Clinical Data Management Director Jobs

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. OVERVIEW Quality Control Specialists are operationally responsible for performing quality control activities associated with Biometrics client’s deliverables. Quality Control Specialists will maintain project level perspective, focus, and communicate effectively as the quality control subject matter expert. KEY TASKS & RESPONSIBILITIES Perform quality control activities (i.e. documentation review, testing) of Biometrics client’s Rave EDC and Data management deliverables including eCRFs, Data Validation Specification checks, Custom functions, Data Extracts, Data Integrations, Data Mapping, Custom Data Management Reports and listings Participate in the design and development of quality control procedures Manage documentation created during the QC process Liaise with study teams and other staff to fulfill job responsibilities and activities Develop and lead execution of training and knowledge transfer opportunities for quality control team Inform the Manager of training issues, project activities, quality issues and timelines as directed Collaborate with the project team to ensure the deliverables are completed on time with high quality Other duties as assigned CANDIDATE’S PROFILE Education/Language: Four-year college degree or higher preferred, analytic discipline a plus (Computer Science or Health related field) Excellent knowledge of English Professional Skills & Experience Minimum 3-5 years in Pharmaceutical/Biotechnology industry or equivalent Knowledge of ICH/GCP guidelines, 21 CFR Part 11, cli

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

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

ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a Senior/ Principal Statistician to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes. We are seeking an experienced Senior/Principal Statistician Consultant to provide statistical leadership and expertise across clinical development programs within the pharmaceutical industry. The successful candidate will contribute to clinical trial design, statistical methodology, data analysis, and regulatory submissions while collaborating with cross-functional teams to support evidence generation and informed decision-making throughout drug development. Key Responsibilities Provide statistical leadership across clinical development programs, from early-phase studies through late-phase clinical trials. Lead clinical trial design, including endpoint selection, sample size calculations, power analyses, and randomization strategies. Develop and review clinical study protocols, statistical analysis plans (SAPs), and other statistical documentation. Oversee statistical analyses and interpretation of clinical trial data to ensure scientific rigor and regulatory compliance. Provide statistical expertise for regulatory submissions and interactions with health authorities, including the FDA and EMA. Collaborate with Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and Medical Writing teams. Review statistical outputs, including tables, listings, and figures (TLFs), to ensure accuracy and consistency with analysis plans. Apply appropriate statistical methodologies to address complex clinical trial design and analysis challenges. Contribute to clinical study reports (CSRs), integrated summaries of safety and efficacy, and other regulatory documents. Identify statistical risks and recommend appropriat

ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a Senior/ Principal Statistician to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes. We are seeking an experienced Senior/Principal Statistician Consultant to provide statistical leadership and expertise across clinical development programs within the pharmaceutical industry. The successful candidate will contribute to clinical trial design, statistical methodology, data analysis, and regulatory submissions while collaborating with cross-functional teams to support evidence generation and informed decision-making throughout drug development. Key Responsibilities Provide statistical leadership across clinical development programs, from early-phase studies through late-phase clinical trials. Lead clinical trial design, including endpoint selection, sample size calculations, power analyses, and randomization strategies. Develop and review clinical study protocols, statistical analysis plans (SAPs), and other statistical documentation. Oversee statistical analyses and interpretation of clinical trial data to ensure scientific rigor and regulatory compliance. Provide statistical expertise for regulatory submissions and interactions with health authorities, including the FDA and EMA. Collaborate with Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and Medical Writing teams. Review statistical outputs, including tables, listings, and figures (TLFs), to ensure accuracy and consistency with analysis plans. Apply appropriate statistical methodologies to address complex clinical trial design and analysis challenges. Contribute to clinical study reports (CSRs), integrated summaries of safety and efficacy, and other regulatory documents. Identify statistical risks and recommend appropriat

POSITION SUMMARY: On site position in Pleasanton, CA Clinical Data Operator accessions patient samples according to standard operating procedures (SOP) with high efficiency and accuracy. Shift: Tuesday - Saturday, Day Shift 630am-3pm. Hourly rate starts at $21.77. PRIMARY RESPONSIBILITIES: Create new orders on Laboratory Inventory Management System (LIMS) and perform necessary checks to ensure proper accessioning. Accession samples with high accuracy and efficiency. Accurately enter patient data into the Laboratory Inventory Management System (LIMS). Ensure that the information in LIMS is up-to-date. Scan test requisition forms and attached paperwork. Ensure that all paperwork belong to patient and upload to case. Protect patient health information (PHI) at all times to ensure compliance with HIPAA and privacy policies. Perform safe and proper handling of samples (blood, buccal, and tissue). Maintain tidiness of workstations and lab. Maintain familiarity with standard operating procedures (SOP) and quality standards determined by the clinical laboratory. Perform safe and proper handling of tools provided to open packages and kit boxes. Sort packages at the dock upon arrival of packages and bring packages up to the lab. This role works with PHI on a regular basis both in paper and electronic form and have an access to various technologies to access PHI (paper and electronic) in order to perform the job. Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire. Must maintain a current status on Natera training requirements. Performs other duties as assigned. QUALIFICATIONS: High School Diploma (or equivalent) required. 0 - 1 year of industry related experience. Previous computer experience is required. Previous data entry experience is preferred KNOWLEDGE, SKILLS, AND

POSITION SUMMARY: On site position in Austin, TX Clinical Data Operator accessions patient samples according to standard operating procedures (SOP) with high efficiency and accuracy. Shift: Tuesday - Saturday, 7am-330pm. Hourly rate starts at $18. PRIMARY RESPONSIBILITIES: Create new orders on Laboratory Inventory Management System (LIMS) and perform necessary checks to ensure proper accessioning. Accession samples with high accuracy and efficiency. Accurately enter patient data into the Laboratory Inventory Management System (LIMS). Ensure that the information in LIMS is up-to-date. Scan test requisition forms and attached paperwork. Ensure that all paperwork belong to patient and upload to case. Protect patient health information (PHI) at all times to ensure compliance with HIPAA and privacy policies. Perform safe and proper handling of samples (blood, buccal, and tissue). Maintain tidiness of workstations and lab. Maintain familiarity with standard operating procedures (SOP) and quality standards determined by the clinical laboratory. Perform safe and proper handling of tools provided to open packages and kit boxes. Sort packages at the dock upon arrival of packages and bring packages up to the lab. This role works with PHI on a regular basis both in paper and electronic form and have an access to various technologies to access PHI (paper and electronic) in order to perform the job. Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire. Must maintain a current status on Natera training requirements. Performs other duties as assigned. QUALIFICATIONS: High School Diploma (or equivalent) required. 0 - 1 year of industry related experience. Previous computer experience is required. Previous data entry experience is preferred KNOWLEDGE, SKILLS, AN

Truveta is the world's first health provider-led data platform with a vision of Saving Lives with Data . We empower researchers, clinicians, and healthcare organizations through high-quality clinical data and AI-driven insights. We are seeking an experienced clinical professional to manage a team of Clinical Terminologists, Data Annotators, and Clinical Abstractors responsible for clinical terminology mapping, data annotation, and data quality. The ideal candidate is a self-starter who excels at developing high-performing teams, driving operational excellence, and delivering projects with exceptional quality and timeliness. Work Location: Hyderabad, India This Opportunity Join the founding team of the Truveta India Development Center (IDC) and play a pivotal role in shaping its future. As one of the initial members, you'll help build and scale a high-impact organization while contributing to products and platforms that advance healthcare through data and AI. This is a unique opportunity to influence both the technical direction and the culture of a growing global engineering hub. Key Responsibilities Lead, mentor, and develop a team of Clinical Terminologists, Data Annotators, and/or Clinical Abstractors by providing coaching, training, and performance guidance. Oversee terminology mapping and clinical data normalization using standards such as SNOMED CT, RxNorm, and LOINC , ensuring exceptional quality and consistency. Drive project execution by managing priorities, monitoring team performance, and ensuring deliverables are completed on time with minimal oversight. Collaborate cross-functionally with Engineering, Product, Program Management, and AI/ML teams to improve clinical data pipelines and annotation processes. Establish and continuously improve quality standards, workflows, documentation, and operational processes to support scalable clinical data operations. Key Qualifications MBBS

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. OVERVIEW The Senior Software Developer will work closely with Product Manager, Implementation Consultants (ICs) and clients to gather requirements to meet the data analysis need of a company or a client. They must have good collaboration skills. The Senior Software Developer will provide direction on analytics aspects to the team on various analytics related activities. KEY TASKS & RESPONSIBILITIES Experienced in Qlik Sense Architecture design and good knowledge on load script implementation and best practices. Hands on experience in Qlik Sense development, dashboarding, data-modelling and reporting techniques. Experienced in data integration through extracting, transforming, and loading (ETL) data from various sources. Good at Data transformation, the creation of QVD files and set analysis. Data Modelling using Dimensional Modelling, Star schema and Snowflake schema. Strong SQL skills (SQL Server) to validate the Qlik sense dashboards and to work on internal applications. Knowledge on deploying of Qlik Sense application using Qlik Management Console (QMC) is a plus. Work with Implementation consultants (ICs), product manager and clients to gather the requirements. Configuration, migration, and support of Qlik Sense applications. Thoughtful implementation of Qlik Sense best practices for efficiency and re-usability. Research and utilize new technologies. Collaborate with the Software Quality Assurance (SQA) team to test the applications functionality. Ensure compliance with eClinical Solutions/industry quality standards,

DeepIntent is the leading healthcare marketing platform, purpose-built to help marketers plan, activate, and optimize data-driven campaigns with speed and precision. Trusted by the world’s top healthcare brands and their agencies, DeepIntent uniquely unites media, identity, and real-world clinical data to power privacy-safe, omnichannel marketing across every screen. Backed by patented technology and proven outcomes, DeepIntent’s platform delivers measurable audience quality and script lift at scale. Learn more at www.deepintent.com . What You’ll Do: DeepIntent is looking for a Data Integrations Specialist to run our client data integrations. This is a highly client-facing role and with strong requirements for good project management skills. This position is to ensure DeepIntent provides a fast, transparent and error free integrations service to our agency and brand clients. Majority of integrations can be configured through the user interface, although some custom cases would require collaboration with backend engineers. Hands on experience with integrations management Manage target list handoffs Supporting existing/live integrations maintenance Acting as quarterback for organization of client discussions and implementations Manage custom PLD reports, work with clients to gather requirements, shepherd implementation with the DSP and custom scripts (where applicable) Collaborate with engineers on escalation cases Manage documentation process for all internal & client integrations Be clients’ main point of contact for all things integrations-related Who You Are: 3+ years of experience in programmatic advertising and/or publishing, supported by a strong analytical background Strong communication skills, confidently able to work in a client facing capacity Confidence to run agency & pharma client meetings Project management skills (must be able to spearhead and manage multiple projects at once) Requirements gathering: ability to partner

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. OVERVIEW The Senior External Data Specialist is responsible for managing the processing of external and/or local lab data received at eClinical Solutions throughout the clinical trial lifecycle. The Senior External Data Specialist will provide subject matter expertise in external data handling of various external data sources (ie: central laboratories, imaging, PK, PD, eCOA, ePRO, etc.) to internal cross-functional teams and external stakeholders to ensure high quality data. The Senior External Data Specialist works to ensure departmental SOPs, guidelines, regulatory and global standards are followed to maintain data integrity and ensure consistency across all assigned projects. This position reports to the Manager, External Data. KEY TASKS & RESPONSIBILITIES In addition to the duties outlined, performs additional duties and responsibilities based on developing skills and capabilities: Act as primary study contact, subject matter expert (SME) and liaison for external data and local lab processing on assigned studies for internal and external stakeholders. Communicate to Clinical Data Manager, study team, and/or Manager, External Data problems involving local lab data point issues and validation issues. Communicate to vendors and client issues involving external data transfers, data point issues and validation issues. Perform QC of laboratory normal ranges prior to entry to ensure documents received are ICH/CGP compliant and accurate. Perform Lab Normal Range data entry and/or QC, meeting processing deliverables on time a

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. OVERVIEW The Data Engineer, Sr - I 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. As a Data Engineer, Sr - I, you will serve as the primary technical lead, spearheading consulting efforts related to clinical systems software. You will also design and develop reporting programs as needed. KEY TASKS & RESPONSIBILITIES Leading consulting efforts and providing high-level technical consulting services to clients, including configuring the elluminate® platform and overseeing specific projects such as trial configuration, quality control, and project management. Designing, developing, testing, and deploying efficient SQL code to support SDTM, custom reports, and visualizations using tools like MS SQL, elluminate® Mapper, and Qlik. Providing technical guidance, training, and support to team members and users on processes, technology, and products. Managing multiple timelines and deliverables for single or multiple clients, and handling client communications as assigned. Possessing high-level debugging skills for ETL or analytical issues by referring to the required source data. Demonstrating in-depth knowledge of

Responsible for the scientific and clinical oversight of clinical trials in support of the development strategy for programs within the Inflammation & Immunology (I&I) portfolio. As an individual contributor, this role focuses on ensuring data integrity and quality for clinical trials across both early and late-stage development, based on portfolio and resourcing needs. The Senior Manager partners with other clinical and medical colleagues, clinical operations, and other functional lines for the successful implementation and execution of the clinical trial(s) within the assigned program. This role is central to ensuring studies are conducted with the highest scientific and ethical standards. The role is also expected to leverage AI tools and other innovative technologies to improve ways of working, enhance efficiency, reduce work redundancy and improve quality. JOB RESPONSIBILITIES Maintains current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment. Authors and reviews key clinical and regulatory documents including, but not limited to, protocols, study-level informed consent forms (ICFs), Investigator's Brochures (IBs), clinical study reports (CSRs), and regulatory submission components. Leads the clinical data review strategy, including the ongoing review of emerging clinical data for safety and efficacy trends. Presents relevant data to internal teams, governance bodies, and other stakeholders. Collaborates with cross-functional team members (e.g., Clinical Operations, Biostatistics, Regulatory Affairs, Clinical Pharmacology) to ensure trial objectives are met and activities are executed seamlessly. Provides scientific and clinical input for site training materials and supports responses to questions from investigators and site personnel regarding the protocol and study conduct.

Opportunity Overview: We’re seeking a Senior Clinical Informatician to serve as a key bridge between clinical expertise and data science. In this advanced role, you’ll apply deep clinical reasoning and informatics expertise to design, evaluate, and optimize data-driven healthcare solutions. You’ll also lead ontology mapping, structured data validation, and annotation quality initiatives supporting our next-generation AI and LLM-enabled healthcare tools. 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: Collaborate with clinicians, data scientists, and engineers to design and validate digital health and analytics solutions. Translate clinical workflows into structured data and logic for algorithms and quality measurement. Lead efforts in ontology mapping, terminology management (SNOMED, ICD, LOINC, RxNorm), and interoperability standards (FHIR, HL7). Oversee labeling and abstraction to ensure model safety, accuracy, and clinical integrity. Mentor junior informaticians and specialists in annotation, data validation, and workflow improvement. What you’ll need: BSN or related clinical degree with active RN license required. 4–6+ years of experience in clinical informatics, analytics, or digital health. Advanced understanding of clinical data, EHR systems, and data standards. Experience with data modeling or AI-driven healthcare products preferred. Master’s degree or informatics certification (RN-BC, CPHIMS, ACHIP, etc.) a plus. Pay & Perks: 💻 Fully remote opportunity with about 5% travel 🩺 Medical, dental, vision, life, disability insurance, and Employee Assistance Program 📈 401K retirement plan with company match; flexible spending and health savings account 🏝️ Up to 184 hours (23 days) of PTO per year + company holidays 👶 Up to 14 weeks of paid parental leave 🐶 Pet insurance The salary range for this p

Clinical Database Programmers are operationally responsible to provide technical support and oversight for the Medidata Clinical Cloud (MCC) implementation activities. Clinical Database Programmers will maintain project level perspective, focus and communicate effectively as the MCC SME on technical and functional electronic data capture programming and data management activities, timelines and deliverables. KEY TASKS & RESPONSIBILITIES Design/develop and test clinical databases including forms, folders, matrices, data dictionaries, unit dictionaries, edit checks, derivations, custom functions, standard and custom reports Performs peer review for the studies built by other Clinical Database Programmers Responsible for the development, maintenance, and compliance of database builds and EDC standards in support of clinical studies including, but not limited to, Global Library, Edit Checks, CRF modules Manages timely-quality deliverables for the study teams for assigned protocol/study(s) Functions as an EDC Subject Matter Expert (SME) providing guidance and best practice recommendations to Data Management, operations teams, and other stakeholders on basic Medidata Rave functionality Working knowledge of additional Medidata Rave modules, including Coder, RTSM, Lab Admin, iMedidata/Cloud Admin or other modules. Other duties as assigned CANDIDATE’S PROFILE Education & Experience Bachelor’s degree or equivalent work experience preferred 2+ years in Pharmaceutical/Biotechnology industry or equivalent preferred Experience with requirements gathering, design and specification development of CRFs, edit checks, site queries, and understanding of database structures and programming languages Professional Skills Ability to work creatively and independently to carry out assignments of a complex nature Ability to communicate and work effectively and cooperatively with other professional staff members Detail oriented, ability to multitask with str