365 Edc Jobs - Page 15

Hi, We are looking to hire someone for Study Data Manager Please go through the JD, we shall call back the relevant Profiles a) Experience in leading clinical studies. b) Experience on Study Conduct and Close Out JOB DECSRIPTION: Need exposure to 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 the operational level to work seamlessly to deliver the assigned project/activity as per timelines. • Identify process Improvement opportunities and ensure learning is shared • Ensure deliverables and/or agreed activities/tasks with customers. are completed with the expected quality. • Have worked on Study set-up, Study Conduct, and Study Closeout for various therapeutic areas. • Have also worked on writing edit check specifications, CRF completion guidelines, and review and corrections of set-up documents for different versions To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 184 b) For Position in Pune Search : Job Code # 185 C) For Position in Bangalore Search : Job Code # 186

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 and Follow the Steps Below: a) For Position in Mumbai Search : EDC Veeva & Inform Programmer Mumbai (Job Code # 181) b) For Position in Pune Search : EDC Veeva & Inform Programmer Pune (Job Code # 182) c) For Position in Bangalore Search : EDC Veeva & Inform Programmer Bangalore (Job Code # 183)

Multiple Positions in Retail Ecommerce & FMCG exploring selling opportunities to get maximum profitability Retail/Telecom/FMCG/Ecommerce/Food/OTC -Sales Required Candidate profile Any Sales Experience B2B B2C Horeca GT MT Retail/Telecom/FMCG/Ecommerce/Food/OTC -Sales Perks and benefits Best in Industry*

SAS Programming: Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures. Perform programming validation to ensure the quality of analysis datasets and programming outputs i.e. Validate Safety and Efficacy Analysis Datasets in adherence with CDISC and client specific standards and maintain quality and accuracy. Project Support: Provide programming support for project teams, including the development of programming strategies, standards, specifications, and programmed analysis. Submission Preparation: Support the preparation and review of electronic submissions. Experience in writing programming specifications for SDTM and ADaM. Document Review: Review key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements. Assess the impact on programming activities. Vendor Interaction: Interact with vendors regarding project standards, programming conventions, programming specifications, and file transfers. Efficiency Improvement: Identify opportunities for increased efficiency and consistency and interactions with strategic vendors. Skills, Knowledge, and Experience: Education: Bachelors degree in statistics, biostatistics, mathematics, computer science, or life sciences. Experience: At least 8 years of programming experience in the clinical industry. Analytical Programming: Demonstrated proficiency in analytical programming. Clinical Data Structure: In-depth understanding of clinical data structure (e.g., CDISC standards) and relational databases. Data Handling: Demonstrated ability in handling and processing upstream data (e.g., multiple data forms, workflow, eDC, SDTM). Output Provision: Demonstrated ability in providing outputs to meet downstream requirements (e.g., ADaM, Data Definition Table, e-submission). Regulatory Knowledge: Good understanding of regulatory, industry, and technology standards and requirements. Statistical Knowledge: Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs. Very strong SAS programming skills required in SAS/Base, PROC SQL, SAS/Stat, SAS Macros and SAS/Graph (Base and Advance SAS).

About Us: Paytm is Indias leading digital payments and financial services company, which is focused on driving consumers and merchants to its platform by offering them a variety of payment use cases. Paytm provides consumers with services like utility payments and money transfers, while empowering them to pay via Paytm Payment Instruments (PPI) like Paytm Wallet, Paytm UPI, Paytm Payments Bank Netbanking, Paytm FASTag and Paytm Postpaid - Buy Now, Pay Later. To merchants, Paytm offers acquiring devices like Soundbox, EDC, QR and Payment Gateway where payment aggregation is done through PPI and also other banks’ financial instruments. To further enhance merchants’ business, Paytm offers merchants commerce services through advertising and Paytm Mini app store. Operating on this platform leverage, the company then offers credit services such as merchant loans, personal loans and BNPL, sourced by its financial partners. Expectations/ Requirements: 1. Key account Manager is principally responsible for Signing New Logos/ Merchants/Brands from Large Enterprise / Corporate Accounts. 2. The BDM achieves these goals by creating Funnel and Closure of accounts. Superpowers/ Skills that will help you succeed in this role: 1. Adaptability: Attitude of optimism and can-do orientation with ability to think creatively and navigate successfully past barriers and obstacles 2. Focus through the Noise: Ability to tune out distractions to focus work on priority goals and tasks 3. Persuasion: Ability to present concepts, ideas and proposals in a manner that is perceived positively by and clearly resonates with intended audiences and stakeholders, while encouraging action. 4. Professionalism: Ability to project a mature and professional attitude, demeanor and appearance as is appropriate to a given situation 5. Sense of Urgency: Ability to prioritize, plan and move decisively when necessary to meet timeframes to avoid timing crises. Why join us: 6. A collaborative output driven program that brings cohesiveness across businesses through technology. 7. Improve the average revenue per use by increasing the cross-sell opportunities. 8. A solid 360 feedbacks from your peer teams on your support of their goals. 9. Respect, that is earned, not demanded from your peers and manager. Compensation : If you are the right fit, we believe in creating wealth for you with enviable 500 mn+ registered users, 21 mn+ merchants and depth of data in our ecosystem, we are in a unique position to democratize credit for deserving consumers & merchants and we are committed to it. Indias largest digital lending story is brewing here. It’s your opportunity to be a part of the story!

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards at all times Core Purpose of the Role : To perform the role as Clinical QA auditor to verify compliance to ICH-GCP, NDCT Rule and other applicable regulatory requirements with respect to BABE/ Phase I studies. Comfortable working and communicating professionally with others to reach understanding and agreement as necessary. Other Responsibilities: To perform or assist any other relevant job with relevant training as and when required by Department Head or Management. Role Accountabilities: To perform study specific in-process audits as per audit plan to ensure that study is conducted in compliance with in-house SOPs, protocol and applicable regulatory guidelines etc., To perform study specific retrospective audits of informed consent document, study files like TMF, case report forms, raw data forms, draft clinical study report and other applicable documents to ensure that study is conducted in compliance with in-house SOPs, protocol and applicable regulatory guidelines etc., To perform database audits in EDC application for applicable studies. To prepare and issue audit reports to respective operations team in consultation with Manager/ Department Head and follow-up the implementation of CAPA to ensure timely closure of audit observations. To initiate change control and follow-up for the same for timely closure in consultation with Manager/ Department Head. To review change control, deviation and other QMS elements taken by operations team and follow-up for its timely closure. To review draft documents like Protocol, ICD, CRF etc., before its finalization. To assist for system audit as co-auditor and or providing input to Compliance QA team, if required. To perform vendor audit as lead/ co-auditor as per vendor audit forecast plan, if required. To review qualification and validation documents, if required by Manager/ Department Head. To assist and or participate whenever required as per Department Head discretion during system audit, internal and external audits and inspection as part of audit/ inspection readiness. To assist in preparation or reviewing the CAPA whenever required during system audit, internal and external audits and inspection. To ensure QA records generated are archived on periodic basis. To assist Manager/ Department Head whenever required to collate quality systems data for trending the Quality metrics. To escalate immediately to Manager/ Department Head in case of any serious non-compliance to protocol and ALCOA+ principles. Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role 1. Experience: 6 - 9 years 2. Demonstrated Capability: Auditing skills, Understanding of regulations & Attention to detail 3. Education: M.Sc., in Life Sciences or M. Pharm., 4. Sound technical Knowledge in ICH GCP, NDCT Rule and other applicable guidelines.

Position Summary: The Database Programmer II is responsible for the design, development, testing, implementation, maintenance and support of clinical databases and applications. Position will interface directly with the internal team (i.e. Data Management, Project Management, etc.), EDC vendor, clients and third-party vendors to gather requirements and provide status updates. Qualifications: Minimum Required: Must have experience in developing and customizing clinical data management databases in a clinical, scientific or health care discipline 3 years experience in clinical database programming Bachelor s and/or a combination of related experience Medidata Rave EDC Rave API integration experience using external vendor modules Good to have Rave Advanced Custom Function programming experience Other Required: Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook. Able to handle a variety of clinical research tasks. Excellent organizational and communication skills Professional use of the English language; both written and oral. Experience in Object Oriented Programming (C#, C++, VBS, etc. ), scripting language (PERL, etc.), SAS, R, SQL Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.) Experience in clinical database management system development. Experience in a clinical, scientific or healthcare discipline. Experience in utilizing various clinical database management systems Broad knowledge of drug, device and/or biologic development and effective data management practices Strong leadership and interpersonal skills Must be able to communicate effectively in the English language. Preferred: Oncology and/or Orphan Drug therapeutic experience Base SAS , SAS/STAT and SAS/ACCESS software SAS Macro programming language Advanced experience in Database Management, object-oriented programming Veeva set up experience

Job Description Position Summary: Provides administrative guidance and support for the Clinical Systems. Essential functions of the job include but are not limited to: Responsible for internal User Access management request to the Clinical Systems and other business systems. Performs entry of data into the Global Directory within Precisions Clinical System across all Sites, Institutions and update as required. Responsible for the creation of Studies, Countries and Sites within the Clinical System as requested. Addresses help desk tickets assigned to answering questions, trouble shoot problems or identify system performance issues or deficiencies. Supports Clinical System modifications and updates to picklists, field requirements Supports the Clinical teams in the ongoing review of Clinical System access and removal of access as identified or requested. Support the leads or manager in any ad-hoc tasks assigned. Qualifications: Minimum Required: Degree, or equivalent combination of education and experience in information systems or technology Other Required: Preferred: Experience in clinical trial systems (e.g., CTMS, EDC, eTMF and RTMS) with detailed understanding of requirements gathering, documentation, configuration and integrations. Skills: Ability to resolve issues independently with good judgement to escalate appropriately. Ability to learn new systems Strong interpersonal, verbal and written communication skills

Designation: Relationship Officer/Team leader JOB LOCATION: - All over Chennai Open Vacancy: - Home loan Sales , Educational loan, MAB OR EDC Demonstrating/Presenting /Introducing/Selling banking products. New Lead generation & follow-up on leads given, maintain record of sales leads. Willing to travel and convince customer to purchase loan in any retail vertical. Good customer approach. Generating lead and can get the closures completed. Travelling throughout the Rural & Urban area visiting the customer. Completing customers loan proposal & submitting to Bank. Processing of all customer files, maintaining records & reports. Maintaining relationship with customers in pre- sales and post sales Required Candidate profile Male Candidates Preferred. Good Customer Approach. Knowledge of local customers and target businesses Age between 18 - 35 years. Graduate. Experience in Sales field is an added advantage. 2-wheeler preferable Walk-Ins Interview Venue: - Chennai Location: - 150/151 Alpha Tower, 6th Floor, North Usman Road, T. Nagar, Chennai 600017 HR Contact & Meet to: - You can WhatsApp share your Resume to below Number with your preferred location name: - Dinesh HR - 8056811701 Sarath HR - 6374232568

Mass offline team focuses on driving acceptance of products and services at offline merchants across rural markets across the country. CM is responsible for accelerating our presence in offline space by driving merchant acquisition, sales & servicing within an assigned geographical area through a team of Business Development Executives/Associates/ Distributors. The incumbent will play a key role in driving market share in offline business. He/She will be expected to lead the team to achieve targets across multiple product lines, including devices, financial and instruments to generate revenues. Responsibilities: Grow merchant network by driving acquisition and servicing to attract and retain them Drive quality in execution by audits and review mechanisms Meet merchants to present products and manage escalations Monitor competition within assigned territory and share inputs with leadership team Drive acquisition and winbacks productivity to ensure market leadership Correct placement of devices to ensure maximum asset utilization Team Handling

Responsible of sales of EDC machines in assigned territory, Lead generation, merchant visits. Detailing benefits of EDC machine to the merchants. This role requires extensive fieldwork daily have to attend gate meeting and achieve tasks assigned

ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. ABOUT THE ROLE Role Description: The Database and Edit Check UAT Tester role is responsible for performing database UAT testing, maintaining database testing documentation, developing edit check test specifications, and conducting UAT for edit checks. This role requires close attention to detail and collaboration with other groups to ensure the accuracy and efficiency of our data management databases and edit checks. Roles & Responsibilities: Perform database testing to ensure the integrity and accuracy of data. Maintain comprehensive database testing documentation. Develop detailed edit check test specifications. Conduct UAT for edit checks to ensure they meet the required standards. Communicate and call out day-to-day issues and risks regarding the area of work. Assist with preparation for inspections and provide responses to questions and findings from regulatory authorities and other audits. Participate in data management and cross-functional working groups, including global network representation. Promote and advocate for data management standard methodologies internally and externally. Basic Qualifications & Experience: Master’s degree and 3 to 4 years of life science, computer science, business administration or related discipline or equivalent experience OR Bachelor’s degree and 5 to 6 years of [life science, computer science, business administration or related discipline or equivalent experience OR Diploma and 9 to 10 years of [Job Code’s Discipline and/or Sub-Discipline] experience General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or clinical research organization (CRO) company) Preferred Qualifications Must-Have Skills: Proficiency in database testing and edit check UAT Familiarity with testing and validation plans Proficient in testing documentation standard methodologies Knowledge of Good Clinical Practice Understanding of clinical data management processes Good-to-Have Skills: Familiarity with electronic data capture (EDC) systems and data management plans (DMP). Familiarity in inspection readiness Familiarity of database audit trails Familiarity of Trial Master Files Soft Skills: Excellent communication and collaboration skills. Detail-oriented with strong analytical and problem-solving abilities. Ability to work independently and as part of a team. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Hi, We are hiring for ITES Company for SDTM Programmer Role. Job description: Minimum 2 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 Key Skills: a) Minimum 2 years of Experience in SDTM, ADAM & TLF is must b) Any Graduate To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Bangalore Search : Job Code # 91 b) For Position in Nagpur Search : Job Code # 92

Greetings from LTIMindtree !!! Wonderful Job opportunity for Advanced Informatica Developer / Admin with multiple combinations. Link to fill your details : https://forms.office.com/r/skHNtkRx16 Skill : 1 MDM (Developers and Admins) 2 IDMC 3 IICS 4 CDQ 5 CDI 6 Axon + EDC No of open positions 70+ Location : Pune

About Us Paytm is India's leading mobile payments and financial services distribution company. Pioneer of the mobile QR payments revolution in India, Paytm builds technologies that help small businesses with payments and commerce. Paytm’s mission is to serve half a billion Indians and bring them to the mainstream economy with the help of technology. About the team This team is directly responsible for growth of EDC Retail team at Paytm. Requirements: 1. Growth of distribution and market share in the assigned area of operations. 2. Visibility & accountability through extensive EDC/POS Machine deployment and sale of the product. 3. Identify and recruit the sales team to align and drive business in the market. 4. Plan the market size, span and geographies for TLs & FSE. 5. Devise the best methods for communicating plans/targets to the team to minimize the expectations vs delivery gap. 6. Monitor the quality parameters as suggested by the management. 7. Validate and conduct audits on the acquisitions and sales done by the team. Must Have: Should have good networking capabilities and be willing to travel extensively throughout their specified area. Skilled in coaching and mentoring, a quick learner who grasps and puts into application the new learnt ideas and concepts. Education - MBA (Marketing) Why join us We aim at bringing half a billion Indians into the mainstream economy, and everyone working here is striving to achieve that goal. Our success is rooted in our peoples collective energy and unwavering focus on the customers, and that’s how it will always be. We are the largest merchant acquirer in India. Compensation: If you are the right fit, we believe in creating wealth for you. With enviable 500 mn+ registered users, 21 mn+ merchants and depth of data in our ecosystem, we are in a unique position to democratize credit for deserving consumers & merchants – and we are committed to it. India’s largest digital lending story is brewing here. It’s your opportunity to be a part of the story!