EDETEK Inc.

EDETEK is seeking a detail-oriented Data Entry Operator to support clinical data processing activities. This role is responsible for accurately entering, reviewing, and maintaining data in accordance with established procedures while ensuring quality, consistency, and timely completion of assigned tasks. The ideal candidate is organized, dependable, and comfortable working with repetitive tasks while maintaining a high level of accuracy. Key Responsibilities - Perform accurate and timely data entry into company systems and databases. - Review source documents to ensure completeness and identify discrepancies. - Verify entered data for accuracy and resolve data inconsistencies when appropriate. - Maintain data integrity by following established Standard Operating Procedures (SOPs) and work instructions. - Collaborate with Quality Control (QC) reviewers to resolve data issues. - Track assigned work and meet productivity and quality targets. - Assist with document organization, data validation, and record maintenance. - Escalate data quality concerns or process issues to supervisors when necessary. - Support continuous improvement initiatives to enhance operational efficiency. - Perform other operational support tasks as assigned.

Role Description EDETEK is seeking a detail-oriented Data Entry Operator to support clinical data processing activities. This role is responsible for accurately entering, reviewing, and maintaining data in accordance with established procedures while ensuring quality, consistency, and timely completion of assigned tasks. The ideal candidate is organized, dependable, and comfortable working with repetitive tasks while maintaining a high level of accuracy. - Perform accurate and timely data entry into company systems and databases. - Review source documents to ensure completeness and identify discrepancies. - Verify entered data for accuracy and resolve data inconsistencies when appropriate. - Maintain data integrity by following established Standard Operating Procedures (SOPs) and work instructions. - Collaborate with Quality Control (QC) reviewers to resolve data issues. - Track assigned work and meet productivity and quality targets. - Assist with document organization, data validation, and record maintenance. - Escalate data quality concerns or process issues to supervisors when necessary. - Support continuous improvement initiatives to enhance operational efficiency. - Perform other operational support tasks as assigned. Qualifications - Associate's or Bachelor's degree, or equivalent work experience. - 1+ years of experience in data entry, administrative support, operations, or a related field. - Excellent attention to detail and commitment to data accuracy. - Strong organizational and time management skills. - Proficiency in Microsoft Excel, Word, and Outlook. - Ability to work independently in a remote environment. - Strong written and verbal communication skills. Requirements - Experience in healthcare, clinical research, life sciences, or regulated industries. - Experience working with electronic data capture (EDC) systems or clinical databases. - Familiarity with Good Clinical Practice (GCP) or quality management processes. - Experience working with large datasets. Benefits EDETEK's Internship Program offers students and recent graduates the opportunity to gain practical experience in a professional environment while developing valuable technical and business skills. Interns are placed within various departments based on organizational needs, educational background, and individual interests. Departments may include, but are not limited to, Clinical Operations, Data Management, Software Development, Artificial Intelligence, Product Development, Quality Assurance, Information Technology, Human Resources, Finance, Business Development, Marketing, Regulatory Affairs, and other business functions.

• Develop and validate SAS programs to generate SDTM, ADaM datasets, tables, listings, and figures for clinical trial data. • Collaborate with biostatisticians and data managers to understand project requirements and statistical analysis plans. • Perform data manipulation and statistical analyses using appropriate programming techniques. • Develop, review and critique programming specifications and outputs to ensure accuracy and compliance with standards. • Mentor and provide guidance to junior statistical programmers to enhance their skills and productivity. • Participate in the development and implementation of programming standards and best practices. • Contribute to regulatory submissions by preparing documentation and providing support during audits.

• Develop competitive, accurate, and commercially sound budgets, proposals, assumptions, and supporting materials for biometrics-related opportunities. • Partner closely with Business Development, Biometrics functional leaders, Project Management, Contracts, Finance, and Operations to support new business opportunities, change orders, and strategic pricing initiatives. • Lead the development of biometrics-related proposals, budget packages, scope assumptions, and supporting response documents for sponsor opportunities. • Review RFPs, protocols, bid grids, and scope documents to identify service requirements, assumptions, risks, exclusions, and pricing considerations. • Draft and refine proposal content related to biometrics services, deliverables, timelines, staffing models, and operational approach. • Coordinate cross-functional inputs from relevant groups to ensure proposals are complete, accurate, compliant, and aligned with client requirements and internal standards. • Develop detailed pricing models and cost estimates for biometrics services. • Prepare budgets for different service models and build pricing assumptions based on protocol design and study complexity. • Evaluate scope changes and prepare budget revisions as needed. • Serve as a key point of contact for proposal and pricing activities related to biometrics opportunities. • Collaborate with Business Development and functional leaders.

• Provide statistical support for clinical trials from study start-up through final reporting and regulatory submission. • Contribute statistical input to study design, sample size determination, endpoint definition, randomization, and analysis strategy. • Author or review statistical sections of protocols, statistical analysis plans, mock shells, and other study documents. • Collaborate with sponsors, clinical teams, data managers, statistical programmers, medical writers, and regulatory teams throughout the study lifecycle. • Review statistical analyses and outputs, including tables, listings, and figures, to ensure quality, accuracy, and consistency. • Support interim analyses, safety reviews, efficacy analyses, and final study reporting. • Participate in the review of ADaM specifications, derived endpoints, and analysis datasets. • Support the preparation of DMC materials, including review of analysis outputs and summaries for DMC meetings, in accordance with applicable procedures and confidentiality requirements. • Interpret statistical results and communicate findings clearly to internal teams and sponsors. • Ensure study deliverables are completed on time and in compliance with SOPs, regulatory requirements, and sponsor expectations. • Support responses to sponsor questions, audit requests, and health authority queries related to statistical matters. • Provide guidance to junior statisticians and support departmental process improvement and standardization efforts. • Contribute to proposal development, bid defenses, and budget assumptions as needed. • Support oncology studies involving endpoints such as ORR, DOR, PFS, OS, BOR, CBR, and TTR. • Contribute to statistical strategies for time-to-event analyses, censoring rules, subgroup analyses, and sensitivity analyses. • Support studies using RECIST, iRECIST, or other disease-specific response criteria, as applicable. • Support statistical activities related to DMC/IDMC reviews for ongoing clinical trials. • Assist with preparation and review of DMC analysis outputs, safety summaries, and meeting materials. • Contribute to DMC charter review and statistical content, where applicable. • Work effectively within blinded and unblinded team structures and maintain strict confidentiality.

• Lead and scale the product engineering organization responsible for EDETEK software products supporting eClinical, Clinical Informatics, data integration, review, analytics, and biometrics workflows. • Provide technical and organizational leadership to multiple engineering teams, including software developers, architects, engineering managers, and technical leads. • Define and execute engineering strategy, technical roadmap, delivery model, and resource plans aligned with company product goals and business priorities. • Oversee software architecture, system design, coding standards, release management, performance optimization, maintainability, and technical debt reduction. • Drive the design and development of enterprise-grade platforms and applications using modern software engineering practices and secure SDLC processes. • Serve as a senior technical leader with strong understanding of Java-based enterprise application development, SAS-based clinical and statistical programming environments, and R-based analytical and data science workflows. • Partner closely with Product Management, Biometrics, Clinical Data Management, Statistical Programming, Regulatory, and Operations teams to translate domain and client requirements into scalable technical solutions. • Support development of products and capabilities relevant to clinical trial technology, including areas such as EDC, data integration, clinical data review, SDTM, ADaM, TLF generation, analytics, reporting, and regulatory-supporting workflows. • Ensure software solutions are designed and maintained in accordance with relevant requirements for security, privacy, auditability, validation readiness, and quality in regulated environments. • Establish and track engineering KPIs, quality indicators, delivery metrics, and team performance measures to improve predictability and execution. • Build, mentor, and retain high-performing engineering teams. Develop managers and senior contributors and create a culture of ownership, collaboration, accountability, and continuous improvement. • Lead hiring, workforce planning, organizational development, and performance management for the engineering function. • Collaborate with QA and Validation teams to ensure appropriate documentation, testing discipline, traceability, and readiness for internal and external audits. • Partner with Cloud Engineering, DevOps, and Security teams to strengthen platform reliability, scalability, observability, disaster recovery, and operational support. • Guide investigation and resolution of critical technical issues, customer escalations, and production support challenges. • Drive engineering excellence in Agile execution, CI/CD, test automation, code review, documentation, and secure development practices.

• The Clinical Data Manager (CDM) handles project management documentation, clinical data management activities, and system implementations for EDETEK’s eClinical, and may be assigned work on other platforms. • This includes writing design specifications for the system (forms, reports, etc.) and facilitating testing of system implementations. • The CDM is also responsible for all other traditional clinical data management operations and activities such as facilitating database audits, coding, SAE reconciliation, system and module testing, data cleaning, and locking and unlocking of clinical databases. • The CDM is responsible for translating the client’s Clinical Data Management requirements and expectations into DMP and implementing the clinical data management plans so that the clients’ expectations are met. • The CDM is responsible for the quality and integrity of the data in the final locked clinical database. • The CDM should thoroughly understand the requirements for Good Clinical Data Management services, including its documentation; be willing to be involved in start-up or wrap-up of in-house and client-specific data management projects; have an understanding of the relevant therapeutic indications, study hypotheses, and trial design; and have a solid understanding of database design and structure. • Support Internal Clinical Data Management Initiatives • Complete Traditional and Assigned Data Management Operations/Activities • Contribute to Project Success by Conducting Duties per CPM/LSCDM Request • Design Case Report Forms (CRFs) • Assist in the Development and Maintenance of Systems Used to Support Project Infrastructure • Work with Clinical Data Specialists (CDSs) to Execute Data Management Plans • Work with Clients/Sponsors as Necessary to Deliver Contracted Clinical Data Management Services and Clinical Data with High Quality and Integrity • Code Data per Selected Coding Dictionaries • Clean Data • Develop / Execute Testing Strategies • Assist with Data Transfers, Loading and Integration • Complete All Required Documentation per EDETEK and Project Requirements • Perform Use Acceptance Testing (UAT) on New Software • Classify Clinical Events per Agreed-upon Strategies/Plans Classification.

• We are seeking a senior QA specialist who will play a critical role in driving compliance and quality across the organization’s biometric services and computer systems. • This role involves hands-on execution of QA activities, leadership in audits and risk management, and close collaboration with cross-functional teams such as data management, biostatistics, statistical programming, software development and validation, and IT and security. • The senior QA specialist will ensure that processes, computer systems, and deliverables adhere to GxP, ICH-GCP, 21 CFR Part 11, and other applicable regulations, as well as internal quality standards through proactive oversight, documentation review, system validation, and continuous process improvement. • Conduct and/or host internal audits and vendor audits. • Review and audit Trial Master File (TMF) for completeness, accuracy, and compliance. • Track and report audit findings, deviations, and CAPAs (Corrective and Preventive Actions). • Perform risk-based audit planning and inspection readiness assessments. • Review and assist in developing policies, SOPs, work practice documents, forms and other Quality Management System (QMS) documents. • Ensure alignment with the company’s Quality Policy and applicable external regulations. • Ensure controlled documents are reviewed periodically and in a timely manner. • Document and manage deviations, nonconformances, and CAPAs. • Maintain quality records and support archiving in accordance with regulatory timelines. • Collaborate with functional managers to establish and periodically review training curricula, including study-specific training for internal teams. • Monitor overdue training, and follow up with individuals and their supervisors until completion. • Participate in validation planning and execution for internal and customer-facing systems. • Collaborate with software validation team and IT to review computer system validation plan (CVP), functional/user requirements specifications, and risk assessments. • Plan, execute, and document internal process audits, project/study audits, and vendor audits. • Coordinate with biometric teams to ensure services are performed in accordance with applicable regulations and EDETEK SOPs, including following QC processes, proper document versioning, review and approval, and appropriate documentation and sign-off for deviations. • Lead or assist in pre-inspection readiness for regulatory audits (e.g., FDA, EMA, MHRA).

• The eClinical / Medidata Database Programmer is responsible for building, configuring, testing, and maintaining clinical study databases and related eClinical system components. • Support clinical trial study startup, database build, edit check programming, system configuration, user acceptance testing, issue resolution, and production support. • Build and configure study databases in Medidata Rave or other eClinical platforms based on protocol, CRF specifications, data management plan, and sponsor requirements. • Configure electronic case report forms, visit schedules, fields, folders, matrices, forms, dynamics, derivations, and edit checks. • Support setup of study-specific workflows, roles, permissions, user groups, sites, countries, and access controls. • Configure standard and study-specific data entry rules, validation checks, and system behavior. • Support setup or configuration of coding dictionaries, external data transfers, lab data, eCOA/ePRO, RTSM/IWRS, or other integrated systems. • Develop and maintain edit checks, derivations, dynamics, and custom functions according to approved specifications. • Review edit check specifications and provide technical input to ensure checks are clear, accurate, and programmable. • Perform unit testing and support independent validation of database configuration and edit checks. • Resolve database build defects identified during testing, UAT, or production use. • Maintain documentation of build changes, testing evidence, and issue resolution. • Review clinical protocol and CRF design requirements. • Support development or review of CRF specifications, edit check specifications, and data validation specifications. • Identify inconsistencies among protocol requirements, CRFs, edit checks, and database configuration. • Collaborate with data managers, clinical teams, programmers, vendors, and sponsors to clarify requirements. • Support user acceptance testing, including test script development, test execution, defect tracking, and resolution. • Assist study teams with database-related questions during study startup, conduct, and closeout. • Troubleshoot production database issues and implement approved changes through change control. • Support mid-study updates, amendments, migration activities, and post-production database changes. • Ensure all database changes are properly documented, tested, reviewed, and approved. • Follow applicable SOPs, work instructions, validation procedures, and study-specific requirements. • Ensure database build activities comply with GCP, 21 CFR Part 11, audit trail expectations, and applicable regulatory requirements. • Maintain clear documentation for system configuration, testing, validation, and change control. • Support audits, inspections, and sponsor requests related to database build and eClinical system configuration.

• Lead and manage clinical study activities from startup through closeout in accordance with protocol, sponsor requirements, project scope, budget, SOPs, GCP, and applicable regulations. • Serve as the primary operational point of contact for assigned sponsors and maintain strong, professional sponsor relationships. • Develop, maintain, and manage study timelines, project plans, status reports, action logs, and risk registers. • Coordinate cross-functional teams, including clinical operations, data management, biostatistics, statistical programming, medical writing, safety, regulatory, and technology teams. • Facilitate internal project meetings, sponsor meetings, and governance discussions, and ensure timely follow-up on action items. • Monitor study progress and identify operational risks, quality concerns, and timeline issues, with proactive mitigation and escalation as needed. • Oversee study vendors and external partners to ensure deliverables are completed with high quality and in accordance with project timelines and expectations. • Support budget tracking, change order review, scope management, and resource planning in collaboration with leadership and other stakeholders. • Ensure inspection readiness and support sponsor audits, internal audits, and regulatory inspections, as applicable. • Promote effective communication and collaboration across global teams and functions. **DMC Coordination Responsibilities** • Lead or support the coordination of Data Monitoring Committee activities for assigned studies. • Develop and maintain DMC timelines, meeting schedules, communication plans, and tracking tools. • Coordinate preparation of DMC deliverables, including data cuts, tables, listings, figures, reports, presentations, and meeting materials, in collaboration with biometrics and other relevant functions. • Monitor readiness of DMC packages and ensure timely collection, review, quality control, and distribution of meeting materials. • Organize DMC meetings, including logistics, document flow, agenda management, attendance coordination, and follow-up activities. • Facilitate communication among sponsors, DMC members, independent statisticians, and internal study teams while maintaining required confidentiality and blinding controls. • Ensure DMC activities are conducted in accordance with the DMC charter, study protocol, sponsor requirements, and applicable procedures. • Maintain complete and accurate documentation of DMC decisions, recommendations, meeting minutes, and action items.