Senior Clinical Data Manager Jobs

Responsibilities: Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines. Develop SDTM specifications and generate SDTM datasets using SAS. Develop ADaM specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan. Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts. Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE). Create electronic submission package to FDA, e.g., define.xml or define.pdf following FDA guidelines with minimum supervision. Proficient in analyze information and develop innovative solutions to programming and data analysis challenges; Support the point of contact (POC) of programming with statisticians for statistical input and analysis interpretation Follow and reinforce regulatory agency requirements during daily job. Serve as a programming team lead and contribute to department initiative. Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams. Review draft and final production deliverables for project to ensure quality and consistency. Skills and Qualifications: Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines. Minimum of 4+ years of clinical programming experience, along with 1+ year of project management and 1+ year of people management experience. Proven knowledge and training in high level computing languages such as. SAS, C/C++, Java, R, Python, MATLAB and SQL. Database programming experience is a plus. Proficient in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members. Proficient in applying concepts in Artificial Intelligence and Machine Learning in the real world. In-depth knowledge of ICH, Good Clinical Practices, Clinical research, Clini

Opportunity Overview: We are seeking a Financial Analyst to join our FP&A team. This is a hands-on, detail-oriented role embedded within our Commercial organization. The right candidate brings sharp analytical instincts, a bias for action, and the ability to deliver reliable financial support at a pace that keeps up with a fast-moving sales team and pricing leader What you’ll do: Develop, maintain, and utilize pricing models to forecast profitability, revenue impact, and margin changes Analyze the cost impact of process and product improvements, incorporating them into financial and pricing models Partner with Commercial, Clinical/Operations, and Actuarial teams to develop comprehensive pricing models and present strategic summaries to executive leadership Review and approve deal opportunities, RFP responses, custom pricing structures, and discounting frameworks Gather and compile data points from internal systems to monitor financial performance, metrics, and client profiles Assist with organization-wide strategic projects and provide scenario modeling, serving as the subject matter expert for pricing strategy and inputs Support budget and forecast preparation for the sales and marketing organizations — partnering with the team to build credible, data-backed plans Utilize Adaptive Insights (Workday Adaptive Planning) to manage planning cycles, scenario modeling, and financial reporting with efficiency and accuracy Apply AI-powered analytics tools to automate routine tasks, surface insights faster, and continuously elevate the quality of financial outputs ISMS roles and responsibilities Fair understanding of Information Security practices. Align to the organization policies and procedures. Ensure to get updated with ISMS roles as assigned by the department/process heads. Required Qualifications: Must-haves 3–6 years of pricing, commercial finance, or operations finance experience; healthcare, BPO, or technology-enabled services industry background preferred Adva

Opportunity Overview: As a Staff Data Scientist at Cohere Health, you will serve as a technical leader across high-priority initiatives, shaping how data science is applied to some of the most complex challenges in healthcare. You’ll drive the design of advanced analytical and modeling solutions, influence strategic direction, and partner deeply across Product, Clinical, and Engineering to deliver scalable, high-impact outcomes. This role goes beyond execution. You’ll define approaches, set standards, and guide others in solving ambiguous, high-leverage problems. You’ll play a critical role in advancing the maturity of data science at Cohere while contributing directly to improving clinical and operational decision-making. What you’ll do: Lead the design and execution of complex, high-impact data science initiatives across multiple domains Define analytical frameworks and modeling approaches for ambiguous, strategic problem spaces Partner with senior stakeholders to shape problem definition, prioritize opportunities, and influence decision-making Develop and deploy advanced models and scalable analytical solutions that drive measurable outcomes Establish best practices for experimentation, model development, and analytical rigor across the team Mentor and guide other data scientists, providing technical leadership and elevating team capabilities Drive cross-functional alignment to ensure solutions are practical, scalable, and integrated into workflows ISMS roles and responsibilities: Good knowledge of Information security Oversee specific business processes within the ISMS. Responsible to manage the ISMS documentation, conduct risk assessments, and implement risk treatment plans. Risk Owners are responsible for identifying, assessing, and managing risks within their areas of responsibility. They are also responsible for implementing risk treatment plans. Conduct the BCP and other test related to information security continuity along with CISO Responsible for monitor

OVERVIEW: The Data Engineer, Pr will work closely with clients and provide high level technical consulting services, configuration of the elluminate platform, development and oversight for specific projects that include trial configuration, quality control, project management, assessing new technologies, process improvements, system validation, SOP development, custom analytics development, clinical software implementations and integrations. platform configuration, ETL and custom analytics development. The Data Engineer, Pr will be a technical escalation point for the team, design solutions and provide oversight and direction on technical development and implementation aspects to the team of existing data engineers on various software service delivery related activities. KEY TASKS & RESPONSIBILITIES: ➢ Function as a technical lead to lead consulting efforts related to clinical systems software and design and develop any reporting programs as needed ➢ Provide programming support and quality control for system configuration, Data Extracts, Custom Reports and Visualizations. ➢ Manage/Mentor technical resources to deliver client services. ➢ Provide training services as needed to internal and external users working with training staff ➢ Ensure compliance with eClinical and industry quality standards, guidelines, and procedures. ➢ Work closely with Sales Teams on staffing and project delivery services. ➢ Define new/enhanced processes to support new and existing modules in elluminate. ➢ Other duties as assigned. CANDIDATE’S PROFILE : Education & Experience: ➢ 10+ years of professional experience, preferably in Services or senior consulting role preferred. ➢ Basic Science/Bachelor of Science or Master of Science degree in Computer Science and/or equivalent work experience preferred . ➢ 8+ years in database design and development experience Position: Data Engineer, Pr ➢ Prior experience of leading technical teams is a plus. ➢ Thorough experience in data warehou

What You Will Achieve A Senior Associate Scientist (R2) position is available in the Conjugation Process Development group of Bioprocess R&D in USA - WA - Bothell. We’re seeking a passionate and creative individual to join a dynamic team of scientists and engineers focused on developing robust, scalable, and high productivity conjugation processes for the manufacture of antibody-drug conjugates (ADCs) for early- and late-phase clinical programs. The work will also involve working with commercial and clinical production facilities to ensure accurate technology transfer and successful large-scale production. You may also be involved in cutting-edge technology development projects that seek to discover new innovations for ADC process development and/or manufacturing. How You Will Achieve It Design, plan, and execute milligram to gram-scale conjugation experiments in the development laboratory. Ensures timely, effective, and high-quality documentation in electronic laboratory notebooks and internal technical reports. Communicate results and findings to stakeholders on a regular basis; present data/strategy to colleagues and management in internal and external venues (technical meetings, project team meetings, and conferences, etc.) as appropriate. Assist in or lead the technology transfer of manufacturing processes to clinical and commercial manufacturing facilities. Provide support and troubleshoot during manufacturing campaigns as needed. Work collaboratively with colleagues both within the group and cross-functionally; contribute to maintaining and improving upon our safe, effective and efficient lab operations. Qualifications Must-Have BS/BA in Chemistry, Biochemistry, Chemical/Biochemical Engineering, or other related disciplines with 3-4 years of experience, or MS in the above fields with 0-2 years of experience.

Become a part of our caring community The Clinical Pharmacist Principal designs, implements, and optimizes clinical programs across healthcare delivery systems. This team member provides strategic advice and guidance to functional team(s). Highly skilled with broad, advanced technical experience. The Clinical Pharmacist Principal works with senior executives to develop and drive segment or enterprise-wide functional strategies. Advises one or more areas, programs or functions and provides recommendations to senior executives on matters of significance, and as an advanced subject matter expert competent to work at very high levels in multiple knowledge and functional areas across the enterprise. Use your skills to make an impact Required Qualifications Doctor of Pharmacy (PharmD) degree from an accredited college of pharmacy Active pharmacist license in good standing Demonstrated experience leading enterprise or cross-functional strategic initiatives Experience designing, implementing, or evaluating programs Strong analytical and data interpretation skills Strong executive communication and presentation skills Experience influencing stakeholders across multiple organizational levels Ability to manage ambiguity and lead complex initiatives from concept through execution Additional Information: As part of our hiring process for this opportunity, we will be using an interviewing technology called HireVue to enhance our hiring and decision-making ability. HireVue allows us to quickly connect and gain valuable information from you pertaining to your relevant skills and experience at a time that is best for your schedule. Work at home requirements: To ensure Home or Hybrid Home/Office employees' ability to work

About Us InStride Health’s mission is to deliver specialty anxiety and OCD care that works for every kid, teen, young adult, and family who needs it. Through this mission, we are expanding access to insurance-based care, increasing engagement in treatment, and improving treatment outcomes. We are doing this by combining research-backed clinical care and innovative technology to eliminate the major problems with care today: difficulty finding providers, months of waiting to be seen, arduous onboarding processes, and inconsistent use of evidence-based therapies and outcomes tracking. Our vision is to become the nation’s most trusted provider of pediatric anxiety and OCD care. Team InStride Health: Our Core Values Give Heart : We lead with heart, treating patients and their families the way we want our loved ones to be treated. Work Smart : We find smarter ways to solve hard problems and fix the broken mental health system by leveraging technology, diversity of thought, and innovation. Have Humility : We leave our egos at the door, empowering our team to collaborate, celebrate diversity, and adopt a growth mindset. Embrace Community: We all belong. We are in this together, and we never worry alone. We believe in each other and recognize that every voice matters. About the Role We are looking for a Senior Product Designer to join our Product team in a full-time, temporary position anticipated to last approximately six months. This role provides additional design capacity during a planned team leave and keeps momentum across several important product initiatives. You will help shape, refine, and elevate complex workflows across InStride’s digital platform, converting clinical and operational friction points into intuitive, high-impact user experiences. You will partner closely with Product Management, Engineering, Data, and our clinical and operational partners to bring speed, craft, and scale to our product ecosystem. We are looking for an experienced product desi

Opportunity Overview: We are seeking a Senior Integration Analyst to join our Integration Services team. In this role, you will lead the technical analysis and design of complex healthcare interoperability solutions that enable seamless integration between the Cohere platform and payer, provider, and third-party systems. You'll partner closely with Product, Engineering, Clinical, Analytics, and external stakeholders to deliver scalable, reliable integrations that improve the patient and provider experience. This is an opportunity to work with cutting-edge healthcare technology, solve complex interoperability challenges, and directly influence the evolution of Cohere's integration platform while contributing to better patient outcomes. This is a remote-first role that may require travel to Boston, MA for new hire onboarding and occasional in-person team meetings and company events. What you’ll do: Serve as a subject-matter expert for healthcare interoperability and payer prior authorization integrations, leading the analysis and definition of data exchanges between the Cohere platform and payer, provider, and third-party systems Lead client-facing integration discovery and requirements-gathering sessions, translating complex payer and provider workflows into clear technical specifications Design scalable, reusable integration workflows using APIs, HL7 FHIR, HL7 v2, X12 EDI, SFTP, flat files, and other data-exchange methods Produce source-to-target mappings, interface specifications, data-flow diagrams, field definitions, validation rules, and error-handling requirements Manage integration analysis across up to three concurrent client initiatives, tracking risks, dependencies, decisions, and open issues Investigate integration failures and coordinate root-cause analysis across technical teams; review payloads, files, logs, and system behavior to resolve data-quality issues Develop test scenarios and support unit, integration, end-to-end, regression, and producti

CLEAR is building THE secure identity company of the future. Our mission is to make experiences safer and easier—physically and digitally. With more than 43 million Members and a growing network of partners across the world, CLEAR's secure identity platform is transforming the way people live, work, and travel. Whether it’s at the airport, stadium, or throughout your everyday life, CLEAR unlocks the magic of frictionless experiences. As a Senior Fullstack Software Engineer on CLEAR’s Healthcare team, you will build and scale secure, interoperable identity and data solutions that connect patients, providers, and partners. You’ll operate at the intersection of modern web platforms, healthcare interoperability standards, and high-assurance identity systems powering frictionless, trusted healthcare experiences nationwide. A brief highlight of our tech stack: Python / React / Typescript AWS cloud What you’ll do: Design and deliver secure, scalable fullstack solutions that integrate with enterprise EHR systems and national health information exchange frameworks Build and maintain healthcare data integrations leveraging FHIR (RESTful APIs/JSON) and HL7 v2 messaging to enable compliant, real-time data exchange Develop identity resolution and patient matching capabilities using identifiers such as MRNs and NPIs to ensure integrity across disparate clinical systems Partner with Engineering, Security, Product, and Health Information Management teams to implement compliant, audit-ready workflows for regulated healthcare processes Collaborate with external vendors (e.g., Epic Technical Services) to troubleshoot integration issues, manage deployments across TST/PRD environments, and ensure production reliability How you’ll measure success: Successful delivery and stability of FHIR/HL7 integrations across healthcare partners Reduction in data integrity issues related to patient matching and identity resolution High system uptime and successful production deployments across tiered

Opportunity Overview: We are seeking an experienced and driven Sr. Technical Talent Acquisition Partner to join our Talent Acquisition team and spearhead hiring initiatives for our Healthcare Technology organization. The ideal candidate will have strong technical hiring expertise, a deep understanding of engineering roles (e.g., software development, data engineering, cybersecurity, cloud, etc.), and a passion for healthcare innovation. In this role, you will lead strategic hiring efforts, partner closely with business leaders to attract top-tier engineering talent aligned with the evolving needs of the healthcare tech landscape. You will play a key role in scaling high-performing technology teams that are building transformative healthcare solutions. What you’ll do: Recruitment: Lead and own the end-to-end recruitment lifecycle from sourcing, screening, and interviewing to offer negotiation and onboarding for critical IT roles across domains like software engineering, data science, cloud, DevOps, cybersecurity, and healthcare IT systems. Assess candidates for both technical and cultural fit; conduct initial technical interviews when appropriate. Drive diversity, equity, and inclusion (DEI) in hiring initiatives. Stakeholder Management: Serve as the primary point of contact for senior-level hiring, workforce planning, and executive recruitment. Partner with business, HRBPs, and leadership to forecast talent needs and develop proactive sourcing strategies. Collaborate with global TA and business teams on talent pipeline planning and role prioritization. Sourcing & Market Intelligence: Design and execute advanced sourcing strategies across platforms, leveraging multiple sourcing channels including job boards, LinkedIn, employee referrals, campus outreach, and recruitment agencies. Employer branding: Represent the company at tech events, career fairs, and employer branding campaigns to attract top talent. Conduct regular market mapping and talent intelligence repor

Opportunity Overview: This is a unique opportunity to join a high-caliber software engineering team that is experiencing rapid growth. You’ll play a key role in building impactful healthcare technology on a modern technology stack, with a focus on our core data and AI platforms. Your work will focus on enhancing the platform's key features while also balancing scalability, reusability, and performance. As a Staff Engineer on the Application Engineering team, you’ll serve as a senior technical leader - responsible for designing and delivering high-quality, scalable software systems that power Cohere Health’s core platform. You’ll act as a multiplier, elevating the technical bar for the team, mentoring engineers, and partnering with product, data, design , clinical and payment teams to deliver solutions that meet compliance, quality, and performance standards. This role is ideal for engineers who thrive on solving complex problems in healthcare, have deep expertise in building distributed systems including data solutions, and want to influence architectural decisions for security and scale, drive cross-collaborations for alignment, establish technical standards for consistency and evolve both application and data engineering best practices at scale. What you’ll do: Technical Leadership & Architecture Define and drive the architecture of large-scale, distributed application systems across the Cohere platform. Ensure solutions are secure, performant, maintainable, and compliant with NCQA, CMS, and payer requirements. Champion platform engineering best practices in CI/CD, testing, release management, and observability. Hands-On Engineering Write clean, maintainable, and well-tested code, primarily in modern frameworks (e.g., Python, TypeScript/React, Java/Kotlin). Lead the development of core features and APIs that directly impact providers, payers, and patients. Partner with DevOps and Data teams to ensure seamless integration, scalability, and operati

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team. What You’ll Do: The Associate Director, Global Regulatory Affairs will be responsible for day-to-day regulatory activities of early/late phase investigational products, leading the writing and submission of IND/CTA/amendments and future marketing application submissions, providing guidance to the team on regulatory filings and responses, and providing critical regulatory intelligence and guidance back to the team. The Associate Director will work on cross-functional teams, partnering with key internal/external team members including Regulatory CMC and Regulatory Operations to ensure the scientific data and submissions fulfills agency expectations in a compliant manner. Responsibilities: Serve as the regulatory representative on core teams, developing and planning regulatory submission strategies, coordinating the preparation of submissions to regulatory agencies, and conducting regulatory intelligence activities Oversee the compilation, review, and submission of regulatory applications and submissions to agencies, ensuring accuracy, completeness, and timeliness Monitor the regulatory environment and communicate developments to various stakeholders within the company (clinical, regulatory, senior leadership, etc) Stay updated on global regulatory guidance and regulations, communicating key updates to senior leadership and project team management to ensure compli

A CAREER WITH POINT72'S INTELLIGENCE TEAM Point72’s Intelligence team sets the industry standard for intelligence driven analysis by proactively identifying, monitoring, and assessing various sources of risk using proprietary tools and specialized tradecraft. We support senior management by providing strategic assessments, actionable recommendations, and real-time escalations. WHAT YOU’LL DO We are looking for a subject matter expert to join a dynamic assessment and selection team with highly visible impact. You will collaborate across departments internally and provide recommendations to senior leaders based on your judgments and insights. You will be a hands-on practitioner, designing and conducting applied research. This is NOT a clinical role. Specifically, you will: Apply domain expertise to support the firm in identifying, assessing, and interviewing candidates Develop and implement research-driven assessment tools and processes Synthesize findings, author reports, and produce high-quality recommendations for senior leaders across the firm Serve as a technical advisor in the domain of psychology and brief internal stakeholders on team processes Identify and integrate emerging research and techniques that improve internal processes WHAT’S REQUIRED PhD degree in cognitive psychology, neuroscience, decision science, social psychology, organizational psychology, or a related field Excellent written and verbal communication skills, with the ability to make complex concepts clear to senior stakeholders Demonstrated experience designing, evaluating, and interpreting qualitative and quantitative assessments and organizational data Experience conducting structured interviews and translating interview data into evidence-based assessments Strong critical thinking skills, including the ability to evaluate alternative explanations and guard against bias Ability to collaborate across departments and provide clear recommendations based on sound judgment Willingness to quickl

Opportunity Overview: This is a unique opportunity to join a high-caliber software engineering team that is experiencing rapid growth. You’ll play a key role in building impactful healthcare technology on a modern technology stack, with a focus on our core data and AI platforms. Your work will focus on enhancing the platform's key features, while also balancing scalability, reusability, and performance. As a Staff Engineer on the Application Engineering team, you’ll serve as a senior technical leader - responsible for designing and delivering high-quality, scalable software systems that power Cohere Health’s core platform. You’ll act as a multiplier, elevating the technical bar for the team, mentoring engineers, and partnering with product, data, and clinical teams to deliver solutions that meet compliance, quality, and performance standards. This role is ideal for engineers who thrive on solving complex problems in healthcare, have deep expertise in building distributed systems, and want to influence architecture and engineering practices at scale. What you’ll do: Technical Leadership & Architecture Define and drive the architecture of large-scale, distributed application systems across the Cohere platform. Ensure solutions are secure, performant, maintainable, and compliant with NCQA, CMS, and payer requirements. Champion engineering best practices in CI/CD, testing, release management, and observability. Hands-On Engineering Write clean, maintainable, and well-tested code, primarily in modern frameworks (e.g., Python, TypeScript/React, Java/Kotlin). Lead the development of core features and APIs that directly impact providers, payers, and patients. Partner with DevOps and Data teams to ensure seamless integration, scalability, and operational readiness. Quality & Compliance Focus Embed automated testing, monitoring, and release safeguards into the development lifecycle. Proactively address compliance and audit-readiness requirements in application

GAQ327R248 About the Role Databricks is looking for an experienced commercial attorney to join our Commercial Legal team, with a primary focus on supporting our Healthcare and Life Sciences (HLS) sales teams. Our HLS customers - health systems, pharmaceutical and biotechnology companies, medical device and diagnostics companies, payers and health services companies, healthcare technology and data companies, and clinical research organizations - bring some of the most complex and interesting legal work on the commercial team. The customers on the other side of the table are sophisticated and heavily regulated, with specific compliance, privacy, and security requirements that need to be understood and addressed. You'll work side-by-side with Sales to lead negotiations, shape deal strategy, and address the issues that matter most to regulated customers - from HIPAA and data privacy to AI terms and security requirements. The role requires strong commercial judgment, the ability to build trust with sales teams and customers alike, and a practical approach to risk. You'll also have a front-row seat to how AI is transforming legal work. Our team is actively building and using AI-powered tools for contract review, research, drafting, and knowledge management, and you'll be part of shaping what that looks like. This position reports to the Senior Director & Associate General Counsel, Commercial. The impact you will have: Lead complex commercial transactions from first engagement through signature, including drafting and negotiating SaaS MSAs and related security and privacy terms, as well as order forms, statements of work, and related transaction documents Negotiate healthcare-specific agreements and provisions, including business associate agreements, healthcare data privacy and security terms, and regulatory compliance requirements Partner closely with Sales, Deal Desk, Finance, Security, Privacy, Product, and other stakeholders to resolve issues that affect dea