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0.0 - 1.0 years
2 - 6 Lacs
Navi Mumbai
Work from Office
Title Our clinical activities are growing rapidly, and we are currently seeking a full-time, office-based Data Coordinator to join our Data Management team in India, Mumbai. If you want an exciting career where you can develop and grow your career even further, then this is the opportunity for you. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Track and maintain metrics regarding the status of the data within EDC systems Clean the clinical database, which includes generating and resolving data clarifications Reconcile clinical data Assist with support activities for the Data Management department Qualifications Bachelor’s degree in life science/ pharmacy/ health related field with strong attention to detail and working knowledge of Excel and Word; Minimum 1-2 years of clinical data management experience Knowledge of medical terminology and Clinical Research is preferred; and Good knowledge about the Clinical Databases (Medidata RAVE is preferred) People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
Posted 6 days ago
5.0 - 10.0 years
5 - 10 Lacs
Navi Mumbai
Work from Office
Title Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Statistical Programming Manager to join our Biostatistics team in India, Mumbai. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Provide support to project teams on programming matters; Manage programming staff, coordinate task assignments and review activities/progress to ensure high quality delivery; Provide leadership and training for the Programming group; Ensure all projects within the team meet objectives and timelines; and Lead the development of Programming standards, applications and processes to maximize efficiencies. Qualifications Bachelor/Master degree in statistics, mathematics, health informatics, computer science, or related field; Proficiency in SAS programming skills; 5 years of clinical programming experience; Strong communication skills and coordination skills; and Good leadership skills. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
Posted 6 days ago
1.0 - 3.0 years
3 - 6 Lacs
Navi Mumbai
Work from Office
Title Our global activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Database Programmer to join our Biometrics team. This position will work in a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Develop, program, validate and maintain clinical trial databases according to company standards; Maintain and contribute to company library of standard CDASH compliant CRFs ; and Act as primary contact to the data management team for assigned studies, supplying all necessary technical support, and ensuring quality of the programming and adherence to company standards. Qualifications Bachelor’s degree/Advanced degree in Life Sciences or Computer Science or equivalent; Min 3 years of Rave study build experience in a similar position in Pharma/Healthcare sector; Custom function (C# Programming) experience is preferred; Certified Medidata Rave Study Builders preferred; Excellent verbal and written communication skills; and Meticulous attention to detail. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
Posted 1 week ago
8.0 - 13.0 years
10 - 15 Lacs
Pune
Work from Office
Our team has deep understanding of EDC tools like Rave, Veeva, InForm, openClinica, clinical data repositories like SAS LSAF, Oracle LSH, eCS elluminate, Metadata Repositories like Nurocor, Sycamore, Formedix, statistical computing environments like Sycamore, Domino, Sas Viya systems, Clinical data review systems, RBQM systems, and more. With experience as solution architects, business analysts, or techno-functional SMEs in GXP compliant validated environments, they guide the creation of solution, data flows and strategies for building clinical development and data management systems. Their offerings encompass technical advisory, consultancy, developing of clinical data platforms and products, system integration, and intelligent automation. Additionally, the team has created innovative tools through advanced technology and data science, aiding numerous clients in expediting the drug development process. What Youll Do You will spearhead the design & implementation of various innovative solutions in the realms of clinical trial, data management, analytics and RBQM. As a solution leader, your role will involve strategizing, offering tech consultancy, conducting assessments, and overseeing technology projects as the solution leader. You will be engaging with clients to review clinical business processes, determining requirements, establishing user narratives, and delivering solutions that have significant impact. You will lead requirements gathering activities and collaborate with product owner to prioritize and groom the backlog to ensure appropriate level of detail is captured at the right time You will lead team who review and Author high-level user stories and develop related tasks, acceptance criteria and review test cases Your team will work closely with project teams in creating requirement Specifications, requirement traceability metrics , user guides and other project requirement documents You will plan and facilitate various requirement gathering, solution meetings and artefacts You will work on creating process flows based on client and internal project discussions You will work to perform business process modelling, data flow, user experience modeling, and basic solution architecture diagramming Your team will act as techno-functional Liaison between client business user and project engineering team to provide correct business context, business rules You will work in building a Business Analysis capability, mentoring and upscaling more junior colleagues, and contributing to the growth of a BA community. What Youll Bring Bachelors degree in engineering / Pharma/ Bioinformatics / Medicine or related disciplines Masters degree in business analyst, Engineering or Science preferred. 8+ years of experience working within Life Science Domain as solution architect / business analyst / data analyst is required. Experience of working in any of Clinical trial design, data management, analytics and RBQM system development, product implementation and Integration like EDC (Rave, Veeva, InForm), Non-EDC(ePRO, LAB,eCOA) , clinical data repository (CDR SAS LSAF, Oracle LSH, eClinical elluminate ), Metadata Repository (MDR Nurocor, Sycamore, Formedix) , statistical computing environment (Domino, Sas Viya) system, CTMS, eTMF, CDMS is required. Strong verbal and written communication skills with ability to articulate results and issues to internal and client teams Experience in driving requirements discussions, workshops and coordinating with internal and external stakeholders, across time zones, during the planning and delivery of technology projects is required Experience working in end-to-end Clinical Data Repository implementation with Biometrics space will be preferred. Exposure to clinical data standards like CDISC (SDTM, ADaM), FHIR, HL7, USDM is required. Experience in building and delivering GxP compliant solutions for large enterprise program is required. Exposure to programming language like R, Python and SAS is preferred. Additional Skills Strong client presence and ability to communicate verbally and in writing complex domain concepts to all audiences. Significant supervisory, coaching and hands-on project management skills. Ability to manage a virtual global team environment that contributes to the overall timely delivery of multiple projects. Willingness to travel to other global offices as needed to work with client or other internal project teams. In-silico, digital twin, and/or modeling experience.
Posted 1 week ago
4.0 - 9.0 years
9 - 19 Lacs
Bengaluru
Remote
Position: Clinical Programmer Experience: 4-9 Years Job Location: Remote Job Description: Minimum of 4+ years of experience in clinical programming for clinical data management in the pharmaceutical or CRO industry. Experience working with different EDC systems (e.g., Medidata Rave, Veeva, Oracle Clinical). Proficient in Python /SAS for data manipulation & automation. Experience in data cleaning , querying , and performing manual & automated data checks to ensure data integrity. Hands-on experience in data visualization and dashboard creation using Power BI , Spotfire , or other BI tools. Thorough knowledge of Data Collection and industry data standards . A person with bachelors or masters degree in computer science, Life Sciences, Biostatistics, or related field.
Posted 1 week ago
9.0 - 13.0 years
27 - 42 Lacs
Chennai
Work from Office
Job Summary The Sr Product Specialist (ISG) will play a crucial role in enhancing and managing our Veeva CTMS and Veeva systems within the Research and Development domain. With a hybrid work model and day shifts the candidate will collaborate with cross-functional teams to ensure seamless integration and functionality of these systems. This role requires a deep understanding of Veeva technologies and R&D processes to drive innovation and efficiency. Responsibilities Lead the implementation and optimization of Veeva CTMS and Veeva systems to support R&D activities. Oversee system configurations and ensure alignment with business requirements. Collaborate with stakeholders to gather and analyze system needs and translate them into technical specifications. Provide technical expertise and support to end-users ensuring smooth operation of Veeva systems. Develop and maintain documentation for system processes and configurations. Conduct regular system audits to ensure data integrity and compliance with industry standards. Coordinate with IT teams to troubleshoot and resolve system issues promptly. Facilitate training sessions for users to enhance their understanding and utilization of Veeva systems. Monitor system performance and implement improvements to enhance efficiency. Engage with vendors and external partners to stay updated on the latest Veeva technologies and best practices. Drive continuous improvement initiatives to optimize system functionality and user experience. Ensure compliance with regulatory requirements and company policies in all system-related activities. Support project management activities including planning execution and monitoring of system-related projects. Qualifications Possess a strong background in Veeva CTMS and Veeva systems with hands-on experience. Demonstrate expertise in Research and Development processes and requirements. Exhibit excellent problem-solving skills and the ability to work independently. Have a proven track record of managing and optimizing enterprise systems. Show proficiency in collaborating with cross-functional teams and stakeholders. Display strong communication skills to effectively convey technical information to non-technical audiences. Certifications Required Veeva Certified Administrator Veeva Vault Certification
Posted 1 week ago
4.0 - 9.0 years
6 - 16 Lacs
Hyderabad, Chennai, Bengaluru
Work from Office
Greetings from HCL! Currently Hiring for "Medidata Rave" Skill Medidata Rave Rave EDC Rave Coder + Argus Any PV tool Pharma, Life Science Experience - 4-14 years Location - Bangalore / Chennai / Noida / Pune / Hyderabad Notice period - Immediate to 30 days Only CTC - Can be discussed Interested candidate please share below details along with update resume Candidate Name- contact Number- Email ID- Total Experience- Relevant Experience- Current company- Preferred location- Notice Period- Current CTC- Expected CTC- Interested candidate please drop mail to "kushmathattanda.baby@hcltech.com" Regards, Kushma kushmathattanda.baby@hcltech.com
Posted 1 week ago
1.0 - 4.0 years
1 - 4 Lacs
Hyderabad / Secunderabad, Telangana, Telangana, India
On-site
What you will do Let's do this. Let's change the world. In this vital role you will leverages domain, technical and business process expertise to provide exceptional end user support of Amgen's external suppliers to ensure their effectiveness to deliver Amgen clinical trials for Amgen study teams. This role involves working closely with internal and external business stakeholder and support analysts to ensure rapid resolution of technical issues, performing route cause analysis and implementation of long-term preventative solutions. You will collaborate with the Product Owner and a team of other Business Analysts to ensure operational support excellence from the team. Roles & Responsibilities: Build strong relationship with key business leads and external partners to ensure their needs are being met Oversee expedited resolution of business-critical issues affecting the delivery of key external business partners Work with Product owner and business stakeholders to collected details requirements and user stories Analyze technical and process problems and work with multi-functional owners to develop solutions Maintain accurate documentation of configurations, processes, and changes Maintain detailed system and user documentation What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a with these qualifications. Basic Qualifications: Bachelor's degree and 0 to 3 years of Life Science/Biotechnology/Information Systems experience OR Diploma and 4 to 7 years of Life Science/Biotechnology/Information Systems experience Preferred Qualifications: Must-Have Skills: Customer focused with excellent written and verbal communication skills who can confidently work with internal Amgen business stakeholders and external service partners on technology topics Experience of working with or supporting systems used to execute clinical trials. E.g. Rave, CTMS, Veeva Excellent problem-solving skills and a committed attention to detail in finding solutions Good-to-Have Skills: Experience of working with or in a Clinical Research Organizations (CROs) or other specialist suppliers supporting clinical trials Experience with Agile software development methodologies (Scrum) Knowledge of network security protocols and tools (e.g., IPSEC, SSL, IDS/IPS, firewalls) Experience of O365 Cloud PC VDI Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Highly organized and able to work under minimal supervision Excellent analytical and assessment skills Ability to work effectively with global, virtual teams Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Familiarity with GxP, CFR 21 Part 11 and systems validation Ambitious to further develop their skills and career
Posted 2 weeks ago
6.0 - 11.0 years
7 - 16 Lacs
Hyderabad
Hybrid
Hi, We have Immediate hiring for Clinical Data Manager Exp: 6 to 11 Years Notice Period: Immediate to Max 15 Days Skill: Clinical data management, UAT, Test case Design Mode of Job: Permanent role
Posted 2 weeks ago
5.0 - 10.0 years
15 - 20 Lacs
Bangalore Rural, Mumbai (All Areas)
Work from Office
Hi, We are hiring for Leading ITES Company for Lead Data Manager Profile. Job Description 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 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 trainings 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 Cases Rave, CDM (startup, close out, conduct) Client interaction and meetings. Bringing up new ideas and executing new plans to cope with the back-log. Training to new team members as and when required. Key Skills: a) Minimum 3 years of Experience in leading clinical studies/ Clinical Data Management b) Hands on experience of Study Conduct and Close Out is must c) Any Graduate 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 # 95 b) To Apply for above Job Role ( Bangalore ) Type : Job Code # 98
Posted 2 weeks ago
5.0 - 10.0 years
15 - 20 Lacs
Pune, Mumbai (All Areas)
Work from Office
Hi , We are hiring for Leading ITES Company for SAS Programmer & CDB Programmer ( J Reviewer/Python/SAS) Role & responsibilities: 1.Create data cleaning reporting solutions study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. 2. Develop library of reusable checks working closely with data engineers and config specialists. 3. Collaborate with cross functional teams in creating business rules and automated check library across TAU. 4. Serves as a technical resource for creating data analytics to help with data validation and cleaning. 5. Provide programming expertise for data cleaning to efficiently ensure high quality data. 6. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. 7. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. 8. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. 9. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) 10. Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable 11. Technical skills and experience using relational databases (e.g. MS SQL Server, Redshift, or Oracle), 12. EDC build and/or clinical data management experience preferred 13. Experience in AWS preferred 14. Experience setting up automated validation is preferred 15. Knowledge of Data lake and creating interactive Dashboards are preferred 16. Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) 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 # 83 b) To Apply for above Job Role ( Pune ) Type : Job Code # 84
Posted 2 weeks ago
2.0 - 7.0 years
15 - 20 Lacs
Navi Mumbai, Pune, Mumbai (All Areas)
Work from Office
Hi We are hiring for the ITES Company for the SAS : J Review Programmer Role Role & responsibilities Programming, specifically Programming, specifically J Review, SQL, R and GitHub. Good to have SAS. Create data cleaning reporting solutions study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. Develop library of reusable checks working closely with data engineers and config specialists. Collaborate with cross functional teams in creating business rules and automated check library across TAU. Serves as a technical resource for creating data analytics to help with data validation and cleaning. Provide programming expertise for data cleaning to efficiently ensure high quality data. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable Technical skills and experience using relational databases (e.g. MS SQL Server, Redshift, or Oracle), EDC build and/or clinical data management experience preferred Experience in AWS preferred Experience setting up automated validation is preferred Knowledge of Data lake and creating interactive Dashboards are preferred Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) 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 ( Pune ) Type : Job Code # 89 b) To Apply for above Job Role ( Mumbai ) Type : Job Code # 90
Posted 2 weeks ago
3.0 - 7.0 years
15 - 20 Lacs
Nagpur, Pune
Work from Office
Hi, We are hiring for Leading ITES Company for Lead Data Manager Profile. Job Description 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 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 trainings 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 Cases Rave, CDM (startup, close out, conduct) Client interaction and meetings. Bringing up new ideas and executing new plans to cope with the back-log. Training to new team members as and when required. Key Skills: a) Minimum 3 years of Experience in leading clinical studies/ Clinical Data Management b) Hands on experience of Study Conduct and Close Out is must c) Any Graduate 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 ( Pune ) Type : Job Code # 96 b) To Apply for above Job Role ( Nagpur ) Type : Job Code # 97
Posted 2 weeks ago
3.0 - 7.0 years
15 - 20 Lacs
Bengaluru, Mumbai (All Areas)
Work from Office
Hi, We are hiring for Leading ITES Company for Clinical Data Management Profile. Plz apply and we shall call back the relevant profiles. Role & responsibilities: Minimum 3 years experience is required as a Leading Clinical Studies/ Clinical Data Management 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 regulatory standards. Read and understand the study protocol and the timelines. Perform test data entry in 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 trainings 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 Cases Rave, CDM (startup, close out, conduct) Bringing up new ideas and executing new plans to cope with the back-log. Training to 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 # 95 b) To Apply for above Job Role ( Bangalore ) Type : Job Code # 98
Posted 2 weeks ago
2.0 - 7.0 years
15 - 20 Lacs
Nagpur, Bengaluru
Work from Office
Hi We are hiring for the ITES Company for the SAS : J Review Programmer Role Role & responsibilities Programming, specifically Programming, specifically J Review, SQL, R and GitHub. Good to have SAS. Create data cleaning reporting solutions study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. Develop library of reusable checks working closely with data engineers and config specialists. Collaborate with cross functional teams in creating business rules and automated check library across TAU. Serves as a technical resource for creating data analytics to help with data validation and cleaning. Provide programming expertise for data cleaning to efficiently ensure high quality data. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable Technical skills and experience using relational databases (e.g. MS SQL Server, Redshift, or Oracle), EDC build and/or clinical data management experience preferred Experience in AWS preferred Experience setting up automated validation is preferred Knowledge of Data lake and creating interactive Dashboards are preferred Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) 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 ( Bangalore ) Type : Job Code # 87 b) To Apply for above Job Role ( Nagpur ) Type : Job Code # 88
Posted 2 weeks ago
2.0 - 7.0 years
10 - 20 Lacs
Pune, Bengaluru, Mumbai (All Areas)
Work from Office
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
Posted 2 weeks ago
4.0 - 8.0 years
10 - 20 Lacs
Pune, Bengaluru, Mumbai (All Areas)
Work from Office
Hi, We are hiring for the leading ITES Company for EDC (Veeva & Inform Programmer) Role. JOB DESCRIPTION: Create eCRF specifications, design, develop and unit test and functionally validate clinical trial setup process Create edit check specifications and program or modify checks at study level within EDC Setup different instances of study URL (e.g.: UAT (User Acceptance Testing), production, testing etc.,) Setup and configure user accounts for study teams Setup and manage blinded and unblinded study configurations Be the SME (Subject Matter Expert) for all database related activities Setup, configure, unit test and functionally validate and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc., Familiar with custom functions within EDC systems Work closely with EDC vendors regarding any tool related issues in the system Ability to troubleshoot database setup as per study needs Prepare, test and implement postproduction changes as per study needs Archive and retire the study URL after database lock Partner with appropriate team members to establish technology standards and governance models • Establish and support business process SOPs. Oversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT (Information Technology), and Quality organizations Be a primary change agent to ensure adoption of new capabilities and business process Be the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality. Work with leaders to resolve issues affecting the delivery of clinical trials Collaborate with standards team in creating standard CRF libraries for study level consumption Work closely with data engineers and data management programmers at study level integration and delivery Lead technology vendor oversight activities. Be a process expert for operational and oversight models. 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 # 181 b) To Apply for above Job Role ( Pune ) Type : Job Code # 182 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 183
Posted 2 weeks ago
4.0 - 9.0 years
10 - 20 Lacs
Pune, Bangalore Rural, Mumbai (All Areas)
Work from Office
Hi We're hiring for Leading ITES Company for EDC (Veeva Programmer) Role Experience in EDC & Veeva is Must. Job Description : Create eCRF specifications, design, develop and unit test and functionally validate clinical trial setup process Create edit check specifications and program or modify checks at study level within EDC Setup different instances of study URL (e.g.: UAT (User Acceptance Testing), production, testing etc.,)) Setup and configure user accounts for study teams Setup and manage blinded and unblinded study configurations Be the SME (Subject Matter Expert) for all database related activities Setup, configure, unit test and functionally validate and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc., Familiar with custom functions within EDC systems Work closely with EDC vendors regarding any tool related issues in the system Ability to troubleshoot database setup as per study needs Prepare, test and implement postproduction changes as per study needs Archive and retire the study URL after database lock Partner with appropriate team members to establish technology standards and governance models Establish and support business process SOPs. Oversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT (Information Technology), and Quality organizations Be a primary change agent to ensure adoption of new capabilities and business process Be the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality. Work with leaders to resolve issues affecting the delivery of clinical trials Collaborate with standards team in creating standard CRF libraries for study level consumption Work closely with data engineers and data management programmers at study level integration and delivery Lead technology vendor oversight activities. Be a process expert for operational and oversight models. Partner with appropriate team members, technology vendors, and CRO partners to avoid and resolve risks. Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents Participate in preparing function for submission readiness and may represent Clinical Information Operations (CIO) group in a formal inspection or audit. Track study deliverables and evaluate study metrics to mitigate risk for major data management deliverables. Adaptable to new ways of working using technology to accelerate clinical trial setup Education and Experience Requirements: Bachelor's degree or related experience. Knowledge of drug development process. Minimum of 4+ years experience in Data Management, Programming, Clinical IT, or other Clinical Research related fields. Hands-on experience with at least one EDC system (e.g.: Medidata Rave, Inform, Veeva etc.,) Experience programming in CQL, working with JSON format and/or C# is preferred Experience integrating other clinical trial modules (e.g.: lab, safety, IRT, coding etc.,) with the EDC system Understanding of industry standard technologies to support Clinical Development needs (e.g., CTMS, SAS, R or Python, Data Warehouses, SharePoint) 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 # 181 b) To Apply for above Job Role ( Pune ) Type : Job Code # 182 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 183
Posted 2 weeks ago
7.0 - 12.0 years
15 - 20 Lacs
Pune, Mumbai (All Areas)
Work from Office
Hi We are Hiring for the ITES Company for the position of SAS: Statistical Programmer Job Description: We are looking for an associate with at least 5 - 10 years of experience for Statistical programming position, having strong understanding of SAS Base/Macros/GTL and experience of SDTM/ADAM/TLFs creation as per CDISC standards. Associate should be able to manage communication with customers, track and ensure quality on-time deliverables, suggest and drive implementation of process improvements for enhanced quality and efficiency gains, institute robust processes to ensure consistent outcomes with quicker turn-around time. Expertise in Base and Advance SAS programming. Expertise in developing macros and developing generalized programs. Development of the complex SAS macros that can be utilized across TAs in multiple studies, review of the developed SAS programs. Expertise in SQL, architecting Data Preparation, Data Visualization, Data Integration, Analytical Reporting. Worked on different SAS tools like SAS Data Integration, SAS Studio, SAS EG, SAS Management Console. SAS Developer with over 5+ years of experience with expertise on different domains. Possess solid ability in integrating programming skills, adapting to new applications and expertise in architecting Data Preparation, Data Visualization, Data Integration, Analytical Reporting. Worked on different SAS tools like SAS Data Integration, SAS Studio, SAS EG, SAS Management Console. Experience in ETL Preparation, data exploration, data preparation, data cleansing, reporting, and technical document preparation. Import /Export data using various techniques like PROC IMPORT, PROC EXPORT, LIBNAME, INFILE, PROC PRINT statements. Good Knowledge of Data management, Data handling, and Creating Data structure Knowledge of Database languages such as MYSQL, Oracle. Knowledge of various SAS Procedures like PROC Means, PROC Freq, PROC Contents, PROC Import, PROC Format, Proc Summary, PROC Sort, PROC Transpose, and PROC Report. Knowledge Of SAS procedures like SAS/Base, SAS/Macro, SAS/SQL, SAS Arrays, Do loops, SQL Joins, Hash join techniques 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 # 208 b) To Apply for above Job Role ( Pune ) Type : Job Code # 209
Posted 2 weeks ago
5.0 - 10.0 years
10 - 15 Lacs
Pune, Mumbai (All Areas)
Work from Office
Hi , We are hiring for Leading ITES Company for SDTM Programmer Profile. Please go through the JD and we will get back to the relevant profiles. Job Description: Minimum 3 years of experience for Senior Statistical programming is a mandate. Having strong understanding of SAS Base/Macros/GTL and experience of SDTM/ADAM/TLFs creation as per CDISC standards. Associate should be able to manage communication with customers, track and ensure quality on-time deliverables Implementation of process improvements for enhanced quality and efficiency gains, institute robust processes to ensure consistent outcomes with quicker turn-around time. Experience in SDTM, ADAM & TLF Experience in EDC & VEEVA Expertise in Base and Advance SAS programming. Expertise in developing macros and developing generalized programs. Development of the complex SAS macros that can be utilized across TAs in multiple studies, review of the developed SAS programs. Expertise in SQL, SAS Macros, Functions, SAS GTL, SAS, and other advanced SAS components. Mentor and supervise developers to build generic standard macros, generic listings or other ad-hoc requests in accordance with business requirements 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 # 208 b) To Apply for above Job Role ( Pune ) Type : Job Code # 209
Posted 2 weeks ago
7.0 - 10.0 years
10 - 20 Lacs
Pune, Bengaluru, Mumbai (All Areas)
Work from Office
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
Posted 2 weeks ago
3.0 - 6.0 years
9 - 12 Lacs
Pune, Bengaluru, Mumbai (All Areas)
Work from Office
Hi We are hiring for Leading ITES Company for Clinical Data Manager Profile. Role & responsibilities: Candidate should have 2-5 years of experience of Clinical Data Manage (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
Posted 2 weeks ago
2.0 - 7.0 years
9 - 12 Lacs
Pune, Bengaluru, Mumbai (All Areas)
Work from Office
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
Posted 2 weeks ago
1.0 - 6.0 years
1 - 6 Lacs
Kolkata, Bengaluru, Mumbai (All Areas)
Hybrid
Job Description Project role: Associate Clinical Data Coordinator/Clinical Data Specialist Work Experience: 1-5 Years Work Location: Kochi/Kolkata/Thane/Bangalore Work Mode: Hybrid(Office based) Must have skills: Clinical Data Management ,Rave, Medidata Rave 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 don't 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 Bachelor's 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
Posted 3 weeks ago
12.0 - 15.0 years
22 - 25 Lacs
Chennai
Work from Office
Team Leadership & Oversight Support and mentor a team of Clinical Data Specialists, promoting consistency, quality, and productivity. Collaborate on training plans, performance goals, and team development. Provide day-to-day guidance and technical support related to data issues. Help manage team capacity, workload distribution, and scheduling across studies. Foster effective collaboration with cross-functional teams. Data Management & Quality Assurance Accurate data maintenance, quality control, and discrepancy resolution in CTMS and EDC systems (e.g., RAVE, Veeva Vault, Clinical One, Inform). Review source documents for adherence to ALCOA-C principles and regulatory guidelines (GCP, HIPAA, FDA). Identify and resolve data inconsistencies and protocol deviations. Collaborate with clinical operations to ensure accuracy and completeness of source documentation. Support audit readiness through rigorous documentation practices and participation in quality reviews. Assist in creating source documents from protocols, CRFs, and lab manuals. Drive timely completion of data cleaning and database lock activities. Track and report key metrics for data quality and operational efficiency. Process Development & Compliance Develop SOPs, training guides, and implement process improvements. Identify inefficiencies and propose solutions to enhance workflow and team productivity. Participate in audits and collaborate on regulatory responses. Promote adherence to industry and internal standards. Cross-Functional Collaboration Serve as the point of contact for clinical data inquiries across assigned studies. Coordinate timelines and deliverables with project managers, monitors, and external stakeholders. Support all phases of the clinical study lifecycle from initiation to close-out. Qualifications and Experience Bachelor's degree in life sciences, health sciences, nursing, or a related field. Minimum 12 years of relevant experience, with at least 7 years in a Clinical Research Coordinator or Clinical Data Management role. Prior Managerial experience is a plus; must exhibit ability and willingness to take on supervisory responsibilities. Strong knowledge of CTMS (e.g., CRIO) and EDC systems such as RAVE, Veeva Vault, Clinical One, and Inform. Solid understanding of GCP, HIPAA, ALCOA-C, and clinical trial protocol standards. Must demonstrate ability to read, interpret, and operationalize clinical protocols. Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint). Ability to work independently while building processes and guiding others. Willingness to align with US operating hours.
Posted 3 weeks ago
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