Allucent

The Quality Assurance Officer II (Quality Officer II) coordinates development and management of Quality Management Systems documents as needed, performs audits as appropriate, co-hosts and may lead customer audits, supports quality issue/deviation/CAPA closures, participates in regulatory inspections, and performs quality control review of regulatory documents as needed of Allucent Quality Department and other quality activities as directed. This position monitors quality activities.   **In this role your key tasks will include:** - Development and management of quality documentation, including but not limited to, SOPs, training, and sponsor documentation as directed - Co-host and may lead customer audits - Participate in regulatory inspections - Perform audits (e.g., process, project, vendor, investigator site), as appropriate - Perform quality control review of regulatory documents as needed - May lead quality issue/deviation investigation, follow-up/closure, and CAPA closures as directed - Provide essential training oversight management, leading maintenance of training curricula and learning management system administration as directed - Assist with the development and delivery of training materials as agreed with senior management - Actively support staff learning & development within the company - Draft and contribute, as Subject Matter Expert (SME) in the field of Quality Officer, activities to the evaluation and harmonization of processes and procedures within the Quality Management System - Assure good communication and relationships with (future) clients - May contribute and take part in client evaluations, visits and bid defenses - May act as primary contact within the quality staff for dedicated areas/assignments - Support other quality activities (e.g., RFI and vendor questionnaire, quality metrics and CSV) as directed - Contribute to other areas of business and other duties as assigned

**About the Role** As a **Senior Clinical Programmer I**, you will lead clinical programming activities that contribute to the successful delivery of global clinical studies, ensuring high-quality data capture, database development, and regulatory compliance throughout the study lifecycle. You will collaborate cross-functionally to design, build, validate, and maintain clinical databases, develop programming solutions and data visualizations, and promote CDISC standards and programming best practices. In addition to managing project timelines, budgets, and deliverables, you will drive process improvements, support business development activities, and provide technical leadership and mentorship to junior team members. **Your main responsibilities will include but are not limited to:** • Lead clinical programming activities across assigned studies, ensuring project timelines, budgets, deliverables, and resource requirements are effectively managed while proactively identifying and escalating risks or change orders. • Design, build, validate, and maintain clinical databases, electronic edit checks, data listings, and data visualization tools to support high-quality data collection, review, and regulatory compliance. • Collaborate cross-functionally with Data Management, Project Management, Biostatistics, and study teams to develop study documentation, clarify technical specifications, and deliver programming solutions that meet project objectives. • Champion industry standards and quality by applying CDISC conventions (CDASH, SDTM, TAUGs), validation principles, and programming best practices to ensure consistent, compliant, and inspection-ready deliverables. • Drive innovation and continuous improvement by leading process enhancements, developing global programming standards and libraries, implementing data analytics and visualization tools, and supporting departmental initiatives.

• Lead clinical programming activities across assigned studies, ensuring project timelines, budgets, deliverables, and resource needs are effectively managed while proactively identifying and escalating risks or change orders. • Design, build, validate, and maintain clinical databases, electronic edit checks, data listings, and data visualization tools to support high-quality data collection, review, and regulatory compliance. • Collaborate cross-functionally with Data Management, Project Management, Biostatistics, and study teams to develop study documentation, clarify technical specifications, and deliver programming solutions that meet project objectives. • Champion industry standards and quality, applying CDISC conventions (CDASH, SDTM, TAUGs), validation principles, and programming best practices to ensure consistent, compliant, and inspection-ready deliverables. • Drive innovation and continuous improvement by leading process enhancements, developing global programming standards and libraries, implementing data analytics and visualization tools, and supporting departmental initiatives.

• Identify, develop and implement the business strategy for the Medical Affairs and Pharmacovigilance departments • Develop and agree upon annual revenues, sales, profit and operational targets for the Medical Affairs and Pharmacovigilance departments • Evaluate and direct the organization's activities to achieve targets for trading performance, quality, culture and legislative adherence. • Develop and agree upon operating procedures / business processes • Preside as needed over (senior) management team meetings • Maintain and develop organizational culture, values, and reputation • Report to applicable stakeholders on business strategy planning, results and performance for the Medical affairs and Pharmacovigilance department • Act as the organization's representative in its dealings with the outside world • Manage direct reporting staff • Actively contribute to staff learning & development within the company • Monitor and assure client satisfaction on existing projects for the Medical Affairs and Pharmacovigilance department with related activities • Identify key accounts and maintain strong long-lasting relationships to win new and repeat business

• Acts as the primary point of contact for the local regulatory authorities, including 24/7 if legally required • Monitors and maintains awareness of safety issues and recommendations published by the local regulatory authorities, concerning the client products or products class • Monitors and maintains awareness of changes to local legislation pertaining to pharmacovigilance • Supports client audits and inspections, as required, including attendance, provision of requested documentation and completion of Corrective Actions and Preventive Actions (CAPAs), if needed • Performs local literature screening and collection of safety information • Assists on the development or the review of the local pharmacovigilance system master file (LPSMF), if required • Supports local signal detection, if applicable • Manages locally risk minimization measures, as applicable • Reports to and maintains regular communication with the EU QPPV • Supports the review of local PV agreements, if requested • Performs local PV training to eg. sales force, affiliate personnel, distributors • Provides monthly activity report on status of local PV system

• Coordinate and manage the activities of Clinical Research Associates (CRAs) across all geographic regions • Maintain close liaison with the Project Manager (PM) and other department leaders on all trial-related and service delivery matters • Support the leadership team through training, process improvements, co-monitoring visits, staff mentoring and/or other special assignments within Global Clinical Operations

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 Clinical Trial Leader (CTL) to join our A-team (office-based*/remote). As a CTL at Allucent, you are providing leadership, management and oversight to the Clinical Research Associates (CRAs) and other clinical functional groups, in their day-to-day clinical trial activities on a global, multi-country, or regional basis. The CTL is responsible for coordinating and managing the planning, implementation, tracking, and ensuring the clinical deliverables as per the trial contract, budget, timelines and with quality. ResponsibilitiesAs an expert in Clinical Trial Leadership, you are: - **Coordinating and managing CRA activities **across all geographies, liaising with sponsor and Project Manager and other functional leads to ensure clinical monitoring deliverables (timeline, budget, quality, productivity) are met. - **Liaising closely with the Project Manager (PM) and other department leaders** if /when necessary, on all trial-related issues and service delivery. - **Supporting the management team **with training, process improvements, co-monitoring visits, mentoring of staff and / or any other special assignments within Global Clinical Operations.

• Identify, develop and implement the business strategy for the Medical Affairs and Pharmacovigilance departments • Develop and agree upon annual revenues, sales, profit and operational targets for the Medical Affairs and Pharmacovigilance departments • Evaluate and direct the organization's activities to achieve targets for trading performance, quality, culture and legislative adherence. • Develop and agree upon operating procedures / business processes • Preside as needed over (senior) management team meetings • Maintain and develop organizational culture, values, and reputation • Report to applicable stakeholders on business strategy planning, results and performance for the Medical affairs and Pharmacovigilance department • Act as the organization's representative in its dealings with the outside world • Manage direct reporting staff • Actively contribute to staff learning & development within the company • Monitor and assure client satisfaction on existing projects for the Medical Affairs and Pharmacovigilance department with related activities • Identify key accounts and maintain strong long-lasting relationships to win new and repeat business

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. As the Sr. Director, CMC, you will: - **Lead end-to-end CMC strategy** across drug substance, drug product, and analytical development—from early-stage evaluation through regulatory submission and commercial launch with a focus on scientific aspects. - **Drive regulatory excellence** by authoring and reviewing CMC submissions, leading Health Authority communications, and ensuring compliance with FDA, EMA, and ICH guidelines. - **Prepare product development plans** from early development through Phase 4. - **Manage and lead direct reports** through development and performance management and by providing training on current and new regulatory requirements. - **Perform other scientist related duties**, as needed.

• Responsible for overall quality and management of the delivery clinical trial projects and programs • Manages complex, cross-functional resource requirements in line with budgeted, time, scope, and quality expectations for project delivery • Oversees budgets and ensuring correct financial forecasting, planning, invoicing and timely implementation of out of scope activities • Reviews and approves content and costing of proposals • Ensures effective risk management across the project delivery lifecycle • Negotiates and influences internal and external team members in a professional manner and with successful outcomes • Effectively solves problems with projects teams by applying strategic thinking and conflict resolution skills • Balances multiple competing priorities, with effective and efficient resource utilization across projects and programs • Serves as key contact for assigned clients on delivery of scope, customer satisfaction on services and capabilities and the assessment of client needs • Shows knowledge of and insight into general business principles and practices, and is able to balance business priorities • Demonstrates a growth mindset, and approaches complex challenges with creativity and flexibility • Leads by example and encourages team members to develop strong solutions for clinical trial delivery • Supports the recruitment and interviewing of new employees • Responsible for supervision of project staff and communication with functional managers, including performance feedback • 10% of Business travel is required for this position, including possible international travel