Edetek

Role Description The Director, Product Engineering is responsible for leading the architecture, development, delivery, maintenance, and support of EDETEK’s software platforms and products across eClinical, Clinical Informatics, and biometrics-related solutions. This role will lead the product engineering organization and work closely with various teams to deliver scalable, secure, compliant, and high-quality software products for the life sciences industry. - 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. Qualifications - Bachelor’s degree in Computer Science, Software Engineering, Bioinformatics, or a related field. Advanced degree preferred. - 12+ years of progressive experience in software engineering, including significant leadership responsibility in product development organizations. - 5+ years of experience leading large engineering teams, including multiple teams or managers. - Strong technical background in Java, SAS, and R, with the ability to engage deeply in system architecture, design review, technical problem solving, and engineering strategy. - Solid experience in the life sciences industry, particularly in organizations developing and supporting eClinical, Clinical Informatics, biometrics, clinical data, or regulatory-supporting software solutions. - Prior experience with or in companies comparable to Medidata, Veeva, Medpace, or other clinical technology providers is strongly preferred. - Proven success delivering complex, enterprise-scale software platforms with demanding requirements for scalability, reliability, security, and compliance. - Experience with cloud-based environments, APIs, distributed systems, databases, CI/CD pipelines, and modern software delivery practices. - Strong understanding of software quality systems, validation expectations, SDLC controls, audit readiness, and compliance considerations in regulated environments. - Demonstrated ability to lead globally distributed teams and collaborate effectively across functions. - Excellent communication, leadership, and stakeholder management skills. Preferred Qualifications - Experience with eClinical and Clinical Informatics platforms such as EDC, CTMS, RTSM/IWRS, eCOA, eConsent, safety systems, data review platforms, integration hubs, or regulatory analytics tools. - Familiarity with clinical trial data standards and biometrics workflows, including SDTM, ADaM, TLFs, metadata-driven design, and statistical reporting processes. - Experience supporting products used in regulated clinical trial environments with expectations for traceability, controlled releases, and validation support. - Experience with AWS or other major cloud platforms. - Experience modernizing legacy systems and leading platform transformation initiatives. - Familiarity with enterprise integration and API-first product architecture. Core Competencies - Engineering leadership - Strong technical judgment - Strategic planning and execution - Team building and organizational development - Cross-functional collaboration - Product and customer focus - Quality and compliance mindset - Operational rigor - Continuous improvement Leadership Expectations - Lead with technical credibility, clarity, and accountability. - Balance business priorities with sustainable architecture and long-term platform health. - Build strong partnerships across Product, Biometrics, QA, Validation, Cloud Engineering, Security, and customer-facing teams. - Create an environment that promotes innovation, disciplined execution, and high-quality delivery. - Develop a strong engineering culture centered on ownership, learning, transparency, and results. Benefits - Choice of comprehensive Medical, Vision and Dental Insurance plans - Paid vacation time and sick days - Corporate holidays annually - Participation in the 401K Plan - Comprehensive perks and discount programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, etc. - Health Advocate and Employee Assistance Program Location This is a remote position, and we are open to candidates based in the United States. Equal Opportunity Employer Statement EDETEK is an equal opportunity employer and does not unlawfully discriminate against employees or applicants for employment on the basis of an individual’s race, color, religion, creed, sex, national origin, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. Whenever possible, the company makes reasonable accommodations for qualified individuals with disabilities to the extent required by law.

We are looking for a high-impact, commercially driven sales leader to accelerate the growth of our eClinical and clinical informatics business across pharmaceutical companies and CROs. This is a hunter role for a self-starting, strategic, and highly credible professional who knows how to open doors, create demand, build executive relationships, and close complex deals.  You will lead front-end business development efforts for our eClinical and clinical informatics software solutions, including engagement with clinical operations, data management, biometrics, IT, medical, regulatory, and executive stakeholders. You must be comfortable selling against well-known competitors and navigating sophisticated buying environments.  The right candidate brings a deep understanding of the clinical technology landscape, strong market awareness of similar platforms and providers, and the ability to position differentiated value in a compelling way. You should be a persuasive presenter, a confident communicator, and a proactive leader who creates momentum rather than waits for direction.  Essential Functions and Responsibilities  - Drive new business growth for eClinical and clinical informatics software solutions in pharmaceutical, biotech, and CRO accounts.   - Hunt for new opportunities through strategic outreach, networking, market mapping, referrals, conferences, and targeted account penetration.   - Develop and execute winning sales strategies to build pipeline, advance opportunities, and close revenue-generating deals.   - Build relationships with key decision-makers, influencers, and budget owners across sponsor and CRO organizations.   - Lead high-impact discovery discussions to understand customer pain points, business drivers, technology gaps, and operational needs.   - Deliver compelling presentations, product positioning, and value-based solution discussions to senior and executive-level stakeholders.   - Clearly articulate competitive differentiation against other market players.   - Partner with internal subject matter experts, product teams, operations, marketing, and leadership to shape client strategy and win business.   - Lead or support proposals, RFP responses, pricing discussions, and contract negotiations.   - Maintain a strong and credible pipeline with disciplined opportunity management and accurate forecasting.   - Track market trends, customer needs, and competitor activity to identify growth opportunities and refine go-to-market strategy.   - Represent the company at industry conferences, client meetings, and strategic business-development events.   - Act with urgency, ownership, and accountability to push opportunities forward and deliver results.

Senior Product Development Specialist will participate in design and development of requirements, testing and pre-sales activities of EDETEK’s CONFORM™ product line. Sr. Product Development Specialist will be contributing to one or more than one component of the CONFORM platform. Daily activities will include interactions with the product leadership team, product owners, software engineers, business analysis and quality departments. Senior Product Development Specialist must ensure that product functions operate in accordance with common CR&D business flows as well as industry regulations. Senior Product Development Specialist contributes to the preparation of product demonstrations, meeting with customers and participation industry forums. He/She must possess knowledge of clinical patient and operational information flows, as well as data management and analytical methods applicable to the conduct of clinical trials. Essential Functions and Responsibilities  - Consult with managers and business users to determine the role of CONFORM modules in clinical studies. - Analyze quantitative and qualitative data to help in developing business solutions capable of fulfilling the needs of business users and improving the quality of service. - Research edging clinical analytics technique and provide detailed information to senior technical and management personnel if any technology can increase the CONFORM’s efficiency and effectiveness. - Work with other team members to implement emerging business intelligence tool to reduce the operational cost in clinical field by defining KPIs, reports, and dashboards. - Integrate CONFORM platform with other software under guidance of senior technical personnel from both data and security perspective. - Assist to apply automation of CONFORM procedures by translating the manual business process into automated processes. - Devise ways to add new functionality to existing software products with assistance from senior product analytics personnel. - Draft use cases for CONFORM’s data-driven strategies, collect required resources for analysis and build tentative data models. - Design and develop new systems under guidance of senior product analytics personnel by choosing and configuring hardware and software. - Assist the installation and configuration of new systems to customize them for the organization. - Conduct manual system testing and develop an automated script to ensure that the systems work as expected. - Assist with UAT, developing and maintaining quality procedures, and ensure that appropriate documentation is in place. - Assist/guide the system’s end users about major functionalities of existing product and write instruction manuals supporting both internal and external training program. - Annotated CRF, converted clinical study datasets conform with SDTM standards, and prepared corresponding documentation. - Performed production and QC programming of analysis datasets, table listings, figure, and patient profile for clinical trials. - Trained employees in internal SAS macro utility and associated CONFORM tools; provided CDSIC related consulting service for major clients. - Leaded several full submission deliverable projects and supported sponsors with multiple ongoing studies regular data update.

The Senior Biostatistician provides statistical support and leadership for oncology clinical trials across multiple phases of development. This role works closely with sponsors and cross-functional teams to support study design, protocol development, statistical analysis planning, data interpretation, and study reporting. The Senior Biostatistician is expected to contribute strong technical expertise, effective client communication, and high-quality delivery of statistical work products in a CRO environment.  Candidates with CRO experience are strongly preferred. Experience supporting oncology studies and Data Monitoring Committee (DMC/IDMC) activities is also preferred.  Essential Functions and Responsibilities - 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.   Oncology-Specific Responsibilities  - 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.   - Work with cross-functional teams on tumor assessment data, adjudication, and endpoint derivation.   DMC / IDMC Experience - 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.

The Senior Biostatistician provides statistical support and leadership for oncology clinical trials across multiple phases of development. This role works closely with sponsors and cross-functional teams to support study design, protocol development, statistical analysis planning, data interpretation, and study reporting. The Senior Biostatistician is expected to contribute strong technical expertise, effective client communication, and high-quality delivery of statistical work products in a CRO environment.  Candidates with CRO experience are strongly preferred. Experience supporting oncology studies and Data Monitoring Committee (DMC/IDMC) activities is also preferred.  Essential Functions and Responsibilities - 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.   Oncology-Specific Responsibilities  - 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.   - Work with cross-functional teams on tumor assessment data, adjudication, and endpoint derivation.   DMC / IDMC Experience - 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.

The Senior Biostatistician provides statistical support and leadership for oncology clinical trials across multiple phases of development. This role works closely with sponsors and cross-functional teams to support study design, protocol development, statistical analysis planning, data interpretation, and study reporting. The Senior Biostatistician is expected to contribute strong technical expertise, effective client communication, and high-quality delivery of statistical work products in a CRO environment.  Candidates with CRO experience are strongly preferred. Experience supporting oncology studies and Data Monitoring Committee (DMC/IDMC) activities is also preferred.  Essential Functions and Responsibilities - 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.   Oncology-Specific Responsibilities  - 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.   - Work with cross-functional teams on tumor assessment data, adjudication, and endpoint derivation.   DMC / IDMC Experience - 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.

The Senior Biostatistician provides statistical support and leadership for oncology clinical trials across multiple phases of development. This role works closely with sponsors and cross-functional teams to support study design, protocol development, statistical analysis planning, data interpretation, and study reporting. The Senior Biostatistician is expected to contribute strong technical expertise, effective client communication, and high-quality delivery of statistical work products in a CRO environment.  Candidates with CRO experience are strongly preferred. Experience supporting oncology studies and Data Monitoring Committee (DMC/IDMC) activities is also preferred.  Essential Functions and Responsibilities - 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.   Oncology-Specific Responsibilities  - 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.   - Work with cross-functional teams on tumor assessment data, adjudication, and endpoint derivation.   DMC / IDMC Experience - 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.

The Senior Biostatistician provides statistical support and leadership for oncology clinical trials across multiple phases of development. This role works closely with sponsors and cross-functional teams to support study design, protocol development, statistical analysis planning, data interpretation, and study reporting. The Senior Biostatistician is expected to contribute strong technical expertise, effective client communication, and high-quality delivery of statistical work products in a CRO environment.  Candidates with CRO experience are strongly preferred. Experience supporting oncology studies and Data Monitoring Committee (DMC/IDMC) activities is also preferred.  Essential Functions and Responsibilities - 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.   Oncology-Specific Responsibilities  - 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.   - Work with cross-functional teams on tumor assessment data, adjudication, and endpoint derivation.   DMC / IDMC Experience - 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.

The Senior Biostatistician provides statistical support and leadership for oncology clinical trials across multiple phases of development. This role works closely with sponsors and cross-functional teams to support study design, protocol development, statistical analysis planning, data interpretation, and study reporting. The Senior Biostatistician is expected to contribute strong technical expertise, effective client communication, and high-quality delivery of statistical work products in a CRO environment.  Candidates with CRO experience are strongly preferred. Experience supporting oncology studies and Data Monitoring Committee (DMC/IDMC) activities is also preferred.  Essential Functions and Responsibilities - 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.   Oncology-Specific Responsibilities  - 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.   - Work with cross-functional teams on tumor assessment data, adjudication, and endpoint derivation.   DMC / IDMC Experience - 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.

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.  Essential Functions and Responsibilities  1. Document & Process Auditing  - 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  2. SOPs, Policies and QMS Maintenance  - 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   3. Training Management  - 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  4. Computer System Validation Support  - 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  - Test scripts, validation protocols (IQ/OQ/PQ), and traceability matrices  - Test run reports and validations summary reports  - Review change requests, bug reports, and ensure re-validation as needed  - Ensure systems comply with 21 CFR Part 11 requirements, including audit trails, access control, and electronic signatures  5. Audit and Inspection Readiness  - Plan, execute, and document internal process audits, project/study audits, and vendor audits.  - Coordinate with IT and product teams to ensure systems and environments are audit-ready by confirming that the following activities are performed in accordance with SOPs:  - Systems are validated and reviewed in a timely manner  - Audit trails and system logs are monitored and reviewed  - Access reviews, system related exercises and tests, and security scans are performed periodically  - 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).  - Track findings, respond to audit reports, manage CAPAs through resolution and effectiveness checks, and ensure timely completion with evidence retained for review  6. Cross-Functional Support  - Act as a QA liaison across departments, including Biometrics, Software Development, and IT/Security.  - Mentor junior QA team members by providing training and peer reviews.  - Represent QA in project meetings, product releases, and client quality discussions.  - Respond to client quality inquiries and due diligence questionnaires.  7. Continuous Improvement  - Lead or contribute to risk assessments for clinical projects, software systems, and vendor engagements.  - Identify quality gaps or inefficiencies and propose remediation or process improvement initiatives.  - Monitor and analyze quality metrics and trends (e.g., deviation rates, audit findings, CAPA effectiveness).  - Contribute to QMS improvement projects and ensure effective cross-functional adoption.