213 Clinical Data Jobs - Page 4

Principal Analyst is responsible for Non-Drug Projects (NDP) Management. The position is a key collaborator with CDO sub functions in ensuring that NDP plans are executed efficiently with timely and high-quality deliverables in Clinical Data Operations. Major Activities (Describe 8-12 main activities) 1. Executes NDP Strategy mapped into CDO BBO ensuring its aligned with CDOLT desired outcomes 2. Build inventory of CDO NDPs ensuring CDO NDP inventory can be mapped to GCO NDP inventory making sure we are not duplicating looking at same thing in both areas 3. Work with CDO SMEs to ensure there is alignment on CDO NDPs marked in the inventory 4. Participate in cross functional meetings to discuss CDO NDPs 5. Build and maintain effective working relationships with cross-functional teams, able to summarize and discuss status of deliverables and other critical NDP aspects (timelines, scope, resource plan) 6. Maintain up-to-date advanced knowledge of industry trends to provide right inputs in NDP discussions 7. Contribute to process improvement/non-clinical project initiatives Key Performance Indicators (Indicate how performance for this job will be measured) 1. Achieve overall goals as set each year by Global Head, Data Operations, GDO and Head Strategy Operations. 2. Ensure that overall NDP Governance Framework is executed to the satisfaction of CDOLT and other stakeholders 3. Alliances established with all stakeholders and positive feedback received from them for NDP Management 4. Priority NDPs are delivered on time and with good quality

Job Title: Clinical Standard and Bio Stats Job Location: Pan India (Preferrable: Delhi or Mumbai) Exp Range: 10 - 18 Years Job Description: Roles and Responsibility: Contributes in building Product and solutions in Digital Data Flow, along with Product Team by providing Subject Matter expertise and knowledge on Industry Trends. Contributes to build differentiated Product offerings to maximize Sales and increase number of customers on Product. Co-leads the global strategic positioning & roadmap from a business view for Clinical Standards, Digital Data Flow, Metadata Repository, Biometrics e.g. SDTM, ADaM, Regulatory Submission Packages and Data Management (EDC, non-CRF, eDTA), TFLs, SDR, USDM (e.g. STDM, ADaM.) Co-leads the design & development for these solutions from a business view Co-leads thought leaderships and external visibility (e.g. articles, webinars, conferences, cross-industry meetings), initiates advisory boards Supports business development team with customer presentations, RFI/RFP requests and go-to-market strategy. Initiates customer leaderships connects and strategic partnerships. Description: At least 7-18 years of global drug development experience in Digital Data Flow, metadata repository, clinical data standards, biometrics, EDC, eDTA, gained preferably at top-15 pharma companies or clinical research organizations (CROs) Extensive hands-on experience with Digital Data Flow, data collection standards, biostatistical programming, STDM, ADaM, TFL and regulatory submission packages, including innovative tools and strategies for automation. Experience in applying AI in standardization, SDTM, ADaM and TFL generation. Experience in strategy setting for generating EDC build from study protocol, SDR Model, USDM Experience in innovative ways to automate testing and validation Track record of building respect and trust with customers, employees and other internal and external stakeholders and partners. Broad cross-pharma senior management network & preferably cross-industry forum expertise (e.g. CDISC, Transcelerate, IMI) Outstanding communication skills with ability to translate technology in a clear & easy-to-understand language Strong interpersonal skills including negotiation skills, facilitation skills and ability to drive for clarity and results when faced with ambiguity. Masters degree in sciences (e.g. biology, biomedical, pharmacist, statistics) or equivalent by expertise. PhD is an advantage

Clinical Data Associate II - Location: Bangalore Karnataka India; Chennai Bangalore Karnataka India; Chennai Job Type: Regular Full-time Division: Precision for Medicine Business Unit: Clinical Solutions Requisition Number: 5545 Position Summary The Clinical Data Associate II provides data management support and assistance in all aspects of the clinical trial data management process from study start up to post database lock for assigned projects under direct supervision Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed This position may perform database development and testing, as well as additional data management activities, Essential functions of the job include but are not limited to Support the Lead DM as a back-up and/or team member, ensuring continuity, responsiveness, and that tasks are performed in a timely manner May perform data entry for paper-CRF studies, as needed May perform quality control of data entry May develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders May assist in building clinical databases Conduct database build UAT and maintain quality controlled database build documentation Assist in specifying requirements for all edit check types e-g electronic, manual data review, edit checks, etc Responsible for creating, revising, appropriate versioning and maintaining data management documentation, Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed Review and query clinical trial data according to the Data Management Plan Assist in line listing data review based on the guidance provided by the sponsor and/or Lead DM Run patient and study level status and metric reporting Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency Assist with coordinating SAE/AE reconciliation Assist with liaising with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables May assist with SAS programming and quality control of SAS programs used in the Data Management department May assist in identifying and troubleshooting operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project May assist in participating in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues May present software demonstrations/trainings, department/company training sessions, present at project meetings May require some travel Perform other duties as assigned Qualifications Minimum Required: Bachelors and/or a combination of related experience Other Required 2+ yearsexperience Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook Able to handle a variety of clinical research tasks Excellent organizational and communication skills Professional use of the English language; both written and oral Preferred Experience in a clinical, scientific or healthcare discipline It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers We want to emphasize that these offers are not associated with our company and may be fraudulent in nature Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process, Apply Now

ICON plc is a world-leading healthcare intelligence and clinical research organization Were proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development, Job Title: Senior Lead Clinical Data Science Programmer [Elluminate] Location : Chennai/ Bangalore What You Will Be Doing Develop, implement and maintain date review and data cleaning capabilities for sponsors led Phase I-IV clinical trials using sponsors technologies in support of efficient study execution and related decision-making including incorporation of emerging approaches to such activities Contributes to related technical and/or process improvement initiatives associated with data reporting and analytics across DS and Astellas broadly Collaborates with any vendors providing data reporting and analytical capabilities and/or support for such capabilities Collaborates cross functionally to ensure that any issues with the data reporting and analysis are addressed as appropriate You Are BS or MS degree, preferably in Computer Science, Informatics/Data Science, or life science discipline Prior pharma or CRO industry experience working on global clinical studies and projects or global process and system initiatives Prior experience in Reporting [Elluminate or Cluepoint] Strong verbal and written communication skills What ICON Can Offer You Our success depends on the quality of our people Thats why weve made it a priority to build a diverse culture that rewards high performance and nurtures talent, In addition to your competitive salary, ICON offers a range of additional benefits Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family, Our Benefits Examples Include Various annual leave entitlements A range of health insurance offerings to suit you and your familys needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your familys well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: https://careers iconplc /benefits At ICON, inclusion & belonging are fundamental to our culture and values Were dedicated to providing an inclusive and accessible environment for all candidates ICON is committed to providing a workplace free of discrimination and harassment All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status https://careers iconplc /reasonable-accommodations Interested in the role, but unsure if you meet all of the requirementsWe would encourage you to apply regardless theres every chance youre exactly what were looking for here at ICON whether it is for this or other roles,

ICON plc is a world-leading healthcare intelligence and clinical research organization Were proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development, Job Title: Clinical Data Enablement Data Aggregation Lead Location : Chennai/ Bangalore What You Will Be Doing Enable the data flow for Phase I-IV clinical trials consistent with aligned commitments inclusive of data ingest, transformation and internal availability of this data for data review, data cleaning and readiness for data analysis Works directly with vendors providing source data (i-e vendors providing lab results, ECGs, biomarkers, etc ?) and/or internal functions such as clinical operations or early development to ensure that related specifications, mechanisms for data transfers and data transfer schedules are established and executed appropriately Contributes to related technical and/or process improvement initiatives associated with the clinical results data flow and efforts within the department and across sponsors broadly Collaborates with vendors providing capabilities and/or support for the clinical data flow to ensure successful delivery of study level data Collaborates cross functionally with areas performing data management, clinical operations, IT support, etc to address any issues with the delivery or stability of the clinical data flow as appropriate You Are BS or MS degree, preferably in Computer Science, Informatics/Data Science, or life science discipline Prior pharma or CRO industry experience working on global clinical studies and projects or global process and system initiatives Prior experience with systems and processes that include an end-to-end data flow and the transformation of data in support of data review and/or data cleaning Strong verbal and written communication skills What ICON Can Offer You Our success depends on the quality of our people Thats why weve made it a priority to build a diverse culture that rewards high performance and nurtures talent, In addition to your competitive salary, ICON offers a range of additional benefits Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family, Our Benefits Examples Include Various annual leave entitlements A range of health insurance offerings to suit you and your familys needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your familys well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: https://careers iconplc /benefits At ICON, inclusion & belonging are fundamental to our culture and values Were dedicated to providing an inclusive and accessible environment for all candidates ICON is committed to providing a workplace free of discrimination and harassment All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status, https://careers iconplc /reasonable-accommodations Interested in the role, but unsure if you meet all of the requirementsWe would encourage you to apply regardless theres every chance youre exactly what were looking for here at ICON whether it is for this or other roles,

Provide basic and some comprehensive data management expertise to the Clinical Data Management (CDM) team to provide efficient, quality data management products that meet customer needs. May also undertake team leadership activities under the supervision of the Data Operations Coordinator (DOC), Data Team Lead (DTL), or Functional Manager. Essential Functions Serve as a Data Operations Coordinator (DOC) for one protocol with less then 5 operations staff (excludes DE) or 15+ easy to moderately complex central laboratory studies, or serve in a leadership role in a specific data management task (eg, coder, tester or database designer for technologies that dont require extensive programming expertise) with guidance. May serve in the role of back-up to a DOC or DTL. May conduct data review. May write and resolve data clarifications. May lead database audit team. May develop and test databases and edit specifications. May perform testing of programming. May perform clinical data coding. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM team Qualifications Bachelors Degree Clinical, biological or mathematical sciences, or related field Req Equivalent combination of education, training and experience in lieu of degree. Medical terminology exposure Excellent organizational, communication, leadership and computer skills Ability to exercise excellent attention to detail Ability to act independently and with initiative required to resolving problems Ability to establish and maintain effective working relationships with coworkers, managers and clients Medical terminology exposure Excellent organizational, communication, leadership and computer skills Ability to exercise excellent attention to detail Ability to act independently and with initiative required to resolving problems Ability to establish and maintain effective working relationships with coworkers, managers and clients

3+ years in Spotfire, business analytics or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred. Program reports of various complexity from documented requirements, using Spotfire, Python, SQL.

Minimum 5+ years of experience In-depth knowledge of data structures and relevant programming languages for data manipulation and reporting (i.e., SAS, SQL, Python, R, etc.) Strong knowledge of complex finding data types, including but not limited to biomarkers, and digital data such as ECG, imaging, etc. In-depth knowledge of SDTM including Define.xml, CDASH, and metadata as well as experience transforming transferred vendor data into SDTM preferred, knowledge of ADaM a plus Experience utilizing tools intended for report writing, analytics, visualizations, or dashboard creation (e.g., Spotfire, Tableau, Qlik, JReview, Business Objects, Oracle BI, etc.) to support ongoing clinical data and safety review

Minimum 5+ years of experience In-depth knowledge of data structures and relevant programming languages for data manipulation and reporting (i.e., SAS, SQL, Python, R, etc.) Strong knowledge of complex finding data types, including but not limited to biomarkers, and digital data such as ECG, imaging, etc. In-depth knowledge of SDTM including Define.xml, CDASH, and metadata as well as experience transforming transferred vendor data into SDTM preferred, knowledge of ADaM a plus Experience utilizing tools intended for report writing, analytics, visualizations, or dashboard creation (e.g., Spotfire, Tableau, Qlik, JReview, Business Objects, Oracle BI, etc.) to support ongoing clinical data and safety review . We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com

DeepIntent is the healthcare advertising platform marketers trust to drive effective campaigns. Purpose-built for healthcare and privacy-safe, the DeepIntent platform unites media, identity, and clinical data to produce industry-defining health intelligence. Consistently proven to deliver real-world results based on real-time optimization, the DeepIntent platform powers more than 600 pharmaceutical brands and all the leading healthcare agencies to innovate, differentiate, and reach their audiences across all channels and devices. For more information, visit DeepIntent.com or find us on LinkedIn. Who You Are: React.js TypeScript Docker GraphQL JavaScript Experience with modern JavaScript libraries and tooling Familiarity with react.js and GraphQL Commanding grasp of HTML, CSS, and related web technologies Strong Computer Science fundamentals Awareness of cross-browser compatibility issues and client-side performance considerations Demonstrated design and UX sensibilities What You ll Do: Collaborate with Experience Designers to iterate on the design and implementation of our product Work with Data Scientists and Backend Engineers to build features and ship experiments Build efficient and reusable front-end systems and abstractions Find and address performance issues Participate in design and code reviews Identify and communicate front-end best practices DeepIntent is committed to bringing together individuals from different backgrounds and perspectives. We strive to create an inclusive environment where everyone can thrive, feel a sense of belonging, and do great work together. DeepIntent s commitment to providing equal employment opportunities extends to all aspects of employment, including job assignment, compensation, discipline and access to benefits and training.

CDI includes a review of disease process, diagnostic findings and missing documentation. A CDI specialist often has both clinical and medical coding backgrounds. Must have 5 years of IPDRG coding experience, CDIP certification, Understand MS-DRG Flexi working Health insurance Provident fund

Challenging. Meaningful. Life-changing. Those aren t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Job Title/Role : Sr. Support Manager, Interactive Response Technology Department Name/Functional Area : Global Clinical Supply Chain > Clinical Supply Chain Technologies > IRT Location : Office based . Position Summary This position supports multiple IRT studies (system development, study management, change management, audits and data provisioning). Supports UAT Services organization as required. Identifies areas of process improvement and participates or leads these initiatives. Duties/Responsibilities Lead successful maintenance support and projects to ensure execution and on time delivery of Interactive Response Technology (IRT) changes, data and support integrations with other clinical systems (e.g., Depots, Central Lab, and EDC), such that the resultant IRTs are fit-for-purpose as defined by protocol and study operational parameters with special emphasis on adherence to BMS standards and quality principles. Works independently and assume support role responsibilities on assigned projects. Collaborate with the IRT Team where necessary to ensure BMS standards and/or for requests by study teams that are not within these standards or best practice are addressed. Bring issues of concern or system failure to the immediate attention of the IRT Leadership Team. During IRT maintenance act as the primary contact for assigned studies for the cross-functional study team and vendor. Additionally, provide timely response to all randomization/IRT issues (including data integrations and delivery) that arise during IRT lifecycle and ensure they are resolved. Maintain vendor performance quality events in ADI log. Act as off hours audit/inspection support contact as needed to support rest of world. Responsible for generation and oversight of patient and container randomization schedules, ensuring parameters reflect the protocol and drug supply requirements. Distribute patient randomization and container schedules as appropriate to Clinical Supply P&L and IRT vendors. Manage special project implementation by identifying project needs, tracking, implementation, and reporting to a central project team. Bring issues of concern or system failure to the immediate attention of the IRT Leadership Team. Support IRT improvement initiatives and manages improvement projects that impact daily operations to improve efficiency. Support key department and enterprise level initiatives as part of the IRT representative. Ensure on time delivery of maintenance support and may be involved in user acceptance testing of IRT systems per BMS SOPs and procedures, write or review User Acceptance Test Plan and causes to ensure thorough testing of high -risked areas and new functionality documented in the user requirements. Ensure systems and associated documentation are compliant with all Regulatory requirements, including cGMP, 21 CFR Part 11, ICH E6 (R2) as well as in accordance BMS SOPs and processes. Ensure effective system access and functionality across all countries and all user locations. Complete all assigned training by due date Support unblinding activities as needed. Ensure on time development of IRT data transfers with vendors and/or third-party vendors. Ensure eTMF compliance at the study level in accordance with group and BMS guidance. Engage and support study and CSMT project teams as deemed necessary. Ensure delivery of data to BMS departments and third-party vendors consistent with BMS SOPs and forms. Additional tasks within scope of expertise and experience as assigned by the supervisor in pursuit of BMS goals. Reporting Relationship This position reports to the Associate Director, Interactive Response Technology (IRT). Qualifications Minimum bachelor s degree Minimum of 3 to 5 years work experience preferably in a health science or related IRT industry (pharmaceutical, hospital-based, laboratory, etc.) Demonstrated analytical skills and a working knowledge of Microsoft Office including SharePoint. Clinical Research experience Working knowledge of IRT Working knowledge of Clinical Trial Management Systems Working knowledge of clinical supplies Able to think outside of the box, have excellent communication and analytical skills to successfully deliver optimal IRT solutions across a diverse and dynamic portfolio. Understand the nature of clinical data and concepts of IRT study design and configuration, resupply settings, blinding, privacy protection, and data quality/integrity standards. Exposure to working in a GMP / GCP environment and with regulatory audit teams. Possess excellent English language written and verbal communication, interpersonal, collaboration and business partnership capabilities required Comfortable working with a global team, partners and customers in a change agile environment MS Project, MS Visio, or any other requirements visualization and analysis tools) With a single vision as inspiring as Transforming patients lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Company Description AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok . Job Description Medical Science Liason Develops and maintains professional relationships with internal and external customers to provide comprehensive medical and scientific support to Abbvie initiatives in assigned therapeutic areas. Executes against the Medical Affairs plan for India. Provides scientific education and training initiatives across Abbvie Oncology portfolio. Plans and leads scientific communication with key therapy leaders and stakeholders, organizing advisory board meetings, facilitating clinical trials, and serving as the medical resource for both external and internal stakeholders. This position is a non-promotional role. The primary focus is providing Healthcare Professionals with fair and balanced scientific information. Facilitates information, education, and research activities for physicians and ancillary healthcare professionals regarding current and future therapies in development or commercialized by Abbvie. Works closely with other Abbvie personnel to ensure information, education, and research needs of healthcare professionals are met and to ensure scientific and technical training needs of commercial organizations are identified and met. Key Responsibilities Area As an internal medical / technical / scientific resource, leads medical affairs objectives in the affiliate country. The role requires competency in practical aspects of patient care, and the ability to use medical and scientific information to facilitate engagement of physicians and others in the clinical and basic scientific issues relevant to Abbvie s products. Responsible for maintaining annual expenses within assigned budget parameters. Responsible for accurate and timely documentation of medical lead activities. The employee must conduct their work activities in compliance with all Abbvie internal requirements and with all applicable regulatory requirements. Abbvie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives. Identify, develop and maintain professional relationships with thought leaders, academic centers and researchers in assigned areas of therapeutic interest to ensure access to current medical and scientific information on Abbvie products. Work closely with the Commercial leaders for business planning , Therapeutic leads & Dir, Medical Affairs to set priorities, and activities. Upon request, present data on Abbvie products to healthcare professionals including physicians, academic institutions, researchers, and other health care professionals. Support research initiatives as requested by Abbvie R&D, Clinical Operations, and Medical Affairs Departments. Serve as internal medical and scientific resource to assigned Abbvie therapeutic areas for development of disease-state and product communications and materials that are medically accurate, balanced, and consistent with regulatory guidelines. Support Round Table and Advisory Board sessions to ensure accuracy of scientific and clinical data. Conducts on-going training to medical affairs, field sales and other internal personnel as required. A high level of travel / field time is to be expected within this position (approximately 60% of time spent outside the office). This role will also serve as the local representative of the Global Medical Office associated functions. (eg PV, HEOR etc) Qualifications Qualifications Requirements Minimum 2-3 years post-qualification work experience in Medical affairs function. Experience working within the pharmaceutical industry or within clinical research is preferred Experience of working collaboratively and cross-functionally in a matrix structure, supporting multiple stakeholders Demonstrated ability to learn quickly and convey clinical and non-clinical technical information effectively to individuals with varying degrees of scientific acumen. Demonstrated strong presentation and teaching skills with ability to effectively share information with others Demonstrated ability to develop and maintain strong relationships; to lead & engage Experience applying analytical skills, to critically evaluate and effectively communicate key clinical data Experience working with technology, including systems such as Microsoft Office.

Madurai HCL Tech is hiring candidates for PMS Analyst role. We are looking for candidates from B.E/B.Tech. Mechanical graduates who is interested in working for Medical domain. The 1st level of interview will be a Face to Face in Madurai office premises. Looking for candidates who passed out their Mechanical graduation with Engineering in 2022/2023/2024. Interested candidates please share us your updated resume along with the below details in mail to keeshouley.m@hcltech.com. Candidate Name: Candidate DOB: Graduation: Passed out year: Current location: Native location: Total Years of Experience: Relevant Years of Experience: Current CTC: Expected CTC: Notice Period: Interested to come for walk-in interview to Madurai premises: Regards, Keeshouley M

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Sr Analyst Qualifications: BE/BTech/MCA Years of Experience: 5 to 8 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, Clinical Automation, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Automation Team focuses on the development and implementation of innovative concepts and application for out clients across different accounts in Operations. The team is responsible for designing and implementing highly interactive, scalable web apps and prototypes at Enterprise level. The team is responsible for collaborate with frontend and backend developers to define API requirements and Ensure API security and authentication mechanisms are robust.You will be expected to develop and implement complex APIs based on requirements using different tools/techs such as .Net, Java, PL/SQL, C# or any other applicable systems. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Agility for quick learning Ability to work well in a team Bachelor's degree in computer science, Information Technology, Engineering or any computer related discipline. Work experience of at least 3 years in relevant industries (Financial Services, Network, Utilities, Health Care, Marketing, Pharma, Retail etc.). Work experience of at least 4 years in designing, coding, APIs, testing, debugging, documenting, and implementing enhancements and fix solutions. Work experience in Implementing APIs based architecture frameworks. Aptitude to learn, think creativity to solve real world business problems, and work in a global collaborative team environment. Proficient verbal and written communication skills in English. Roles and Responsibilities: Work as a technical lead to architect and develop innovative concepts and applications for our clients across different accounts in Operations. Design and implement highly interactive, scalable web apps and prototypes at Enterprise level. Build and modify high-performance APIs and Monitor API performance and troubleshoot issues promptly. Implement APIs based on architecture frameworks and guidelines. Work with DevOps engineers to integrate new code into existing continuous integration (CI) and continuous delivery/deployment (CD) pipelines. Able to lead Automation initiatives within his account. Work closely with the team and client to understand requirements and guiding them to deliver the most effective solution. Participate in the development of automation solutions, from prototyping new functionality and technologies to integrating them in our overall products and offerings, thus developing expertise and skills in this domain. Collaborate with frontend and backend developers to define API requirements and Ensure API security and authentication mechanisms are robust. You should be able to pilot and deploy automation solutions at scale. Partner with the testing team to ensure applications/components are fully functional. Oversee and fix any defects or performance problems discovered in testing. Participating in analyses of requirements as well as functional design whenever necessary. Be involved in the design of the solution. Performing design, coding, application maintenance and testing activities. Take ownership of the successful implementation of the solution. Interact with the end client as required to ensure the solution is implemented as per requirements. Deliver code to time and quality expectations. Fully unit test developed solutions. Qualifications BE,BTech,MCA

Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Analyst Qualifications: BE,MCA,BTech Years of Experience: 3 - 5 Years Language - Ability: English - Advanced What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.In this role, you will be expected to develop clinical trial reports using SAS/ J-review / Congnos / SQL / PLSQL as per the study requirement. What are we looking for? SAS Clinical SQL Databases Strong analytical skills Collaboration and interpersonal skills Written and verbal communication Ability to meet deadlines Adaptable and flexible Clinical Database Programming Experience in any clinical report development using PL/SQL or SAS JReview experience is added advantage. Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualifications BE,MCA,BTech

Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Sr Analyst Qualifications: BE/BTech/MCA Years of Experience: 5 to 8 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.In this role, you will be expected to develop clinical trial reports using SAS/ J-review / Congnos / SQL / PLSQL as per the study requirement. What are we looking for? SAS Clinical Oracle Procedural Language Extensions to SQL (PLSQL) Python (Programming Language) R Programming Clinical Database Programming Adaptable and flexible Ability to perform under pressure Problem-solving skills Agility for quick learning Ability to establish strong client relationship Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualifications BE,BTech,MCA

Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Sr Analyst Qualifications: BE/BTech/MCA Years of Experience: 5 to 8 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.In this role, you will be expected to develop clinical trial reports using SAS/ J-review / Congnos / SQL / PLSQL as per the study requirement. What are we looking for? Clinical Database Programming Clinical Data Management Oracle Procedural Language Extensions to SQL (PLSQL) Adaptable and flexible Ability to perform under pressure Problem-solving skills Agility for quick learning Ability to work well in a team SAS Clinical Structured Query Language (SQL) Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualifications BE,BTech,MCA

Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Specialist Qualifications: BE/BTech/MCA Years of Experience: 7 to 11 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.In this role, you will be expected to develop clinical trial reports using SAS/ J-review / Congnos / SQL / PLSQL as per the study requirement. What are we looking for? SAS Clinical Oracle Procedural Language Extensions to SQL (PLSQL) Python (Programming Language) R Programming Clinical Database Programming Adaptable and flexible Ability to perform under pressure Problem-solving skills Agility for quick learning Ability to establish strong client relationship Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualifications BE,BTech,MCA

Skill required: Clinical Data Services - Clinical EDC Build Designation: Clinical Data Svs Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 3 to 5 years Language - Ability: English(International) - Expert What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.You will be expected to develop clinical study databases by building electronic case report forms and program edit checks as per specifications. Support any updates or changes to the study database (e.g. Protocol amendments) through the change control process. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: Clinical Database Developers:Overall experience of 4+ years with exposure to EDC platforms like Medidata RAVE EDC, Inform, Oracle Clinical, Veeva etc. preferred.Extensive experience in database design, edit check programming, custom function programming and unit testing.Experienced in various modules such as IVRS/RWS integration and Lab administration. Medidata RAVE study builder certified preferred.

Skill required: Clinical Data Services - Clinical EDC Build Designation: Clinical Data Svs Sr Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 5 to 8 years Language - Ability: English(International) - Expert What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.You will be expected to develop clinical study databases by building electronic case report forms and program edit checks as per specifications. Support any updates or changes to the study database (e.g. Protocol amendments) through the change control process. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: Overall experience of 4+ years with exposure to EDC platforms like Medidata RAVE EDC, Inform, Oracle Clinical, Veeva etc. preferred.Extensive experience in database design, edit check programming, custom function programming and unit testing.Experienced in various modules such as IVRS/RWS integration and Lab administration. Medidata RAVE study builder certified preferred.

Skill required: Clinical Data Services - Clinical EDC Build Designation: Clinical Data Svs Specialist Qualifications: BSc/Master of Pharmacy Years of Experience: 7 to 11 years Language - Ability: English(International) - Expert What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.You will be expected to develop clinical study databases by building electronic case report forms and program edit checks as per specifications. Support any updates or changes to the study database (e.g. Protocol amendments) through the change control process. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: Data Review Report Programmers:Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred.Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders.Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery.Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred.

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Sr Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 5 to 8 years Language - Ability: English(International) - Expert What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.You will be expected to develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: Data Review Report Programmers:Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred.Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support.Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders.Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery.Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred.

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Sr Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 5 to 8 years Language - Ability: English(International) - Expert What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.You will be expected to develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: Data Review Report Programmers:Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred.Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support.Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders.Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery.Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred.

and quality data management products) to Data Management (DM) team to meet sponsor and company needs. Perform Clinical Data Management and/or Coding activities, and may provide leadership either in the role of the Lead Coder or in a specific CDM task (e.g. Data Operations Coordinator (DOC) or lead a coding related task on a mega trial). Essential Functions Serve independently as a Clinical Data Coder and/or Lead Coder or DOC for one or more protocols. Manage delivery of coding activities and/or stand alone coding projects through full study life-cycle (with minimal guidance). Validates/tests the coding application and programming of coding reports may also test coding related datasets, coding related edits or any coding related programming activities. Perform comprehensive data management and coding related tasks including, conducting data review and writing and resolving data clarifications. Manage coding related project timelines with guidance from the DOC or Data Team Lead (DTL) or Manager. Perform Serious Adverse Event (SAE) reconciliation activities. May serve as a back-up for a Lead Coder, DOC or DTL. Perform comprehensive quality control procedures, Assist in implementing new technology. Independently bring coding and project related solutions to the DM team. Handle audit requirements for respective studies including stand-alone coding projects as applicable. Understand and comply with core operating procedures and work instructions. Perform other duties as directed by the study team or Manager, or meet objectives as assigned Develop and maintain good communication and working relationship with the team. Qualifications Pharmacy, dental, medical, nursing, life sciences or related field qualification or educational equivalent 2 years of relevant experience or equivalent combination of education, training and experience. Excellent knowledge of medical terminologies, pharmacology, anatomy and physiology. In-depth knowledge of medical dictionaries used for coding (e.g., MedDRA, WHODD etc.). Understanding of the Data Management process from study start-up through to database lock. Ability to exercise excellent attention to detail and act independently with the initiative required to resolve problems. Good understanding of database technologies related to data management and coding. Knowledge of operating procedures and work instructions and the ability to apply them in practice. Excellent written and oral communication skills in English language, organizational and leadership skills. Ability to establish and maintain effective working relationships with co-workers, managers and clients. LPN - Licensed Practical Nurse - State Licensure Req