The Proposal Development Manager interprets RFPs and RFIs to build compelling, differentiated responses while coordinating with subject matter experts to define operational strategies. They are responsible for creating detailed budgets, managing proposal lifecycles, and continuously improving internal processes and response libraries.
The Business Analyst acts as a liaison between stakeholders and IT to deliver REMS programs and technology solutions. They are responsible for gathering requirements, coordinating cross-functional projects, and ensuring all deliverables meet regulatory and compliance standards.
Lead and oversee global post-marketing case processing activities while ensuring compliance with GVP, FDA requirements, and company SOPs. Manage pharmacovigilance workflows, provide strategic narrative development, and lead client meetings as a subject matter expert.
The Senior Clinical Data Manager is responsible for the entire data management process from study set-up to close-out, including oversight of CRF tracking, data validation, and database lock. They act as the primary contact for study-specific issues and provide expert guidance to clients regarding EDC solutions and protocol implementation.
The Medical Writer will critically evaluate clinical literature and write complex regulatory documents such as protocols, investigator brochures, and clinical study reports. They will also manage project timelines, interact directly with clients, and mentor other team members.
The medical writer will critically evaluate and interpret medical literature to draft and edit complex clinical development documents such as protocols and regulatory submissions. They will also manage project timelines, coordinate directly with clients, and mentor team members throughout the writing process.
The Medical Writer will critically evaluate and interpret medical literature to draft and edit various clinical development documents, including protocols and study reports. They will also manage project timelines, coordinate directly with clients, and mentor team members throughout the writing process.
The Senior Nonclinical Writer will lead the development, writing, and management of highly technical nonclinical documents for regulatory submissions. They will collaborate with cross-functional teams to ensure scientific integrity and alignment with global regulatory guidelines.
The Senior Biostatistician will independently create randomization schedules, develop statistical analysis plans, and lead clinical trial projects across various phases. They will also collaborate with sponsors, regulatory teams, and programmers to ensure high-quality statistical outputs and regulatory compliance.
The Medical Writer will analyze medical literature and write clinical development documents such as protocols, investigator brochures, and study reports. They will also manage project timelines, coordinate directly with clients, and mentor other team members.
The Medical Writer will critically analyze medical literature and write clinical development documents such as protocols, investigator brochures, and study reports. They are also responsible for managing project timelines, coordinating with clients, and mentoring team members.
The Medical Writer will analyze medical literature and write clinical development documents such as protocols, investigator brochures, and study reports. They will also manage project timelines, interact directly with clients, and mentor team members.
The Medical Writer will analyze medical literature and clinical data to draft and edit regulatory documents such as protocols, investigator brochures, and clinical study reports. They will also manage project timelines, coordinate directly with clients, and mentor team members throughout the writing process.
The Senior Data Team Lead is responsible for the entire data management process from study set-up to close-out, acting as the primary contact for clients and internal management. They provide oversight for data processing activities, mentor new clinical data managers, and ensure compliance with regulatory standards.
The Senior Biostatistician will independently create randomization schedules, develop statistical analysis plans, and lead projects across various clinical trial phases. They will also collaborate with sponsors and regulatory teams to ensure high-quality statistical analyses and provide support for data safety monitoring boards.
Serves as the Database Administrator for Argus Safety, managing configuration, maintenance, and E2B reporting via gateway technologies. Provides technical leadership for system upgrades, case migrations, and ensures alignment with global regulatory requirements.
The role focuses on advancing AI and emerging technologies to improve operational efficiency, quality, and business outcomes across all service lines. It involves establishing AI governance frameworks and partnering with cross-functional leaders to drive technology adoption and organizational change.
The role focuses on driving the adoption of AI and emerging technologies to improve operational efficiency and business outcomes across all service lines. It involves leading cross-functional strategies, establishing AI governance, and partnering with leadership to implement innovative technology solutions.
The role involves processing drug safety cases independently and leading the development of high-quality safety narratives and deliverables. The associate will act as a Subject Matter Expert, managing client meetings and ensuring compliance with regulatory guidelines.
Serve as the Database Administrator for Argus Safety, managing configuration, maintenance, and E2B reporting via gateway technologies. Provide technical leadership for system upgrades, case migrations, and regulatory alignment with Eudravigilance standards.
Lead the design and optimization of scalable clinical data engineering solutions to support regulatory compliance and advanced analytics. Partner with cross-functional teams to transform raw clinical data into standardized, CDISC-compliant formats and high-performance data architectures.
Lead the full life-cycle of KerusCloud support and statistical services, including study design, simulation, and the preparation of protocols and analysis plans. Provide statistical consultancy to sponsors and collaborate with product development to define key features of trial simulation software.
The Senior Medical Writer is responsible for authoring and editing complex clinical development documents, including protocols and regulatory summaries. They must manage project timelines, coordinate directly with clients, and mentor junior medical writers.
The role involves generating tables, listings, and graphs from clinical trial databases using SAS. The programmer will also develop specifications and deliverables adhering to SDTM, ADaM, and regulatory submission standards.
Generate tables, listings, and graphs from clinical trial databases using SAS and the System Development Life Cycle. Lead study or small programming project teams to ensure regulatory submission challenges are met.
The Senior Medical Writer is responsible for authoring and editing complex clinical development documents, including protocols and study reports, while ensuring scientific rigor. They will manage project timelines, coordinate directly with clients, and mentor junior medical writers.
Develop business requirements and specifications to create Power BI dashboards and reporting pipelines for clinical operations. Mentor team members in data science methodologies and manage the end-to-end development of data models.
The Senior Biostatistician is responsible for developing Statistical Analysis Plans (SAPs), creating randomization schedules, and producing high-quality statistical analyses for phase 1-4 studies. They lead projects, manage client meetings, and provide statistical support for Data Safety Monitoring Boards and regulatory submissions.
Lead the generation of tables, listings, and graphs from clinical trial databases using SAS and SDLC methodologies. Manage project tasks independently while providing guidance to junior colleagues and supporting business development activities.
The Medical Writer will evaluate and interpret medical literature to support study design and write various clinical development documents. They will also mentor other writers and manage project timelines effectively.
