Everest Clinical Research

Contracts Specialist

• supporting the site start up process of clinical studies by negotiating and executing Clinical Trial Agreements and their budgets
• ensuring the quality and timeliness of negotiations
• conducting timely site follow ups and contacting sites every few business days
• raising any changes in site circumstances as they arise
• negotiating study-specific CDAs, CTAs, Amendments or other related documents
• tracking all site interaction in a timely and accurate manner
• escalating any issues to the Site Contract Manager and study team as necessary

Site Contracts Specialist II

Director

• direct the operational delivery of clinical trial safety services
• ensure all active clinical trials meet client-specific Service Level Agreements (SLAs)
• oversee the timely preparation and distribution of Investigator Letters and expedited safety reports
• lead the architectural design and implementation of the CRO’s initial US post-marketing safety infrastructure
• formulate the roadmap to expand post-marketing services globally
• author and launch a comprehensive suite of post-marketing Standard Operating Procedures (SOPs)
• establish operational workflows for global literature screening and localized digital media safety monitoring
• ensure compliance with expedited reporting timelines

Senior Director, Pharmacovigilance, Drug Safety

Financial Planning and Analysis

• Oversee Project Finance team inclusive of portfolio assignments, line management, and supporting new hire process as required by the position
• Oversee financial performance of a portfolio of clinical trial projects, including revenue, costs, margins, and cash flow
• Ensure accurate revenue recognition in compliance with general accounting and company policies
• Monitor project budgets, identify variances, and partner with project teams to implement corrective actions
• Lead monthly project forecasting processes, including revenue, backlog, and margin projections
• Act as a strategic finance partner to Project Management and Clinical Operations leadership
• Review project budgets and ensure alignment with contractual terms and operational assumptions
• Develop and deliver regular reporting on project financial performance, KPIs, and risk indicators
• Directly manage and develop a team of 5 Project Finance and Commercial Contracts professionals based in North America and Europe

Director, Project Finance

Medical writer

• Work closely with the Everest project team members assigned to the project to achieve project milestones according to the project timeline.
• Perform Everest internal QC procedures for clinical documents developed by other Medical Writers, such as clinical study protocols, Clinical Study Reports (CSRs; full, abbreviated, or synoptic), pharmacokinetic (PK) reports, statistical reports, integrated efficacy or safety summaries, patient narratives, manuscripts, posters, and abstracts.
• Apply therapeutic area experience and scientific knowledge in the review and include QC checks for protocol-related information, accuracy of in-text numbers and source references, and consistency of document styles and formats.
• Act as a lead medical writer in the preparation of clinical documents or scientific publications.
• Perform literature searches to support senior medical writers.
• Perform document e-publishing for CSRs and other clinical/regulatory documents.

Medical Writer

Clinical Research

• Manage clinical trial programs/projects from one or multiple clients
• Provide day to day technical and operational leadership to project teams
• Provide statistical oversight on projects in the assigned drug development programs/projects
• Ensure sound statistical methodologies in study design, sample size estimation, statistical analysis planning, and reporting
• Coach, mentor, develop, and provide technical review and advice to less experienced Biostatisticians and Statistical Programmers
• Participate in the writing of trial protocols and research proposals
• Review and provide input to clinical data management deliverables
• Write Statistical Analysis Plans, Statistical Reports
• Perform overall Quality Control review on statistical deliverables
• Ensure compliance with relevant regulatory requirements
• Interact with regulatory agencies and support sponsor in new drug applications

Principal Biostatistician

• Leadership and Project Management: Lead efforts in statistical operations to achieve quality and on time delivery
• Statistical Planning and Methodologies: Provide statistical expertise for clinical trials and research projects
• Statistical Programming: Develop and/or review ADaM dataset specifications
• Statistical Analysis and Reporting: Perform statistical analyses as per SAP and contribute to reporting meetings

Senior Biostatistician

• Work with a Director, Senior Director, and/or Executive Director of Biostatistics, Statistical Operations, or Biometrics to manage clinical trial programs/projects from one or multiple clients
• Provide day-to-day technical and operational leadership to project teams supporting these programs/projects
• Coach, mentor, develop, provide technical review, and provide advice and expertise to direct subordinate Biostatisticians and Statistical Programmers
• Perform semi-annual and annual performance review and develop developmental plans
• Lead statistical and programming teams, interact with clients and/or Everest internal project leaders

Associate Director, Biostatistics

• Lead efforts in resolving day to day work related issues
• Provide statistical expertise for design, analysis and reporting of clinical trials
• Develop and/or review ADaM dataset specifications
• Perform statistical analysis as per SAP
• Provide statistical input to Case Report Forms (CRF) design
• Properly archive study files in accordance with trial sponsor’s requirements.

Billing Specialist

• Reconcile invoices sent to customers with monthly work effort trackers maintained by Project Managers to ensure all delivered work is billed in a timely fashion
• Compare amounts billed to accrued revenue, for large global pharma customers and follow up with Project Managers and resolve any discrepancies
• Assist with the study closeout process by reconciling revenue and billings to ensure all invoices are issued, payments are collected, and all billable costs have been accurately captured and invoiced
• Identify and resolve discrepancies for consideration prior to final closeout
• Prepare and provide billing-related audit confirmations for sponsors, ensuring accuracy, completeness, and timely delivery
• Assist with requests for reconciliation of billing history reports
• Manage billings and collections for assigned accounts and act as back-up for other members of the Billings Team

Billing Analyst

• Lead and oversee all billing operations, ensuring accurate, timely, and compliant invoicing to Sponsors in accordance with the billing schedule, contract terms and sponsor requirements.
• Review and approve new sales orders and change orders entered in Netsuite to ensure billing terms are understood and the sales order set-up facilitates timely and accurate billing.
• Review credit requests and generate credit notes in the accounting system, ensuring accuracy, and proper authorization.
• Oversee month-end billing close processes, including preparation and review of billing summary reports, analysis of variances, and escalation of outstanding issues to the project managers.
• Manage, mentor, and coach the billings team, fostering a high-performance culture through training, and performance management.
• Establish and enforce billing controls, policies, and standard operating procedures to ensure accuracy, consistency, and continuous improvement across all billing activities.
• Continually seek opportunities to improve automation in the billings function.
• Partner cross-functionally with Project Managers and Finance teams to ensure timely invoice preparation, issue resolution, and alignment on contract terms and deliverables.

Billing Manager

Designer

• Design clinical database for new studies based on requirement specifications in various electronic data capture (EDC) systems
• Design includes case report forms (CRF), edit checks, study roles, laboratory, coder, RTSM
• Perform post go-live changes (database modifications) based on updated requirement specifications in various electronic data capture (EDC) systems
• Provide impact assessment for modifications
• Perform Unit Testing on database design
• Assist User Acceptance Test (UAT) activities
• Address UAT findings
• Setup 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 Data Manager (DM) in investigating and addressing issues related to the database design
• Assist study decommission and archiving
• Develop new features and functionality within the database design functional areas to increase efficiency
• Review study design requirement specifications
• Maintain database design timelines and promote good project management practices
• Assist Clinical Data Management in planning, directing, and managing the clinical database design and maintenance process
• Follow up on regulatory requirements, industry trends, and best practices by participating in training and activities
• Contribute to the development and maintenance of the company’s database design procedural documents

Senior Clinical Database 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 EDC systems, provide impact assessment for modifications.
• Perform unit testing on the database design, assist User Acceptance Test (UAT) activities, and address UAT findings.
• Perform quality control (QC) review of databases designed by other designers.
• Set-up and configure the development environment for new studies.
• Assist with the creation of the Database Integration Specification with other systems, provide Integration Technical Detail as needed, program and assist with the integration and testing.
• Support the Data Manager in investigating and addressing issues related to the database design.
• Assist with study decommission and archiving.
• 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.
• Mentor and provide guidance to new Database Designers on the procedures and best practices related to the database design.
• Review study design requirement specifications, ensuring the specifications adhere to EDC platform standards and Everest Standards with best design practice.
• Contribute to the development of database design project timelines.
• 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 and participating in relevant training and/or relevant association activities.
• Participate in EDC vendor’s technical learning and exchange meetings and other internal and external training meetings.
• Develop and maintain the company’s database design procedural documents, Work Instructions, checklists, guides, and templates for all EDC systems.
• Provide input to all database design-related data management procedural documents.
• Cooperate with and assist the Quality Assurance department with QC audits on assigned databases.
• Validate and disseminate real-time study monitoring reports to the Sponsor and internal team members.
• Participate in and contributes to Clinical Data Management initiatives.

Senior Clinical Database Designer II

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

• 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