Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer electronics engineers is dedicated to delivering prescription-grade therapy with an outstanding user experience. We have pioneered the world’s first drug-free wearable therapy, clinically proven to alleviate symptoms in adults with drug-resistant Restless Legs Syndrome (RLS). Join us in transforming healthcare, improving lives, and driving meaningful change through innovative medical technology. We are seeking an experienced and strategic Director, Clinical Affairs to lead the planning, execution, and oversight of clinical studies supporting the development, regulatory approval, reimbursement, and commercialization of Noctrix Health’s medical devices. This leader will be accountable for the successful delivery of clinical programs, ensuring studies are executed efficiently, compliantly, on schedule, and within budget while generating high-quality clinical evidence that supports regulatory and business objectives. The Director, Clinical Affairs will serve as a key cross-functional leader and liaison among Clinical Affairs, Clinical Research, Regulatory Affairs, Quality, Product Development, and external partners. This individual will provide leadership across clinical operations, including sponsor oversight, site management, CRO and vendor management, clinical data quality, study execution, and evidence generation. This position reports to the Senior Vice President, Clinical & Regulatory Affairs . This is a full-time, hybrid position that is located at our Pleasanton headquarters. Responsibilities: Lead the planning, execution, and oversight of medical device clinical studies from study start-up through close-out Contribute to clinical development strategies supporting product development, regulatory submissions, reimburse
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Job Title Head of Clinical Affairs Personal Health Job Description Your role Provide clinical and medical thought leadership to inform strategic decisions, product roadmaps, solution innovation, and market expansion. Build and strengthen critical business capabilities across Medical Affairs, Medical Safety, and Clinical Affairs. Lead the development of innovative medical and clinical strategies that advance product development and commercialization priorities. Lead one or more Clinical Affairs disciplines, including clinical development, medical writing, clinical research, and clinical programming, based on expertise and business need. Shape and execute complex clinical research programs in partnership with clinical, academic, and industry stakeholders, overseeing high-impact initiatives. Own strategic planning activities, including organizational design, workforce planning, budget stewardship, and methodological innovation. Provide strategic oversight of clinical evidence generation, interpretation, and dissemination, while engaging effectively with regulatory bodies and key external stakeholders. Advance Philips thought leadership by contributing to intellectual property, white papers, publications, and external scientific visibility. Lead the Annual Operating Plan, ensuring effective fiscal management, resource allocation, and prioritization of strategic investments. Define strategy and value propositions within the function, using evidence and market insight to guide innovation and business priorities. Build influential internal and external networks and represent Philips as a credible ambassador for Clinical and Medical Affairs. Lead talent strategy across the function, including succession planning, performance management, capability building, and career development. Set clear priorities, goals, a
What if the work you did every day could impact the lives of people you know? Or all of humanity? At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients. Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible. Position Summary: The Senior Informatics Sales Specialist will use their strong genomics, healthcare and Informatics technical knowledge and expertise to identify and close Informatics opportunities. This involves selling to prospective customers and Illumina colleagues on Next Generation Sequencing and Genomic data analysis pipelines, applications and products primarily for use in clinical research or testing. They will act as an influencer and expert resource for customers and others to ensure success while enabling sales growth through strategic activities and creative problem solving. The Informatics Sales Specialist should be viewed as a “go to” subject matter expert for all things Informatics, with primary focus on Illumina’s clinical software products. As an Informatics Sales Specialist, you are impacting clinical data analysis and interpretation through effective engagement with C-level executives, Laboratory Directors, Healthcare practitioners, IT leaders, and data analysts. You are establishing Illumina as a prominent cloud-based enterprise platform provider to the Clinical, Pharma, and Healthcare se
Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X . About This Role Axsome Therapeutics is seeking a Manager/Senior Manager, Statistical Programming to provide programming support for multiple neurology compounds across all phases of development. This role will serve as lead programmer on assigned clinical trials, working closely with Biostatistics and Data Management. The Senior Manager, Statistical Programming will apply programming methodology to summary and analysis of clinical trial data, developing and utilizing SAS programs and macros to create and validate CDISC Study Data Tabulation Model (SDTM) conformed datasets, Analysis Dataset Model (ADaM) datasets, and Tables, Figures, and Listings (TFLs) as scoped in the Statistical Analysis Plan (SAP) for reporting purposes in the Clinical Study Report (CSR). This position will also manage Contract Research Organizations (CROs) providing programming support, and eSubmission package planning, execution, and quality checks of package components for
Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X. About This Role Axsome Therapeutics is seeking a Associate Director/Director, Biostatistics to provide statistical support for multiple neurology compounds across all phases of development. Reporting to the Senior Director, Biostatistics, the Associate Director/Director, Biostatistics will serve as lead statistician on assigned clinical trials, and in collaboration with project team members provide statistical input on trial design, protocol development, and manage creation of Statistical Analysis Plans (SAPs). Additionally, the Associate Director/Director, Biostatistics will manage Contract Resource Organization (CRO) partners in the creation of statistical outputs, with hands-on quality checks of the outputs. This role will contribute to Clinical Study Report (CSR) writing, and regulatory submission documents. This role is based at Axsome’s HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully r
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 packages to FDA, e.g., define.xml or define.pdf following FDA guidelines with no supervision. Expert-level in analyze information and develop innovative solutions to programming and data analysis challenges; Serve as 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 initiatives. 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. Work with global team or sponsors to coordinate project deliverables, timelines and resources. Skills and Responsibilities: Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines with 5+years of clinical programming 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. Expert-level in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members. Expert level in applying concept in Artificial Intelligence and Machine Learning in real world. In-depth knowledge of ICH, Good Clinical Practices, Clinical research, Clinical tria
The Clinical Research Associate is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices, and Pfizer standards. The Clinical Research Associate role is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company’s image with its external stakeholders. The Clinical Research Associate is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner, and other members of the study team, as required, in activities associated with the set-up, running and close out of sites in a clinical trial. JOB RESPONSIBILITIES : Responsible for investigator site management and monitoring for assigned sites: Clinical Trial Monitoring • Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan and applicable prevailing laws, Good Clinical Practices, and Pfizer standards to achieve project goals, timelines and quality • Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site initiation through to database lock, ensuring relevant timelines and quality deliverables are met.During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery • Interface with the study team as needed, facilitate information flow between members of the study team, vendor
Use Your Power for Purpose The Global Clinical Supply (GCS) Interactive Response Technology (IRT) Implementation Analyst is a position within Global Central Operations Network (GCON) GCS Strategic Hubs (GSH) team and will be based in Philippines. The IRT Implementation Analyst will be reporting to the GSH Team Lead in Philippines, with a matrix reporting relationship to the Engagement Leader, IRT Global Oversight Team (IGOT) within Clinical Supply Informatics & Technology (CSIT). GCS manages the execution of supply chain strategies to deliver Investigational Medicinal Product to patients involved in Pfizer’s clinical research trials across the globe. IGOT is a well-established high performing team within Pfizer's GCS unit striving to deliver best in class IRT systems providing randomization and drug management capabilities in support of Pfizer's dynamic investigational product portfolio. The patients we serve are our number one priority and IGOT aims to employ the highest quality standards across our internal and vendor IRT solutions. As part of an innovative clinical supply chain, we routinely challenge the status quo in efforts to optimize our systems and processes. The IRT Implementation Analyst is an individual contributor who performs defined implementation activities under the direction of an accountable IRT Lead, Design Lead, or functional lead. Responsibility and independence will expand progressively based on completion of required training, demonstrated proficiency, and role readiness. This role requires providing support across other global time zones based on business need, specifically from 8:00 p.m. to 5:00 a.m Philippine Time or 9:00 p.m. to 6:00 a.m. Philippine Time (equivalent to 8:00 a.m. to 5:00 p.m. U. S. Eastern Time). What You Will Achieve The IRT Implementation Analyst is a new role within the IRT IGOT that will support requirements a
About the team OpenAI’s Forward Deployed Engineering team partners with customers to turn research breakthroughs into production systems. We operate at the intersection of customer delivery and core platform development. About the Role As a Deployment Lead Life Sciences, you will define how OpenAI delivers complex systems to customers. You will own how they are built, shipped, and adopted. You’ll translate business outcomes into a technical plan, run day-to-day execution across FDEs, Researchers, and Customer Engineers, and partner with customer teams to ensure delivery supports their goals. You will focus on the Life Sciences vertical, partnering with pharmaceutical companies, clinical research organizations, and other data and services providers to deploy next-generation AI capabilities across their drug discovery, development, and operations. You will own delivery end-to-end: embedding with Life Sciences customers to map workflows and success criteria, ensuring components ship on time, and leading readiness and change management for adoption. You’ll track progress, manage dependencies, make sequencing decisions, and drive 0→1 prototypes through MVP and scale. You will also share field insights with Product and Research to guide roadmap and priorities. Success will be measured first and foremost by impact - deployments that deliver measurable value against customer goals, drive adoption, and become critical to their workflows. Additional measures of success include delivery reliability (milestones hit, low reopen/churn), operating leverage (patterns reused across deployments), judgment under pressure, and product impact (field signal that shifts roadmaps/architectures). This is a high-trust, high-autonomy role. Success requires deep technical project management expertise, extreme ownership of outcomes, and an ability to immerse in customer workflows and partner with customer teams to solve complex engineering problems at pace. This role is based in New York. We us
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. What you will be doing: Beacon Biosignals is looking for a Senior Product Manager to own the roadmap and day-to-day product decisions for our clinician- and site-facing web application, the primary way clinicians, clinical research sites, and trial teams interact with Beacon's machine-learning-enabled brain health platform. This role reports to the Manager, Web Applications. In this role, you’ll work within Beacon's Web Apps team to drive major development milestones for the next generation of Beacon's web applications for clinicians and clinical sites. You’ll shape product direction in partnership with the team’s manager and turn it into quarterly plans your team can execute against. You’ll be a clear, credible voice for the product with external users and internal stakeholders such as Beacon’s clinical, scientific, regulatory, and commercial teams. This is a remote position, with a preference for candidates based near Beacon HQ in Boston, or another Beacon hub (e.g., New York City). What success looks like: Build deep knowledge of clinicians, sleep technicians, site coordinators, investigators, and sponsor teams, and use it to ensure the roadmap reflects their real needs and Beacon's business goals. Own a single product that serves both diagnostic and clinical trial workflows, identifying where needs overlap and diverge, and make clear, well-reasone
Advance patient care in gynecologic oncology as an Associate Medical Director at Natera. In this clinical leadership role, you will direct medical strategy and clinical development for our advanced cell-free DNA (cfDNA) and liquid biopsy portfolio, focusing on minimal residual disease (MRD) and recurrence monitoring for gynecologic malignancies (ovarian, endometrial, cervical, vulvar, and vaginal cancers). You will collaborate across research, development, commercial, and medical affairs teams to ensure the scientific rigor, clinical relevance, and clinical adoption of our molecular testing solutions. Primary Responsibilities: Clinical Development Partner with the Sr. Medical Director, Oncology on the clinical development of cell-free DNA (cfDNA) molecular diagnostics and liquid biopsy assays for gynecologic cancers. Direct the development and execution of clinical strategies and evidence-generation plans that demonstrate clinical utility in gynecologic oncology, including minimal residual disease (MRD) tracking, recurrence monitoring, treatment response assessment, and clinical trial enrichment. Medical Education and Communication Oversee medical education and scientific communications for healthcare providers focused on gynecologic oncology, including tumor boards, webinars, and field medical enablement. Partner with commercial and marketing teams to deliver clear, data-driven clinical evidence and educational materials to gynecologic oncology stakeholders, including gynecologic oncology surgeons, medical oncologists, pathologists, radiation oncologists, genetic counselors, and advanced practice providers. Representation and Advocacy Represent Natera at medical congresses and industry events, including SGO, ASCO, and ESMO, both in person and virtually. Build and maintain relationships with external experts, clinical investigators, cooperative groups such as NRG/GOG, and professional societies within gynecologic oncology. Maintain a standard of scientific rigor and
ABOUT US Nestem Technologies is ISO 9001:2015 Certified and Govt Recogonized Leading Healthcare BPO Service provider. Medical Coding Job offered For US Healthcare BPO. Also Nestem Provides Pharmacovigilance, Clinical Research and Clinical Data Management Courses with Assured Placements MEDICAL CODING Medical Coding is the process of converting Verbal Descriptions into numeric or alpha numeric by using ICD 10-CM, CPT and HCPCS. ELIGIBILITY UG / PG in Life Science, Medical, Paramedical, Dental, Pharmacy, physiotherapy, Nursing, Microbiology, Biochemistry, Biotechnology, Biology, Bio-Medical, Botony, Zoology, Bioinformatics, Genetics, BAMS, BHMS, BSMS, BNYS, BUMS, BEMS, Nutrition & Dietetics, Neuro Science, Food Microbiology, Industrial, Medical, Applied Microbiology, Genomics, Plant Biology, Advance Zoology COURSE OFFERED FOR FRESHERS 1. Medical Coding For Beginners (MCB) 2. Advance certification in Medical Coding (ACMC) HIGHLIGHTS OF NESTEM TECHNOLOGIES ISO 9001:2015 Certified and Govt Registered Institution Presentation and Video Classes by well Experienced Certified Trainers Complete Anatomy, Physiology and Pathology Training Complete Medical Coding (ICD-10 CM, CPT-4 & HCPCS) Training Complete Coverage of Industrial Requirement Flexible Class Timings, Placements with Certification High End Study Materials Software's for Practice, Free Communication, Technical & Attitude Classes PLACEMENTS & PAY DETAILS FOR TRAINED After successful completion of the Training job offer will be provided in Leading MNC's. Placements will be in Chennai, Vellore, Trichy, Coimbatore, Salem, Pune, Bangalore & Hyderabad. 10700/- to 14600/- PM initially DIRECT PLACEMENT ONLY IN CHENNAI *We provide direct placement for those having well knowledge in Human Anatomy & Physiology at FREE OF COST. This assistance will be given at our specific MNC Client in Chennai. For further Information Call us on 860 8291 818
We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate with purpose, hold ourselves accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger – helping to simplify health care one person, one family and one community at a time. Position Summary Empowering health care decisions through evidence-based insights. CVS Healthspire™ Life Sciences Solutions is committed to advancing clinical research by translating real-world data into actionable knowledge. The Lead Director of Recruitment Operations will be responsible for serving as the primary interface between clients and internal resources during the implementation and ongoing work to support client recruitment projects. The role will collaborate with Business Development, Operations and other key areas as necessary to ensure a successful launch of the project as well as ensure successful delivery to the customer. Key areas of responsibility include: Lead and develop the team that supports the business development process by translating client needs, protocol requirements, and recruitment considerations into actionable solution design Set direction, establish priorities, and build the operating discipline needed to scale the function effectively Directly support the sales process by understanding client needs, analyzing protocols, and shaping population funnel strategies Translate client requirements into practical recruitment solutions that can be executed successfully Development of required recruitment materials and process to generate success; development of targeting criteria, materials and experience flows and gaining ne
JOB SUMMARY: Natera is seeking a Data Privacy Director to help advance and operationalize the enterprise privacy program across our commercial, clinical, and product environments. This is a broad, hands-on leadership role supporting the full range of the Privacy team's work — from privacy impact assessments and regulatory analysis to contract and legal privacy-focused reviews — with a strong business-enablement orientation. This role reports to the Vice President, Data Privacy and partners with cross-functional teams to embed privacy principles throughout the lifecycle of data, technology, and innovation initiatives. The Director may also provide guidance and mentorship to privacy team members and external resources supporting the program. The Director will also serve as a key integration point between Privacy and Product, embedding privacy-by-design into product and software development lifecycles and partnering with engineering to make privacy practical and scalable. In partnership with Medical Affairs, Clinical Operations, and Data Sciences (R&D), this leader will also enhance and maintain data governance frameworks that support clinical research initiatives and the responsible use of data for quality improvement and development activities. Together, these efforts will help strengthen Natera’s privacy program, building efficient, repeatable processes that expand team capacity while enabling responsible innovation and growth. Regarding culture, we seek people who demonstrate Natera's values, enjoy challenging problems, empower others to thrive, lead by example, and adapt their playbook when necessary. RESPONSIBILITIES: Privacy Program Enablement Lead privacy impact assessments, regulatory analyses, and risk-based recommendations that balance compliance with business enablement Conduct privacy reviews of contracts and legal engagements, drafting recommendations for counsel review, alignment, and approval Apply a risk-based lens to enable business d
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
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