The IT Support Specialist will resolve technical support tickets via ServiceNow and manage the configuration and deployment of hardware. They are also responsible for system patch management, user account administration, and maintaining office equipment.
The Sales Enablement and RFI Manager develops, writes, and finalizes responses to client Requests for Information (RFIs) and capabilities presentations. They also coordinate between Business Development and functional leaders while maintaining the RFI content database.
The Sales Enablement and RFI Manager develops and finalizes responses to client Requests for Information (RFIs) and creates capabilities presentations. They coordinate between Business Development and functional leaders to maintain and optimize the RFI content database and proposal templates.
The Quality Assurance Auditor I is responsible for conducting internal audits to ensure compliance with regulatory requirements and company SOPs. They also assist with external client audits, regulatory inspections, and the investigation of non-conformities.
The Quality Assurance Auditor I is responsible for conducting internal audits to ensure compliance with regulatory requirements and company SOPs. They also assist with external client audits, regulatory inspections, and the investigation of non-conformities.
The Quality Assurance Auditor I is responsible for conducting internal audits to ensure compliance with regulatory requirements and company SOPs. They also assist with external client audits, regulatory inspections, and the investigation of non-conformities.
The Senior Clinical Data Manager leads data management activities, including project planning, timeline management, and serving as the primary contact for clinical trial deliverables. They are also responsible for hands-on tasks such as CRF design, database validation, query resolution, and ensuring compliance with regulatory standards.
The Senior Clinical Data Manager leads data management activities, including project planning, database design, and ensuring high-quality deliverables for clinical trials. They act as the primary contact for clients, manage timelines, and provide training and oversight to the data management team.
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 data entry personnel.
The Senior Clinical Data Manager leads data management activities, including project planning, database design, and ensuring high-quality deliverables for clinical trials. They also manage client relationships, provide training to team members, and support regulatory audits and inspections.
The Principal 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 clinical trial standards and sponsor requirements.
The Senior Clinical Data Manager will lead data management activities, ensuring high-quality deliverables and adherence to project timelines. They are responsible for managing client relationships, overseeing EDC system training, and performing hands-on data management tasks such as CRF design and database validation.
The Clinical Data Manager will plan, manage, and control data processing activities for assigned clinical trials while ensuring compliance with sponsor requirements. They are responsible for leading data management projects, designing CRFs, performing quality control, and supervising junior data management personnel.
The Associate Director will lead the strategy for open-source application development to support clinical data standards and statistical programming. They will oversee the design and maintenance of R and Python-based tools while ensuring compliance with regulatory expectations and data integrity principles.
The Associate Director will lead the strategy and governance for open-source application development to support clinical data standards and analytics. They will oversee the design and maintenance of R and Python-based tools while ensuring alignment with regulatory expectations and data integrity principles.
The Associate Director will lead the definition and governance of open-source application development strategies to support clinical data standards and statistical analytics. They are responsible for overseeing the design and maintenance of R and Python-based tools while ensuring alignment with regulatory expectations and automation goals.
Develop and execute safety data review plans for clinical trials, focusing on AEs, SAEs, and laboratory data. Perform medical coding using MedDRA and WHODrug dictionaries while coordinating with data managers to ensure high-quality data collection.
Design and specify study data tabulation and analysis models for clinical trials in accordance with industry standards. Develop SAS programming codes to generate accurate statistical output reports and provide technical guidance to junior programmers.
Support medical writing and safety monitoring teams through QC review of regulatory documents and data verification of statistical outputs. Manage document e-publishing, archiving, and provide secretarial support for DMC/DSMB meetings.
Direct the operational delivery of clinical trial safety services and lead the strategic expansion of post-marketing safety infrastructure from the US to a global scale. Manage regulatory submissions, aggregate reporting, and the financial performance of the safety business unit.
The role serves as the primary contact for IWRS/IRT and eDiary users, providing overnight technical support and issue resolution. Responsibilities include monitoring data accuracy, executing application testing, and maintaining system documentation.
Act as the primary lead and contact for clients regarding IWRS/IRT and eDiary solutions, ensuring high-quality data monitoring and issue resolution. Responsibilities include performing drug management analysis, executing UAT, and mentoring junior monitors to ensure compliance with SOPs.
The role serves as the primary contact for IWRS/IRT and eDiary users, providing technical support and issue resolution. Responsibilities include monitoring data accuracy, executing application testing, and maintaining requirements documentation.
The Medical Writer is responsible for preparing and quality-checking clinical documents, including protocols, CSRs, and scientific publications. They also handle document e-publishing and may serve as a DMC Administrator to coordinate committee meetings and charters.
Author accurate regulatory documents such as CSRs, protocols, and IBs to support clinical trial authorizations and marketing applications. Lead writing projects from initiation to close-out while managing sponsor relationships and performing peer quality reviews.
The role involves serving as the DMC Secretary, managing administrative tasks for committees, and supporting project management for clinical safety. Additionally, the associate performs quality control on regulatory documents and assists with safety event case processing.
Lead complex statistical programming projects and resolve technical issues to ensure high-quality, on-time delivery of clinical trial deliverables. Develop and validate SDTM and ADaM datasets while providing mentorship and technical guidance to junior programmers.
Lead clinical trial programs by providing statistical oversight on study design, analysis planning, and reporting. Manage project teams, mentor junior biostatisticians, and ensure all deliverables meet regulatory requirements and CDISC standards.
Lead and manage clinical trial programs by providing technical and operational leadership to biostatisticians and programmers. Responsible for ensuring sound statistical methodologies in study design, analysis planning, and the delivery of high-quality regulatory reports.
Lead the development and validation of SDTM and ADaM datasets and specifications for clinical study reports and regulatory submissions. Ensure the quality and consistency of statistical tables, listings, and figures while managing project timelines and client expectations.
Develop and validate SDTM and ADaM datasets and generate statistical output reports based on the Statistical Analysis Plan. Provide programming support for Clinical Study Reports and perform database integrity checks to assist in data cleaning.
Lead the statistical design, analysis, and reporting of clinical trials while managing project timelines and deliverables. Oversee statistical programming activities, including the development of ADaM datasets and the creation of Statistical Analysis Plans.
Lead the statistical design, analysis, and reporting of clinical trials while managing project timelines and quality deliverables. Develop statistical analysis plans, perform programming validation, and contribute to clinical study reports and publications.
Lead clinical trial programs by providing statistical oversight on study design, analysis planning, and reporting. Manage project teams and ensure all deliverables meet regulatory requirements and quality standards.
Lead the statistical planning, analysis, and reporting for clinical trials, including the creation of SAPs and the development of ADaM datasets. Manage project deliverables and collaborate with data management teams to ensure high-quality clinical research outputs.
Lead statistical and programming teams to manage clinical trial programs, ensuring sound methodologies in study design and reporting. Provide technical leadership, mentor staff, and interact with clients and regulatory agencies to support drug development and commercialization.
Manage clinical trial programs and provide technical and operational leadership to statistical programming teams to ensure quality and timely deliverables. Oversee the development of reporting standards and perform quality control reviews of SDTM, ADaM, and TLF deliverables for regulatory submissions.
Develop and validate SDTM and ADaM datasets and generate statistical output reports based on the Statistical Analysis Plan. Provide programming support for clinical study reports, safety data integrations, and database integrity checks.
Develop and validate SDTM and ADaM datasets and generate statistical output reports based on the Statistical Analysis Plan. Provide programming support for clinical study reports, data cleaning, and regulatory safety reporting.
Design and maintain clinical databases for new studies using various EDC systems, including the creation of CRFs and edit checks. Support data managers in investigating design issues and contribute to the development of company procedural documents and standards.
Design and maintain clinical databases for new studies using various EDC systems, including the creation of CRFs and edit checks. Provide technical guidance, perform quality control reviews, and collaborate with Data Managers to ensure protocol requirements are met.
Design and maintain clinical databases for new studies using various EDC systems, including the creation of CRFs and edit checks. Support data managers in troubleshooting design issues and contribute to the development of company-wide database design procedures.
Design and maintain clinical databases for new studies using various EDC systems, including creating CRFs and edit checks. Provide technical leadership through quality control reviews, mentoring junior designers, and developing procedural documentation.
Lead the development and validation of SDTM and ADaM datasets and specifications for clinical study reports. Ensure the quality and consistency of statistical tables, listings, and figures while managing project timelines and regulatory submissions.
Develop and validate SDTM and ADaM datasets and generate statistical output reports based on Analysis Plans. Provide technical guidance to junior programmers and ensure all deliverables comply with industry and regulatory standards.
Lead complex statistical programming projects, overseeing timelines, resource allocation, and the quality of deliverables for clinical trials. Perform hands-on programming for SDTM/ADaM specifications and provide technical guidance and mentorship to junior programmers.
Design and specify study data tabulation and analysis models for clinical trials in accordance with industry standards. Develop SAS programming codes to generate statistical output reports and perform independent validation of datasets.
Lead data management activities, including the development of project plans, managing client relationships, and overseeing deliverables for clinical trials. Perform hands-on tasks such as designing eCRFs, managing database modifications, and ensuring data quality through validation and reconciliation.
Develop and validate SDTM and ADaM datasets and generate statistical output reports based on the Statistical Analysis Plan. Provide programming support for clinical study reports, safety data integrations, and database integrity checks.
The role involves designing and maintaining clinical databases, including the creation of eCRFs and Data Validation Specifications. It also requires managing UAT processes, developing SAS codes for monitoring reports, and ensuring compliance with corporate SOPs and regulatory requirements.
Design and maintain clinical databases in various EDC systems, including creating CRFs, edit checks, and managing database modifications. Collaborate with Data Managers and QA to ensure specifications adhere to company and industry standards while managing project timelines.
Design and maintain clinical databases in various EDC systems, including creating CRFs, edit checks, and integration specifications. Support Data Managers in investigating design issues and ensure all specifications adhere to company and platform standards.
The role involves designing and maintaining clinical databases, including creating eCRFs and authoring data validation specifications. It also requires managing UAT processes, developing SAS codes for monitoring reports, and ensuring compliance with corporate SOPs and regulatory requirements.
Lead and oversee clinical study startup teams to ensure high-quality, timely, and compliant execution of project activities. Act as a subject matter expert to drive site activation, regulatory submissions, and maintain strong client partnerships.
Lead and oversee clinical study startup teams to ensure high-quality, timely, and compliant execution of startup services. Act as a subject matter expert to drive site activation, regulatory submissions, and maintain strong client partnerships.
The Controller will manage the monthly and year-end financial close process while overseeing accounts payable, accounts receivable, and general ledger teams. They are also responsible for monitoring global cash flow, ensuring tax compliance, and enhancing internal financial policies and ERP systems.
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 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, maintaining data management plans, and ensuring compliance with sponsor requirements and regulatory standards.
The Principal Statistical Programmer will lead complex clinical trial projects, coordinate study teams, and ensure the quality of programming deliverables. They will also provide technical guidance and mentorship to junior staff while ensuring compliance with industry and regulatory standards.
