Clinical Data Management Director Jobs

Vault RIM process and system is highly dependent on accurate & complete metadata at all levels and there is also ​an increasing amount of data that Health Authorities are requiring to be tracked and submitted.​ The Regulatory Data Coordinator is responsible for driving key & critical activities within the Pfizer RIM system in support of enabling the assessment and subsequent management of new or required changes (system events). They will specifically review all events initiated across the product lifecycle, completing system impact assessments, and creating Activities, Regulatory Objectives, Submissions to enable GRS to take the necessary actions. The Coordinator also ensures that Event Details, Change Items & Label Concepts are associated and have the appropriate details as well as creating the Global Content Plan in readiness for content authoring across the enterprise. The Coordinator will work with the CMC Product strategist(s), labeling leads, Clinical & Country Regulatory Strategists through a mix of strategic and operational support, demanding a detailed understanding of regulatory system structures, product licences & master data as well as the end-to-end regulatory change management experience within & across domains. Job responsibilities: Manage all RIM events and related records, including event and registration details, ensuring structures and relationships accurately reflect product market registrations, align with master data standards, and remain updated in accordance with health authority decisions. Interpret health authority communications, drive appropriate system updates, notify stakeholders as needed, and collaborate with GRS stakeholders, CMC strategists, PGS, and cross-functional teams to understand and fulfill data requirements. Review and approve data change requests, ensuring compliance with data governance standards, policies, an

Become a part of our caring community The Senior Data & Reporting Professional supports the Michigan Integrated Long-Term Services and Supports (MI LTSS) program through advanced analytics, operational reporting, performance monitoring, regulatory compliance reporting, and strategic data management. You will transform complex clinical, operational, quality, and financial data into actionable insights that support program oversight, state contract compliance, quality improvement initiatives, and executive decision-making. Your work assignments involve moderately complex to complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. You will work independently, exercises considerable latitude in determining objectives and approaches to assignments, and begin to influence departmental strategy. The Senior Data & Reporting Professional partners closely with LTSS Care Management, Utilization Management, Quality, Finance, Compliance, Provider Operations, and Market Leadership to monitor program performance, identify operational opportunities, and support achievement of LTSS program requirements. Develop and maintain operational, clinical, quality, compliance, and executive dashboards supporting the MI LTSS program. Integrate and validate data from multiple systems, including care management platforms, quality monitoring tools, provider networks, claims data, assessment systems, and regulatory reporting sources. Create recurring and ad hoc reports supporting operational performance, regulatory compliance, quality improvement initiatives, and strategic program planning. Monitor LTSS performance indicators including Health Risk Assessments, InterRAI assessments, Nursing Facility Level of Care Determination (NFLOCD) completion, Person-Centered Service Plans, Integrated Care Team (ICT) participation,

The Ontology Engineer is a foundational technical hire on the AI, ML and Data Science team specializing in Knowledge Representation. This role is responsible for designing and maintaining the formal ontological architecture that makes cross-organizational data alignment. This is not a taxonomy or metadata management role. It requires genuine formal depth in description logics, upper ontology theory, and the ability to reason about what an ontology commits to and what it leaves open. Our platform sits between hospitals, distributors, GPOs, manufacturers, and regulators, enabling transactional execution, clinical data alignment, and analytics optimization across organizational boundaries. Each party maintains its own implicit ontology encoded in its schemas, workflows, and data. The Ontology Engineer will define the formal structures and processes that make alignment across them possible. These structures should be auditable, compositionally sound, and maintainable over a multi-year lifecycle as all parties' systems evolve. This Engineer will work directly with teammates that are familiar with ontology formalisms and with domain experts who understand the operational realities of HCSC data. They will be expected to make and defend design decisions at the level of formal correctness, not just practical convenience, and to direct and evaluate LLM-assisted ontology discovery and enrichment pipelines with the rigor that formal alignment demands. Essential Duties: Design and maintain the ontology, covering the canonical structural layer (organizations, items, contracts, transaction), source data ontologies (supporting the canonical) and the process layer (data curation, ontology matching, workflows). Establish the rules for when two records from different systems refer to the same thing, and when they don't — recognizing the answer can differ by use case. Establish mappings from trading partner source data to the canonical ontology, with documented proven

POSITION SUMMARY: Join Natera’s R&D operations as the Sample Management Manager . You will direct biobanking, cold chain logistics, and the full lifecycle of clinical diagnostic samples. Every sample represents a real person, and you will ensure that tracking, storage, and distribution meet the rigorous standards required to advance cell-free DNA testing. You will lead a high-performing team, optimizing workflows and using data to maintain accuracy and regulatory adherence in a high-stakes clinical environment. PRIMARY RESPONSIBILITIES: Develop and implement standardized procedures for sample intake, storage, tracking, and distribution Treat regulatory guidelines (e.g., GMP, GLP, ISO) and company policies as the foundation of your work, ensuring strict compliance Manage Laboratory Information Management Systems (LIMS) to maintain sample integrity and traceability Lead, train, and develop the Sample Management team to operate with pace and precision Think team by partnering directly with R&D, Quality, Supply Chain, and external partners to align sample management practices without needing translation layers Use data to troubleshoot discrepancies, root-cause logistical issues, and resolve quality concerns Use data to pressure-test workflows and implement technology enhancements that improve precision and scale Prepare rigorous reports and audits to support quality assurance and regulatory inspections Operational Responsibilities Take ownership of sample management operations, proactively allocating resources and designing workflows to meet rigorous clinical timelines Provide clear guidance to the team, establishing policies and removing operational bottlenecks without relying on heavy hierarchy Take ownership of operational challenges, relying on data rather than opinion to resolve workflow and capability gaps Manage scheduling, performance requirements, and operational budgets Act as an advisor to the team, directly stepping in to assist with issue res

JOB DESCRIPTION: Plan, coordinate and oversee all start-up activities of internal disciplines (Drug supply, Regulatory, Safety, Data Management etc.) and being the main contact (supervise, steer etc.) for involved CROs and other external vendors, if applicable Agree and/or ensure implementation of study principles and deliverables (safety, timelines, quality, milestones, budget, etc.) and follow-up to guarantee adherence Facilitate communication and ensure adequate collaboration between all involved parties Communicate effectively processes to in-/external service groups and clients in accordance with all applicable procedures (e.g. BIOM, Task List etc.) Participate in teams related to trial conduct (e.g. Clinical Study team, Extended Joint Abbott- CRO Clinical Team, Drug supply team etc.) and organize/attend external key study meetings (Kick-off meeting, CRA meeting, Investigator meeting, etc) as applicable Read, review and/or assist in preparation of core project documents (e.g. Investigator Brochure, Concise Clinical Development Plan, Protocol, Informed Consent Form) as applicable Review key Clinical Trial Management strategies like: Communication plan / Feasibility / Patient & Site recruitment / Drug supply / EC&RA Submission, etc. Oversee and manage with the CRO Project Manager the study conduct in order to ensure adequate and timely delivery of study data and documentation in Trial Master File (TMF): Use efficiently tools to monitor status of e.g. patient recruitment and take corrective action if necessary Ensure respect of agreed deliverables, and communicate efficiently within the teams (timelines, milestones, budget, quality) Co-coordinate timely availability of all supplies important for the conduction of trials, including the re-supply of sites Monitor data c

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description The Clinical Program Manager is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring all Gilead clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of Gilead’s products. You will oversee and be responsible for the successful execution of studies and/or multiple studies within a program or multiple programs, including financial responsibility. You will be responsible for the resource management of studies, includi

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. Job Description You will play a supportive role in late stage oncology clinical development. Working in collaboration with the Clinical Scientist Program Lead, you are accountable for various aspects of ongoing clinical trial program-related activities. These activities include, but are not limited to, collaboration on functional area activities during program implementation, clinical study start-up/execution/close out, data analysis/reporting and support of regulatory filings. RESPONSIBILITIES: · Acquires and uses knowledge of clinical trial design to develop specific study concept sheets and protocols. · Participates in protocol review discussions concerning scientific and procedural aspects of study design. · Prepares study protocols, amendments, specific sections of study manuals and Investigator meeting notebooks, and other documents as needed with guidance and supervision. · With supervision, contributes to the design and development of CRFs, Data Management Manuals and Data Analysis Plans. <

POSITION SUMMARY: The Supervisor of the clinical laboratory is a member of the Operations Department whose role is to oversee employees' performance and serve as a liaison between employees and senior management to meet company goals and quality objectives. The supervisor is responsible for daily supervision of lab staff performing duties such as laboratory testing and data review. Duties include but are not limited to coaching, motivating, staffing, evaluating, and training staff. The supervisor works closely with the manager to ensure company and team goals are met while adhering to good manufacturing practices and CLIA/CAP guidelines. PRIMARY RESPONSIBILITIES: • Provides direct supervision to professional individual contributors and/or skilled, support individual contributors • Ensures production work is consistently completed according to department goals. • Administers company policies that directly affect subordinate employees. • Monitors team members to ensure adherence to SOPs and safety procedures • Oversees training and development of all staff members • Document nonconformances and all corrective actions taken when test systems deviate from the established performance specifications as needed. Escalates protocol deviation to lead/supervisor. • Handles employee issues in collaboration with the department manager and Human Resources. • Ensures alignment with team for reasoning behind instructions/processes and changes • Plans and leads shift meetings. Meets regularly with individual team members to discuss goals and progress • Go-to person when manager is not present. • May assist lab team in day-to-day tasks • Keeps team morale up and maintains professionalism of team members, including by acting as role model. • Identifies trends and issues and effectively executes solutions • Actively interacts with interdepartmental teams such as OPS, Accessioning, Engineering, Stats, R&D, and Support. • Performs other duties as assigned.

This is an exciting opportunity to advance Natera’s regulated product portfolio of cutting-edge molecular diagnostic tests. As a Staff Biostatistician, you will leverage your strong applied statistics, IVD, and Clinical Research expertise to drive the strategy, design, analysis, and interpretation of clinical validation studies for kidney disease and other high-priority germline projects. PRIMARY RESPONSIBILITIES: Strategic Study Design and Analysis: Independently lead the design, analysis, and interpretation of clinical validation studies to support in vitro diagnostic approvals (e.g., CDx, 510(k), PMA, etc.) Regulatory Compliance: Ensure statistical methodologies and analyses meet the standards set by regulatory agencies such as FDA. Drive statistical interactions with regulatory authorities. Documentation and Reporting : Prepare comprehensive statistical analysis protocols (SAPs), reports, and presentations for cross-functional and external collaborators and stakeholders. Cross-Functional Leadership : Serve as the statistical lead on high-priority project teams. Partner with Clinical Science, Data Management, and Product teams to integrate statistical expertise into project planning and execution. Identify risks, communicate concerns, and champion solutions to interdisciplinary project teams Clinical Research and Beyond: Drive design and execution of high-impact research clinical trials, studies, and publications that push the development of our world-class product portfolio Stay current with advancements in Biostatistics and clinical validation methodology, implementing innovative approaches to support diagnostic product development and regulatory submissions Mentor and provide technical supervision to junior team members QUALIFICATIONS: Education : Ph.D. or Master's degree in Biostatistics, Statistics, or a related field Experience : At least 8 years of relevant industry experience, preferably within molecular diagnostics, biotechnology,

This is an exciting opportunity to advance Natera’s regulated product portfolio of cutting-edge molecular diagnostic tests. As a Staff Biostatistician, you will leverage your strong applied statistics, IVD, and Clinical Research expertise to drive the strategy, design, analysis, and interpretation of clinical validation studies for kidney disease and other high-priority germline projects. PRIMARY RESPONSIBILITIES: Strategic Study Design and Analysis: Independently lead the design, analysis, and interpretation of clinical validation studies to support in vitro diagnostic approvals (e.g., CDx, 510(k), PMA, etc.) Regulatory Compliance: Ensure statistical methodologies and analyses meet the standards set by regulatory agencies such as FDA. Drive statistical interactions with regulatory authorities. Documentation and Reporting : Prepare comprehensive statistical analysis protocols (SAPs), reports, and presentations for cross-functional and external collaborators and stakeholders. Cross-Functional Leadership : Serve as the statistical lead on high-priority project teams. Partner with Clinical Science, Data Management, and Product teams to integrate statistical expertise into project planning and execution. Identify risks, communicate concerns, and champion solutions to interdisciplinary project teams Clinical Research and Beyond: Drive design and execution of high-impact research clinical trials, studies, and publications that push the development of our world-class product portfolio Stay current with advancements in Biostatistics and clinical validation methodology, implementing innovative approaches to support diagnostic product development and regulatory submissions Mentor and provide technical supervision to junior team members QUALIFICATIONS: Education : Ph.D. or Master's degree in Biostatistics, Statistics, or a related field Experience : At least 8 years of relevant industry experience, preferably within molecular diagnostics, biotechnology,

About eClinical Solutions eClinical Solutions is transforming clinical development with elluminate®, our Clinical Data Cloud , helping life sciences organizations unify, analyze, and unlock the value of their data faster than ever before. By combining a modern cloud platform with expert data services, we empower smarter decisions across the clinical trial lifecycle—accelerating innovation that ultimately improves patient outcomes. Our engineering teams build enterprise-grade, revenue-generating products at the intersection of cloud, data, analytics, and emerging AI technologies . If you’re excited about building sophisticated software that makes a real-world impact on healthcare, this is the place to do it. You will make an impact: At eClinical Solutions, we are modernizing the clinical data ecosystem through cloud-native technologies, intelligent automation, and AI-enabled workflows. We are looking for a Product Manager, Platform & Data Integration to own the definition and delivery of platform capabilities that enable scalable and intelligent connectivity across the clinical technology landscape. In this role, you will own one or more platform capabilities spanning APIs, data connectors, interoperability, metadata exchange, data ingestion, and AI-enabled automation. Working closely with engineering, UX, architecture, services, and customers, you will transform complex technical challenges into intuitive, high-value platform capabilities that simplify connectivity, improve customer outcomes, and accelerate clinical trial execution. As part of our AI-first product organization, you’ll be expected to use modern AI tools as a force multiplier throughout the product lifecycle. From customer research and product discovery to requirements development, prioritization, and delivery, you’ll leverage AI to accelerate execution while applying sound product judgment to every decision. You will collaborate closely with cross-functional teams an

Beacon Biosignals is transforming precision medicine for the brain, from clinical development to clinical care. For Life Sciences partners, we offer the leading at-home EEG platform for clinical development of novel therapeutics for neurological, psychiatric, and sleep disorders. Our Diagnostics business is building the most comprehensive at-home platform for precision diagnostics, combining EEG and cardiopulmonary signals to deliver reimbursable assessments for sleep and central nervous system disorders. Together, we're changing the way patients are diagnosed and treated for any disorder that affects brain physiology. We're looking for an organized, innovative marketing professional to serve as the operational engine behind our Diagnostics arm of our marketing team. You'll be the person who makes things happen, turning strategy into action, managing our tech stack, coordinating event participation, owning customer communication, and building systems that help our marketing and sales teams work smarter. Beacon's robust asynchronous work practices ensure a first-class remote work experience, but we also have in-person office hubs available located in Boston, New York and Paris. What You'll Do CRM and Data Management In partnership with our RevOps team, maintain clean, actionable data across our diagnostics marketing and sales systems Implement tagging structures and workflows that enable our team to work more efficiently Manage the marketing attribution model across touchpoints Own day-to-day execution within our CRM: email campaigns, workflows, lead tracking, and list management Digital Marketing Maintain and update Diagnostic-specific pages on our website (Framer CMS); coordinate with internal designers on content refreshes Build and manage an editorial calendar and grow our LinkedIn presence (with expansion to other platforms) Track relevant awareness days, research milestones, and cultural moments to keep our content tim

Opportunity Overview: We are looking for a Sr. Forward Deployed Automation Strategist to play a key role in delivering value for our Platform-as-a-Service (PaaS) customers. Reporting into our Senior Manager, PaaS Value Delivery, you will be part of a small, fast-paced team working directly with clients to strategically design, execute, and maintain a robust prior authorization decisioning automation program. Ultimately, the work you do will have a direct impact on the growth of the company and our ability to assist more patients at a time in their healthcare journey when they need help most. What you’ll do: Consult Platform-as-a-Service (PaaS) clients on designing an optimal decision automation program that maximizes platform value Translate complex client requirements into a detailed technical blueprints for development teams to leverage when implementing new clients Collaborate with Product, Development, Design, and Engineering teams in scoping new functionality, or enhancing existing functionality, to meet client automation needs Develop strategic roadmaps related to continuous improvement of decision automation performance in order to drive increased value for clients Analyze authorization data and leverage data visualization softwares to build and maintain analytical reports that inform internal and external stakeholders on platform performance Ensure client’s KPIs are met and ensure end-to-end automation success for each client through each stage of customer lifecycle Identify opportunities to scale and improve consultation workflows What you’ll need: 5+ years experience working in a client facing role; Demonstrated expertise in building client relationships and driving client engagement, value, and satisfaction Understanding of healthcare systems, medical terminologies, clinical workflows, and regulations Ability to navigate ethical dilemmas in healthcare data management and analysis while upholding professional standards and integrity Advanced Proficie

Opportunity Overview: We are looking for a Lead Forward Deployed Automation Strategist to play a key role in delivering value for our Platform-as-a-Service (PaaS) customers. Reporting into our Senior Manager, PaaS Value Delivery, you will be part of a small, fast-paced team working directly with clients to strategically design, execute, and maintain a robust prior authorization decisioning automation program. Ultimately, the work you do will have a direct impact on the growth of the company and our ability to assist more patients at a time in their healthcare journey when they need help most. What you’ll do: Consult Platform-as-a-Service (PaaS) clients on designing an optimal decision automation program that maximizes platform value Translate complex client requirements into a detailed technical blueprints for development teams to leverage when implementing new clients Collaborate with Product, Development, Design, and Engineering teams in scoping new functionality, or enhancing existing functionality, to meet client automation needs Develop strategic roadmaps related to continuous improvement of decision automation performance in order to drive increased value for clients Analyze authorization data and leverage data visualization softwares to build and maintain analytical reports that inform internal and external stakeholders on platform performance Ensure client’s KPIs are met and ensure end-to-end automation success for each client through each stage of customer lifecycle Identify opportunities to scale and improve consultation workflows What you’ll need: 8+ years experience working in a client facing role; Demonstrated expertise in building client relationships and driving client engagement, value, and satisfaction Understanding of healthcare systems, medical terminologies, clinical workflows, and regulations Ability to navigate ethical dilemmas in healthcare data management and analysis while upholding professional standards and integrity Advanced Profici

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours! eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here! We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need. OVERVIEW The Implementation Consultant at eClinical Solutions is responsible for liaising with our clients and internal stakeholders to align our client’s clinical data strategy to tools and functionality within elluminate. The Implementation Consultant is a savvy pharmaceutical/biotech/CRO professional with advanced experience in the handling, cleansing or analysis of clinical data. The Implementation Consultant has excellent organization skills and is a creative solution-oriented individual. The Implementation Consultant has experience with the delivery of technical products and exhibits prowess with analytic data review tools. KEY TASKS & RESPONSIBILITIES ➢ Participate in elluminate implementations by providing business process and product best practices consulting services to support the technical an