80 Rave Jobs

6-8 years of experience in Clinical Data Management/Clinical Data base programming or relevant field. Location: Mumbai Pune, Bangalore, Hyderabad, Kolkata Good technical experience on EDC systems (Rave/Veeva) Ability to provide technical expertise. Proactively communicate ownership of studies. Critical thinking to identify root causes and best practices. Knowledge of create high quality EDC specification. Knowledge of both SDTM and C-DASH (Clinical Data Acquisition Standards Harmonization) Knowledgeable of study protocols and create specifications that align to key deliverables. Knowledge of creation of Edit check specification and knowledge of programming edit check Knowledge of EDC design EDC edit check foundational standards library (Master specifications). Experience in setting eCRF in Rave/Veeva EDC Experience in programming FEC and simple edit checks To Apply share your cv to afreen@liveconnections.in Whatspp:8297161110

Job Title / Primary Skill: Data Team Lead Years of Experience: 9-12 Years Job Location: Bangalore/Kochi/Kolkata Must Have Skills: Clinical data management, conduct, closeout, start up, SSU, Study lead Good To Have Skills: Rave Job Description 9+ of direct Data Management experience with a minimum of 2 year as a CDM project lead Pref Manage end-to-end delivery of data management services for single/multi-service projects with minimal guidance, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Data Management (DM) team to provide high quality data management products that meet customer needs. Provide leadership to the team in the areas of project planning, execution, and close-out; Overview of financial management for data management activities; communications; and milestone deliverables. Perform role of Data Team Lead (DTL). • Gather Study Set up requirements through discussion and communication with relevant stakeholders. • With Minimal guidance - support, overview of validation of new Device integrations. • Oversight & Perform regular Data cleaning activities to ensure clean data with quality and timely deliverables to sponsor. • Ensure that all the deliverables are of expected quality standards and meet customer expectations. • With guidance, ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW). • Support Training of New joiners. • Lead internal study meetings and internal/ sponsor audits and participate in Study Kick off meetings and other sponsor meetings. • Tracks and manages the projects, oversee project progress, identify risks and take corrective action to rectify any errors as recommended as required. • With Guidance manage & oversight the implementation of new technology / database revisions. • Work closely with the programming team for process innovation and automation. • Be compliant to trainings and eSOP reading. • Provide review and expert opinion in developing, revising, and maintaining core operating procedures and working instructions. • Communication with Line Manager, and other team members across functions should be collaborative. • Perform other duties as directed by Line Manager. Professional Attributes 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. Advanced computer applications like Microsoft excel, word, Inbox etc Advanced Should have Advanced understanding of Drug development lifecycle and Overall Clinical research process Advanced Educational Qualification: Bachelor's Degree In health, clinical, biological or mathematical sciences, or related field with proven experience in Data Management Req

Our Clinical/Drug Development division displays a substantial history of contributing to numerous client projects with significant results in drug development. The Drug Development RD Technologists possess a deep understanding of technological solutions for clinical development processes including clinical study design, data management, analytics, and quality risk management platforms and products. They are well-versed in software related to clinical trial protocol design, electronic data capture (EDC), external data capture, data conformance, transformation, analysis, and reporting. Our team is well versed about industry standards such as CDISC, FHIR, OMOP, and their respective usage. Our team specializes in designing bespoke solutions or products implementation for clinical design, Clinical data management, and analytics systems. 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 design implement various innovative solutions in the realms of Clinical data management, analytics Work in clinical data management and analytics area as part of strategy building, assessment and technology implementation project as business and data analyst Lead and participate in clinical business process discussions with clients, identify requirements and user stories Conduct online interviews and workshops to gather requirements to support the business needs of users Author high-level user stories and develop related tasks, acceptance criteria and review test cases Participate in clinical business process discussions with clients, identify requirements and user stories Work closely with project teams in creating Requirement Specifications, RTM and other project documents Plan and facilitate various Agile meetings and artefacts, including sprint planning, review retrospectives, daily stand-ups Perform business process modelling, data flow, user experience modeling, and basic solution architecture diagramming Act as techno-functional Liaison between client business user and project engineering team to provide correct business context, business rules The ideal candidate will have a strong background in the project lifecycle, with experience in large and complex programs. They will have a track record of successfully managing people, and be able to provide support and escalation routes for queries, define and plan analysis deliverables, and agree on analysis approaches. Experience in building a Business Analysis capability, mentoring and upscaling more junior colleagues, and contributing to the growth of a BA community is also essential. What Youll Bring Bachelors degree Pharma/ Bioinformatics / Medicine or related disciplines Master's degree in Business Analyst, Engineering or Science preferred. 5-10 years of experience working within Life Science Domain as solution architect / business analyst / data analys t is required. Experience of working in building solution around drug development - clinical data management areas like discrepancy management, clinical data repositories, clinical issue management, Operational data repositories, operational reports Experience working in end-to-end Clinical Data Repository implementation with Biometrics space will be preferred. Experience working in Clinical data management area as BA or Subject matter expert Understand the end to end process for clinical data management and Analysis Exposure to clinical data coordination and clinical data management area. 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.

Candidate should be Graduation/Post Graduation (B.Tech./ M. Tech.) in Electrical/ Mechanical/ Energy Engineering from reputed University with an experience more than 3 years in energy sector. Roles and Responsibilities • Carrying out site visit for field energy parameter measurement related to energy audit and completing energy surveys. • Proficient in conducting energy audits and using specialized tools and equipment. • Collecting energy monitoring data and keeping accurate records. • Prepare energy audit reports with energy analysis results and cost-saving recommendations. • Excellent communication and presentation skills with customers and venders and colleagues during audits • Able to travel across India and abroad to gather plant operating parameters. • Ability to manage and execute multiple projects. • Ability to execute assignment independently

Job Title / Primary Skill: Clinical data specialist Years of Experience: 2-5 Years Job Location: Kochi/Kolkata Must Have Skills: Clinical data management, data management, rave, conduct, closeout, start up Good To Have Skills: Rave Job Description 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. Undertake team leadership activities under the supervision of the Data Operations Coordinator (DOC), Data Team Lead (DTL), or Functional Manager. 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. Serve in the role of back-up to a DOC or DTL. Conduct data review. Write and resolve data clarifications. Lead database audit team. Develop and test databases and edit specifications. Perform testing of programming. 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. Professional Attributes 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. 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. Educational Qualification: Bachelor's Degree Clinical, biological or mathematical sciences, or related field Req • Equivalent combination of education, training and experience in lieu of degree.

You will play a crucial role in producing key data and reports to support data review reporting development. This involves evaluating requirements, designing specifications, coordinating with programmers, programming reports, and ensuring validation and rollout activities are carried out effectively. You will provide quantitative analytical support independently or as part of a team, with minimal guidance and supervision. Your primary responsibilities will include: - Producing and tracking reports for various line functions within Global Drug Development to monitor clinical data - Creating understandable and actionable reports on clinical data for key stakeholders - Collaborating on user requirements documents, functional specifications, and testing scripts - Interacting with end-users to create specifications and work with programmers for successful delivery - Offering quantitative analytical support to global program teams and assisting in analyzing reports - Supporting the planning, execution, and close-out of Clinical Programs/Trials - Collating and delivering analytics reports for critical decision-making purposes - Maintaining appropriate documentation and working with internal SMEs and key stakeholders to analyze clinical program/trial operational data - Providing training to end-users on the best use of various data review tools - Programming reports of varying complexity within clinical reporting systems using SQL, PL/SQL, C#, VB script, SAS, Python, R - Demonstrating good knowledge of Novartis Clinical Data Standards for creating report specifications or outputs - Supporting special projects of limited scope, both clinical and non-clinical - Offering study-level expertise and involvement in CTTs - Leading or supporting special projects across various responsibilities, such as systems issues, processes, user support, and training Your performance will be evaluated based on: - Quality and timeliness of deliverables - Revisions to deliverables due to logic or programming errors - Customer feedback and satisfaction To be successful in this role, you should have: - At least 5-7 years of experience in clinical review, reporting programming, business analytics, or clinical trial setup in the pharmaceutical, CRO, or Life Science industry - Strong knowledge of programming languages (SQL, PL/SQL, C#, VB script, SAS, Python, R) - Familiarity with Data Review and/or Business Intelligence tools (e.g., Spotfire, JReview) - Understanding of clinical data management systems and relational databases applied to clinical trials - Attention to detail, quality, time management, and customer focus - Ability to communicate technical concepts to non-technical users - Strong verbal and written communication skills for global collaboration - Knowledge of Drug Development Process, ICHGCP, CDISC standards, and Health Authority guidelines - Capability to train and supervise new or less experienced associates Novartis offers a supportive community of smart, passionate individuals dedicated to making a difference in patients" lives. If you are ready to contribute to breakthroughs that change lives, join us in creating a brighter future together. For more information about Novartis and to explore career opportunities, visit: https://www.novartis.com/about/strategy/people-and-culture If you are interested in staying connected with Novartis for future career opportunities, sign up for our talent community: https://talentnetwork.novartis.com/network To learn about the benefits and rewards of working at Novartis, read our handbook: https://www.novartis.com/careers/benefits-rewards Novartis is committed to fostering an inclusive work environment and diverse teams that reflect the patients and communities we serve. If you require accommodation due to a disability, please contact [email protected] with your request and contact information, including the job requisition number.,

Job Description Project role: Clinical Data Specialist Work Experience: 2 -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

Looking for Trainer Who Provides Offline training on Clinical Data Management On Part time basis Provides training and monitors performance to ensure the team are operating at the highest level to design and deploy clinical databases. Required Candidate profile Should have Experience on clinical data management Entire Work Process EDC SAE Reconciliation. should have Experience on Softwares (Oracle Inform/ Mediidata Rave) Interested Contact - 9133469786

As an Industry & Functional AI Decision Science Consultant within the Accenture Strategy & Consulting Global Network - Data & AI practice, you will have the opportunity to work on high-visibility projects with esteemed Pharma clients worldwide. You will collaborate with leaders in strategy, industry experts, and business intelligence professionals to shape innovative solutions leveraging emerging technologies. Your role will involve supporting the delivery of consulting projects, developing assets and methodologies, and working on a variety of projects such as Data Modeling, Data Engineering, Data Visualization, and Data Science. Additionally, you will be expected to acquire new skills that are applicable across different industry groups, support strategies and operating models, and make presentations to clients when necessary. We are seeking individuals with a Bachelor's or Master's degree in Statistics, Data Science, Applied Mathematics, Business Analytics, Computer Science, Information Systems, or a related quantitative field. The ideal candidate will have proven experience working on Life Sciences, Pharma, or Healthcare projects, with a solid understanding of Pharma datasets including commercial, clinical, Real World Evidence (RWE), and Electronic Medical Records (EMR). Proficiency in Statistical Models, Machine Learning, hypothesis testing, multivariate statistical analysis, and optimization is essential, along with hands-on experience in handling datasets like Komodo, RAVE, IQVIA, Truven, and Optum. Strong programming skills in languages such as R, Python, SQL, and Spark are required, as well as experience with cloud platforms like AWS, Azure, or Google Cloud for deploying language models. Familiarity with Data Visualization tools like Tableau, Power BI, Qlikview, or Spotfire is advantageous. In this role, you must possess excellent analytical and problem-solving skills, a data-driven mindset, proficiency in Excel, MS Word, PowerPoint, and strong communication, interpersonal, and presentation skills. Your ability to solve complex business problems, deliver client satisfaction, and build points of view on industry trends will be crucial to your success in this position. Join us in a culture committed to accelerating equality for all and engage in boundaryless collaboration across the organization.,

Job Title / Primary Skill: Manager Clin Data Mgmt Years of Experience: 12-16 Years Job Location: Kochi Must Have Skills: Clinical data management, data management, rave, Line management Good To Have Skills: Rave Job Description Manage and support team of Data Management professionals to efficiently produce databases that meet customer requirements. Essential Functions • Provide expert review and guidance for production of Data Management deliverables including CRF/e-CRF, database design and set-up, validation definition and programming, Data Management Plan and database deliverables to internal and external customers. Provide technical advice and solutions with internal and external customers to solve problems and improve efficiency. Ensure that staff is trained and compliant with current operating procedures and work instructions and project scope of work. Identify and address professional development/training needs of staff. Mentor staff members to develop Data Management process, system, and drug development expertise. Provide operational input into proposals and scope of work. Participate in proposal defenses. • Hold at least bi-monthly meetings with direct reports to discuss, at a minimum: project status, including timelines, delivery updates, financial aspects of the group or project, and potential risks, associated mitigation and support required; status of any initiatives that they may be involved in; the team's utilization rates; the direct report's training and other administrative obligations, such as Standard Operating Procedures (SOPs) and corporate training mandates; personnel issues; and career or training objectives. • Develop and implement plans for measuring and improving employee engagement, ensuring global consistency. • Collaborate with project leads to address work scheduling for current and projected projects, staffing needs, technological needs, and projected peak workloads, ensuring global consistency, where possible. Develop and manage associated action plans to hold members accountable. • Efficiently conveying messages from leadership to direct reports and teams, as well as effectively communicating issues and opportunities up to leadership. • Might be needed to serve as the designated substitute or alternatively ensure coverage is in place for direct reports during their absence or in case of turnover. • Attend and participate in Bid Defenses, Kick off Meetings (KOM), as applicable. Support Request for Information (RFI), Request for Pricing (RFP), and budgets, as requested. • Participate / Support internal and external audits and inspections, as required. Also ensure required staff is assigned, trained and prepared to support. Professional Attributes 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. 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. Educational Qualification: Bachelor's Degree Clinical, biological or mathematical sciences, or related field Req • Equivalent combination of education, training and experience in lieu of degree.

Immediate Joiners preferable. Role & responsibilities •Utilizes primary development tools including Oracle RDC, Oracle Inform, Medidata, Rave, SAS, and other supporting tools to design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. •Generates and maintains all required documentation, including the development of specifications, coding, and validation efforts in support of annotated Case Report Forms (CRFs), database creation, coding configuration, edit check procedures, import setup and processing, export setup and processing, listings, and custom reports. •Serves on project teams to coordinate and lead development activities for clinical programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive feedback. Keeps those responsible for project management informed of any issues that might impact project target dates, scope, or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources. •Ensures quality deliverables by providing review of study level core deliveries for accuracy. Attends sponsor audits and assists with in-progress audits. •Reviews and provide input on study budgets and monitors scope of work to actual work, alerting management of potential change orders. Preferred candidate profile 3-5 years experience of Medidata Rave Experience in DB build, eCRF form designing, Edit Checks programming, Migrations, Publish checks Understanding of Protocol Interpretation. Simple to moderate Custom functions Strong Communication.

Jeppesen RAVE scripting We are looking for a Python Developer experienced in Jeppesen RAVE scripting (Atrium) . You will work with airline teams, OEMs, and IFE vendors to develop, script, and test customized crew-facing workflows, content, and tools deployed via RAVE . This role involves deep collaboration with cabin crew stakeholders, product managers, and technical teams to deliver seamless, user-friendly solutions that enhance cabin operations and crew efficiency onboard. Key Responsibilities: Develop and maintain RAVE , including customization, rules event scripting, content updates, and logic handling. Translate airline crew SOPs into logic using RAVE (in Atrium). Collaborate with product managers, UX designers, and crew training teams to ensure usability and compliance. Required Skills: 3+ years of hands-on experience with Python scripting for embedded, UI, or content delivery systems. Experience developing or customizing applications for RAVE . Python Behave for BDD Familiarity with crew-facing workflows , passenger service systems, or digital cabin operations. Proficiency with XML/JSON , data mapping, and content lifecycle management. Experience working in Linux-based environments or aircraft software test benches.

Review and understand the study protocol and the timelines.Perform data review data reconciliation and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate. Implement study team feedback as required on the data. Perform external checks to handle manual discrepancies and action the same. Develop specifications implementation and testing for the edit checks and listings (DVS) Location- Pune Bangalore Kolkata Hyderabad Mumbai Contact Person Sangeetha Tamil Hariharan Arumugam

Clinovo is currently seeking a Clinical Data Managers for one of our clients. TITLE : Clinical Data Managers LOCATION: Bangalore Primary Job Function Manage end-to-end delivery of data management services for single/multi-service projects with minimal guidance, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs. Provide leadership to the team in the areas of project planning, execution, and close-out; financial management; communications; and milestone deliverables. Perform role of Data Team Lead (DTL). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents. Core Job Responsibilities Client Management: Serve as primary point of contact for customer on data management deliverables With minimal guidance, provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise With guidance, provide input for and perform direct negotiations with customer, e.g., timelines, financial, process, resources Maintain strong customer relationships Service Management: Meet with Data Operations Coordinator (DOC) and/or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders With minimal guidance, support DM service delivery with comprehensive DM process and technical expertise in executing projects. Serve as the escalation point for unresolved data issues with guidance, work with client data managers, vendors, internal team members for resolution Work with functional manager(s) to ensure appropriate resources are assigned to meet project deliverables With guidance, create and/or review and sign-off on all data management plan (DMP) documents Implement proactive quality management plan. Identify any service and quality issues with agreed upon specifications per the DMP and contract/SOW and work with functional manager(s) to resolve With guidance, track service performance and provide leadership to identify root causes of issues and implement remedial actions Continuously look for opportunities to improve efficiency of tasks and quality of deliverables Identify compliance issues and work with functional manager(s) to ensure timely follow-up and resolution With guidance, maintain internal tracking databases and systems Financial Management/Business Development Support: With guidance, ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW) Manage SOW/budget Review financial reports monthly and participate in project reviews as requested Identify out of scope tasks and track change orders to completion With guidance, may serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing With guidance, participate in and support RFP process (review RFP documents, pricing, attend bid defense) Other: Provide input on DM process improvements or project solutions to CDM team/CDM department Provide input on the development and implementation of a new technology or tool Participate in a focus team or global or local best practice team Perform other duties as directed by functional manager(s) Preferred Skills and Experience: Previous experience and proven competence in managing study delivery through full DM life-cycle (at least 1 medium Phase III). Demonstrated data management skills and thorough knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology). Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology. Knowledge of operating procedures and work instructions and the ability to apply them in practice. Knowledge of Good Clinical Practices and applicable regulatory guidelines. Excellent communication, interpersonal, customer service, and teamwork skills. Excellent organizational and problem-solving skills. Excellent project management skills. Ability to work with minimal supervision, using available resources, e.g., functional managers, senior DTLs. Comprehensive understanding of clinical drug development process. Ability to establish and maintain effective working relationships with coworkers, managers, and customers. Previous experience and proven competence in managing study delivery through full DM life cycle (at least 1 medium Phase III). Demonstrated data management skills and thorough knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology). Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology. Knowledge of operating procedures and work instructions and the ability to apply them in practice. Knowledge of Good Clinical Practices and applicable regulatory guidelines. Excellent communication, interpersonal, customer service, and teamwork skills. Excellent organizational and problem-solving skills. Excellent project management skills. Ability to work with minimal supervision, using available resources, e.g., functional managers, senior DTLs. Comprehensive understanding of clinical drug development process. Ability to establish and maintain effective working relationships with co-workers, managers and customers. Minimum Education: Bachelor's Degree Health, clinical, biological, or mathematical sciences, or related field Required. Role & responsibilities Preferred candidate profile

Experience: 5 - 7 yrs Work Mode: Work from Office Work Location: Bangalore LOOKING FOR IMMEDIATE JOINERS ONLY Job Description - Clinical Data Manager : OVERVIEW The Clinical Data Manager (CDM) is an independent role responsible for supporting the study team and developing comprehensive study documentation, designing database specifications, and overseeing validation, maintenance/data cleaning, and closeout activities for clinical trial databases. The CDM is recognized as the platform expert, leveraging cutting-edge tools and technologies to provide continuous data insights and ensure the timely delivery of high-quality results for Sponsors. The CDM has a strong foundation in clinical data management, combined with the agility to adapt as processes evolve towards the integration of clinical data science. KEY TASKS & RESPONSIBILITIES Define project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design and Data Review and Data Reconciliation tools. Understand external data collection, its integration into the clinical trial, and the management and reconciliation processes required to ensure its accuracy and relevance. Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables. Perform holistic data review and trending analysis via reporting and elluminate analytics to proactively identify issue, risks and develop mitigation strategies. Utilize artificial intelligence (AI) and machine learning (ML) for anomaly and outlier detection to enhance the efficiency and quality of trial data. Monitor and interpret key performance indicators (KPIs), metrics, dashboards, Clinical Trial Operational Analytics (CTOA), and reports to provide actionable recommendations to study lead(s)/project manager. Perform Query Management Define specifications and collaborate with technical team on configuration of centralized data management platform, elluminate Data Central for data cleaning strategy and oversight activities. Prepare and maintain data management documentation (e.g., DMP, CCGs, Help Text, DVS) and update throughout trial lifecycle. Review and ensure the quality control of team-developed deliverables, covering eCRFs, study documents, program/report specifications, outputs, and elluminate Data Central with analytics modules. Actively evaluate and contribute to enhance processes to increase efficiency and effectiveness. Collaborate and work as a team to ensure the deliverables are completed on time with high quality. Ensure compliance with industry quality standards, regulations, guidelines, and procedures. Other duties as assigned. CANDIDATE’S PROFILE: Education & Experience 5+ years’ experience in Clinical Data Management preferred. Bachelor’s degree in a health-related field or equivalent experience preferred. CCDM Certification preferred. Professional Skills Strong project management experience and project team leadership skills including work planning, work delegation and solving complex problems. Strong analytical and strategic thinking skills Detail oriented, ability to multitask with strong prioritization, planning and organization skills. Excellent collaborative skills Demonstrated command of the English language with proficiency in both verbal and written communication Technical Skills Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology Proficient with EDC and Clinical Data Management Systems Experience with Cloud SaaS platforms (preferred)Experience with data reporting tools such as Qlik, JReview, Spotfire preferred. Experience with RBQM methodology preferred. Exposure to CDISC guidelines and standards

JD CDM: 2 to 3 yrs of minimum Clinical Data Management experience Must have exposure to Study Start up, Conduct and Study Closeout. If not three phases should have good exposure to minimum two phases. Rave (Medidata) or Veeva EDC hands on experience is must. Must Have: Setup experience should have knowledge of DMP (Data Management Plan) creation, Edit check creation, Data Transfer specification creation, UAT knowledge (not mandatory). Conduct Experience Data Cleaning experience (Query Handling), Postproduction Changes, SAE reconciliation, LAB Reconciliation, ECOA/EPRO Reconciliation, PK/PD Reconciliation, Dataset review etc . Study Lock Freezing/Locking, should have good experience of Study lock Client facing role and Mentoring are added advantage. 1 Execute Data Management Activities I.e., Data Cleaning, Executing Manual and System checks, Update relevant trackers, Discrepancy and query management, Issue resolution, Database lock activities. 2 Participate in innovation and process improvement initiatives. 3 Identify and develop action plan in coordination with the TL for activities not meeting the client SLAs. 4 Archive all necessary information for audit purposes according to quality and security requirements, to ensure reliable and timely retrieval of documentation and information. 5 Support multiple clinical trials, across diverse therapeutic areas, to successful conclusion and provide technical oversight when required. 6 Study Setup hands on experience. 7 Working exposure in RAVE/VEEVA EDC, Knowledge of Spotfire reporting tool , 8 Third party data handling experience (Lab, PK, Image etc), Client facing role (experience in client communication)

JD CDM: 4 - 6 yrs of minimum Clinical Data Management experience Must have exposure to Study Start up, Conduct and Study Closeout. If not three phases should have good exposure to minimum two phases. Rave (Medidata) or Veeva EDC hands on experience is must. Must Have: Setup experience should have knowledge of DMP (Data Management Plan) creation, Edit check creation, Data Transfer specification creation, UAT knowledge (not mandatory). Conduct Experience Data Cleaning experience (Query Handling), Postproduction Changes, SAE reconciliation, LAB Reconciliation, ECOA/EPRO Reconciliation, PK/PD Reconciliation, Dataset review etc . Study Lock Freezing/Locking, should have good experience of Study lock Client facing role and Mentoring are added advantage. 1 Execute Data Management Activities I.e., Data Cleaning, Executing Manual and System checks, Update relevant trackers, Discrepancy and query management, Issue resolution, Database lock activities. 2 Participate in innovation and process improvement initiatives. 3 Identify and develop action plan in coordination with the TL for activities not meeting the client SLAs. 4 Archive all necessary information for audit purposes according to quality and security requirements, to ensure reliable and timely retrieval of documentation and information. 5 Support multiple clinical trials, across diverse therapeutic areas, to successful conclusion and provide technical oversight when required. 6 Study Setup hands on experience. 7 Working exposure in RAVE/VEEVA EDC, Knowledge of Spotfire reporting tool , 8 Third party data handling experience (Lab, PK, Image etc), Client facing role (experience in client communication

Job Description: The ideal candidate will have over 4 years of experience working within Data Warehouse platforms in a regulated industry, specifically within a clinical trial environment (IDAR). This role demands a deep understanding of data visualisation tools, scripting languages, and SDTM data structures, along with the ability to work independently on complex assignments. Responsibilities: The service holder will be responsible to function in a continuous improvement framework with respect to systems deployment, life cycle management and enhancements supported user groups. The Analyst will contribute to initiatives to yield faster and more effective report development, efficient change management services for analytics platforms. The analyst will have technical expertise with clinical data and report building, and experience gained through working with diverse and complex business processes and associated system infrastructures. The Analyst is required to work in a matrix environment across functions and departments What Required: More than 4 years experience as a Business Analyst, working within Data Warehouse platforms in a regulated industry within a clinical trial environment (IDAR) In depth knowledge of Tibco Spotfire, Power BI or Tableu or other equivalent visualization development tool Hands on experience of Python, R, SAS and similar scripting languages [Must] Hands-on of SDTM data structure (for IDAR) [Must] Knowledge to gather requirements and writing user requirement documentation Ability to work independently on assignments of moderate to high complexity without support. Interested candidates may share resume with Puja.k@maxisclinical.com

Job Summary CDM: 6 yrs of minimum Clinical Data Management experience Must have exposure to Study Start up, Conduct and Study Closeout. If not three phases should have good exposure to minimum two phases. Rave (Medidata) or Veeva EDC hands on experience is must. Must Have: Setup experience should have knowledge of DMP (Data Management Plan) creation, Edit check creation, Data Transfer specification creation, UAT knowledge (not mandatory). Conduct Experience Data Cleaning experience (Query Handling), Postproduction Changes, SAE reconciliation, LAB Reconciliation, ECOA/EPRO Reconciliation, PK/PD Reconciliation, Dataset review etc . Study Lock Freezing/Locking, should have good experience of Study lock Client facing role and Mentoring are added advantage. 1 Execute Data Management Activities I.e., Data Cleaning, Executing Manual and System checks, Update relevant trackers, Discrepancy and query management, Issue resolution, Database lock activities. 2 Participate in innovation and process improvement initiatives. 3 Identify and develop action plan in coordination with the TL for activities not meeting the client SLAs. 4 Archive all necessary information for audit purposes according to quality and security requirements, to ensure reliable and timely retrieval of documentation and information. 5 Support multiple clinical trials, across diverse therapeutic areas, to successful conclusion and provide technical oversight when required. 6 Study Setup hands on experience. 7 Working exposure in RAVE/VEEVA EDC, Knowledge of Spotfire reporting tool , 8 Third party data handling experience (Lab, PK, Image etc), Client facing role (experience in client communication

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

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

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.

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.

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.)

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. Experience in doing external data reconciliation 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.