Jobs at ClinChoice

Lead and manage clinical projects, ensuring compliance with regulations and overseeing trial operations, specifically in hematology and oncology.

Lead cross-functional teams to manage complex clinical trials across various health sectors while ensuring compliance with GCP and regulatory standards.

Manage and support planning, execution, and oversight of global Phase I-III clinical trials. Oversee CROs/vendors, track timelines, enrollment, deviations, and sample management. Maintain TMF/eTMF inspection readiness, support study start-up, coordinate cross-functional stakeholders, and ensure GCP/ICH compliance throughout study lifecycle.

The Business Development Director will generate leads, assess opportunities, build relationships with clients, and meet revenue targets for a CRO.

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 Principal Statistical Programmer Consultant leads programming efforts for clinical studies, ensuring quality deliverables and compliance with industry standards, while collaborating with study teams and managing concurrent project activities.

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

Entry-level statistical programming trainee role supporting data analysis and programming tasks using SAS, R, Python, MATLAB, SQL and related tools. Requires strong attention to detail, teamwork, communication skills, and proficiency with Microsoft Office.

The Statistical Programmer/Analyst III analyzes data, develops SAS programs following CDISC standards, creates datasets, and supports regulatory submissions. Responsibilities include data analysis, programming, and communication with statisticians.

The role involves completing a clinical programming training program, producing statistical analysis with SAS/R, ensuring compliance to SOPs, and developing SAS programs for study data analysis.

The Principal Data Scientist Consultant will develop and maintain clinical datasets using R, ensure CDISC compliance, generate reports, and contribute to internal tools while collaborating with clinical teams.

The Senior Statistical Programmer Consultant leads programming efforts in clinical studies, ensures high-quality programming deliverables, and collaborates with team members to implement statistical programming aspects of clinical protocols.

Author and review CMC sections for regulatory submissions (NDAs, MAAs), ensure compliance with ICH and regional requirements, collaborate with SMEs across QA, manufacturing and regulatory teams, maintain high-quality documentation, manage timelines, identify CMC regulatory risks and propose mitigations to obtain approvals.

Lead CMC regulatory activities including preparing and submitting CMC modules 2 and 3, managing product registrations and post-approval submissions, developing and executing local/regional regulatory strategies, supporting product lifecycle management, ensuring compliance with local requirements, interacting with health authorities, compiling Product Quality Reviews, and reviewing formulation, ingredient lists, claims, and labeling per SOP.

Lead statistical design and analysis for respiratory & immunology clinical studies: develop protocols, sample size, randomization, SAPs; ensure data and report accuracy; mentor statisticians and manage project deliverables while liaising with clients and regulatory authorities.

Lead biostatistical design and analysis for respiratory and immunology clinical studies. Develop protocols, sample size calculations, randomization, and statistical analysis plans; ensure data and reporting accuracy; validate analyses; mentor and manage statisticians; provide CRO oversight and client-facing statistical guidance throughout drug development.

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 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.