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2.0 - 3.0 years
0 Lacs
India
On-site
Location: Pune-Kothrud/Wakad(Offline/Online) Experience: 2-3 yrs Qualification: Graduate/Post Gradu Job Description: Job Summary: We are seeking a highly qualified and experienced Clinical Data Management (CDM) Trainer to deliver a structured and in-depth curriculum covering Clinical Research, Drug Development, GCP-ICH Guidelines, Clinical Data Management, Pharmacovigilance, and Regulatory Affairs. The ideal candidate should have a strong background in clinical research and data management with proven experience in training or academic instruction. Key Responsibilities: Design, update, and deliver training content aligned with the clinical data management curriculum. Conduct engaging classroom and/or online sessions with clear understanding and explanation of: Clinical Research concepts and terminology Drug Development process and phases GCP-ICH E6 compliance and ethical practices Clinical Data Management principles including CRF design, query management, and source data validation Pharmacovigilance protocols including AE reporting and safety management Regulatory frameworks including CFR, CDSCO, ICMR, and CT Rules 2019 Provide real-world examples and case studies to enhance learner understanding. Assess student learning through quizzes, assignments, and interactive discussions. Stay updated with evolving industry guidelines and trends. Offer mentorship and support to trainees preparing for roles in clinical research and data management. Required Qualifications: Education: Master’s degree or higher in Life Sciences, Pharmacy, Clinical Research, Biotechnology, Medicine, or related field. Experience: Minimum 2–3 years of professional experience in Clinical Research, Clinical Data Management, or related domain. Minimum 1 years of teaching/training experience (corporate training or academic instruction preferred). Hands-on experience with regulatory compliance, pharmacovigilance systems, and EDC tools (e.g., Medidata Rave, Oracle Clinical, etc.) is a plus.
Posted 2 weeks ago
1.0 years
0 Lacs
Navi Mumbai, Maharashtra, India
On-site
Our clinical activities are growing rapidly, and we are currently seeking a full-time, office-based Data Coordinator to join our Data Management team in India, Mumbai. If you want an exciting career where you can develop and grow your career even further, then this is the opportunity for you. Responsibilities Track and maintain metrics regarding the status of the data within EDC systems Clean the clinical database, which includes generating and resolving data clarifications Reconcile clinical data Assist with support activities for the Data Management department Qualifications Bachelor’s degree in life science/ pharmacy/ health related field with strong attention to detail and working knowledge of Excel and Word; Minimum 1-2 years of clinical data management experience Knowledge of medical terminology and Clinical Research is preferred; and Good knowledge about the Clinical Databases (Medidata RAVE is preferred) Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What To Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps. EO/AA Employer M/F/Disability/Vets Show more Show less
Posted 2 weeks ago
15.0 years
0 Lacs
Bengaluru, Karnataka, India
On-site
eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. Overview The Manager of Data Management assumes operational leadership in overseeing the end-to-end data management services across designated projects and studies in the realm of modern clinical data management. This role entails close collaboration with clients and vendors to ensure the timely delivery of high-quality outputs within budgetary constraints. The Manager strategically integrates advanced technologies and data science techniques to augment the efficiency and quality of clinical trials within our organization. Through this strategic approach, the Manager aims to enhance the operational effectiveness and scientific rigor of our data management practices. Key Tasks & Responsibilities Acts as the key scientific and technical data management expert; define and drive the data management strategy and standards for the Therapeutic Areas (TA) as well as Risk Based Monitoring (RBM) standards, tools, data provisioning, and reporting Manage the data management delivery team and develop the capability for the group to support the existing workload while building expanding the capability as necessary to support the growth of the organization Ensure Data Management deliverables meet/exceed project/study team expectations regarding quality, time, and cost and that Data Management documentation is filed/archived according to applicable eClinical Solutions and regulatory requirements Subject matter expert of end-to-end study execution, inclusive of cross-functional core teams to optimize study-specific clinical trial processes Manage a team of study leads, responsible for data management task, ensuring target dates are met, risks identified and escalated as necessary Provide technology expertise and guidance business development/sales opportunities Develop staff and provide clear performance targets for appraisal Participate in expert working groups/innovation discussions Champion of the elluminate ® DM tools Provide project and strategic consulting and management activities while delivering the highest degree of quality, optimizing efficiencies, and ensuring consistency and repeatability Develop, implement, and execute data management strategies to allow Clients to better leverage their clinical data through elluminate® Data Central and analytics modules Develop a mindset throughout the organization that will foster intimate customer relationships resulting in account growth and repeat business Dual Role comprising of operational leadership and study data management Mentor and assist with the growth of all data management employees by recruiting, developing, and retaining top performers Regularly present updates on the status of the Data Management team to the eClinical Leadership Team and others, as required Contribute to and monitor eClinical Solutions division and project financials with a focus on annual budgets versus actual revenue, gross margin, and net profit targets Monitor and interpret key performance indicators (KPIs), metrics, dashboards, Clinical Trial Operational Analytics (CTOA), and reports to provide actionable recommendations to eClinical Leadership Team and others, as required Interact with multiple vendors including clinical CROs, lab vendors, IVRS on assigned projects to ensure data needs are met Ensure compliance with eClinical and industry quality standards, guidelines, and procedures Proactively address any/all issues as and when appropriate Identify and promote appropriate training and development programs for staff Act as DM representative at industry meetings/conferences Other duties as assigned CANDIDATE PROFILE Education & Experience Bachelor’s degree in health-related field or equivalent experience preferred 15+ years’ experience working in the Life Sciences industry preferred CCDM certification preferred Professional Skills Strong project management experience and project team leadership skills, with significant experience supporting Pharmaceutical/Biotechnology/Medical Device organizations in a consultative role preferred Ability to proactively detect and act upon identified clinical data trends Strong project management skills and experience with scope management, resource management, financial management, project planning and resource allocation Demonstrated experience managing complex client relationships requiring multiple DM services and projects Strong data management and EDC experience required Strong prior customer interface experience with a demonstrated ability to develop, maintain and grow strong Client relationships Proven ability to motivate and mentor data management staff resulting in a world-class delivery team A detail-oriented team player with strong organizational skills and the ability to multi-task, prioritize and plan within a high-energy, solutions-based environment where the customer comes first. Excellent command of the English language (both written and verbal) Technical Skills Proficiency in Microsoft Office Applications Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology Strong familiarity with EDC and Clinical Data Management Systems: Medidata Rave is preferred Experience with project and budget tracking Experience with Cloud SaaS platforms (preferred) Experience with data reporting tools such as Qlik, JReview, Spotfire preferred Experience with RBQM methodology Demonstrated working knowledge of CDISC guidelines and standards Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours! eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here! We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need. Show more Show less
Posted 2 weeks ago
5.0 - 10.0 years
15 - 20 Lacs
Bangalore Rural, Mumbai (All Areas)
Work from Office
Hi, We are hiring for Leading ITES Company for Lead Data Manager Profile. Job Description Perform day to day Clinical Data Management activities. Work and coordinate with the team to perform data management activities and deliver an error free quality database in accordance with the data management plan and regulator standards. Read and understand the study protocol and the timelines. Perform test data entry in TEST environment, data listing review, data reconciliation and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate. Perform external checks to handle manual discrepancies and action the same. Ensure an error free, quality data with no open queries. Escalate any discrepancy in the clinical data to the study lead as appropriate. Timely completion of trainings Any other tasks deemed appropriate To perform medical data collection and analysis of Prostate Cancer Data using databases like HIS/ EMR (Electronic Medical Record) and Cases Rave, CDM (startup, close out, conduct) Client interaction and meetings. Bringing up new ideas and executing new plans to cope with the back-log. Training to new team members as and when required. Key Skills: a) Minimum 3 years of Experience in leading clinical studies/ Clinical Data Management b) Hands on experience of Study Conduct and Close Out is must c) Any Graduate To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 95 b) To Apply for above Job Role ( Bangalore ) Type : Job Code # 98
Posted 2 weeks ago
5.0 years
0 Lacs
India
Remote
CloudLabs Inc was founded in 2014 with the mission to provide exceptional IT & Business consulting services at a competitive price, to help clients realize the best value from their investments. Within a short span, CloudLabs evolved from pure-play consulting into a transformative partner for Business Acceleration Advisory, Transformative Application Development & Managed Services - enabling digital transformations, M&A transitions, Automation & Process-driven optimizations & complex Integration initiatives for enterprises across the globe. As a Strategic Planning & Implementation Partner for global companies, CloudLabs has seen a 200% uptake in winning high-value, high-impact and high-risk projects that are critical for the business. With offices in the US, Canada, Australia & India and with the team of 150+ experienced specialists, CloudLabs is now at an inflection point and ready for its next curve of progress. Please write/follow us here: Website: cloudlabsit.com LinkedIn: CloudLabs Inc E-Mail: info@cloudlabsit.com What we offer: We welcome candidates rejoining the workforce after career break/parental leave and support their journey to reacclimatize too corporate. Flexible remote work. Competitive pay package. Attractive policy, medical insurance benefits, industry leading trainings. Opportunity to work remotely is available. Job description: We're seeking an experienced Medidata Rave(EDC) Study Designer to support delivering strategic initiatives supporting the Global Clinical IT team. In this role, the individual will be supporting business initiatives within Medidata Rave suites of applications. This individual should have demonstrated prior experience as a member of an Agile team and be highly motivated with excellent analysis and execution skills. Duties and Responsibilities Develop and maintain data management documentation and guidelines in accordance with Good Clinical Practices (GCP) and Good Documentation Practices (GDP). Provide subject matter expertise to project team members during all phases of project life cycle. Develop, test, and maintain data management systems. Provide subject matter expertise prior, during and post internal and external audits and inspections. Collaborate with Data Managers, Study Teams, Vendors, and Site Staff to formulate Data Transfer plans for secondary data sources (e.g., Lab data, Site data). Batch import agreed data sources into the EDC system. Develop, program, validate, and maintain Medidata Rave EDC clinical trial databases in accordance with company standards. Create EDC design specifications encompassing the data dictionary, event definitions, electronic consent, branching logic, edit checks, advanced query rules, calculated fields, and dynamic form and event rules. Work with Data Managers and study teams to design and construct the EDC database based on global eCRF libraries. Configure and optimize multiple patient user interfaces to support varying modes of data collection (eCOA- mobile device or tablet, EDC- laptop/desktop computer). Conduct, test, and produce Rave EDC Migration activities as required. Develop test scripts and coordinate EDC user acceptance testing (UAT) to ensure accuracy of database structure, content, and validation controls aligned with the original specifications. Coordinate and manage the deployment of new or modified EDC databases into production. Assist in mapping the EDC database to the company enterprise data warehouse. As part of continuous improvement efforts, develop and implement EDC design standards to enhance quality and streamline database build processes. Provide input into the development and revision of department SOPs. Maintain compliance with corporate, core and study-specific learning requirements. Experience with Medidata Custom Functions (C#/SQL) would be preferred. Preferred Qualifications Bachelor 's Degree in related field. 5+ years of experience developing, supporting, and maintaining healthcare systems. Prior experience with EDC system (Medidata Rave, Expert) Medidata Rave EDC Certified Study Builder certification is highly preferred Prior experience with MEDS reporter, SQL Advanced system analysis skills and experience with EDC technologies such as (iMedidata, architect modules, reporting modules). Demonstrated experience in systems analysis, SDLC, change management, and requirements gathering. Experience requirement: Minimum 5 years of relevant experience. Location: India only. Job type: Remote. Show more Show less
Posted 2 weeks ago
2.0 - 7.0 years
10 - 20 Lacs
Pune, Bengaluru, Mumbai (All Areas)
Work from Office
Hi, We are hiring for Leading ITES Company for Lead Study Data Manager Profile Skills: a) Minimum 5 Years of Core Clinical Data Management Experience with minimum 1 year of experience of leading a clinical trial. . b) Experience on Study Conduct and Close Out c) Any Graduate JOB DECSRIPTION: Need exposure of Inform or Medidata Rave database Responsible & Accountable for the assigned study conduct activities, in clinical trials Validate clinical trial data to ensure consistency, integrity and accuracy based on project specific guidelines. Generate data queries based on validation checks or raise Manual queries to resolve data inconsistencies. To perform reconciliation of data from external sources (e.g. Serious Adverse Events, IWRS, Central Laboratory). SPOC for the study communications Proactively highlight any risks associated with the study along with the mitigation plan. Establish a partnership with the stakeholders at operational level to work seamlessly to deliver the assigned project/activity as per timelines. Identify process Improvement opportunities and to ensure learning is shared Ensure deliverables and/or agreed activities/tasks with customer. are completed with the expected quality. Have worked on Study set-up, Study Conduct and Study Close out for various therapeutic areas. Have also worked on writing edit check specification, CRF completion guidelines and review and corrections of set up documents for different versions. To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 184 b) To Apply for above Job Role ( Pune ) Type : Job Code # 185 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 186
Posted 2 weeks ago
2.0 years
0 Lacs
Pune, Maharashtra, India
On-site
Our global activities are growing rapidly, and we are currently seeking a full-time, Pune-based Clinical Database Programmer to join our Biometrics team. This position will work in a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Responsibilities Develop, program, validate and maintain clinical trial databases according to company standards; Maintain and contribute to company library of standard CDASH compliant CRFs ; and Act as primary contact to the data management team for assigned studies, supplying all necessary technical support, and ensuring quality of the programming and adherence to company standards. Qualifications Bachelor’s degree/Advanced degree in Life Sciences or Computer Science or equivalent; 2-3 years of Rave study build experience in a similar position in Pharma/Healthcare sector; Custom function (C# Programming) experience is preferred; Certified Medidata Rave Study Builders preferred; Excellent verbal and written communication skills; and Meticulous attention to detail. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Hybrid work-from-home options (dependent upon position and level) Competitive PTO packages Company-sponsored employee appreciation events Employee health and wellness initiatives Flexible work schedule Competitive compensation and benefits package Structured career paths with opportunities for professional growth Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What To Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps. EO/AA Employer M/F/Disability/Vets Show more Show less
Posted 2 weeks ago
3.0 - 5.0 years
0 Lacs
Bengaluru, Karnataka, India
On-site
eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. Overview Quality Control Specialists are operationally responsible for performing quality control activities associated with Biometrics client’s deliverables. Quality Control Specialists will maintain project level perspective, focus, and communicate effectively as the quality control subject matter expert. Key Tasks & Responsibilities Perform quality control activities (i.e. documentation review, testing) of Biometrics client’s Rave EDC and Data management deliverables including eCRFs, Data Validation Specification checks, Custom functions, Data Extracts, Data Integrations, Data Mapping, Custom Data Management Reports and listings Participate in the design and development of quality control procedures Manage documentation created during the QC process Liaise with study teams and other staff to fulfill job responsibilities and activities Develop and lead execution of training and knowledge transfer opportunities for quality control team Inform the Manager of training issues, project activities, quality issues and timelines as directed Collaborate with the project team to ensure the deliverables are completed on time with high quality Other duties as assigned CANDIDATE’S PROFILE Education/Language Four-year college degree or higher preferred, analytic discipline a plus (Computer Science or Health related field) Excellent knowledge of English Professional Skills & Experience Minimum 3-5 years in Pharmaceutical/Biotechnology industry or equivalent Knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology, software development lifecycle activities and industry standards (CDASH, SDTM) preferred Experience performing quality control activities of clinical trial deliverables preferred Excellent verbal and written communication skills Detail oriented, ability to multitask with strong prioritization, planning and organization skills Excellent team player Technical Skills & Experience Extensive knowledge of Medidata Rave EDC platform and other modules of Rave preferred Familiarity with Databases: SQL Server, Oracle highly preferred Extensive validation experience of eCRFs, Edit Checks, Custom Functions, Data Management reports and good understanding of Database structures and Programming languages Proficiency in Microsoft Office Applications, specifically MS Word, MS Excel and PowerPoint Show more Show less
Posted 3 weeks ago
7.0 years
0 Lacs
Bengaluru East, Karnataka, India
On-site
Job Title: Associate Director, Statistical Programming Introduction to role The Associate Director of Statistical Programming will oversee statistical programming activities for multiple clinical studies, maintain programming infrastructure, and ensure compliance with SOPs to produce quality and timely deliverables. This role requires extensive experience and proven skills in the use of SAS within a Statistical Programming environment, along with a complete understanding of statistical programming processes, procedures, and roles. The successful candidate will support Biostatistics in statistical analysis, including generating analysis data listings, tables, and figures, and creating all files necessary to support an electronic submission in the eCTD format. Additionally, strong people management and supervisory skills are essential to provide direct line management to statistical programmers, identify training needs, and optimize staff utilization. The role also involves managing the day-to-day activities of external partners in delivering program deliverables. Accountabilities Serve as the Lead Programmer and Manager of the statistical programming efforts. Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards. Independently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications. Develop and validate technical programming specifications for protocol-specific efficacy tables, listings, figures/graphs. Independently develop and validate programs that generate protocol-specific efficacy tables, listings, figures/graphs using Alexion specifications. Ensure that the filing of study documentation is maintained to the standard required according to processes and acceptable for audit. Directly support the Clinical and Statistical Programming Director in all aspects of the management and development of the Statistical Programming team. Participate in the ongoing review of the processes used by the Statistical Programming group to ensure processes are continually complied with and updated as necessary. Create and/or review programming plans, and ensure appropriate resource allocation and prioritization. Act as the primary department contact to ensure that department standards are implemented in all studies. Manage adherence to all company policies, SOPs, and other controlled documents; ensure all programming activities adhere to departmental standards. Collaborate closely with Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Operations, and other functions within Alexion to address their needs for programming support. Essential Skills/Experience 7+ years statistical programming experience in the CRO or Pharmaceutical Industry. 4+ years project management experience in the CRO or Pharmaceutical Industry. Experience with CDISC SDTM and ADaM models and transforming raw data into those standards. Strong people management skills and supervisory skills gained from direct line management or supervisory experience. Proven abilities to lead and manage cross-functional projects, and people, from concept to completion. Strong verbal and written communication skills - ability to clearly and effectively present information. An excellent understanding of the roles and responsibilities of all related disciplines, in particular Biostatistics, Clinical Data Management, and Pharmacovigilance. Advanced knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a windows environment with a demonstrated mastery of SAS/STAT procedures. Extensive experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate analysis datasets, tables, listings, and figures/graphs. Knowledge of clinical database design, specifically electronic data capture using Inform, Medidata, and Oracle. Advanced experience with: Constructing technical programming specifications. Relational Databases. Good Clinical Practices. Good Programming Practices. 21CFR Part 11 Standards. Integrated Summary Safety/Efficacy Analyses. Creating all files necessary to support an electronic submission in the eCTD format. Desirable Skills/Experience BS/MS/MA in Statistics, Biostatistics, Computer Science, Mathematics or related area. Competencies: Accountability Collaboration Decision Quality Drive for Results Perseverance Problem Solving Informing Peer Relationships Time Management Building Effective Teams Managing Through Systems At AstraZeneca's Alexion division, we are driven by our passion for making a difference in the lives of patients with rare diseases. Our unique approach combines the agility of a biotech with the resources of a global biopharma leader. We foster an inclusive culture where innovation thrives, empowering our employees to grow both personally and professionally. Join us to be part of a team that is dedicated to transforming lives through groundbreaking science and compassionate care. Ready to make an impact? Apply now! Show more Show less
Posted 3 weeks ago
5.0 years
0 Lacs
India
Remote
About CloudLabs: CloudLabs Inc was founded in 2014 with the mission to provide exceptional IT & Business consulting services at a competitive price, to help clients realize the best value from their investments. Within a short span, CloudLabs evolved from pure-play consulting into a transformative partner for Business Acceleration Advisory, Transformative Application Development & Managed Services - enabling digital transformations, M&A transitions, Automation & Process-driven optimizations & complex Integration initiatives for enterprises across the globe. As a Strategic Planning & Implementation Partner for global companies, CloudLabs has seen a 200% uptake in winning high-value, high-impact and high-risk projects that are critical for the business. With offices in the US, Canada, Australia & India and with the team of 150+ experienced specialists, CloudLabs is now at an inflection point and ready for its next curve of progress. Please write & follow us here: Website: cloudlabsit.com LinkedIn: CloudLabs Inc Email us : info@cloudlabsit.com What we offer: We welcome candidates rejoining the workforce after career break/parental leave and support their journey to reacclimatize too corporate. Flexible remote work. Competitive pay package. Attractive policy, medical insurance benefits, industry leading training. Opportunity to work remotely is available. Experience Required: Minimum 5 years’ experience. Job Location : India Job Type: Remote Qualifications: Bachelor 's Degree in related field. 5+ years of experience developing, supporting, and maintaining healthcare systems. Prior experience with EDC system (Medidata Rave, Expert) Prior experience with MEDS reporter, SQL Advanced system analysis skills and experience with EDC technologies such as (iMedidata, architect modules, reporting modules). Demonstrated experience in systems analysis, SDLC, change management, and requirements gathering. Basic Qualifications: Bachelor’s degree in related field. Experience as a developer and/or systems analyst; soliciting business requirements, story grooming, writing acceptance criteria. Prior experience as a member of an Agile software development team In-depth knowledge and hands-on experience in developing complex Business Rules, study structure and EDC applications (eCOA/ePRO, iMedidata, Cloud Admin, Balance RTSM, CTMS, Coder, Grants Manager, MMI, RSR, eConsent, Safety Gateway, End of study, TSDV, Monitor) Strong written and verbal communication skills; ability to present in an organized manner to both technical and non-technical audiences. Identify new technologies to improve the customer experience. Must have experience integration knowledge between EDC, Veeva and Seibel CTMS Ability to generate hi-level requirements and understanding of the business process workflow. Experience in a Medical Device or Regulated Industry. Job description: We are seeking an experienced Medidata Rave/ EDC developer to support delivering strategic initiatives supporting the Global Clinical IT team. In this role, the individual will be a technical developer to support business initiatives within Medidata Rave suites of applications. This individual should have demonstrated prior experience as a member of an Agile team and be highly motivated with excellent analysis and execution skills. Duties and Responsibilities Analyzes, designs, and develops new application software and/or interfaces between applications. extensive knowledge on implementing Medidata Classic Rave, Rave EDC (Rave), eCOA/ePRO, iMedidata, Cloud Admin, Balance RTSM, CTMS, Coder, Grants Manager, MMI, RSR, eConsent, Safety Gateway, End of study, TSDV, Monitor tools. Creates and maintains system documentation according to the IT methodology (code, designs, test specifications, and other deliverables as necessary) for Medidata applications (Rave, Coder, MMI, RSR, RTSM, and eConsent). Provides production support by proactively monitoring applications and seeking to improve application availability, quality, and performance by ensuring achievement of Service Level Agreements (SLA) and participating in required on-call support, as needed. Interacts with the business divisions to understand all data requirements to develop payments for the trials. Defines and implements EDC solutions. Understand and perform Risk analysis on the EDC upgrade and plan accordingly for the upgrade. Participates in all phases of the software development project including- off the shelf versus build custom analysis, design, construct, implementation, testing, and post-implementation activities. Works closely with database teams / server team /security team on topics related to data requirements from the vendor. ability to think outside the box and ensure has a full understanding of the request or problem to help identify a solution and willingness to lend a helping hand to support the businesses across the organization. Develops robust systems with an eye on the long-term maintenance and support of the application. Accountable for technical issue resolution including diagnosis of problem, recommendations for workarounds, and defect correction. Understands agile development methodology and is familiar with working in Product Teams. Maintains collaborative working relationship with IT business partners, IT services (database, data center, servers, desktop, networking, security), and software vendors, as needed. Show more Show less
Posted 3 weeks ago
5.0 years
0 Lacs
Greater Kolkata Area
On-site
Description Clinical Programmer II Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job 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. Provides leadership, training, guidance, and support to other department members based upon expertise in specific skill sets. Collaborates with clients, peers, lead programmers, project teams and/or requestors to clarify and finalize specifications, and uses expanded technical skills to meet evolving project needs. Assists in project review meetings and assists with departmental review meetings. Attends Quick Start Camps (QSCs) as the lead clinical programmer for assigned studies. Leads clinical programming activities on up to eight (8) concurrent studies depending upon scope, similarity, program, and resourcing requirements. Manages project resources, proactively alerting management of delivery and resourcing needs. Possesses and maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading related literature, self-training, attending training classes, attending professional meetings, etc. Qualifications What we’re looking for Bachelor’s degree preferred, In lieu of Bachelor’s degree, equivalent related education and experience. The ability to deal effectively with sponsors and internal customers at all levels. Excellent communication and interpersonal skills, both written and spoken, with an ability to inform. Demonstrated experience in managing multiple priorities in a highly dynamic environment Experience working in a matrix-structured environment is preferred Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and Voicemail Experience with programming languages, such as PL/SQL, SAS, C#, or VB preferred. Ability to travel as necessary (up to 25%) Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Show more Show less
Posted 3 weeks ago
3.0 - 6.0 years
0 Lacs
Chennai, Tamil Nadu, India
Remote
Job Summary We are seeking a dedicated Product Specialist with 3 to 6 years of experience to join our team. The ideal candidate will have strong technical expertise in RAVE and Medidata Rave and it is beneficial if they have experience in Research and Development. This hybrid role offers the opportunity to work both remotely and on-site with a day shift schedule. No travel is required. Responsibilities Oversee the implementation and maintenance of Medidata Rave systems to ensure seamless operation and data integrity. Provide technical support and troubleshooting for RAVE-related issues to ensure minimal downtime and maximum efficiency. Collaborate with cross-functional teams to gather requirements and translate them into technical specifications for RAVE system enhancements. Conduct regular system audits and data quality checks to maintain high standards of data accuracy and compliance. Develop and deliver training sessions for end-users to enhance their proficiency with Medidata Rave systems. Create and maintain comprehensive documentation for system configurations processes and procedures to ensure knowledge transfer and continuity. Monitor system performance and proactively identify areas for improvement to optimize system functionality. Assist in the development and execution of test plans for system upgrades and new features to ensure robust and reliable performance. Coordinate with vendors and external partners to resolve technical issues and implement system updates. Provide insights and recommendations based on data analysis to support decision-making and strategic planning. Ensure compliance with regulatory requirements and industry standards in all aspects of system management and data handling. Participate in project planning and execution to support the successful delivery of research and development initiatives. Stay updated with the latest industry trends and technological advancements to continuously improve system capabilities and user experience. Qualifications Possess a strong technical background with hands-on experience in RAVE and Medidata Rave. Demonstrate excellent problem-solving skills and the ability to troubleshoot complex technical issues. Exhibit strong communication skills to effectively collaborate with cross-functional teams and provide user training. Have a keen eye for detail to ensure data accuracy and system compliance. Show proficiency in creating and maintaining technical documentation. Display the ability to analyze data and provide actionable insights. Have experience in Research and Development which is a plus. Demonstrate the ability to work independently and manage multiple tasks in a hybrid work environment. Exhibit a proactive approach to identifying and addressing system improvements. Show commitment to staying current with industry trends and technological advancements. Possess strong organizational skills to manage system audits and data quality checks. Demonstrate the ability to coordinate with external partners and vendors. Have a customer-focused mindset to provide excellent technical support and user training. Certifications Required Certified Medidata Rave Professional Show more Show less
Posted 3 weeks ago
0 years
0 Lacs
Navi Mumbai, Maharashtra, India
On-site
Our global activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Database Programmer to join our Biometrics team. This position will work in a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Responsibilities Develop, program, validate and maintain clinical trial databases according to company standards; Maintain and contribute to company library of standard CDASH compliant CRFs ; and Act as primary contact to the data management team for assigned studies, supplying all necessary technical support, and ensuring quality of the programming and adherence to company standards. Qualifications Bachelor’s degree/Advanced degree in Life Sciences or Computer Science or equivalent; Min 3 years of Rave study build experience in a similar position in Pharma/Healthcare sector; Custom function (C# Programming) experience is preferred; Certified Medidata Rave Study Builders preferred; Excellent verbal and written communication skills; and Meticulous attention to detail. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What To Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps. EO/AA Employer M/F/Disability/Vets Show more Show less
Posted 4 weeks ago
0 years
0 Lacs
Pune, Maharashtra, India
On-site
About Birlasoft Ltd. Empowered By Innovation Birlasoft, a global leader at the forefront of Cloud, AI, and Digital technologies, seamlessly blends domain expertise with enterprise solutions. The company’s consultative and design-thinking approach empowers societies worldwide, enhancing the efficiency and productivity of businesses. As part of the multibillion-dollar diversified CKA Birla Group, Birlasoft with its 12,000+ professionals, is committed to continuing the Group’s 170-year heritage of building sustainable communities. Role: Assistant Manager Experience: 4 to 6 Years in Bid Management Industry: Life Sciences Location: Noida, Mumbai, Pune & Bengaluru Must Have Manage the end-to-end bid process, from opportunity identification to proposal submission (awareness of ICTS, ERP, Data & Digital tracks) Flair for multi-team liaisioning to drive RFP/RFIs to completion (Solution Architects/Sales, Finance, etc) Prepare draft proposal sections, presentations, and sales collateral. Create and maintain bid plans, track deliverables, and manage timelines Good to Have Prepare and review the commercial aspects of the bid, ensuring accurate pricing and profitability. Drive continuous improvement through post-bid reviews Awareness of Life Sciences market trends and certifications in any of the fields (AI, Cloud, Data, ERP - Veeva, Medidata, etc) Show more Show less
Posted 4 weeks ago
5 years
0 Lacs
Greater Kolkata Area
Remote
Description Senior Clinical Programmer (Spotfire/Cluepoints) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Utilizes primary development tools including Medidata, Rave, Oracle OC/RDC, Oracle Inform, and/or 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, programs, 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. Provides technology support to the clinical programming staff, Project Analysts, Data Managers, etc., who design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. This includes support of the development of specifications, coding, and validation efforts in support of annotated CRFs, database creation, coding setup, edit-check procedures, import setup and processing, export setup and processing, listings, and custom reports Provides application administration and technical support as the subject matter expert on core business packages including but not limited to: Oracle Inform, MDSOL Rave, Oracle RDC, -, SAS, and supplemental packages such as migration mentor/review, reporting tools, custom functions. Ensures high quality deliverables by providing senior review of study level/program level/multi study 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; manages and executes the change order to completion. Provides input and supporting details for change orders. Monitors applications for workflow alerts, system errors, and performance issues. Provides second tier help desk support, as needed. Performs system integration activities, application updates, and user acceptance testing. Provides leadership, training, guidance, and support to other department members based upon expertise in specific skill sets. Collaborates with clients, peers, lead programmers, project teams, and/or requestors to clarify and finalize specifications; uses expanded technical skills to meet evolving project needs. Assists in project meetings and actively contributes and participates in departmental review meetings. Attends Quick Start Camps (QSCs) as the lead Clinical Programmer role for assigned studies. Leads clinical programming activities on three (3) to ten (10) concurrent studies depending upon scope, similarity, program, and resourcing requirements. Manages project resources, proactively alerting management of delivery and resourcing needs. Possesses and maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading related literature, self-training, attending training classes, attending professional meetings, etc. Qualifications What we’re looking for Bachelor’s degree preferred, or equivalent combination of related education and experience. 5 years of experience, must have Data visualization experience in Spotfire/Tableau/PowerBI (Useful) Experience with either Python/SAS/SQL. Clinical background experience is a must, with preferred experience in iMedidata Rave & Veeva EDC. Good to have Spotfire API experience/knowledge. The ability to deal effectively with sponsors and internal customers at all levels. Excellent communication and interpersonal skills, both written and spoken, with an ability to inform. Demonstrated experience in managing multiple priorities in a highly dynamic environment Experience working in a matrix-structured environment is preferred Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and Voicemail Experience with programming languages, such as PL/SQL, SAS, C#, or VB preferred. Ability to travel as necessary (up to 25%) Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Posted 1 month ago
2 - 7 years
10 - 20 Lacs
Pune, Bengaluru, Mumbai (All Areas)
Work from Office
Hi, We are hiring for Leading ITES Company for Lead Study Data Manager Profile Skills: a) Minimum 5 Years of Core Clinical Data Management Experience with minimum 1 year of experience of leading a clinical trial. . b) Experience on Study Conduct and Close Out c) Any Graduate JOB DECSRIPTION: Need exposure of Inform or Medidata Rave database Responsible & Accountable for the assigned study conduct activities, in clinical trials Validate clinical trial data to ensure consistency, integrity and accuracy based on project specific guidelines. Generate data queries based on validation checks or raise Manual queries to resolve data inconsistencies. To perform reconciliation of data from external sources (e.g. Serious Adverse Events, IWRS, Central Laboratory). SPOC for the study communications Proactively highlight any risks associated with the study along with the mitigation plan. Establish a partnership with the stakeholders at operational level to work seamlessly to deliver the assigned project/activity as per timelines. Identify process Improvement opportunities and to ensure learning is shared Ensure deliverables and/or agreed activities/tasks with customer. are completed with the expected quality. Have worked on Study set-up, Study Conduct and Study Close out for various therapeutic areas. Have also worked on writing edit check specification, CRF completion guidelines and review and corrections of set up documents for different versions. To Apply WhatsApp 'Hi' @ 9151555419 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
Posted 1 month ago
0 - 2 years
0 Lacs
Gurugram, Haryana, India
On-site
Description Investigator Management Solutions (IMS) Specialist II Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Processes investigator payments by: Maintaining the investigator payment portion of the IMPACT and Medidata System. Reviewing data with project manager for quality and completeness. Processing and creating approved grant payment requests via the IMPACT and Medidata system and forwarding or interfacing with A/P; and Distributing investigator payments to respective sites Creates, maintains, and reconciles MS Excel Project Grant Tracker as necessary. Reviews and interrogates Clinical Trial Agreements (CTAs) and CTA amendments to ensure payments are made according to the documented payment terms and schedule. Discrepancies should be escalated to their line manager or the appropriate project team member as needed. Communicates with site to secure invoices and resolve queries Communicates with IMS Lead and IMS 1 on resolution and processing of invoices Confident to communicate with sites in global locations both in writing and on the telephone Escalates to clinical team where appropriate to follow up on invoice discrepancies, past due invoices and to request refunds from sites. Ensures proper account and project coding are applied to third party invoices as it relates to investigator payments. Assists with customer audits of site payments and sponsor deposits. Trains and mentors less experienced staff members on departmental Standard Operating Procedures (SOPs), processes, tools, and templates. Minimal travel may be required (up to 25%). Works with sponsor systems and applications as required by the project. Qualifications What we’re looking for BA/BS degree in Business, Accounting, or equivalent combination of education and experience. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), email, and voicemail. Excellent written and verbal communication skills. Excellent English. Other foreign language proficiency preferred. Ability to organize and prioritize work to meet deadlines in a dynamic environment. Above average attention to detail, and interpersonal skills with a team-oriented approach. Oracle experience preferred but not mandatory. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
Posted 1 month ago
5 - 10 years
15 - 20 Lacs
Bangalore Rural, Mumbai (All Areas)
Work from Office
Hi, We are hiring for Leading ITES Company for Lead Data Manager Profile. Job Description Perform day to day Clinical Data Management activities. Work and coordinate with the team to perform data management activities and deliver an error free quality database in accordance with the data management plan and regulator standards. Read and understand the study protocol and the timelines. Perform test data entry in TEST environment, data listing review, data reconciliation and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate. Perform external checks to handle manual discrepancies and action the same. Ensure an error free, quality data with no open queries. Escalate any discrepancy in the clinical data to the study lead as appropriate. Timely completion of trainings Any other tasks deemed appropriate To perform medical data collection and analysis of Prostate Cancer Data using databases like HIS/ EMR (Electronic Medical Record) and Cases Rave, CDM (startup, close out, conduct) Client interaction and meetings. Bringing up new ideas and executing new plans to cope with the back-log. Training to new team members as and when required. Key Skills: a) Minimum 3 years of Experience in leading clinical studies/ Clinical Data Management b) Hands on experience of Study Conduct and Close Out is must c) Any Graduate To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 95 b) For Position in Bangalore Search : Job Code # 98
Posted 1 month ago
0 - 3 years
0 Lacs
Bengaluru, Karnataka
Work from Office
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 Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Posted 1 month ago
0 years
0 Lacs
Bengaluru, Karnataka
Work from Office
CDC II _ Office based (Hybrid) ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Clinical Data Coordinator II to join our diverse and dynamic team. As a Clinical Data Coordinator II at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. What you will be doing Assist Data Management Study Lead in maintenance of eCRF, Data Validation Specifications, and Study Specific Procedures. Manage clinical and third-party data reconciliation based on edit specifications and data review plans. Tracks and communicates status of study and task metrics to clinical data scientist, project team, and functional management. Address data related questions and recommend potential solutions. Identify root cause to systematically resolve data issues. Your profile Bachelor's degree in a relevant field, such as Life Sciences or Healthcare. Intermediate knowledge of clinical data management within the pharmaceutical or biotechnology industry. Familiarity with data management software and systems (e.g., Medidata, Oracle RDC, or similar). Strong attention to detail and the ability to work effectively in a fast-paced environment. Excellent communication skills and the ability to collaborate with cross-functional teams. Knowledge of regulatory guidelines and standards (e.g., ICH-GCP) is a plus. What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Posted 1 month ago
2 - 7 years
10 - 20 Lacs
Pune, Bengaluru, Mumbai (All Areas)
Work from Office
Hi, We are hiring for Leading ITES Company for Lead Study Data Manager Profile Skills: a) Minimum 5 Years of Core Clinical Data Management Experience with minimum 1 year of experience of leading a clinical trial. . b) Experience on Study Conduct and Close Out c) Any Graduate JOB DECSRIPTION: Need exposure of Inform or Medidata Rave database Responsible & Accountable for the assigned study conduct activities, in clinical trials Validate clinical trial data to ensure consistency, integrity and accuracy based on project specific guidelines. Generate data queries based on validation checks or raise Manual queries to resolve data inconsistencies. To perform reconciliation of data from external sources (e.g. Serious Adverse Events, IWRS, Central Laboratory). SPOC for the study communications Proactively highlight any risks associated with the study along with the mitigation plan. Establish a partnership with the stakeholders at operational level to work seamlessly to deliver the assigned project/activity as per timelines. Identify process Improvement opportunities and to ensure learning is shared Ensure deliverables and/or agreed activities/tasks with customer. are completed with the expected quality. Have worked on Study set-up, Study Conduct and Study Close out for various therapeutic areas. Have also worked on writing edit check specification, CRF completion guidelines and review and corrections of set up documents for different versions. To Apply WhatsApp 'Hi' @ 9151555419 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
Posted 2 months ago
5 - 10 years
15 - 20 Lacs
Bangalore Rural, Mumbai (All Areas)
Work from Office
Hi, We are hiring for Leading ITES Company for Lead Data Manager Profile. Job Description Perform day to day Clinical Data Management activities. Work and coordinate with the team to perform data management activities and deliver an error free quality database in accordance with the data management plan and regulator standards. Read and understand the study protocol and the timelines. Perform test data entry in TEST environment, data listing review, data reconciliation and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate. Perform external checks to handle manual discrepancies and action the same. Ensure an error free, quality data with no open queries. Escalate any discrepancy in the clinical data to the study lead as appropriate. Timely completion of trainings Any other tasks deemed appropriate To perform medical data collection and analysis of Prostate Cancer Data using databases like HIS/ EMR (Electronic Medical Record) and Cases Rave, CDM (startup, close out, conduct) Client interaction and meetings. Bringing up new ideas and executing new plans to cope with the back-log. Training to new team members as and when required. Key Skills: a) Minimum 3 years of Experience in leading clinical studies/ Clinical Data Management b) Hands on experience of Study Conduct and Close Out is must c) Any Graduate To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 95 b) For Position in Bangalore Search : Job Code # 98
Posted 2 months ago
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