213 Clinical Data Jobs - Page 3

Hi We are looking to hire Medical Data Reviewer for our Client. Please go through the JD and Apply. Responsibilities: Review subject/ patient level data for accuracy, to identify any anomalies, trends in patient reported data Review and provide inputs ion design of eCRF Review investigation product dosing Review all reported Adverse Events (AEs), Concomitant Medication and medical Ensure that any out of range data/ anomaly is verified Review all laboratory data on study subjects Review data in the form of visualizations and identify potential issues of concern Training new team members Qualifications: Bachelor/ Masters degree or equivalent in Life sciences/ Alternative Medicine (preferred) Eligibility: Good English communication skills Experience of handling clinical trial/ safety data - > 4 years To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 359 b) To Apply for above Job Role ( Pune ) Type : Job Code # 360 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 361

Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Specialist Qualifications: Bachelor of Pharmacy 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.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. The role may require you to 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 role may also need expertise in managing clinical data management projects. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills 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 Bachelor of Pharmacy

Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Specialist Qualifications: Bachelor of Pharmacy 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.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. The role may require you to 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 role may also need expertise in managing clinical data management projects. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Roles and Responsibilities: 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. o 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. o Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders. o Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery. o Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred. o Good analytical and communication skills. Qualifications Bachelor of Pharmacy

Skill required: Clinical Data Services - Clinical Database Programming 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 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.

Job Overview 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 (e.g., 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. . 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

Hi, We are hiring for Leading ITES Company for Lead Study Data Manager Profile Skills: a) Minimum 5 Years of Core Clinical Data Management Experience with minimum 1 year of experience of leading a clinical trial. . b) Experience on Study Conduct and Close Out c) Any Graduate JOB DECSRIPTION: Need exposure of Inform or Medidata Rave database Responsible & Accountable for the assigned study conduct activities, in clinical trials Validate clinical trial data to ensure consistency, integrity and accuracy based on project specific guidelines. Generate data queries based on validation checks or raise Manual queries to resolve data inconsistencies. To perform reconciliation of data from external sources (e.g. Serious Adverse Events, IWRS, Central Laboratory). SPOC for the study communications Proactively highlight any risks associated with the study along with the mitigation plan. Establish a partnership with the stakeholders at operational level to work seamlessly to deliver the assigned project/activity as per timelines. Identify process Improvement opportunities and to ensure learning is shared Ensure deliverables and/or agreed activities/tasks with customer. are completed with the expected quality. Have worked on Study set-up, Study Conduct and Study Close out for various therapeutic areas. Have also worked on writing edit check specification, CRF completion guidelines and review and corrections of set up documents for different versions. To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 184 b) To Apply for above Job Role ( Pune ) Type : Job Code # 185 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 186

Hi We are hiring for Leading ITES Company for Clinical Data Manager Profile. Role & responsibilities: Candidate should have 2-5 years of experience of CDM with experience in Conduct Scope of work Perform day-to-day Clinical Data Management activities. Work and coordinate with the team to perform data management activities and deliver an error-free quality database in accordance with the data management plan and regulator standards. Read and understand the study protocol and the timelines. Perform test data entry in the TEST environment, data listing review, data reconciliation, and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate. Perform external checks to handle manual discrepancies and action the same. Ensure an error-free, quality data with no open queries. Escalate any discrepancy in the clinical data to the study lead as appropriate. Timely completion of training Any other tasks deemed appropriate To perform medical data collection and analysis of Prostate Cancer Data using databases like HIS/ EMR (Electronic Medical Record) and Caisis, Rave, CDM (startup, closeout, conduct) Client interaction and meetings. Bringing up new ideas and executing new plans to cope with the backlog. Training new team members as and when required. To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 205 b) To Apply for above Job Role ( Pune ) Type : Job Code # 206 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 207

Hi We are hiring for Leading ITES Company for Clinical Data Manager Profile. Role & Responsibilities: Candidate should have 2-5 years of experience of CDM with experience in Conduct Scope of work Perform day-to-day Clinical Data Management activities. Work and coordinate with the team to perform data management activities and deliver an error-free quality database in accordance with the data management plan and regulator standards. Read and understand the study protocol and the timelines. Perform test data entry in the TEST environment, data listing review, data reconciliation, and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate. Perform external checks to handle manual discrepancies and action the same. Ensure an error-free, quality data with no open queries. Escalate any discrepancy in the clinical data to the study lead as appropriate. Timely completion of training Any other tasks deemed appropriate To perform medical data collection and analysis of Prostate Cancer Data using databases like HIS/ EMR (Electronic Medical Record) and Caisis, Rave, CDM (startup, closeout, conduct) Client interaction and meetings. Bringing up new ideas and executing new plans to cope with the backlog. Training new team members as and when required. To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 205 b) To Apply for above Job Role ( Pune ) Type : Job Code # 206 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 207

Position Summary: The Senior Coder provides Coding in both MedDRA and WHODRUG dictionaries for assigned Studies on a full time basis. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives: study specific plans and guidelines will be followed. This position will perform Coding quality reviews. Working closely with the Coding Manager to ensure priority coding tasks are performed and completed in a timely manner. Working with the Coding manager to focus the medical coders as a senior coder. Essential functions of the job include but are not limited to: Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency (MedDRA and WHODRUG) Support other members as a back-up and/or coding team member, ensuring continuity, responsiveness, and that tasks are performed in a timely manner Backup the Coding manager for oversight of the team. Perform quality control of Coding Provide input into Coding timelines for overall deliverables. Ensure that clinical data coding deadlines are met with quality. May assess resource needs for assigned projects, as needed. Review/feedback from all stakeholders Conduct coding dictionary upgrade UAT and maintain quality controlled documentation as needed Responsible for creating, revising, appropriate versioning and maintaining data management coding documentation. Train clinical research personnel on the study specific Coding related items as needed. Review and query coding data according to the Data Management Plan and Coding standards Run coding status and metric reporting. Assist in participating in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to coding activities Trains and ensures that all data management project team members coding have been sufficiently trained. Communicate with study sponsors and project teams as needed regarding coding. Present any coding demonstrations/trainings, department/company training sessions, project meetings Perform other duties as assigned. Qualifications Minimum Required: 5+ years experience within Data Management Bachelors within scientific/science background and combination of related experience Other Required: 5+ years performing Dictionary medical coding (MedDRA and WHODrug) Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook. Able to handle a variety of data management task and oversight. Excellent organizational and communication skills Professional use of the English language; both written and oral. Basic knowledge of drug, device and/or biologic development and effective data management practices Preferred: Experience in a clinical, scientific or healthcare discipline. Oncology and/or Orphan Drug therapeutic experience Skills: Demonstrates strong knowledge of ICH-GCP, relevant Precision Oncology SOPs, and regulatory guidance, as well as the ability to implement and drive outcomes

Precision for Medicine is seeking a talented Medical Coder to provide comprehensive Coding and related data management support throughout all phases of the clinical trial data management process. With direct supervision work with a team of medical coders, you will ensure adherence to Standard Operating Procedures (SOPs), regulatory guidelines, and study-specific plans. This role encompasses a range of responsibilities, including data coding and quality review within a dynamic team environment . Position Summary: The Coder provides Coding in both MedDRA and WHODRUG dictionaries for assigned Studies on a full time basis. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives: study specific plans and guidelines will be followed. This position will perform Coding quality reviews. Working closely with the Coding Manager to ensure priority coding tasks are performed and completed in a timely manner Essential functions of the job include but are not limited to: Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency (MedDRA and WHODRUG) Support other members as a back-up and/or coding team member, ensuring continuity, responsiveness,and that tasks are performed in a timely manner Perform quality control of Coding Provide input into Coding timelines for overall deliverables. Ensure that clinical data coding deadlines are met with quality. May assess resource needs for assigned projects, as needed. Review/feedback from all stakeholders Conduct coding dictionary upgrade UAT and maintain quality controlled documentation as needed Responsible for creating, revising, appropriate versioning and maintaining data management coding documentation. Train clinical research personnel on the study specific Coding related items as needed. Review and query coding data according to the Data Management Plan and Coding standards Run coding status and metric reporting. Assist in participating in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to coding activities Trains and ensures that all data management project team members coding have been sufficiently trained. Communicate with study sponsors and project teams as needed regarding coding. Present any coding demonstrations/trainings, department/company training sessions, project meetings Perform other duties as assigned. Qualifications Minimum Required: 4+ years experience within Data Management Bachelors within scientific/science background and combination of related experience Other Required: 2+ years performing Dictionary medical coding (MedDRA and WHODrug) Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook. Able to handle a variety of data management task and oversight. Excellent organizational and communication skills Professional use of the English language; both written and oral. Basic knowledge of drug, device and/or biologic development and effective data management practices Preferred: Experience in a clinical, scientific or healthcare discipline. Oncology and/or Orphan Drug therapeutic experience Skills: Demonstrates strong knowledge of ICH-GCP, relevant Precision Oncology SOPs, and regulatory guidance, as well as the ability to implement and drive outcomes Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice . Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionFor . 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.

**NOTE - This role is an office-based role in Pune ** Client Profile A leading AI platform designed for law firms, combining advanced technology with deep legal expertise to deliver impactful data-driven outcomes. The platform offers human-level accuracy in analyzing complex legal data, enabling firms to quickly access critical insights when needed most. Trusted by top litigation lawyers, it has supported over $1 billion in settlements, including courtroom successes, and is reshaping the future of legal practice. About the Role We are seeking a detail-oriented and tech-curious healthcare professional to join our growing team as a Medical Documentation Reviewer (Medical AI). In this role, you'll play a critical part in building accurate, high-quality datasets that power next-generation AI tools in healthcare. If you have a clinical background and are excited to work at the intersection of medicine and technology, this role is for you. Key Responsibilities Clinical Data Annotation - Use your healthcare expertise to annotate and label electronic health records, clinical notes, discharge summaries, and trial documentation with precision and care. Quality Assurance - Ensure accuracy, consistency, and adherence to protocols across all annotations. Provide feedback and perform peer reviews to maintain high data standards. Process Improvement - Collaborate with team leads to refine annotation guidelines, improve workflows, and implement process enhancements for greater efficiency. AI Tools & Technology - Work with advanced annotation tools (e.g., Doccano) and EHR systems (e.g., Epic, Cerner). Basic understanding of SQL or data querying is a bonus. Qualifications & Experience 2+ year of experience in US healthcare. BDS, B.Pharm/M.Pharm, or other healthcare-related field. Proficiency in English (verbal and written). Hands-on experience with annotation tools and EHR platforms. Familiarity with Microsoft Office, Google Workspace. Why Join Us? As a Series-A startup, joining us means becoming a vital contributor to our success, where your ideas and efforts will directly shape our products, company culture, and long-term vision. Were in an exciting phase of scaling, presenting opportunities for both company and career growth as we expand our market presence and develop new features and services.

Greetings From Sri Sai Medicode Clinical Data Management Freshers Location - Tirupati Only.. Offline Training With Placement Qualification - Any Life sciences Graduates Only CV's On Mail - srisaimedicode@gmail.com Clinical Research Also

Responsible and accountable for all regulatory activities in assigned Consumer Health portfolio and assigned geography, including but not limited to following: D rug product licensing: new registration, post-approval maintenance Imported and locally manufactured products Export products Support to PV, GSM in relation to PSUR, AE reporting, Work closely with Head of RA CH South Asia to plan and execute regulatory strategies for assigned portfolio and assigned geography in alignment of these with business plans and strategies supporting business expansion, brand value. Interact with relevant health authorities (not limited to CDSCO, FSSAI, Ayush, Legal Metrology) and other government institutions as needed to progress responsible projects. Ensure products remain compliant with all relevant regulatory and corporate requirements throughout their product life cycle. Contribute to development and implementation of standards to enable compliant practices and processes. Partner with relevant internal functional and cross-functional stakeholders (local, region, global), external manufacturing sites in delivering project outcomes aligned with desired business direction. Ensure maintenance of required licenses for proper operating of the company, eg GMP certificates, manufacturing licenses where applicable, special business operating licenses and provision thereof on request. YOUR TASKS AND RESPONSIBILITIES: Liaise with Country Head of RA CH, regional RA APAC team and other stakeholders to a. Develop registration strategy and milestone plan for new drugs in line with local business priorities and export business. b. Manage the compilation and submission of applications for product registration and maintenance of licenses. c. Provide regulatory input in order to obtain timely regulatory approvals for the products by coordinating with other relevant functions. Responsible to manage the regulatory activities for imported products and overseeing product registration for Exports to support local business priorities and export business. Work closely with local PS, Supply Chain management and Quality organization to ensure regulatory compliance of locally manufactured products, to ensure required licenses for proper product distribution are in place, including artwork maintenance, regulatory input into issue management. Responsible for managing Manufacturing License applications/renewals, Artwork preparations management, support to tender business by procuring relevant certificates. Responsible for Regulatory compliance, including : a. Prepare RA report and ensure global and local registration database are updated timely and in accordance with applicable local/global guidance documents b. Provide RA division support to plan and prepare for inspection by health authorities and internal audits. c. Support internal partners by giving regulatory input / recommendation to ensure that company comply with current applicable regulatory affairs laws and regulations. d. Regulatory quality management: Responsible for local and internal compliance to regulatory affairs relevant processes and systems. e. Ensure regulatory compliance for a sustainable life-cycle management: Labeling, CMC changes and product lifecycle support are performed in accordance with local regulations and relevant Bayer SOPs. f. Ensure mandatory compendial /Pharmacopoeia compliance of input materials and finished products. Obtain revised product permission from State Drug Authorities / Central Drug authority in case of compendial / Pharmacopoeial amendments of finished product label claim. To work on application files for products based on the documentation provided from local/regional/global RA and other cross-functional partners in accordance with local regulations, of acceptable standard and quality to present them to the Health Authority. Handling the test license applications to the zonal offices for import of required materials for testing in India. Co-ordinate testing of drug formulations at central drug testing laboratory and other laboratories as relevant as part of the registration process as we'll as commercial consignments. Provide technical support for the analysis of imported products by Authorities or the samples drawn by ADC customs. Provide updated regulatory intelligence by identifying current and emerging national regulations (requirements, guidelines) which impact the drug development and / or marketing processes and ensures appropriate contribution and communication with all involved functions (Commercial, RMSQC, etc) in order to ensure regulatory compliance and support marketing plan. Estimation and evaluation of regulatory intelligence and requirements to take appropriate actions and cascade the relevant BUs. Contributes actively to design and assessment of RA strategic options. WHO YOU ARE: Post graduate (preferably Pharmacy) with at least 8 years of regulatory experience. PhD is preferred. The experience must include at least few years of operational experience in handling regulatory activities for locally manufactured products, imported products and export to neighboring countries. Exposure of formulation and development and/or quality assurance activities highly desired. In depth understanding of CMC, non-clinical and clinical data aspects for regulatory submission. Strong managerial and leadership skills to lead and motivate cross functional teams, in line with our company LIFE values. Strong team building abilities. Excellent computer skills in MS office particularly in MS Word, Power point, Excel etc Good communication, presentation and negotiation skills with positive and learning attitude.

The Manager, CSAR - SAS Clinical Data Reporting and Spotfire Programmer will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting SAS Clinical Data Reporting and Spotfire programming activities. The Manager, CSAR - SAS Clinical Data Reporting and Spotfire Programmer will create patient data reports and dashboards, adhering to Amgen standards, procedures, and best practices using SAS for programming and Spotfire for visualization. The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality deliverables, internal and external clinical systems, and other CSAR activities related to the use electronic data capture technology. The position will be responsible for quality and deliverables at the study and portfolio level. The Manager, CSAR - SAS Clinical Data Reporting and Spotfire Programmer will also be expected to help deliver large system transformation projects, with a focus on project management, contribution of subject matter expertise, stakeholder engagement, and change management. The successful candidate will be a strong leader with demonstrated ability to influence stakeholders, while also acting as an individual contributor on study specific and general CSAR/Global Development Operations projects or operational work. Proven capability of providing support for study deliverables. Has operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC). Responsibilities include, but are not limited to, the following Support of clinical trial platform technologies? Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Coordinating and providing programming support to Clinical Study Teams ? Works collaboratively with Clinical Data Management to meet study deliverables and timelines Acting as a technical point of contact for systems deliverables on defined programs Experience in creating complex Spotfire visualizations and dashboards, with the ability to justify or suggest charts based on business scenarios. Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Assist in preparing for and responding to audit findings (internal or external). Knowledge Good Clinical Practice ? Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking. Drug development and clinical trials processes? Data management processes? Programming of clinical trial databases and applications? Proficient in SAS programming and Spotfire data visualization software Systems development lifecycle? Programming Languages ? Project planning and management? Collaborating with global cross-functional teams (team/matrix environment) Quality management? and Risk Analysis Regulatory filings and inspections Process improvement methodologies Preferred Qualifications Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related discipline? Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena? General project management and planning experience ? Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.) Basic Qualifications Bachelor’s degree or equivalent in life science, computer science, business administration or related discipline ?with 9 to 13 yrs of experience. Specialist knowledge / experience in life sciences or a medically related field? General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)

The Manager, CSAR - SAS Clinical Data Reporting and Spotfire Programmer will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting SAS Clinical Data Reporting and Spotfire programming activities. The Manager, CSAR - SAS Clinical Data Reporting and Spotfire Programmer will create patient data reports and dashboards, adhering to Amgen standards, procedures, and best practices using SAS for programming and Spotfire for visualization. The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality deliverables, internal and external clinical systems, and other CSAR activities related to the use electronic data capture technology. The position will be responsible for quality and deliverables at the study and portfolio level. The Manager, CSAR - SAS Clinical Data Reporting and Spotfire Programmer will also be expected to help deliver large system transformation projects, with a focus on project management, contribution of subject matter expertise, stakeholder engagement, and change management. The successful candidate will be a strong leader with demonstrated ability to influence stakeholders, while also acting as an individual contributor on study specific and general CSAR/Global Development Operations projects or operational work. Proven capability of providing support for study deliverables. Has operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC). Responsibilities include, but are not limited to, the following Support of clinical trial platform technologies? Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Coordinating and providing programming support to Clinical Study Teams ? Works collaboratively with Clinical Data Management to meet study deliverables and timelines Acting as a technical point of contact for systems deliverables on defined programs Experience in creating complex Spotfire visualizations and dashboards, with the ability to justify or suggest charts based on business scenarios. Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Assist in preparing for and responding to audit findings (internal or external). Knowledge Good Clinical Practice ? Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking. Drug development and clinical trials processes? Data management processes? Programming of clinical trial databases and applications? Proficient in SAS programming and Spotfire data visualization software Systems development lifecycle? Programming Languages ? Project planning and management? Collaborating with global cross-functional teams (team/matrix environment) Quality management? and Risk Analysis Regulatory filings and inspections Process improvement methodologies Preferred Qualifications Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related discipline? with 9-13 years of experience Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena? General project management and planning experience ? Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.) Basic Qualifications Bachelor’s degree or equivalent in life science, computer science, business administration or related discipline ? Specialist knowledge / experience in life sciences or a medically related field? General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)

Data Analyst II Job Description Manage data cleaning activities for specified clients/studies Liaise directly with client/CRO DMs to develop a query management strategy during study start-up Enact and maintain data cleaning schedule in accordance with the established query management strategy ¢ Maintain visibility to data lock schedules and ensure reconciliation is complete prior to data lock periods ¢ Ensure a seamless communication and follow up with our selected external client and internal clients. ¢ Analyze client data discrepancies. Update database accordingly to the clients needs and in compliance with the GCP rules when appropriate. ¢ Lead the communication with the other departments in relation to the discrepancy solving until resolution. ¢ Provide direct answers to the selected external client or internal clients and provide advice when the request is not directly feasible. ¢ Negotiate the timelines when needed. ¢ Involve selected external clients or internal client in decision making to ensure clients needs are being considered. ¢ Act as primary strategic representative between selected external clients and other Covance departments in the scope of the data reconciliation. ¢ Review the study Statement of Work to ensure compliance of the request with the protocol when appropriate. ¢ Perform quality checks on data revisions and answers provided to clients. ¢ Generate and review Covance database reports and resolve issues as needed. ¢ Lead escalation of issues that may impact resolution of the discrepancies on time. Manage workload and priorities to ensure all clients deadlines are respected. ¢ Work in a team-oriented, global environment with the focus on customer service, both internal and external. ¢ Assist and support management in the implementation of global processes and procedures ensuring seamless integration. ¢ Responsible for effective and timely adherence to management communications, meeting and procedures. ¢ Support a culture of continuous improvement, quality and productivity. ¢ Assist management team with audits, reportable issues, CAIRs, and other quality issues as needed. ¢ Responsible for providing expert technical and administrative support to CLS data processing systems and act as a lead in resolving process and or application issues as necessary.

Regional Medical Advisor (RMA) - General Specialty Medicine, East Region The RMA will serve as a key representative for our company, engaging with essential stakeholders in the field. The objective of our medical affairs team is to provide scientific expertise across identified regions, products, and therapy areas to these valued customers. Responsibilities and Primary Activities Scientific Expertise : Develop and maintain a comprehensive understanding of the companys products, particularly in the cardiovascular therapeutic area, while staying updated on the latest medical advancements, clinical guidelines, and treatment protocols. Stakeholder Engagement : Build and maintain relationships with Scientific Leaders (SLs), Key Decision Makers (KDMs), healthcare professionals, and academic institutions. Engage in scientific discussions, present clinical data, and provide educational support to Key Opinion Leaders (KOLs) regarding the companys products and therapeutic areas. Support to Medical Strategy : Collaborate with the line manager to provide strategic inputs and expertise to product management. Medical Education : Deliver scientific and medical education to internal stakeholders, including sales and marketing teams. Collaborate with the Medical Affairs team to develop and present training materials. Scientific Exchange : Facilitate knowledge transfer between the company and external stakeholders by participating in medical conferences, advisory boards, and scientific meetings to gather insights and share data. Clinical Data Communication : Interpret and communicate clinical trial data, real-world evidence, and other scientific information to healthcare professionals and regulators, ensuring compliance with regulations and company policies. Clinical Research Support : Provide medical support for local studies, including identifying study sites for Investigator Initiated Trials. Cross-Functional Collaboration : Work closely with Clinical Development, Regulatory Affairs, Marketing, and Market Access teams to provide scientific input, support clinical trial design, and align on medical communication plans. Medical Initiatives : Support and lead medical projects aligned with the therapy area, involving strong stakeholder interaction. Medical Information : Address medical inquiries and provide timely, accurate responses to healthcare professionals and other stakeholders, ensuring that medical information materials are current and compliant. Sales Force Training : Train sales colleagues on assigned therapy areas and assist in pre-launch and launch training for new products. Compliance : Adhere to legal, regulatory, and compliance guidelines, ensuring all activities are conducted ethically and in accordance with applicable laws. Overall, the RMA in Medical Affairs acts as a scientific expert and liaison between the company and external stakeholders, playing a crucial role in building scientific credibility, fostering relationships, and supporting the companys strategic objectives in the healthcare industry. Values and Behaviours Consistently demonstrate company values with a focus on excellence. Collaborate harmoniously with internal and external stakeholders. What You Must Have Educational Background : A strong academic foundation in life sciences, such as a medical degree (MD) or doctorate (Ph.D.). Industry Experience : At least 1 year of experience in the pharmaceutical cardiovascular therapy area, including roles in clinical research or medical affairs that expose the candidate to scientific and medical aspects of the industry. Therapeutic Area Expertise : Demonstrated knowledge and expertise in the relevant cardiovascular therapeutic area, including experience with clinical trials and publications. Scientific and Clinical Knowledge : Strong understanding of medical and scientific principles, including clinical trial design, data analysis, and interpretation, along with familiarity with relevant disease states and treatment guidelines. Communication and Relationship-Building Skills : Excellent interpersonal, communication, and presentation skills are essential for effectively conveying scientific information to various stakeholders. Analytical and Problem-Solving Skills : Ability to analyse complex scientific data, identify insights, and provide recommendations, particularly in interpreting clinical trial results and addressing medical inquiries. Adaptability and Flexibility : Capability to work in dynamic environments, adapt to changing priorities, and travel frequently to engage with external stakeholders. Regulatory and Compliance Knowledge : Familiarity with legal, regulatory, and compliance guidelines, including Good Clinical Practice (GCP) and ICH guidelines, as well as local regulations governing medical communications. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Required Skills: Advisory Board Development, Advisory Board Development, Clinical Development, Clinical Knowledge, Clinical Testing, Educational Program Development, Emergency Care, Good Clinical Practice (GCP), Healthcare Education, Health Economics Research, Investigator-Initiated Studies (IIS), Life Science, Management Process, Medical Affairs, Medical Communications, Medical Information Systems, Medical Marketing Strategy, Medical Policy Development, Medical Writing, Pharmacovigilance, Product Knowledge, Product Management, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Compliance Consulting {+ 5 more} Preferred Skills: Job Posting End Date: 06/30/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Regional Medical Advisor (RMA) - General Specialty Medicine, South Region The RMA will serve as a key representative for our company, engaging with essential stakeholders in the field. The objective of our medical affairs team is to provide scientific expertise across identified regions, products, and therapy areas to these valued customers. Responsibilities and Primary Activities Scientific Expertise : Develop and maintain a comprehensive understanding of the companys products, particularly in the cardiovascular therapeutic area, while staying updated on the latest medical advancements, clinical guidelines, and treatment protocols. Stakeholder Engagement : Build and maintain relationships with Scientific Leaders (SLs), Key Decision Makers (KDMs), healthcare professionals, and academic institutions. Engage in scientific discussions, present clinical data, and provide educational support to Key Opinion Leaders (KOLs) regarding the companys products and therapeutic areas. Support to Medical Strategy : Collaborate with the line manager to provide strategic inputs and expertise to product management. Medical Education : Deliver scientific and medical education to internal stakeholders, including sales and marketing teams. Collaborate with the Medical Affairs team to develop and present training materials. Scientific Exchange : Facilitate knowledge transfer between the company and external stakeholders by participating in medical conferences, advisory boards, and scientific meetings to gather insights and share data. Clinical Data Communication : Interpret and communicate clinical trial data, real-world evidence, and other scientific information to healthcare professionals and regulators, ensuring compliance with regulations and company policies. Clinical Research Support : Provide medical support for local studies, including identifying study sites for Investigator Initiated Trials. Cross-Functional Collaboration : Work closely with Clinical Development, Regulatory Affairs, Marketing, and Market Access teams to provide scientific input, support clinical trial design, and align on medical communication plans. Medical Initiatives : Support and lead medical projects aligned with the therapy area, involving strong stakeholder interaction. Medical Information : Address medical inquiries and provide timely, accurate responses to healthcare professionals and other stakeholders, ensuring that medical information materials are current and compliant. Sales Force Training : Train sales colleagues on assigned therapy areas and assist in pre-launch and launch training for new products. Compliance : Adhere to legal, regulatory, and compliance guidelines, ensuring all activities are conducted ethically and in accordance with applicable laws. Overall, the RMA in Medical Affairs acts as a scientific expert and liaison between the company and external stakeholders, playing a crucial role in building scientific credibility, fostering relationships, and supporting the companys strategic objectives in the healthcare industry. Values and Behaviours Consistently demonstrate company values with a focus on excellence. Collaborate harmoniously with internal and external stakeholders. What You Must Have Educational Background : A strong academic foundation in life sciences, such as a medical degree (MD) or doctorate (Ph.D.). Industry Experience : At least 1 year of experience in the pharmaceutical cardiovascular therapy area, including roles in clinical research or medical affairs that expose the candidate to scientific and medical aspects of the industry. Therapeutic Area Expertise : Demonstrated knowledge and expertise in the relevant cardiovascular therapeutic area, including experience with clinical trials and publications. Scientific and Clinical Knowledge : Strong understanding of medical and scientific principles, including clinical trial design, data analysis, and interpretation, along with familiarity with relevant disease states and treatment guidelines. Communication and Relationship-Building Skills : Excellent interpersonal, communication, and presentation skills are essential for effectively conveying scientific information to various stakeholders. Analytical and Problem-Solving Skills : Ability to analyse complex scientific data, identify insights, and provide recommendations, particularly in interpreting clinical trial results and addressing medical inquiries. Adaptability and Flexibility : Capability to work in dynamic environments, adapt to changing priorities, and travel frequently to engage with external stakeholders. Regulatory and Compliance Knowledge : Familiarity with legal, regulatory, and compliance guidelines, including Good Clinical Practice (GCP) and ICH guidelines, as well as local regulations governing medical communications. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Required Skills: Advisory Board Development, Advisory Board Development, Clinical Development, Clinical Knowledge, Clinical Testing, Educational Program Development, Emergency Care, Good Clinical Practice (GCP), Healthcare Education, Health Economics Research, Investigator-Initiated Studies (IIS), Life Science, Management Process, Medical Affairs, Medical Communications, Medical Information Systems, Medical Marketing Strategy, Medical Policy Development, Medical Writing, Pharmacovigilance, Product Knowledge, Product Management, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Compliance Consulting {+ 5 more} Preferred Skills: Job Posting End Date: 06/30/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Regional Medical Advisor (RMA) - General Specialty Medicine, North Region The RMA will serve as a key representative for our company, engaging with essential stakeholders in the field. The objective of our medical affairs team is to provide scientific expertise across identified regions, products, and therapy areas to these valued customers. Responsibilities and Primary Activities Scientific Expertise : Develop and maintain a comprehensive understanding of the companys products, particularly in the cardiovascular therapeutic area, while staying updated on the latest medical advancements, clinical guidelines, and treatment protocols. Stakeholder Engagement : Build and maintain relationships with Scientific Leaders (SLs), Key Decision Makers (KDMs), healthcare professionals, and academic institutions. Engage in scientific discussions, present clinical data, and provide educational support to Key Opinion Leaders (KOLs) regarding the companys products and therapeutic areas. Support to Medical Strategy : Collaborate with the line manager to provide strategic inputs and expertise to product management. Medical Education : Deliver scientific and medical education to internal stakeholders, including sales and marketing teams. Collaborate with the Medical Affairs team to develop and present training materials. Scientific Exchange : Facilitate knowledge transfer between the company and external stakeholders by participating in medical conferences, advisory boards, and scientific meetings to gather insights and share data. Clinical Data Communication : Interpret and communicate clinical trial data, real-world evidence, and other scientific information to healthcare professionals and regulators, ensuring compliance with regulations and company policies. Clinical Research Support : Provide medical support for local studies, including identifying study sites for Investigator Initiated Trials. Cross-Functional Collaboration : Work closely with Clinical Development, Regulatory Affairs, Marketing, and Market Access teams to provide scientific input, support clinical trial design, and align on medical communication plans. Medical Initiatives : Support and lead medical projects aligned with the therapy area, involving strong stakeholder interaction. Medical Information : Address medical inquiries and provide timely, accurate responses to healthcare professionals and other stakeholders, ensuring that medical information materials are current and compliant. Sales Force Training : Train sales colleagues on assigned therapy areas and assist in pre-launch and launch training for new products. Compliance : Adhere to legal, regulatory, and compliance guidelines, ensuring all activities are conducted ethically and in accordance with applicable laws. Overall, the RMA in Medical Affairs acts as a scientific expert and liaison between the company and external stakeholders, playing a crucial role in building scientific credibility, fostering relationships, and supporting the companys strategic objectives in the healthcare industry. Values and Behaviours Consistently demonstrate company values with a focus on excellence. Collaborate harmoniously with internal and external stakeholders. What You Must Have Educational Background : A strong academic foundation in life sciences, such as a medical degree (MD) or doctorate (Ph.D.). Industry Experience : At least 1 year of experience in the pharmaceutical cardiovascular therapy area, including roles in clinical research or medical affairs that expose the candidate to scientific and medical aspects of the industry. Therapeutic Area Expertise : Demonstrated knowledge and expertise in the relevant cardiovascular therapeutic area, including experience with clinical trials and publications. Scientific and Clinical Knowledge : Strong understanding of medical and scientific principles, including clinical trial design, data analysis, and interpretation, along with familiarity with relevant disease states and treatment guidelines. Communication and Relationship-Building Skills : Excellent interpersonal, communication, and presentation skills are essential for effectively conveying scientific information to various stakeholders. Analytical and Problem-Solving Skills : Ability to analyse complex scientific data, identify insights, and provide recommendations, particularly in interpreting clinical trial results and addressing medical inquiries. Adaptability and Flexibility : Capability to work in dynamic environments, adapt to changing priorities, and travel frequently to engage with external stakeholders. Regulatory and Compliance Knowledge : Familiarity with legal, regulatory, and compliance guidelines, including Good Clinical Practice (GCP) and ICH guidelines, as well as local regulations governing medical communications. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Required Skills: Advisory Board Development, Advisory Board Development, Clinical Development, Clinical Knowledge, Clinical Testing, Educational Program Development, Emergency Care, Good Clinical Practice (GCP), Healthcare Education, Health Economics Research, Investigator-Initiated Studies (IIS), Life Science, Management Process, Medical Affairs, Medical Communications, Medical Information Systems, Medical Marketing Strategy, Medical Policy Development, Medical Writing, Pharmacovigilance, Product Knowledge, Product Management, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Compliance Consulting {+ 5 more} Preferred Skills: Job Posting End Date: 06/30/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

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. What You ll Do: As a Sr. Data Scientist , you will work closely across DeepIntent Data Science teams located in New York City, India, and Bosnia. The role will focus on building predictive models, implement data drive solutions to maximize ad effectiveness. You will also lead efforts in generating analyses and insights related to measurement of campaign outcomes, Rx, patient journey, and supporting evolution of DeepIntent product suite. Activities in this position include developing and deploying models in production, reading campaign results, analyzing medical claims, clinical, demographic and clickstream data, performing analysis and creating actionable insights, summarizing, and presenting results and recommended actions to internal stakeholders and external clients, as needed. Explore ways to to create better predictive models Analyze medical claims, clinical, demographic and clickstream data to produce and present actionable insights Explore ways of using inference, statistical, machine learning techniques to improve the performance of existing algorithms and decision heuristics Design and deploy new iterations of production-level code Contribute posts to our upcoming technical blog Who You Are: Bachelor s degree in a STEM field, such as Statistics, Mathematics, Engineering, Biostatistics, Econometrics, Economics, Finance, OR, or Data Science. Graduate degree is strongly preferred 5+ years of working experience as Data Scientist or Researcher in digital marketing, consumer advertisement, telecom, or other areas requiring customer level predictive analytics Advanced proficiency in performing statistical analysis in Python, including relevant libraries is required Experience working with data processing , transformation and building model pipelines using tools such as spark , airflow , docker You have an understanding of the ad-tech ecosystem, digital marketing and advertising data and campaigns or familiarity with the US healthcare patient and provider systems (e.g. medical claims, medications) You have varied and hands-on predictive machine learning experience (deep learning, boosting algorithms, inference ) You are interested in translating complex quantitative results into meaningful findings and interpretable deliverables, and communicating with less technical audiences orally and in writing You can write production level code, work with Git repositories Active Kaggle participant Working experience with SQL Familiar with medical and healthcare data (medical claims, Rx, preferred) Conversant with cloud technologies such as AWS or Google Cloud 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.

-Contributes, with appropriate oversight, to all aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards. May lead specific aspects of global clinical trial(s). Core member of the Clinical Trial Team, Contributes to operational excellence through process improvement and knowledge sharing Major accountabilities: Contributes to all operational/clinical trial deliverables that are in scope of the specific JD, according to timelines, budget, operational procedures, quality /compliance and performance standards. Conduct/Contribute to study start-up activities such as overseeing protocol development, CRF development, Informed Consent Form development. May/may not be involved in identifying new sites for clinical trials; analyze capability and make recommendation for trial inclusion. Ensuring proper handling of all study conduct and close out activities including but not limited to site close out, final drug accountability and audit readiness of Trial Master File documentation (if in scope of the specific JD). Responsible for education, implementation and compliance to standards (SOPs) and best practices for clinical operations/clinical data review activities within assigned clinical trial(s) and within clinical program(s), including sharing lessons learned. Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators: Timely, efficient and quality execution of assigned trials and trial related activities within budget, and in compliance with quality standards. Proactive operational planning with effective contingency and risk mitigation plans. Adherence to Novartis policy and guidelines and external regulations Minimum Requirements: Work Experience: Operations Management and Execution. Project Management. Financial Management. Collaborating across boundaries. Skills: Trial Planning and Feasibility. Over The Counter Product Development. Post Authorization Data Safety. Regulatory Strategy. Clinical Trial Set-up, Management Conduct. Languages : English.

Provide highly advanced expert support functional and technical leadership to ensure the scientific integrity/validity for clinical development, early development, and/or research projects. Develops and applies biostatistics and programming methods to ensure valid conclusions. Provide statistical support for regulatory submissions including planning, analysis and reporting of clinical safety and efficacy summaries. May also provide statistical support to research or other RD areas. To meet challenges in data review, big data, analytics and reporting of clinical trial data may also Independently provide timely and professional leadership of special projects that focus on innovative tools and systems -Strategically and tactically supports Director Clinical Data Standards. Responsible for advising/leading the planning, development and implementation of Industry (CDISC and regulatory) compliant, high quality, clinical data standards, infrastructure or automation technologies. Providing expert support stellar customer focus to business users and teams on their use, including: -Data standard collection tools in EDC (CRFs, edits checks, derivations, core configurations) -Data transfer specifications -Analysis data/TFL standards/Define -Automation solutions / technologies -Business infrastructure, business rules and guidelines. May lead global teams Key Responsibilities Study Level- Responsible for all statistical tasks on assigned clinical or non-clinical trials, and perform these tasks for high complexity trials with a high level of independence seeking peer input/review as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plan, and reporting activities. Contribute to planning and execution of exploratory analyses, innovative analyses related to publications and pricing reimbursement submission and/or PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive and implement novel methods and innovative trial designs and dose-finding strategies in alignment with the Lead Statistician. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities, pricing agencies and other drug development activities, as required. Independently lead interactions with external review boards/ethics commit-tees, external consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Represent the Biostatistics Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness throughout the assigned trials. Collaborate with other line functions. Explain statistical concepts in an easily understandable way to non-statisticians and provide adequate statistical justifications and interpretation of analysis results for actions/decisions/statements, when required. Establish and maintain sound working relationships and effective communication within the clinical trial team and Biostatistics Pharmacometrics team. Independent oversight of all Biostatistics resources and deliverables for as-signed trials. Ensure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities. Project Level- Responsible for strategic statistical input and influence into one or more projects (development plan, regulatory strategy, publication strategy, pricing reimbursement strategy, statistical deliverables). May be a core member of one or more early project teams representing Bio-statistics and Pharmacometrics. Collaborate with clinical, regulatory and other strategic functions to drive quantitative decision making in drug development and enable successful im-pact on robust drug development plans. Collaborate cross-functionally (eg, with data management, statistical programming, medical writing) to ensure timeliness and quality of statistical deliverables. Facilitate seamless transition of projects from early to late development. Effective partnership with other functions to ensure integrated quantitative in-put into project. Propose and implement innovative designs and methods to optimize drug development. Plan, prioritize and oversee project level statistical activities and ensure efficient resource management and effective partnership with vendors. Drive adherence to organizational standards and regulatory guidelines. Represent Biostatistics and Pharmacometrics at internal and external decision boards (eg regulators) Significantly contributes to project team preparation and may play a prominent role representing Biostatistics at HA meetings. Disease Area / TA/Indication level: As partner to clinical and scientific leadership, drive strategic statistical input and excellence to development programs within the assigned TA/DA/indications. Franchise or Global Line Function level: Lead or significantly contribute to initiatives at global line function level, or cross-functional Franchise level, requiring coordination of diverse of team members. May contribute to line function review. Enterprise level: Actively contribute to cross-functional organizational / process /scientific consulting improvement initiatives. Represent Biostatistics in due-diligence teams for low- to mid-complexity in-licensing opportunities with supervision. Contribute to the review and implementation of health authority guidance. Identify, evaluate, and promote the use and the acceptance within and outside the organization, of innovative methods, through scientific collaborations, publications in scientific peer reviewe'd journals, presentations and chairing sessions at professional meetings. External: Represent Biostatistics and Pharmacometrics in interactions with external re-view boards/ethics committees, external consultants and other external parties with increasing independence. Chair sessions at professional meetings. People Management: Develop and mentor statisticians. As a local manager, responsible to recruit, retain and professionally develop up to 8 biostatisticians. Role Requirements- MS (in Statistics or equivalent) with 10+ years relevant work experience or PhD (in Statistics or equivalent) with 6+ years relevant work experience Fluent English (oral and written) Strong interpersonal and communication skills bridging scientific and business needs. Effective utilization of innovative statistics and quantitative analytics to influence assigned program team decisions and support department to deliver objectives. Proven knowledge and expertise in statistics and its application to clinical trials. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Demonstrated excellence in use of statistical software packages (eg SAS, R). Strong knowledge of drug development and Health Authority guidelines. Experience independently leading a multidisciplinary team to achieve team objectives. Expert skills to facilitate and maximize the contribution of quantitative team. Hands-on experience in leading the interface to regulatory agencies/leading the early clinical development campaign. Strong understanding of Franchise/Therapeutic Area and or regulatory activities. Expert scientific leadership skills demonstrated in facilitating and optimizing the (pre/early/full-) clinical development strategy. Strong track record for global scientific leadership in the development and evaluation of modern program/trial design methodologies. May have proven people leadership ability. Demonstrated strong skills in building partnerships and collaborations. Demonstrated skills in coaching and mentoring associates. Good business ethics

The Therapeutic Data Strategy Director (TDSD) bridges science and operations by defining how the clinical data strategy is operationalized across the complete data flow within GCO. The TDSD is responsible for ensuring data regulatory compliance, the availability of End-to-End (E2E) standards, that instruments and devices are thoroughly discussed, defined, and finalized prior to the database build and that the operational impact of any new changes are known, , mitigated, and captured in the appropriate knowledge database. In collaboration with the GPT, GCT, and CTT, the TDSD aligns on the fit for purpose data package as part of a program / indication level quality by design to support data strategy needs in the drug development lifecycle of a molecule or across therapeutic area (TA) within an assigned unit in Novartis. This role creates and implements strategies for the end-to-end data product, ensuring application of Novartis clinical data standards and defining the clinical data acquisition and data review, strategy to support the submission of our clinical programs. The TDSD is responsible for ensuring that delivery and timelines are met with quality, whilst ensuring cost efficiencies and stakeholders satisfaction. Major Accountabilities (Describe the 10-14 main results of the role to be achieved) Creation and Execution of operational data strategy: Collaborate with the Global Program Clinical Head (GPCH) to establish and maintain a data strategy for the clinical data standards of the assigned Therapeutic Area, as we'll as the design, collection, processing, transformation, of clinical data supporting the needs for reporting and submission. Impact assessment of proposed data collection and analysis Drive capability inputs to data team s resource algorithm based on future incoming demands Matrix data operations leader who is the single focal point for the sustained industry leading cycle time for data product and ensures compliance with relevant Novartis processes Ensures the provision of resource with the skillset to develop robust lean E2E specification. Leads the full spectrum of standard development and compliance across their portfolio. Consults to drive quality into the study protocol and operational processes. Driving implementation of a lean global data strategy and define minimum data requirements Ensure the minimum data requirements remain intact and understanding the operational impact eg, resources, and time of any amendments as we'll as work with clinical development, analytics and regulatory line functions to understand the scientific, clinical, statistical and regulatory impacts. Support assessment on opportunity to capitalize on non-traditional options (eg, historical data, synthetic data, cross-sponsor shared control arms, adaptive designs, pragmatic trials, decentralization, etc). Work with COPH and Vendor Program Strategy Director (VPSD) to define the provision of ancillary data, including vendor capabilities. Author the Operational Data Strategy Section of Operational Execution Plan (OEP) (key customers, dataflow, and targets to generate Data-as-a-Product (DaaP) etc). Establishes a performance-oriented culture that is driven / supported by analysis of real-time activity and quality metrics Contribute to the development of the Data Operations organization. Define/contribute to the development of long-term goals and operating policies through his/her leadership role on the management team. As an extended member of the Data Operations Leadership Team support functional excellence for Data Operations by contributing to the definition of the strategic goals and operating policies, and leading/contributing to strategic initiatives in line with the overall Data Operations strategy. Support the BDL activities from CDO perspective. End-to-End Ownership of the Clinical Data Flow: Ensures that data is collected and reviewe'd as efficiently as possible, and that extraneous data is not procured. Drives implementation of a lean global data strategy and defines fit for purpose data quality requirements sufficient to support good decision making and meet regulatory requirements. Collaborates cross-functionally to define quality by design review process to ensure fit for purpose data quality sufficient to support good decision making. Accountable for managing operational strategy around data cleaning and data review at portfolio level. Drives standards and processes to facilitate data right the first time. Act as point of escalation for data specific project management issues and for broader data demands (eg changing scope, addition of analysis/reporting events). End-to-End Standards Oversight Lifecycle Management: Responsible for compliance with data requirements and the availability of end-to-end clinical data standards (data collection through analysis) for a program/molecule/indication. Influence and support the design of new clinical data standards as required at the enterprise/ therapeutic area level. Drives identification of needs, adoption and maintenance of data standards. Operational Project Management: Develop, communicate, and drive implementation of a global data operationalization strategy to deliver value-adding data; CDS supports and guides the Data Team (as part of the CTT) in ensuring the overall program /OEP strategy is aligned with execution. Establish key customers of Clinical Data and establish approach for future consumption. Works with the business to ensure adherence to timelines, adoption of the data strategy and delivery of the target data product quality. Accountable for managing the strategy of the data cleaning, review, and data related specifications at portfolio and study level. Ensure high quality, timely and efficient Data Operation deliverables for projects and trials partnering with other Data Operations functions within assigned Development Unit or program. Work alongside the Operational Program Lead and Trial Lead to ensure all data related risks and issues are identified and mitigated. Link between business needs and technical development/deployment and technology usage in data operations. Influencer and interlocutor for adoption and compliance with company efficiency process and objectives within data workflow. Assesses / approves changes that impact the data collection strategy.

Summary -To plan and lead Category initiatives for a clearly defined sub-category globally OR one category regionally OR all categories in one country OR multiple cross-divisional categories in one country; to develop the sub-category strategy as part of the wider Category Strategy; to lead proactive sourcing projects, specification definition and demand management, as we'll as manage sub-category-specific supplier performance and innovation activities. About the Role Position Title: Global Category Manager, Clinical RD Location : Hyd-india #LI Hybrid Job Purpose: The Global Category Manager, responsible to manage Clinical functional services Categories in space of Data Management, Statistical Programming, Trial Monitoring, Regulatory, Pharmacovigilance Medical Writing, plans and leads all strategic Procurement activities within the assigned categories, at a global level and develops proposals for strategic sourcing decisions. The role provides high value procurement solutions to the business and category strategies; supports third party vendor selection, vendor development, technology management and supplier performance measurement activities. The Global Procurement Category Manager ensures best-in-class delivery of external services in support of functions and to realize year-on-year productivity improvements, cost savings, and process improvements working in close collaboration with Business Stakeholders. Your responsibilities include but not limited to: The role is responsible for all Novartis Global spend for assigned Global Clinical Operations functions . These services have FSP long term engagements with goals for value creation and continuous improvement. Specifically, you will be responsible to develop sourcing strategies for clinical study delivery supporting Novartis development pipeline. Establish strategic category plans tailored to assigned categories/sub-categories, in congruence with organizational objectives. Lead the sourcing, negotiation and contracting to leverage buying power and recommend appropriate Procurement strategies and tactics to obtain desired results Support/Lead the design and implementation of executive governance around preferred suppliers the objective of which is to ensure performance delivery, continuous improvement, and access to innovation from supplier arrangements to achieve value contribution targets on a global basis Negotiate complex Commercial Terms and masterservices Agreements working collaboratively with Business Stakeholders, Legal, Data Privacy and Supplier Quality Accountable for a proportion of the overall Clinical category savings target and leads proactive category projects, spanning sourcing projects, demand management and process improvement, as we'll as managing sub-category specific supplier performance and innovation activities to support the delivery of the global procurement targets. Provide financial and business analysis (eg Data mining of supplier spend from Procurement and Financial Systems, output analysis and interpretation), supporting global market intelligence in the category area and acting as the focal point for category subject matter expertise to the global business and procurement community. Support in the indirect management of Clinical Sourcing Managers by assisting in their quarterly and year end reviews, provide support in establishing their goals within the category and assist in their development. Essential Requirements: Successful project execution by providing all external solutions in time / at the required quality / within budget as verified by the business. Value Delivery - optimized Total Cost of Ownership and cost productivity/savings in compliance with approved Novartis Finance Productivity guideline. Successful and measurable execution on efficiency programs Measurable and continuous process improvement compliance assurance. Understanding the Procurement KPIs related to market insights, price and demand development as we'll as procurements performance. Compliance with all GxP relevant processes Strong project management and/or other leadership experience. Knowledge of Global RD Clinical CRO market What you'll bring to the role: masters Degree/other advanced degree in Lifesciences or Pharmaceutical sciences MBA degree is preferred A minimum of 12 years Core experience in strategic negotiations, alliances, and operations in RD at a pharmaceutical company or a contract research organization. Emphasis on business, experience with clinical processes and activities and associated ESP services, with excellent understanding of study management and overall integration of clinical data system and processes

-Contributes, with appropriate oversight, to all relevant aspects of global clinical trial(s) activities to deliver study outcomes within schedule, budget, quality/compliance and performance standards. May lead specific aspects of global clinical trial(s). Core member of the Clinical Trial Team. -Applicable to Clinical Scientific Expert IThe Clinical Scientific Expert I (CSE I) provides clinical and scientific support through all phases of a clinical study under the guidance of the (A)CD(M)D in compliance with Novartis processes, ICH GCP and regulatory requirements. This role applies the principles of clinical data review excellence and identifies clinical data insights to ensure data is scientifically plausible and to identify trends, signals and risks associated to trial endpoints and patient safety. The CSE I is a core member of the Clinical Trial Team (CTT) and may support program level activities as assigned. Major accountabilities: Implementing issue resolution plans; -Assist with program level activities (eg, tracking of program -Managing interactions with relevant line functions including data management, drug supply management, clinical development and/or Novartis Country Pharma Organizations; -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators: Timely, efficient and quality execution of assigned trials and trial related activities within budget, and in compliance with quality standards. Proactive operational planning with effective contingency and risk mitigation plans. Applicable for Clincial Scientific Expert I: -Performing clinical data review and insights consistently and accurately which meets the Novartis quality standards, timelines, and is inspection ready. High quality contributions to study documents (eg protocol, ICF, clinical sections of CTA) -Clearly demonstrates Novartis Values and Behaviors (ie Innovation, Quality, Collaboration, Performance, Courage and Integrity. Minimum Requirements: Work Experience: Cross Cultural Experience. Operations Management and Execution. Collaborating across boundaries. Project Management. Skills: Clinical Research. Clinical Trial Protocol. Clinical Trials. Data Integrity. Learning Design. Lifesciences. Risk Monitoring. Trends Analysis. Languages : English.