucent ensuring they are approved in accordance with Allucent procedures and good medical practices. Supports Business Development efforts with support of senior colleagues by reviewing the proposal and attending client meetings including Bid Pursuit Meetings.
• Key tasks: Independently provide medical monitor support to assigned clinical trials; Provide input on Protocol design and Strategic clinical recommendations; Prepare Medical Monitoring and relevant plans; Review Serious Adverse Events, SUSARs, safety narratives and perform Analysis of Similar Events; Assist clinical data management with MedDRA and WHO coding; Review clinical trial documents for medical consistency; Assist in set up and conduct of Data Safety Boards and Dose escalation meetings; Attend and present in Kick-Off, Investigators’ meeting; Provide 24/7 urgent medical support; Training of project teams; Support protocol deviation guidance; Identify trial risks and provide input to Risk plan; Ensure conduct of safety reviews; Independently review and understand trial medical deliverables and track budget; Draft and contribute as SME to evaluation/improvement of processes; Support Business Development; May advise and assist clients on product development and trial designs; May provide therapeutic consultation for post marketing activities; Assure strong relationships with key accounts; Support in preparation of new proposals; Contribute to client evaluations and bid defense; Contribute to other areas of business as required.

Associate Medical Director / Medical Director

Financial Planning and Analysis

• Provide work instruction and support to the shared services organization (finance and accounting, credit and collections, accounts payable, investigator payments, payroll, project finance, travel & expense, credit card administration, and treasury support)
• Ensure timely and accurate processing of accounting transactions and compliance with policies and procedures
• Maintain an environment of continuous improvement and accurate reporting
• Develop and oversee administration of internal metrics across accounting and finance functions
• Utilize metrics to influence efficiencies across internal teams and business partners
• Identify and develop priorities to drive continuous improvement
• Lead projects/initiatives across the finance organization
• Define and agree SLAs with in-scope entities, including KPIs, and manage performance
• Manage Procure-to-Pay (Accounts Payable, Travel & Expense, Credit Card administration, Payment Execution) and Order-to-Cash (Invoicing, Credit Management, Collections, Payment Application, Credit Note Processing)
• Provide and coordinate finance training for relevant staff and operations teams
• Actively contribute to staff learning & development and provide process training
• Identify issues, propose solutions, coordinate with stakeholders, and see to completion
• Adhere to accounting standards and ensure client satisfaction and internal financial accuracy

Finance Manager

• At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
• We are looking for Project Financial Analyst Associate to join our A-team (hybrid). The Project Financial Analyst Associate (PFAA) assists the Project Financial Analyst (PFA) and Project Team with financial activities on the studies that we conduct for our sponsor and includes activities from project start-up to project close-out. This position regularly interacts with the PFA and Project Management to support project requirements.
• Upon contract signature, the PFAA works with the Project Team, PFA, and the proposal function to ensure that the project is set up in Microsoft Dynamics, including the WBS for time keeping, project budgets, and payment schedule details, ensuring all are tied out to the fully executed contract.
• For any subsequent agreements (i.e. Change Order), the PFAA will ensure all respective updates are made in Microsoft Dynamics and tie to the latest fully executed agreement.
• The PFAA will be responsible for assisting in the initiation of any upfront advance requests with the Invoicing Department upon contract signature.
• The PFAA will manage time movement requests for T&M projects in Microsoft Dynamics.
• For T&M studies, the PFAA will distribute financial reports to the project teams, including realization, profitability, budget vs actual, and confirm if a Change Order is needed.
• Upon Project Completion, PFAA will update Microsoft Dynamics, including study status, provide summary of final financial reporting to the PFA and Project Team, and assist the PFA in final reconciliations of invoicing.
• Good knowledge and hands-on experience handling monthly financial reports and closely working with Billing team to ensure smooth invoicing process.
• Knowledge of month-on-month revenue recognition process.
• PFA to Assist in updating journals on agreed timeline and ensuring Invoice is accurately sent out.
• Ensure financial information is complete accurately as per the monthly calendar and reporting to ensure month end close activities.
• Read and understand the contract to help ensure adherence to project scope and contractual deliverables.
• Provide financial support and work with PFA and study teams to implement corrective actions and process improvements.
• Actively contribute to staff learning & development within the company.
• Monitor and assure client satisfaction on finance related activities.

Project Financial Analyst, Associate

• Independently manage all aspects of monitoring for assigned clinical trials across study phases, including site initiation, routine monitoring, and close-out visits.
• Ensure compliance with protocols, GCP, ICH, SOPs, and applicable regulatory requirements.
• Build strong site relationships, acting as a primary point of contact and ensuring high-quality data collection.
• Identify and resolve site issues, escalating as needed to maintain trial integrity and patient safety.
• Activities around regulatory affairs, site activation and study-startup.
• Travel throughout The UK.

Senior Clinical Research Associate

System Administrator

• Serve as the primary administrator for the Microsoft Dynamics 365 F&O platform, ensuring optimal system performance, security, and availability.
• Manage user access, security roles, and permissions in compliance with internal controls, segregation of duties, and audit requirements.
• Monitor and maintain system performance, scheduled batch jobs, and key operational processes to ensure uninterrupted financial operations.
• Configure, customize, and deploy forms, views, workflows, and packages to meet evolving business and compliance requirements.
• Lead and support data-related activities, including imports, validations, reconciliations, and data integrity initiatives using D365 data management tools and Excel add-ins.
• Troubleshoot and resolve complex functional and technical issues, collaborating with internal IT teams and external vendors to implement long-term solutions.
• Manage and support system integrations (e.g., payroll, expense, banking, reporting tools) by monitoring data flows, resolving integration errors, and optimizing integration performance.
• Plan, coordinate, and execute user acceptance testing, patch validations, and production release rollouts, ensuring minimal disruption to business operations.
• Maintain and enhance a comprehensive knowledge base, including process documentation, configuration records, and troubleshooting guides.
• Collaborate closely with finance leadership, business process owners, and IT teams to align system capabilities with organizational needs and regulatory requirements.
• Stay current on Microsoft D365 Finance updates, roadmap items, and new functionality, proactively assessing their potential impact and value to the organization.
• Identify, recommend, and implement process and system improvements to enhance efficiency, data quality, and user experience.
• Support and maintain Power BI and other business intelligence platforms to ensure reliable reporting and analytics delivery.
• Partner with finance and operations teams to design, develop, and optimize dashboards, reports, and analytics strategies that drive data-informed decision-making.
• Contribute to the development and maintenance of a centralized data lake and reporting framework to enable enterprise-wide analytics capabilities.
• Ensure the stability, availability, and performance of reporting environments in coordination with operational and technical teams.

Systems Administrator, Corporate Applications

Vice President

• Lead Regulatory Writing & Strategy: Write, review, and guide CMC documents and submissions with accuracy and insight.
• Shape Product Development: Influence strategies and plans from early development through post-approval.
• Engage with Health Authorities: Lead meetings, prepare briefing packages, and serve as the expert voice in regulatory interactions.
• Provide Scientific Leadership: Share expertise in CMC, compliance, and audits while mentoring teams and supporting client success.
• Drive Collaboration & Solutions: Partner with clients and cross-functional teams to solve challenges and deliver innovative outcomes.

VP, Chemistry, Manufacturing and Controls – CMC

Compliance

• Step into a leadership role guiding clients through the complexities of drug, biologic, and medical device development—leading teams, shaping strategies, and ensuring successful submissions.
• You’ll be the trusted expert who turns regulations into real-world impact on global healthcare.
• Lead and mentor regulatory teams; shape strategies; ensure the delivery of high-quality, scientifically sound submissions.
• Serve as a Subject Matter Expert, Technical Lead, or Consulting Lead across diverse project teams.
• Review and author regulatory and scientific documents while driving successful outcomes for clients.
• Act as a trusted expert in Health Authority (HA) interactions and translate regulatory requirements into clear, actionable plans. In this role, you will act as a Subject Matter Expert, Technical Lead, or Consulting Lead across diverse project teams.
• Has advanced knowledge of HA Regulatory Guidance & Regulations pertaining to preparation of regulatory filings through all phases of drug or device development and lifecycle management
• Reviews and prepares HA meeting requests and briefing documents.
• Provide specialized CMC regulatory expertise across both pre-and post marketing strategies.
• Provides strategic advice and expertise in translating regulatory requirements into practical plans and solutions.
• Evaluates change impact and necessary HA reporting requirements and strategies for drug products or devices from development through post-approval management.
• Has advanced knowledge of CTD format and structure for regulatory submissions.