Jobs at ClinChoice

Develop, validate, and maintain statistical programs (TLFs) using SAS and R. Perform data manipulation, analysis, visualization, and QC. Collaborate with biostatisticians and data management, ensure CDISC and regulatory compliance, and support submission documentation.

Conduct timely alert triage and signal validation by reviewing case and aggregate safety data from clinical, post-marketing, literature, and quality sources. Support signal evaluation, develop post-marketing surveillance strategies and product-specific safety assessments, participate in cross-functional teams, evaluate novel analysis tools, track signal management activities, and maintain related documentation.

Provide medical and scientific judgment for aggregate safety reports (PBRER/PSUR), identify important safety concerns, review drafts and final reports, collaborate with Global Risk Assessment and report authoring teams, document revisions, and contribute to benefit-risk evaluations and HA feedback discussions.

Freelance Clinical Research Associate performing site initiation, interim, and close-out visits (on-site or remote); managing investigator sites; liaising with sponsor and client; delivering sponsor training; ensuring compliance for medical device studies.

Support global market access by preparing and maintaining regulatory dossiers and registration documentation; manage registration tracking databases; coordinate with affiliates, law firms, R&D, and marketing; obtain Certificates of Free Sale and other market-specific documents to meet launch timelines and compliance.

Manage biometrics project teams across Data Management, Biostatistics, Statistical Programming, and Medical Writing from study start-up through closeout. Serve as primary client/vendor liaison, coordinate meetings, timelines, milestones, and action items, manage project financials and contracts support, identify risks and change orders, ensure training completion, support business development (RFPs/RFIs), and escalate or resolve issues.

Manage biometrics project teams from study start-up through closeout, coordinating Data Management, Biostatistics, Statistical Programming and Medical Writing. Serve as client/vendor liaison, create timelines, lead meetings, manage financials and contracts, identify risks and change orders, support RFP/RFI and governance, and drive cross-functional collaboration and issue resolution.

The Business Development Director will sell CRO services, generate leads, assess opportunities, and develop and grow client accounts, focusing on relationship management and exceeding revenue targets.

The Business Development Director will identify and pursue new business opportunities, manage client relationships, develop account plans, and exceed revenue targets for CRO services.

Manage preparation, submission, tracking, and legalization of regulatory documents for global medical device registrations and US FDA Certificates to Foreign Governments. Coordinate responses to inquiries, maintain documentation practices and tracking tools, support internal/external teams, and ensure compliance with QSR/ISO/MDR standards.

Administer and configure the Learning Management System: create courses, curricula, user accounts, roles, reports, enrollments, and qualifications; respond to LMS requests, support learners, ensure training compliance, collaborate with Quality Training Manager, and identify process and quality improvements while complying with QMS/ISMS/PIMS and GDPR requirements.

Provide administrative support to the HR team including recruitment assistance, onboarding, recordkeeping, HR documentation, basic reporting, benefits and payroll support, training logistics, and employee engagement while maintaining confidentiality and HR policy compliance.

Perform toxicological literature searches and prepare safety and risk assessments for raw materials, INCI ingredients, impurities, and degradants; draft Full Safety Assessments per regulatory requirements (European Cosmetics Directive); calculate Margin of Safety and California Proposition 65 evaluations; support formula approval recommendations, complete required trainings, and participate in process improvements while escalating issues to the Team Lead.

The Business Development Director is responsible for driving growth by securing new clients and expanding services, managing the full sales lifecycle, and maintaining relationships with key stakeholders in the life-sciences industry.

Support clinical project teams by managing study documentation, regulatory submissions, site agreements, trial logistics, CRF tracking, site payments, and meeting organization. Maintain tracking systems, ensure compliance with GCP/ICH and local regulations, tutor junior CTAs, and assist with monitor activities and clinical supply logistics.

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.

The Labeling Artwork Controller is responsible for managing the artwork development process, ensuring timely, compliant delivery by coordinating teams and driving improvements.

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).

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.