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5 - 8 years

7 - 10 Lacs

Bengaluru

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

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7 - 11 years

9 - 13 Lacs

Bengaluru

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

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5 - 8 years

7 - 10 Lacs

Bengaluru

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

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3 - 5 years

5 - 7 Lacs

Mumbai

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Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Analyst Qualifications: Master of Pharmacy,BSc Years of Experience: 3 - 5 Years Language - Ability: English - Expert What would you do? Experience 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. -Create reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation.-Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred.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: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualifications Master of Pharmacy,BSc

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3 - 5 years

5 - 7 Lacs

Mumbai

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Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Analyst Qualifications: Any Graduation,BSc Years of Experience: 3 to 5 years Language - Ability: English - Expert What would you do? Exposure to EDC platforms like Medidata RAVE EDC, Inform, Oracle Clinical, Veeva etc. preferred.-Extensive experience in database design, edit check programming, custom function programming and unit testing.-Experienced in various modules such as IVRS/RWS integration and Lab administration.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: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualifications Any Graduation,BSc

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5 - 8 years

7 - 10 Lacs

Mumbai

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Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Sr Analyst Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 5 to 8 years What would you do? -Exposure to EDC platforms like Medidata RAVE EDC, Inform, Oracle Clinical, Veeva etc. preferred.-Extensive experience in database design, edit check programming, custom function programming and unit testing.-Experienced in various modules such as IVRS/RWS integration and Lab administration.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: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualifications Bachelor of Pharmacy,Master of Pharmacy

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1 - 3 years

3 - 5 Lacs

Bengaluru

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Skill required: Clinical Data Operations - Customer Retention Program Implementation Designation: Associate Qualifications: Any Graduation Years of Experience: 1 - 3 Years What would you do? Intelligent Sales and Customer Operations provides an end-to-end, integrated, seamless solution across marketing, sales and service. The solutions enable clients to drive sustainable growth by enhancing their capabilities to deliver consistent, hyper-relevant experiences across the customer lifecycle. In the Inside Sales team you will provide support for lead/opportunity generation:conduct calls / send emails / connect via social media to generate leads, schedule "first meetings" for sales/pre-sales, conduct customer surveys, identify participants for events, and bring awareness of the product or offering on behalf of sales/marketing teams. The Customer Retention Program Implementation team is focused on driving loyalty, deliver customer and brand experiences, and address unmet customer needs that can impact customer perceived value. This team defines the value associated with such a program. What are we looking for? Ability to establish strong client relationship Ability to perform under pressure Adaptable and flexible Detail orientation Problem-solving skills Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Qualifications Any Graduation

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2 - 3 years

4 - 8 Lacs

Mumbai

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Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Sr Analyst Qualifications: Bachelor of Pharmacy,Master of Pharmacy Years of Experience: 5-8years What would you do? Exposure to EDC platforms like Medidata RAVE EDC, Inform, Oracle Clinical, Veeva etc. preferred.-Extensive experience in database design, edit check programming, custom function programming and unit testing.-Experienced in various modules such as IVRS/RWS integration and Lab administration.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: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualifications Bachelor of Pharmacy,Master of Pharmacy

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3 - 7 years

15 - 20 Lacs

Bengaluru, Mumbai (All Areas)

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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 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 95 a) For Position in Bangalore Search : Job Code # 98

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13 - 17 years

30 - 35 Lacs

Bengaluru

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As the Head of Data Programming and Global Development Operations (GDO) Site Head India (Associate Director), you will have an exciting dual role that combines the best of both worlds In your role as Head of Data Programming, you will be part of the Data Monitoring, Management, and Innovation (DMMI) department You will have the opportunity to lead a team of clinical data programmers who work with advanced technical solutions such as SAS, R and other relevant applications You will manage/plan workload, set the team s strategy and priorities and mentor staff effectively In this role, you will contribute to global assets across a variety of therapeutic areas, shaping strategic decisions in clinical data programming and enabling the organization in activities like (medical) data review, safety surveillance and central data monitoring You will also be leading the Data Review Visualization and Reporting Governance In your role as the GDO Site Head India, you will be representing GDO leadership in the R&D organization in India That means that, although other functions will not report into you, you will be enabling the other GDO functions for all matter related to their team s roles in India That encompasses but is not limited to: 1) setting operational priorities and planning operational direction for the GDO India team in alignment with GDO functional leadership and planned key milestones and priorities; 2) be accountable for maintaining key performance indicators and metrics in collaboration with GDO key functions and team members; 3) provide leadership, direction and operational oversight for staff to ensure timely delivery and quality of assigned activities; 4) support GDO functional managers in resource management, planning and forecasting, and contribute to achieving functional objectives and company s strategic objectives; 5) representing GDO India at national and/or international forums as appropriate And finally, you will be an active member of the DMMI extended leadership team as well as the R&D India leadership team Who are youBSc or MSc (in a numerate discipline preferably in Mathematics, Statistics or Computer Science) or, alternatively a BSc or MSc, in a Lifesciences, Medical or PharmD supported by on-the-job training/certification in data programming or equivalentProven track record of success in statistical/data programming role, data management or equivlant roles at the global level in clinical development at a pharmaceutical/biotech company, or at a CRO, equivalent to a minimum of 10 years directly relevant experience Experience in an international environment with deliverables that were global, is a must Proven success as a people manager for 5+ years, including managing a team of statistical or data programmers Advanced skills in SAS and/or R Experience Python or other programming languages are a plus Full familiarity of CDISC SDTM standards are a mustStrong understanding of systems, processes and interfaces related to clinical development programsDemonstrated ability to manage assets effectively, ensuring timely delivery and quality outcomesAbility to provide solutions for complex programming challenges and evaluate alternatives to identify optimal solutions Having participated and succesfully led task forces or initiatives within and outside of the function, ideally at the global level

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8 - 10 years

27 - 32 Lacs

Bengaluru

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2. Job Title : Senior Data Modeler// Experience : 8-10+ years // Domain : Healthcare // Job Location : Onsite (Hyderabad/ Bangalore/ Pune/ chandigarh) // Per day rate: INR 12,000 - INR 14,000 per day (Max) Skills & Qualifications: Experience: 8-10+ years in data modeling with a strong focus on healthcare data. Proven experience in data profiling and data quality assessments. Strong conceptual data modeling skills, with the ability to translate business requirements into well-structured data models. Experience with any data modeling tools (e.g., Erwin, IBM Infosphere Data Architect, Oracle Data Modeler, etc.) as long as the candidate can demonstrate the ability to apply logical data design. Expertise in healthcare data, including patient data, claims data, clinical data, or other healthcare-specific datasets. Strong knowledge of relational and dimensional data modeling. Experience working with data integration tools, ETL processes, and databases. Understanding of data governance, data security, and compliance, especially in the healthcare domain. Excellent communication skills for liaising with business and technical teams. ",

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1 - 6 years

10 - 11 Lacs

Mumbai

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Overview: The Insights product is a new offering for Guidepoints Institutional investment and corporate clients, that offers teleconferences, surveys, and in-person events. The teleconferences live in a transcript library portal, which covers a wide of industries/topics that enables our clients to make informed decisions. All content features experts from Guidepoint s proprietary global network and is conceptualized and hosted by former investment professionals (i.e., private equity/hedge fund), sell-side equity research analysts, and industry professionals. Visit Insights team biographies at https: / / www.guidepoint.com / insights / #team. Guidepoint Insight is seeking an Equity Analyst to support the expansion of our research coverage of global private biotech companies. This role plays a critical part in building and scaling the Guidepoint Library, a central resource offering transcript-based insights through teleconferences with KOLs, and industry experts. These insights, conceptualized and hosted by former investment professionals, industry veterans and former scientists, help Guidepoints institutional clients make well-informed decisions across sectors like healthcare, industrials, technology, consumer, and more. As a Equity Analyst, working with the Director of Research, you will be responsible for developing deep research coverage, facilitating expert-led discussions, and ensuring high-quality content creation. Reporting directly to the Director of Research, you will be instrumental in creating content that spans topics such as scientific basis of the platforms, competitiveness of emerging pipelines at private biotech companies, industry landscape, regulatory decisions, drug launches and go-to-market strategies. You will also lead efforts to recruit and vet experts, ensuring that the insights gathered are accurate, relevant, and valuable to our clients. What You ll Do: Research Coverage: Monitor a coverage universe of global private companies in certain therapeutic indications within biotech sector. Industry Analysis: Track key market and business drivers, including material news flows, earnings releases, investor presentations, clinical trials, medical conferences, drug launches within your coverage companies and therapeutic indications. Content Development: Create and moderate teleconferences featuring experts from Guidepoint s network summarized in high-quality, detailed transcripts. Content Editing: Ensure high-quality content creation and editing of teleconference transcripts. Summarize, edit, and vet key discussion points of these teleconferences. Reporting : Collaborate with the Director of Research to drive the growth of Guidepoint s content library, scaling research coverage across multiple industries. Strategic Collaboration: Work closely with cross-functional teams, to align research initiatives with business objectives and market demands. Compliance Integrity: Uphold Guidepoint s compliance policies by ensuring that expert profiles and teleconference content adhere to company protocols. What You Have: Ph.D degree in biological sciences or MBBS. 3-6 years of experience in financial services, investment research, covering Biotech / Pharma sector. 1-2 years of experience in pharmaceutical/biotech companies on competitive assessment, drug development, or business development will be considered as well. Demonstrated ability to understand and analyze pathophysiology of the disease, biological rationale of therapeutic targets, clinical data, drug labels and competitive dynamics. Strong understanding of institutional buy-side/sell-side research and investing workflows. Ability to work effectively in a fast-paced, entrepreneurial environment with a strong sense of ownership. Excellent organizational and time-management skills. Strong interpersonal skills with the ability to communicate effectively with professionals at all levels. Intellectual curiosity and a passion for learning about new industries and trends. Fluent in English, both written and verbal. What We Offer: Competitive compensation package with performance-based bonuses. Employee medical coverage and benefits. Central office location in a dynamic business hub. Opportunity to work in a lean, entrepreneurial environment with direct access to leadership and decision-makers. A collaborative, casual work environment with a focus on autonomy and innovation. If you are passionate about research and possess a proven ability to drive innovation, we invite you to apply for this exciting opportunity at Guidepoint Insight. Please submit your resume detailing your relevant experience and accomplishments. About Guidepoint: Guidepoint is a leading research enablement platform designed to advance understanding and empower our clients decision-making process. Powered by innovative technology, real-time data, and hard-to-source expertise, we help our clients to turn answers into action. Backed by a network of nearly 1.5 million experts, and Guidepoint s 1,300 employees worldwide we inform leading organizations research by delivering on-demand intelligence and research on request. With Guidepoint, companies and investors can better navigate the abundance of information available today, making it both more useful and more powerful. At Guidepoint, our success relies on the diversity of our employees, advisors, and client base, which allows us to create connections that offer a wealth of perspectives. We are committed to upholding policies that contribute to an equitable and welcoming environment for our community, regardless of background, identity, or experience. LI- Hybrid LI-AK1

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1 - 2 years

3 - 4 Lacs

Chennai, Bengaluru

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Job Title - EDC IT Platform Engineer Career Level - D1 AstraZeneca is currently looking for EDC Functional Test Engineer to join our R&D IT : EDC Product Team to help support, manage and maintain our EDC p roduct along with it s numerous integration products . AZ s EDC System is Medidata s Rave, and at AZ is GxP compliant and part of Clinical Development Platforms and is used across late science teams across all therapeutic areas. You will be a part of our BizDevOps team therefore will be responsible to work cross functionally with other team members such as P roduct Lead, DevOps Lead and Release manager & other technical engineers. Key Responsibilities: Facilitate key discussions with various stakeholders as requested by system owner/platform lead and provide SME technical support on system testing of the Core EDC Product , and any data integrations (in and out) of EDC . Perform impact analysis for any change that happens on the EDC system Work with business and perform risk assessment during change implementations/ system upgrades or updates to integrations Follow and participate in validation lifecycle for upgrades, changes, & new integrations Co-develop validation packages in accordance with standard operating procedures (SOPs). Provide support of code review and solution ing for downstream customer requirements, including data extraction methods (SQL, Webservices, APIs) Actively participate in business meetings and bring new ideas to the table Responsible to solve day-to-day incidents, service requests and work towards incident-reduction and automation. Also, update Service Now (ticket management tool) for all events with respect to the incidents, service requests, changes and problems. Constantly thrive to learn and upskill according to the organization s goals and demands. Create Gxp Validation Test cases in Jira Xray for system/upgrade testing Perform validation test executions in Jira Xray , for bot h system testing and regression testing. Assist in creating or create UAT test cases that cover the essential business scenarios/use cases for the business . Facilitate process requirements gathering: capturing user stories, requirement analysis, data analysis, programming, database management, and systems integration. Mandatory Skills Extensive experience of using Medidata RAVE UI (Classic or Rave EDC) to perform the following actions: Study build, edit checks programming, deployment to production and migration Understanding about different roles and permissions in Rave Understanding of core configuration and clinical views Understanding of what data extraction capabilities there are Hands on Experience of Inbound Rave Web Services ( eg IVRS or discrepancy inputs) Experience of setting up Rave safety gateway (RSG) and SAE notifications Experience of setting up SAS extracts Experience on setting up Target Source Data Verification (TSDV) Hands on experience of being involved in URL upgrade(s) (Medidata release updates) Knowledge on system validation process / Application Life Cycle Management Must have strong communication skills and interpersonal skills Responsible to work on technical tasks to keep the Rave URL(s) and it s integrations in a maintained state Adhere to AZ core ITIL guidelines and perform tasks as incident, change, problem etc. W orking experience in clinical standard and data collection , clinical data conversion or clinical data programming /testing . Understanding of CDASH, SDTM, ADaM CDISC controlled Terminology and FDA/ICH guidelines for clinical study data Effective in stakeholder management, translating technical concepts, and working within team environments. Skilled in project management basics and creating clear technical documentation. Preferred Skills Hands on Experience of custom function , SAS programming Knowledge on Coder / Coder+ setup & Lab setup Hands on Experience of outbound Rave Web Services (ODM Adapter, Biostats Adapter) Hands on Experience of Rave backend data model, sql script writing, stored procedures Hands-on knowledge in agile management tools like Service NOW Hands-on experience in performing system testing including authoring and executing test cases Passion for learning, innovating, and delivering valuable software to people. Any other programming languages/technical skills e.g : Python, JAVA, etc. Knowledge of other Medidata products and/or Cloud EDC testing ( Rave/Inform/Veeva) experience. Educational Requirements Bachelor or master s degree in computer science or life science related discipline with IT/CRO/Pharma experience with total of 8 + years of experience Date Posted 18-Feb-2025 Closing Date 30-Mar-2025

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