The Clinical Project Manager will lead Phase I to IV clinical trials, ensuring projects are delivered on time, within budget, and in compliance with regulatory standards. They will also manage cross-functional teams, facilitate sponsor communication, and support business development initiatives.
The Clinical Trial Assistant will support the operationalization of clinical trials by managing documentation, maintaining Trial Master Files, and coordinating with investigational sites and vendors. They will also assist with regulatory submissions, site feasibility, and the tracking of trial metrics to ensure compliance with ICH-GCP guidelines.
The role involves standardizing clinical trial data reporting, developing interactive dashboards, and ensuring data accuracy across various business units. Additionally, the monitor will support clinical trial technology startup activities, perform user acceptance testing, and provide analytical support for product development initiatives.
The Clinical Trial IWRS Monitor acts as the primary contact for IWRS/IRT helpdesk support and manages issue resolution in collaboration with technical and data teams. They are also responsible for monitoring system data quality, executing application testing, and maintaining comprehensive documentation for clinical studies.
The Principal Clinical Data Manager acts as the primary contact for data management deliverables and oversees hands-on tasks including database design, UAT, and data validation. They are responsible for project-level resource planning, managing database modifications, and ensuring compliance with sponsor requirements and regulatory standards.
The Manager will provide technical and operational leadership for clinical trial programs while managing client relationships and project deliverables. They are also responsible for mentoring staff, overseeing budget planning, and contributing to business development activities.
The Senior Clinical Database Designer will develop and maintain clinical database designs, including eCRFs and EDC systems, to ensure efficient and accurate data collection. They will also oversee user acceptance testing, manage project timelines, and provide technical support to clinical trial teams.
Design and maintain clinical databases for new studies using various electronic data capture (EDC) systems. Collaborate with data management teams to ensure data integrity, perform unit testing, and support regulatory compliance through quality audits.
The Medical Writer will prepare and QC clinical documents such as study protocols, CSRs, and scientific publications while ensuring adherence to project timelines. They will also perform literature searches, manage document e-publishing, and potentially serve as a DMC administrator.
The Senior Medical Writer authors regulatory documents such as clinical study protocols, reports, and briefing packages while ensuring compliance with sponsor styles and regulatory standards. They also lead writing projects, act as the primary client contact, and perform peer reviews to ensure high-quality deliverables.
The Clinical Data Management Specialist performs data entry, processing, and quality control activities for clinical trials in compliance with sponsor requirements. They assist in designing databases, writing data management plans, and validating electronically captured data to ensure high-quality study deliverables.
The Clinical Data Manager will plan, manage, and perform data processing activities while leading assigned projects to ensure compliance with sponsor requirements. They are also responsible for designing Case Report Forms, validating clinical data, and supervising junior staff to maintain high-quality deliverables.
Serve as the Data Monitoring Committee (DMC) Secretary by managing committee recruitment, meeting coordination, and documentation. Support project management activities to ensure clinical trials are executed within timelines, budgets, and regulatory requirements.
The developer is responsible for the full-stack design, development, and maintenance of custom Java web applications within a clinical research environment. They will collaborate with cross-functional teams to gather requirements, perform system testing, and ensure the security and performance of web-based solutions.
Conduct PK/PD data analysis using non-compartmental analysis and support modeling and simulation tasks. Contribute to clinical trial protocol development, statistical analysis plans, and the authoring of regulatory documents and study reports.
The Senior Site Contracts Specialist independently leads the negotiation, execution, and management of clinical trial agreements and study budgets. This role acts as a key liaison between investigative sites, sponsors, and study teams to ensure timely study startup and effective issue resolution.
The Statistical Programmer will develop and validate SDTM and ADaM datasets and generate statistical output reports based on clinical trial data. They will also support clinical data cleaning, perform database integrity checks, and ensure all documentation meets regulatory and company standards.
Provide strategic clinical pharmacology and pharmacometric expertise to support drug development programs and regulatory submissions. Lead advanced PK/PD modeling and simulation activities while providing scientific mentorship to the team.
The Senior QA Auditor will conduct internal audits to ensure compliance with regulatory requirements and company SOPs while managing corrective and preventative action investigations. Additionally, the role involves supporting external client audits, performing vendor qualification assessments, and facilitating employee training on quality procedures.
Lead clinical operations delivery for assigned studies across start-up, conduct, and closeout, ensuring quality, regulatory compliance, timelines, and budget commitments. Provide team leadership and oversight of site activation, monitoring, study documentation, vendor and site coordination, and resolution of risks and quality issues.
The Statistical Programmer will develop and validate SDTM and ADaM datasets while ensuring compliance with industry standards and regulatory requirements. They will also provide programming support for clinical study reports, safety data integrations, and ongoing data cleaning activities.
The Senior Clinical Database Designer II is responsible for designing and maintaining clinical databases within various EDC systems, including CRF creation and edit check programming. They also provide technical leadership, mentor junior staff, and ensure all database designs adhere to regulatory standards and project timelines.
Design and maintain clinical databases within various EDC systems while ensuring compliance with protocol requirements and industry standards. Collaborate with cross-functional teams to perform unit testing, manage database modifications, and support data management initiatives.
The Global Head of Clinical Delivery provides strategic leadership and operational oversight for all clinical execution capabilities across global programs and geographies. This executive is responsible for driving operational excellence, managing client portfolios, and ensuring high-quality, compliant delivery of clinical studies.
The manager will lead clinical data and safety monitoring operations, specifically focusing on the administration and project management of DMC/DSMB committees. They are responsible for mentoring team members, ensuring regulatory compliance, and driving departmental goals while maintaining strong client relationships.
The Senior Clinical Research Associate performs clinical trial monitoring activities, including reporting, tracking study progress, and ensuring site compliance with protocols and regulatory requirements. They also manage site relationships, oversee essential documentation, and assist with site inspections and audits.
The Manager will lead the medical and scientific writing functional area by planning, performing, and delivering high-quality regulatory documents while mentoring project team members. They are also responsible for recruiting and developing staff, managing client relationships, and contributing to business development and departmental process improvements.
The Principal Biostatistician will provide technical and operational leadership for clinical trial programs, ensuring sound statistical methodologies in study design and reporting. They will also mentor junior staff, contribute to protocol development, and ensure all activities comply with regulatory requirements.
The Senior Biostatistician will lead statistical and programming operations for clinical trials, ensuring high-quality deliverables and adherence to project timelines. They will provide statistical expertise for study design, analysis, and reporting, while collaborating with data management and clinical teams.
Develop and validate SDTM and ADaM datasets and statistical output reports in accordance with clinical trial protocols and regulatory standards. Support clinical data acquisition and cleaning processes by performing data integrity checks and collaborating with data management teams.
