Provide medical oversight for Phase I-IV clinical trials, including the review of safety data and participant eligibility. Lead safety surveillance activities, manage regulatory reporting, and serve as a medical subject matter expert for sponsors and project teams.
The Senior Transparency Specialist will lead clinical trial transparency projects, managing client communications and ensuring high-quality deliverables. They will also perform document redaction and anonymization while ensuring compliance with global regulatory requirements.
The specialist will independently plan and conduct GCP audits, manage audit documentation, and develop CAPA plans to resolve findings. They will also monitor vendors and clinical investigator sites to ensure adherence to quality standards and regulatory requirements.
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 oversee data processing activities, ensure compliance with regulatory standards, and mentor clinical data managers.
The Regulatory Affairs Specialist will manage the tracking, archiving, and publishing of regulatory submissions in compliance with ICH and health authority standards. They will also perform quality control checks on documents and coordinate with clinical CROs and third-party vendors to ensure project timelines are met.
The Senior Statistical Programmer will generate tables, listings, and graphs from clinical trial databases using SAS while adhering to SDTM and ADaM standards. They will also lead study or small programming project teams and ensure compliance with regulatory submission requirements.
The Medical Writer will critically analyze medical literature and write various clinical development documents, including protocols and study reports. They will also manage project timelines, interact directly with clients, and mentor team members throughout the writing process.
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 QC audits. They act as the primary contact for study-specific issues and coordinate directly with clients and suppliers to ensure project timelines and quality standards are met.
Generate tables, listings, and graphs from clinical trial databases using SAS while adhering to SDTM and ADaM standards. Lead study or small programming project teams to ensure successful regulatory submissions.
The Senior Statistical Programmer will generate tables, listings, and graphs from clinical trial databases using SAS while adhering to SDTM and ADaM standards. They will also lead study or small programming project teams and ensure compliance with regulatory submission requirements.
The Senior Clinical Data Manager oversees the entire data management process from study set-up to close-out, ensuring data integrity and regulatory compliance. They act as the primary contact for clients and suppliers, coordinating project facets and mentoring junior team members.
The role involves leading the development, writing, and management of highly technical nonclinical submission documents for various regulatory filings. You will collaborate with cross-functional teams to ensure scientific integrity and alignment with current regulatory guidelines.
The Senior Clinical Data Manager oversees the entire data management process from study set-up to close-out, ensuring data integrity and regulatory compliance. They act as the primary contact for clients and suppliers while mentoring junior staff and coordinating cross-functional study activities.
The Senior Statistical Programmer will generate tables, listings, and graphs from clinical trial databases using SAS while adhering to SDTM and ADaM standards. They will also lead study or small programming project teams and ensure compliance with regulatory submission requirements.
The Senior Statistical Programmer will generate tables, listings, and graphs from clinical trial databases using SAS. They will also lead study or small programming project teams while ensuring compliance with regulatory submission standards.
The Senior Clinical Data Manager oversees the entire data management process from study set-up to close-out, ensuring data integrity and regulatory compliance. They act as the primary contact for study-specific issues, coordinate with cross-functional teams, and mentor junior staff.
The Senior Manager will lead medical writing teams, mentor staff, and oversee complex regulatory documentation and project delivery. They are responsible for managing client relationships, ensuring compliance with regulatory standards, and implementing strategic initiatives to support clinical research objectives.
The Data Team Lead is responsible for overseeing clinical trial data management activities, including eCRF development, data validation, and query resolution. They also lead small project teams and ensure compliance with regulatory standards such as ICH and 21 CFR Part 11.
The Senior Pharmacovigilance Physician independently manages complex medical-review assignments and provides comprehensive medical judgment on safety issues. They also lead client discussions, perform signal detection activities, and serve as a medical subject-matter expert for the team.
Lead complex clinical trial projects and regulatory submissions while managing client meetings and cross-functional collaborations. Develop statistical analysis plans, provide expert biostatistical consulting, and support data safety monitoring boards.
Lead complex clinical trial projects and regulatory submissions while providing expert biostatistical guidance to sponsors. Collaborate with cross-functional teams to develop statistical analysis plans, review protocols, and ensure high-quality data deliverables.
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.
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 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 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 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 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 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 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 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 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 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.
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 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.
