• Drive Multi-Project Programs: Lead the end-to-end lifecycle of complex clinical initiatives, collaborating with principal investigators, sponsors, and vendors to execute strategic project plans that meet study objectives • Accelerate Site Activation: Partner closely with research site staff to streamline activation activities and ensure operational readiness for all assigned clinical projects • Design Clinical Frameworks: Collaborate with researchers to develop high-level trial project plans, radiation treatment manuals, and independent review charters to support study design and development • Strategize Funding & Proposals: Lead the development of grant applications and business proposals, coordinating cross-functional input to secure funding and meet critical deliverables • Optimize Matrix Team Performance: Maximize team productivity and work quality by effectively managing resources, balancing competing priorities, and ensuring strict adherence to project timelines • Champion Quality & Compliance: Ensure all clinical activities and documentation maintain rigorous compliance with Good Clinical Practice (GCP) and the Code of Federal Regulations (CFR) • Deliver Executive Insights: Synthesize complex project data into actionable reports for leadership to track progress against organizational goals

• The Executive Director (ED) is the Clinical Operations lead in a country/cluster and is responsible for execution of all Clinical Trials in scope for Global Clinical Trial Operations (GCTO) country operations • Adherence to GCP, local and global policies and procedures to conduct high-quality, inspection ready studies is essential • The position is accountable for trial quality and audit responses and completion of CAPAs • Ensures a single point of contact for managing clinical trial execution in all its aspects across phases in scope of GCTO within the country/cluster • Supports the regional GCTO leadership team, leading strategic development of their country/ cluster to deliver clinical trials as per global clinical research pipeline requirement • Strategic country/ cluster representative for initiatives at all levels of the organization. • Build and lead the team to effectively manage resources ensuring appropriately skilled and high performing team to effectively deliver the portfolio across therapy areas and achieve on agreed GCTO, GCD, and Research and Development objectives

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description This role involves owning the full lifecycle of a sample distribution program, ensuring that all phases from design through delivery are executed on schedule and in compliance with regulatory requirements. - Develop and maintain SOPs and PDMA compliance documentation - Coordinate the technical implementation of sample-tracking tools in the CRM system - Train the field sales team on proper sampling procedures - Act as the primary liaison between the client and salesforce, presenting project updates and reports This is a remote, contractual position, that goes until the end of September 2026, with the likelihood of extension. Candidates applying for this role must be located in the EST or CST time zones of the USA. Key Responsibilities - Oversee the entire physician sampling initiative from defining processes and launching new sample offerings to ongoing distribution and reconciliation - Manage logistics and inventory, tracking sample usage, and closing the loop on returned or expired samples - Coordinate between clinical operations, medical affairs, and commercial teams to ensure alignment with clinical guidelines and product lifecycle strategies - Collaborate with clinical data management and medical affairs teams to capture and document clinical data related to physician sampling programs - Support audit readiness by ensuring documentation and sampling processes meet clinical trial support standards - Contribute to clinical process improvement initiatives, ensuring digital tools and operational processes support commercial sampling activities - Draft, update, and enforce SOPs and compliance materials for all sampling activities - Work closely with IT and technical teams to implement or upgrade the CRM’s sample-tracking module - Design and deliver training programs for the sales field team on sampling SOPs and PDMA compliance - Serve as the main point of contact for client teams and physician offices - Track program performance and prepare regular reports on sample distribution, inventory levels, and compliance KPIs Qualifications - 4-5 years’ experience managing pharmaceutical or sales support programs - Demonstrated ability to run a full sample program “from end to end”, including inventory management and sample accounting - Solid knowledge of FDA/PDMA regulations for drug samples - Proven skill in writing and maintaining SOPs and compliance documents for projects - Hands-on experience with CRM platforms (e.g. Salesforce, Veeva) - Ability to coordinate with IT and vendors on system configuration and data integration - Background in pharma or biotech environments, especially commercial operations - Experience working in pharmaceutical, biotech, or clinical research environments - Understanding of clinical governance frameworks such as GxP (GCP, GVP, or GMP) - Experience collaborating with clinical stakeholders, regulatory teams, or medical affairs - Familiarity with clinical documentation standards, audit preparation, and healthcare regulatory oversight Preferred Qualifications - Experience with sample distribution software or electronic sample closets - MBA or advanced degree in life sciences/pharmacy; PMP or Six Sigma/Lean certification - Exposure to clinical systems integration - Experience supporting clinical-commercial hybrid programs - Background working in regulated healthcare environments

• Responsible for developing, implementing, and monitoring quality assurance and performance improvement (QAPI) programs • Lead or participate in the clinic’s Quality Assessment and Performance Improvement (QAPI) program • Develop and implement action plans to address deficiencies and improve care delivery • Conduct regular audits and quality reviews to ensure compliance with clinical policies & procedures • Facilitate staff education and training related to quality improvement, patient safety, and best practices • Collaborate with physicians, nurses, dietitians, social workers, and leadership to support evidence-based clinical initiatives • Prepare and present quality reports to clinic leadership and governing bodies • Ensure accurate documentation, data collection, and reporting for internal and external stakeholders • Promote a culture of accountability, safety, and continuous improvement within the clinic • Manage the execution and achievement of Quality key performance indicators and other clinical initiatives