The Senior Medical Writer will lead the development of complex clinical documents such as regulatory submissions, protocols, and clinical study reports. They will also act as a primary technical contact for clients and provide senior-level review and guidance to junior staff.
The Senior Drug Safety Specialist manages safety service operations, ensuring compliance with regulatory guidelines and effective project delivery. They act as a Safety Lead, overseeing case processing, medical coding, and the preparation of safety reports for clinical and post-marketing projects.
The Project Manager is responsible for the end-to-end management of clinical research projects, including cross-functional team leadership, financial oversight, and ensuring adherence to regulatory standards. They will manage study delivery, client communication, and site coordination to ensure project objectives are met within budget and timelines.
The Clinical Research Associate 2 is responsible for site management, monitoring activities, and ensuring compliance with regulatory requirements and SOPs. They coordinate site selection, manage trial documentation, and support recruitment efforts to ensure successful trial execution.
The Clinical Trial Specialist supports in-house site start-up and maintenance activities while ensuring compliance with federal regulations and ICH/GCP guidelines. Responsibilities include managing Trial Master File (TMF) documentation, assisting with feasibility processes, and coordinating submissions to IRBs and Ethics Committees.
The Clinical Research Associate 2 is responsible for site management, monitoring clinical trial activities, and ensuring compliance with regulatory requirements and SOPs. They coordinate site selection, manage site budgets and contracts, and provide training to investigators to ensure protocol adherence.
The Clinical Research Associate 2 is responsible for site management, monitoring clinical trial activities, and ensuring compliance with regulatory requirements and SOPs. They coordinate site selection, manage site budgets and contracts, and train investigators to ensure protocol adherence.
Develop statistical analysis plans, reporting specifications, and perform statistical analyses for clinical studies. Coordinate with cross-functional teams to ensure data integrity, regulatory compliance, and accurate reporting of clinical trial results.
The Statistical Programmer 1 will perform, plan, and implement statistical programming for complex studies, including the creation of tables, figures, and listings. They will also manage SDTM and analysis dataset programming while ensuring quality control and effective communication with internal and external project teams.
The Senior Statistical Programmer will lead complex clinical study programming, including the development of SDTM and analysis datasets. They will also mentor junior staff, manage project timelines, and collaborate with internal and external stakeholders to ensure high-quality deliverables.
Serve as the primary statistical Subject Matter Expert for US-based sponsor engagements and provide strategic leadership across clinical development programs. Partner with business development teams to support proposals and help establish and grow the US-based Biometrics function.
The Clinical Research Associate is responsible for site management, monitoring activities, and ensuring compliance with regulatory requirements and SOPs. They will coordinate site selection, manage trial documentation, and support recruitment efforts to ensure successful trial execution.
The Clinical Research Associate 2 is responsible for site management, monitoring activities, and ensuring compliance with regulatory requirements and SOPs. They coordinate site selection, manage trial documentation, and support recruitment efforts to ensure successful trial execution.
Lead the planning, execution, and delivery of clinical studies while managing sponsor relationships and project financial health. Coordinate cross-functional teams and ensure compliance with FDA regulations and ICH-GCP standards.
Lead global and regional clinical trials with a focus on renal therapeutic areas, serving as the primary contact for clients and vendors. Oversee study management activities, including timelines, budgets, and compliance with regulatory guidelines.
Lead global and regional clinical trials with a focus on autoimmune diseases, serving as the primary contact for clients and vendors. Oversee study management activities, including timelines, budgets, and compliance with regulatory guidelines.
The Project Manager is responsible for the end-to-end management of clinical research projects, including cross-functional team leadership, financial oversight, and ensuring adherence to regulatory standards. They also manage client relationships, site feasibility, and the timely delivery of project milestones.
