Everest Clinical Research

Software Engineer

• Lead efforts in resolving day-to-day work-related issues and problems, ensuring quality of deliverables, as well as improving the efficiency and productivity of statistical programming work
• Lead assigned projects by applying project management skills and statistical programming techniques; achieve on-time delivery of deliverables with quality, as well as earn client’s trust and repeat business
• Develop SDTM and ADaM dataset specifications for CSRs, ISS, and ISE following company’s or client’s Standard Operating Procedures (SOPs) and project specific requirements
• Perform quality control (QC) review of these documents prepared by others
• Program and validate SDTM and ADaM datasets following approved dataset specifications for CSRs, ISS, and ISE
• Perform CDISC standard compliant checks on SDTM and ADaM datasets
• Generate, review, and resolve Pinnacle 21 validation issues
• Perform additional QC checks on these deliverables using company Working Instruction (WI) QC checklists
• Perform overall quality/consistency review of statistical TLGs before delivering them to the internal team or the client
• Create SDTM and ADaM define.xml files
• Perform QC review of these files prepared by others
• Participate and/or lead programming teams in support of product regulatory submission related activities
• Learn and maintain expertise in the use of the utilities and macros developed for the Statistical Programmers
• Develop new macros and utilities
• Program and perform QC/validation of complex data integrity checks to ensure data quality and ongoing scientific data surveillance
• Complete job-required and project-specific training
• Comply with applicable Everest and trial Sponsor’s Policies, SOPs, and WIs
• Document data and programming information in accordance with corporate SOPs and guidelines
• Archive clinical trial data (SDTM and ADaM datasets) and programming information in accordance with corporate archival SOPs and guidelines

Senior Statistical Programmer

• Lead projects with higher level of complexity/challenges/difficulties
• Lead efforts to resolve complex statistical programming issues or problems
• Perform a leadership role in statistical programming projects
• Assist statistical programming management in properly planning and allocating resources
• Participate in developing and maintaining clinical trial data and statistical programming standards
• Perform hands on primary statistical programming and validation programming on assigned projects
• Create SDTM mapping specifications and ADaM data specifications
• Perform quality control (QC) review of these documents prepared by others
• Create SDTM and ADaM define.xml files
• Provide training, mentorship, and technical guidance to less experienced Statistical Programmers

Principal Statistical Programmer

Designer

• Design clinical database for new studies based on requirement specifications in various electronic data capture (EDC) systems
• Perform post go-live changes (database modifications) based on updated requirement specifications in various electronic data capture (EDC) systems and provide impact assessment for modifications
• Perform Unit Testing on database design, assist User Acceptance Test (UAT) activities, and address UAT findings
• Set up and configure the development environment for new studies
• Assist the creation of the Database Integration Specification (DIS) with other systems, provide Integration Technical Detail (ITD) as needed, program the integration, and assist the integration test
• Support the Data Manager in investigating and addressing issues related to the database design
• Review study design requirement specifications for assigned projects, ensuring the specifications adhere to EDC platform standards and Everest Standards
• Maintain database design timelines and promote good project management practices
• Follow up on regulatory requirements, industry trends, benchmarking, and best working practices in data management and database design by reading, participating in relevant training, and/or associated activities
• Validate and disseminate real-time study monitoring reports to Sponsor and internal team members.

Clinical Database Designer I

• Develop new features and functionality within the database design functional areas
• Assist Clinical Data Management in planning, directing, and managing the clinical database design and maintenance process
• Review the protocol and associated study reference materials
• Maintain database design timelines
• Follow up on regulatory requirements, industry trends, benchmarking, and best working practices
• Design and review case report forms (CRFs/eCRFs)
• Author and review the Data Validation Specifications
• Develop and review User Acceptance Test (UAT) plans
• Coordinate and oversee the UAT process
• Design and review patient Case Report Forms and database schema
• Test data capture/entry screens through UAT
• Participate in EDC vendor’s technical learning and exchange meetings
• Provide user training to CRAs on EDC systems
• Contribute to the development and maintenance of the company’s database design procedural documents
• Plan, manage, control and perform data processing activities for assigned projects
• Review the Data Management Plan (DMP)
• Review data, issue and resolve queries
• Assist in resolving medical coding discrepancies
• Cooperate with the Quality Assurance Department with quality control audits
• Define and monitor clinical trial data flow and quality control processes
• Accurately and efficiently validate electronically captured data
• Write clear queries on missing data and data points failing pre-defined range checks
• Develop and test SAS codes for clinical trial database logical checks and study specific monitoring reports.

Senior Clinical Database Designer

Manager

• Own the end-to-end intake and delivery of project/opportunity proposals
• Analyze clinical research protocols and opportunity and client requirements
• Drive and develop on-time, high quality, functionally and technically sound proposals
• Act as a central bid leader to plan, notify, coordinate and follow up with internal and external parties
• Support the coordination and execution of bid defense meetings, project contracting, transition of key information to project delivery teams
• Support capability building for the proposals/contracts and business development function at Everest

Proposals Manager

• Develop new features and functionality within the database design functional areas to increase the efficiency of database design at the study level, and to improve and enhance the company’s database design capabilities
• Assist Clinical Data Management in planning, directing, and managing the clinical database design and maintenance process
• Review the protocol and associated study reference materials to contribute to the development of the clinical database design project timeline
• Maintain database design timelines and promote good project management practices
• Follow up on regulatory requirements, industry trends, benchmarking, and best working practices in data management and database design by reading, participating in relevant training and/or relevant association activities
• Design and review case report forms (CRFs/eCRFs) and setup electronic data capture (EDC) systems for clinical trials
• Author and review the Data Validation Specifications for assigned projects
• Develop and review User Acceptance Test (UAT) plans for clinical databases designed by other designers
• Coordinate and oversee the UAT process for clinical databases
• Design and review patient Case Report Forms and database schema
• Test data capture/entry screens through UAT
• Participate in EDC vendor’s technical learning and exchange meetings as well as other internal and external training meetings
• Participate in trial Investigators Meetings and provide user training to CRAs on how to use EDC systems, and on Dataflow and Quality Control Processes
• Contribute to the development and maintenance of the company’s database design procedural documents, work instructions, checklists and templates for all EDC systems
• Provide input to all data management procedural documents
• Plan, manage, control and perform data processing activities for assigned projects. These tasks are performed in a timely and accurate manner and in compliance with trial sponsors’ requirements
• Review the Data Management Plan (DMP) for assigned projects
• Review data, issue and resolve queries
• Assist the Lead Data Manager, sponsor or Investigative Site with resolving queries
• Assist in resolving medical coding discrepancies resulting from coding of medical history, adverse events, procedures and medicinal products
• Cooperate with and assist the Quality Assurance Department with quality control audits on assigned databases
• Validate and disseminate real-time study monitoring reports to sponsor and internal team members
• Define and monitor clinical trial data flow and quality control processes in accordance to corporate SOPs, Good Working Practices, and unit guidelines
• Accurately and efficiently validate electronically captured data
• Write clear queries on missing data and data points failing pre-defined range checks and/or logical checks
• Participate in and contributes to Clinical Data Management initiatives
• Develop and test SAS codes for clinical trial database logical checks and study specific monitoring reports

• Design clinical database for new studies based on requirement specifications in various electronic data capture (EDC) systems.
• Perform post go-live changes (database modifications) based on updated requirement specifications.
• Perform Unit Testing on database design, assist User Acceptance Test (UAT) activities, and address UAT findings.
• Set up and configure the development environment for new studies.
• Review study design requirement specifications for assigned projects, ensuring adherence to EDC platform standards and Everest Standards.
• Validate and disseminate real-time study monitoring reports to Sponsor and internal team members.

Clinical Research

• Lead efforts in resolving day to day work related issues and problems, securing quality, improving efficiency and productivity of statistical and programming operations
• Provide statistical expertise for design, analysis and reporting of clinical trials and research projects
• Develop and/or review ADaM dataset specifications
• Perform statistical analysis as per SAP, and address peer/QC review comments and findings
• Provide statistical input to Case Report Forms (CRF) design and database/variable structure

Senior Biostatistician

Clinical Operations

• Taking a leadership role in facilitating the efforts of functional area directors and managers in project planning, identification of tasks and deliverables, assessment of resource needs and utilization, and risk identification/mitigation
• Ensures that ongoing projects have existing project plans as required by the established Standard Operating Procedures (SOPs)
• Ensures that project progress status is tracked and reported, and issues are promptly identified and resolved
• Works with functional area directors and managers to be jointly accountable for smooth project start-up, continuation, and successful completion
• Interacts with clients for projection of resource requirements and project management purposes
• Responsible for defining project scope and estimating budgets, planning, directing, leading project activities, managing resources and budgets, as well as project team performance of cross-functional teams engaged in clinical research and development activities
• Accountable for reporting of project progress status to Everest internal management and its clients
• May assist the organization in responding to and preparing for Request for Information (RFI) and Request for Proposals (RFP), and subsequently defining scope of work and budgets, and performing contract administration activities

Senior Clinical Project Manager

• responsible for working with the Clinical Operations team to deliver high-quality, client-centered, and profitable approaches to clinical startup services
• proactively drives projects during the startup phase and interacts with clients as a startup subject matter expert
• build and maintain strong client relationships and mutually beneficial long-term partnerships
• lead and oversee clinical study startup teams and project start up activities
• partner with Clinical Operations Leads, Project Managers, sponsors, and cross-functional teams to develop and execute effective startup strategies
• actively drive study startup performance across site identification, feasibility, site selection, ethics/regulatory submissions, site activation, contract and budget negotiations, and essential document collection
• ensure quality and completeness of startup deliverables by performing reviews of regulatory submissions, essential documents, startup trackers, and study records
• monitor project startup timelines, KPIs, cycle times, and quality metrics
• provide leadership, mentoring, and line management for Clinical Trial Assistants and Site Contracts/Budgets teams
• perform business analysis and benchmarking within startup services and identify opportunities for continuous improvement

Associate Director, Clinical Operations – Study Startup

• The Senior Project Manager position is responsible for taking a leadership role in facilitating the efforts of functional area directors and managers in project planning
• Identification of tasks and deliverables
• Assessment of resource needs and utilization
• Risk identification/mitigation
• Performs overall company-wide project progress tracking utilizing strategic planning and project tracking methods and tools
• Ensures that ongoing projects under their scope have existing project plans as required by the established Standard Operating Procedures (SOPs)
• Ensures that project progress status is properly tracked and reported
• Issues are promptly identified and resolved
• Work with functional area directors and managers to be jointly accountable for smooth project start up, continuation, and successful completion
• Interact with clients for projection of resource requirements and project management purposes
• Responsible for defining project scope and estimating budgets, planning, directing, leading project activities
• Managing resources and budgets, as well as project team performance of cross-functional teams engaged in clinical research and development activities
• Accountable for reporting of project progress status to Everest internal management and its clients
• Activities including, but not limited to site selection, study start-up, clinical operations, statistics, data management, subject randomization and drug supply management (Interactive Web Response Systems [IWRS]), data monitoring and/or adjudication committees, regulatory submissions, vendor management, and medical/scientific writing
• When required, assist the organization in responding to and preparing for Request for Information (RFI) and Request for Proposals (RFP)
• Defining scope of work and budgets
• Performing contract administration activities.

• owns the end-to-end intake and delivery of project/opportunity proposals, enabling responsive and customer focused solutions
• driving cross functional collaboration, input and review, and ensuring organizational goals and strategies are reflected
• interacts closely with both external customers and internal stakeholders to analyze clinical research protocols and opportunity and client requirements
• drive and develop on-time, high quality, functionally and technically sound proposals comprising of project/opportunity budgets, written proposals, responses to Request for Information questionnaires, and ongoing iterations of budgets and contracts through to contract finalization
• acts as a central bid leader to plan, notify, coordinate and follow up with internal Everest solutions teams and external parties such as clients and third-party vendors to provide customized and proposal specific budgets, responses, and delivery strategies as input to the proposal development process
• supports the coordination and execution of bid defense meetings, project contracting, transition of key information to project delivery teams

• Design and specify study data tabulation models and analysis data models for clinical trials
• Generate complete and efficient analysis data models following approved dataset designs or specifications
• Perform independent validation of datasets created by other programmers or statisticians
• Develop SAS programming codes and generate complete and accurate statistical output reports
• Document data and programming information in accordance with corporate SOPs and guidelines
• Archive clinical trial data and programming information
• Provide technical guidance and support to less experienced Statistical Programmers

Medical Director

• Provide hands-on medical monitoring and clinical expertise to support the design, conduct, and interpretation of clinical trials
• Ensure subject safety, data integrity, and protocol compliance
• Serve as the primary Medical Monitor for assigned studies, providing real-time medical guidance
• Review safety data and contribute to clinical discussions
• Collaborate with Clinical Operations, Data Management, Biostatistics, and Pharmacovigilance

• Provide hands-on medical monitoring and clinical expertise to support the design, conduct, and interpretation of clinical trials
• Responsible for ensuring subject safety, data integrity, and protocol compliance in accordance with ICH-GCP
• Act as the primary Medical Monitor for assigned studies
• Serve as a key medical point of contact for investigative sites and sponsors
• Provide real-time medical guidance and review safety data
• Contribute to clinical and scientific discussions to support high-quality study execution

Senior Statistical Programmer

Principal Statistical Programmer

Clinical Database Designer I

Senior Clinical Database Designer

Proposals Manager

Senior Clinical Database Designer

Clinical Database Designer I

Senior Biostatistician

Senior Clinical Project Manager

Associate Director, Clinical Operations – Study Startup

Senior Clinical Project Manager

Proposals Manager

Senior Statistical Programmer

Medical Director

Senior Medical Director