Jobs at ClinChoice

Provides regional safety oversight for consumer products across their lifecycle, including development and post-market surveillance. Evaluates safety data, identifies risks and signals, develops safety assessments, and communicates clinical insights. Partners with the Regional Medical Safety Officer and cross-functional teams across regulatory, quality, R&D, and local pharmacovigilance. Supports safety deliverables, timelines, benefit-risk evaluations, and complex data analysis while representing safety decisions in regional meetings.

Assist with checking and completing 2025 and 2026 finance files, as well as filing and printing documents. The role requires an honest, responsible, computer-literate accountancy student who can work with minimal supervision and demonstrate initiative.

Manage 2-3 clinical trials with site start-up, on-site and remote monitoring, SDV, CRF review, safety reporting, investigational product and trial material management, study closeout, site training, and supervision/mentoring of junior CRAs. Support submissions, CRF design, and quality control for oncology and complex trials.

Lead statistical activities for clinical studies, including protocol development, sample size calculations, randomization, statistical analysis plans, data quality oversight, and reporting. Ensure the validity, accuracy, consistency, and timeliness of analyses, tables, figures, listings, and statistical methods sections. Provide statistical guidance, mentor junior statisticians, coordinate assignments, review work, and support high-quality delivery across pharmaceutical, biotechnology, medical device, and consumer health projects.

Leads statistical activities for clinical trials across pharmaceutical, biotech, medical device, and consumer health projects. Acts as lead statistician, overseeing statistical strategy, SAPs, analysis database specifications, clinical study report sections, output interpretation, quality, and regulatory compliance. Collaborates with clinical, programming, data management, and regulatory teams; guides statistical programmers; communicates results and risks to technical and non-technical stakeholders; and ensures adherence to FDA, ICH, GCP, and company SOPs.

Leads and supports statistical programming deliveries for oncology clinical studies, implementing protocol and clinical development programming, producing compliant documentation, ensuring quality and standards adherence, managing concurrent activities, and coordinating with statisticians, programmers, data managers, and study leaders. The role independently delivers high-quality programming, escalates risks, supports team planning, and contributes to process improvements within a CRO client-facing environment.

Leads and supports statistical programming deliverables for oncology clinical studies, implementing protocol and clinical development requirements. Independently programs high-quality outputs, develops specifications, oversees documentation, ensures standards and automation compliance, supports team activities, manages risks, and collaborates with statisticians, lead programmers, data managers, and study leaders. The role also contributes to programming best practices and requires strong knowledge of clinical research, drug development, ICH, Good Clinical Practices, and regulatory requirements.

Leads statistical activities for oncology clinical trials, serving as lead statistician for study strategy and deliverables. Authors and reviews Statistical Analysis Plans, Analysis Database Specifications, and statistical sections of clinical study reports. Interprets analysis outputs, ensures regulatory compliance, collaborates with clinical, programming, data management, and regulatory teams, and guides statistical programmers. Communicates statistical results and risks to technical and non-technical stakeholders.

Develop and validate SDTM and ADaM datasets, statistical programming specifications, tables, listings, figures, patient profiles, and FDA submission packages using SAS. Support clinical study reports and integrated safety and efficacy summaries while collaborating with statisticians and cross-functional teams. Lead programming activities, mentor team members, interpret regulatory requirements, resolve programming challenges, and review deliverables for quality and consistency.

Provides regional safety oversight for consumer products throughout their life cycles, including development and post-market surveillance. Evaluates safety data from reports, literature, and other sources; identifies and manages risks; develops safety assessments; and communicates clinical insights to cross-functional stakeholders. Partners with regional medical safety and pharmacovigilance teams, supports safety deliverables, manages complex product portfolios, analyzes large datasets, and ensures compliance with timelines and SOPs.

Responsible for managing the end-to-end artwork development process for packaging and labeling, ensuring timely delivery and compliance. Coordinate with teams and vendors, drive improvements, and supervise controllers.

Manage the end-to-end artwork development process for packaging and labeling, ensuring quality compliance, coordinating teams, and driving improvements.

Lead statistical strategy and deliverables for clinical trials (primarily immunology), author and review SAPs and ADS, interpret analysis outputs, ensure regulatory compliance, collaborate with clinical, programming, data management and regulatory teams, oversee/mentor statisticians and programmers.

Lead day-to-day ERP operations for Microsoft Dynamics 365, manage system project lifecycles, permissions, issue resolution, testing, deployments, and timesheet/resource processes. Coordinate cross-functional stakeholders and vendors, develop documentation and training, and drive standardization and automation to improve operational efficiency across global teams.

Serve as project management process owner for Periodic Safety Update Reports (PSURs): optimize processes, deploy consistent PM methodologies, manage project tools (Microsoft Project, LeanKit), support audits/inspections, retrieve and route documents within medical device quality systems, track metrics (PSURs, CERs, safety surveillance), lead/project-manage staff, and partner cross-functionally with medical, R&D, regulatory, and quality teams.

Lead clinical programming for FDA submissions: annotate CRFs, develop SDTM/ADaM datasets and specifications, produce TLFs and patient profiles, create define.xml submission packages, mentor and lead programming teams, coordinate with statisticians and global sponsors, and ensure regulatory compliance (ICH/GCP).

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The Physician Sub-Investigator Consultant conducts medical assessments, oversees study participants, ensures compliance with protocols, and manages adverse events in clinical trials.

The Regulatory Affairs Specialist Consultant assists in regulatory documentation management, ensures compliance, performs completeness checks, and updates regulatory systems under supervision.

Manage clinical study activities and site performance for medical device trials, conducting monitoring visits, ensuring GCP/ICH compliance, handling site communications, and delivering high-quality trial documentation across multiple sites with frequent travel.