1157 Clinical Research Jobs - Page 37

UPASANA HEALTHCARE AND HOSPITALS PRIVATE LIMITED is looking for Infection Control Nurse with experience to join our dynamic team and embark on a rewarding career journey. Observing and recording patients' behavior. Coordinating with physicians and other healthcare professionals for creating and evaluating customized care plans. In order to provide emotional and psychological support to the patients and their families, RNs create a harmonious environment. Diagnosing the disease by analyzing the patient's symptoms and taking required actions for his/her recovery. Maintaining reports of patient's medical histories, and monitoring changes in their condition. Carrying out the requisite treatments and medications

Data Analyst II 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 Data Analyst II to join our diverse and dynamic team. As a Data Analyst II at ICON, you will play a crucial role in analyzing complex datasets to support decision-making and enhance clinical operations and research processes. You will contribute to the advancement of innovative treatments and therapies by providing actionable insights and leveraging data analytics to drive performance across the organization. What You Will Be Doing: Conducting thorough data analysis to support clinical trial design and execution. Collaborating with cross-functional teams to identify opportunities for data-driven innovation and optimization within clinical research. Interpreting complex datasets to derive insights and inform strategic decision-making. Assisting in the development of data visualization and reporting tools to effectively communicate findings. Establishing partnerships with stakeholders to leverage data analytics and improve research outcomes. Your Profile: Bachelor s degree in Radiology and Life science. 1.5+ years of experience in different Imaging Modalities such as CT, MRI and more Strong analytical skills with the ability to translate data into actionable insights. Excellent communication and interpersonal skills, with the ability to collaborate effectively with diverse teams. 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 or submit a request here . 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. Are you a current ICON Employee? Please click here to apply

Data Analyst II We are currently seeking a Data Analyst II to join our diverse and dynamic team. As a Data Analyst II at ICON, you will play a crucial role in analyzing complex datasets to support decision-making and enhance clinical operations and research processes. You will contribute to the advancement of innovative treatments and therapies by providing actionable insights and leveraging data analytics to drive performance across the organization. What You Will Be Doing: Conducting thorough data analysis to support clinical trial design and execution. Collaborating with cross-functional teams to identify opportunities for data-driven innovation and optimization within clinical research. Interpreting complex datasets to derive insights and inform strategic decision-making. Assisting in the development of data visualization and reporting tools to effectively communicate findings. Establishing partnerships with stakeholders to leverage data analytics and improve research outcomes. Your Profile: Bachelor s degree in Radiology and Life science. 1.5+ years of experience in different Imaging Modalities such as CT, MRI and more Strong analytical skills with the ability to translate data into actionable insights. Excellent communication and interpersonal skills, with the ability to collaborate effectively with diverse teams. 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 or submit a request here . 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. Are you a current ICON Employee? Please click here to apply

Job Type: Part-Time / Hourly -Remotely from anywhere across India / Globally. Job Position : Medical Director / Sr.Consultant -Medical Oncology. Job Description: We are currently looking for Medical Oncologist with strong experienced in Medical Oncology with an entrepreneur mindset prepared to work in a collaborative Team as our Internal Team member / Partner/ External Partner / having busy Medical Oncology Practices handled atleast 100-10000's of Cancer Patients ( In top 20 Cancers) in his experience with a reputed Medical Research University & Hospital or in a startup /mid-size company/ MNC / Top Onco Pharma MNC. Qualification : 1) MBBS with DNB / MD /MS/Mch with specialization in medical Oncology practice or Medical Oncology Research/Onco Surgeon from reputed Medical University & Hospital. Experience : 5 - 25 Years experience in medical Oncology Practice or Cancer Medical Research Post MBBS, MD /MS OR Post MSc, PhD in Medical Oncology by Research from Reputed Medical Research University needs to apply.

Job Type: Part-Time / Hourly -Remotely from anywhere across India / Globally. Job Position : Medical Director / Sr.Consultant -Medical Oncology. Job Description: We are currently looking for Medical Oncologist with strong experienced in Medical Oncology with an entrepreneur mindset prepared to work in a collaborative Team as our Internal Team member / Partner/ External Partner / having busy Medical Oncology Practices handled atleast 100-10000's of Cancer Patients ( In top 20 Cancers) in his experience with a reputed Medical Research University & Hospital or in a startup /mid-size company/ MNC / Top Onco Pharma MNC. Qualification : 1) MBBS with DNB / MD /MS/Mch with specialization in medical Oncology practice or Medical Oncology Research/Onco Surgeon from reputed Medical University & Hospital. Experience : 5 - 25 Years experience in medical Oncology Practice or Cancer Medical Research Post MBBS, MD /MS OR Post MSc, PhD in Medical Oncology by Research from Reputed Medical Research University needs to apply.

Job Type: Part-Time / Hourly -Remotely from anywhere across India / Globally. Job Position : Medical Director / Sr.Consultant -Medical Oncology. Job Description: We are currently looking for Medical Oncologist with strong experienced in Medical Oncology with an entrepreneur mindset prepared to work in a collaborative Team as our Internal Team member / Partner/ External Partner / having busy Medical Oncology Practices handled atleast 100-10000's of Cancer Patients ( In top 20 Cancers) in his experience with a reputed Medical Research University & Hospital or in a startup /mid-size company/ MNC / Top Onco Pharma MNC. Qualification : 1) MBBS with DNB / MD /MS/Mch with specialization in medical Oncology practice or Medical Oncology Research/Onco Surgeon from reputed Medical University & Hospital. Experience : 5 - 25 Years experience in medical Oncology Practice or Cancer Medical Research Post MBBS, MD /MS OR Post MSc, PhD in Medical Oncology by Research from Reputed Medical Research University needs to apply.

Proven experience in building training materials, ideally within the clinical domain. Strong understanding of Data Management principles. Proficiency in instructional design, including content chunking, visual design, and learning technologies. Experience with authoring tools such as Articulate Storyline, Rise, and Adobe Suite. Proficiency in video editing software (e.g., Camtasia) and interactive tools (e.g., Kahoot!). Excellent command of MS Office Suite. Strong communication and collaboration skills. Ability to work independently and manage multiple projects simultaneously.

Apply knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents. Essential Functions Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA). Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. Conduct/Lead ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Act as Signal Management Lead on post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Set-up and update products signaling strategies. Author and/or QC review all types of signal management deliverables. Lead/ conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks . Responsible for full documentation and tracking of signals. In a PV support role, lead/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents. Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed. Participate in internal and external audits and inspections, as required. Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics. Read, acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Serve as the interface between the global project lead and the working team conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members. Provide mentorship and training to less experienced resources. Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns participate in project review meetings with management communicate and document project issues to project team members and department management in a timely manner. Ensure Good Documentation Practices (GDP). Support and/or contribute to technology / innovation activities. Qualifications Bachelors Degree In a Scientific or Healthcare discipline Req 2 - 3 years relevant work experience. Pref Equivalent combination of education, training and experience. Req Excellent knowledge of Lifecycle Safety services and processes. Intermediate willingness and aptitude to learn new skills across Lifecycle Safety service lines. Advanced In depth knowledge and understanding of applicable global, regional, local regulatory requirements. Intermediate i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and International Conference of Harmonization (ICH) guidelines, SOPs. Intermediate Proven ability to meet strict deadlines. Advanced manage competing priorities and ability to be flexible and receptive to changing demands. Intermediate Excellent organizational skills and time management skills. Intermediate Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint). Intermediate Good knowledge of medical terminology. Intermediate Proven ability to follow instructions/guidelines, work independently and on own initiative. Intermediate Excellent attention to detail and accuracy maintaining consistently high quality standards. Advanced Excellent written/verbal communication and report writing skills. Intermediate Sound judgment. Intermediate independent thinking and decision making skills. Intermediate Self-motivated and flexible. Advanced Ability to establish and maintain effective working relationships with coworkers, managers and clients. Intermediate Effective mentoring and coaching skills. Intermediate Good understanding of operational metrics, productivity and initiatives. Intermediate Demonstrate effective project management and leadership skills. Intermediate

We re on a mission to change the future of clinical research. At Perceptive, we help the biopharmaceutical industry bring medical treatments to the market, faster. Our mission is to change the world but to do this, we need people like you. Apart from job satisfaction, we can offer you: HEALTH: - Medical plan for you and your dependents. - Personal Accident Insurance - Life Insurance - Critical illness cover WEALTH: - Salary structure and Flexi basket - Provident fund of 12% - Gratuity scheme YOURSELF: Internal growth and development programs & trainings Job Summary: A Senior Medical Writer will create, research, edit and coordinate the production of clinical documents related to independent review, including independent review charters, clinical data forms, manual case report forms, applicable reviewer training materials, project deviations and supplementary imaging reports, either independently or using available central content and templates. The medical writer will serve as a contact with clients. Key Accountabilities: Information Content authoring Gather, review, analyze, and evaluate relevant resources to prepare, develop, and finalize applicable clinical documents for submission to regulatory authorities. Prepare, develop, and finalize applicable clinical documents not intended for submission to regulatory authorities. Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input. Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions, and other processes, as applicable. Perform literature searches/reviews as necessary to obtain background information and training for development of documents. Draft and/or ghost-write clinical documents for more experienced medical writers Act as support to others in the team to ensure that all documentation is accurate and encompasses all relevant information based on Stakeholder needs. Initiate and participate in departmental or interdepartmental process improvement and training initiatives, including development of departmental SOPs, central content, and general guidelines for clinical documentation and workflow procedures. Initiate and participate in marketing initiatives, such as white paper, abstract, poster, and manuscript development Document Project Management Serve as primary client contact for medical writing projects, negotiating deliverable timelines, and resolving project-related issues. Serve as the medical writing representative on assigned project teams communicate content requirements, lead/facilitate authoring team meetings to agree on expectations Coordinate and conduct interdepartmental team reviews of draft and final documents, Evaluate progress on tasks, identify issues and facilitate resolutions, and advance document development to approval, according to Perceptive and/or client guidelines/SOPs. Distribute final documents to project team and client in a timely manner and to agreed timescales Identify potential project challenges and raise with all relevant stakeholders, including changes in timelines or out of scope requests, and suggest possible resolution options. Attend project team meetings as required. Ensure appropriate filing of applicable project documentation May provide project management of contractual and financial aspects. Relationship management Implements stakeholder engagement/communications plan. Deals with problems and issues, managing resolutions, corrective actions, lessons learned and the collection and dissemination of relevant information. Collects and uses feedback from customers and stakeholders to help measure effectiveness of stakeholder management. Helps develop and enhance customer and stakeholder relationships. Quality management Uses appropriate methods and a systematic approach in the development, maintenance, control and distribution documents. Prepares documents for publishing readiness, ensuring document consistency and integrity Ensures documentation adheres to FDA/EMA or other appropriate regulatory guidelines, and / or relevant SOPs. Provides medical editing review of draft and final documents prepared by other medical writers before internal or external distribution. This includes both copyediting and content review. Follows required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions, and other processes, as applicable. Makes changes to and controls the updates and distribution of quality standards. Relationship management Implements stakeholder engagement/communications plan. Deals with problems and issues, managing resolutions, corrective actions, lessons learned and the collection and dissemination of relevant information. Collects and uses feedback from customers and stakeholders to help measure effectiveness of stakeholder management. Helps develop and enhance customer and stakeholder relationships. Other Carryout any other reasonable duties as requested. Skills: Excellent interpersonal, verbal, presentational and written communication skills Ability to consistently produce documents of high quality A flexible attitude with respect to work assignments and new learning Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Must have the ability to work methodically in a fast-paced, time-sensitive environment Demonstratable ability to apply critical thinking to problems and tasks Shows initiative and self-confidence, is adaptable and is able to cope with changing and evolving priorities Ability to identify and implement process improvements Proactively participates in skills improvement training and encourages their teams to participate Ability to negotiate on behalf of medical writing to ensure resources, timelines, and expectations are aligned Maintains an up-to-date awareness of trends, tools, technology, techniques, processes and documentation requirements that affect technology within the Life sciences domain A self-starter and able to work under own initiative Proven ability of using Microsoft Office products (including Word, Excel & PowerPoint) Knowledge and Experience: Experience using tools to communicate progress to Stakeholders Experience of regulated environments Understanding of Agile methodologies Experience of working in and knowledge of the life sciences sector Solid knowledge of industry guidelines and regulations, i.e., ICH-GCP. Experience of regulatory documents in a contract research organization, pharmaceutical or biotechnology firm, or some experience in the conduct of clinical research/medical communications. Solid Professional experience in the same or very similar role Experience using data analysis tools (e.g. Tableau, Power BI) desirable Proven ability of using Microsoft Office products (including Word, Excel & PowerPoint) Education: Bachelors Degree in a technical discipline (Science, pharmacy, nursing, or other health-related discipline preferred etc.) or a related study, or equivalent project-related experience English: Fluent (written and verbal) Non-English language (Written and verbal) desirable Come as you are.

Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations Standard Operating Procedures (SOPs) and internal guidelines under guidance and support of senior operation team members. Essential Functions To Prioritize and complete the assigned trainings on time. Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements. To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming - Adverse Events(AE)/endpoint information determining initial/update status of incoming events database entry coding AE and Products, writing narratives, Literature related activities as per internal/ project timelines. Ensure to meet quality standards per project requirements. Ensure to meet productivity and delivery standards per project requirements. To ensure compliance to all project related processes and activities. Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Work towards ensuring your individual training plan and training transcript are reconcilable. Creating, maintaining and tracking cases as applicable to the project plan. Identify quality problems, if any, and bring them to the attention of a senior team member. To demonstrate problem solving capabilities. Liaise with different functional team members, e.g. project management, clinical, data management health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related issues. May liaise with client in relation to details on day to day case processing activities. To mentor new teams members, if assigned by the Manager. Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes. Perform other duties as assigned. Lead/ Support department Initiatives 100% compliance towards all people practices and processes In addition to the above mentioned responsibilities, depending on the project requirement, the team member may perform medical review of non-serious adverse events (AEs) and non-serious adverse drug reactions (ADRs) which includes reviewal of AE coding, past medical history, concomitant medications, expectedness/ listedness, causality assessment and other medical information and ensure completeness and accuracy of data according to applicable regulations and guidelines, SOPs, project-specific guidelines, and medical evaluation guidelines and communicate with the team leads for any correction required in the case and maintain appropriate documentation for all communications. Qualifications High School Diploma or equivalent Scientific or healthcare discipline or allied life sciences Req Bachelors degree in life sciences or related field and up to 3 years of relevant experience, inclusive of up to 1 year of Pharmacovigilance experience. Req or equivalent combination of education, training and experience. Pref Good knowledge of medical terminology. Intermediate Working knowledge of applicable Safety Database and any other internal/Client applications. Intermediate Knowledge of applicable global, regional, local clinical research regulatory requirements. Intermediate Excellent attention to detail and accuracy. Intermediate maintain high quality standards. Intermediate Good working knowledge of Microsoft Office and web-based applications. Intermediate Strong organizational skills and time management skills. Intermediate Strong verbal/written communication skills. Intermediate Self-motivated and flexible. Intermediate Ability to follow instructions/guidelines, utilize initiative and work independently. Intermediate Ability to multi-task, meet strict deadlines, manage competing priorities and changing demands. Intermediate Ability to delegate to less experienced team members. Intermediate Ability to be flexible and receptive to changing process demands. Intermediate Willingness and aptitude to learn new skills across Safety service lines. Intermediate Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients. Intermediate Ability to work as a Team Player, contribute and work towards achieving Team goals. Intermediate Ensure quality of deliverables according to the agreed terms. Intermediate Demonstration of IQVIA core values while doing daily tasks Advanced Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Intermediate Regular sitting for extended periods of time. Intermediate May require occasional travel. Intermediate Flexibility to operate in shifts. Intermediate

Join global organization with 82000+ employees around the world, as a IT Project Manager based in IQVIA Bangalore. You will be part of IQVIA s world class technology team and will be involved in design, development, enhanced software programs or cloud applications or proprietary products. Essential Functions Validates the project scope, plans and schedules for moderately complex projects; adheres to metrics for project success and begins to suggest appropriate metrics; provides input to and applies standards (e.g. delivery process, roles and responsibilities, operational norms, compliance). Identifies risks to program success and escalates to management as necessary. Manages project delivery process, scope, and costs of moderately complex projects under broad supervision; drives completion of the project. TManages stakeholder relationships; develops and executes communication plan. Manages change by identifying impacts of the project, building awareness and support for change within the organization, and contributing to development of training. Evaluates project results against success metrics; recommends or implements changes to processes, resources and solutions that improve productivity and end product. Consistently delivers established team reporting and guidance metrics. Qualifications Bachelors Degree Computer Science, a related field, or equivalent experience Req Five (5) years of experience in IT Project Management (software and/or product development) Proven expertise in project and program management, preferably PMP and Agile Certified Strong knowledge of Software Development Life Cycles (SDLC), agile methodologies, and the role of project management within the SDLC Strong leadership skills with proven ability to lead a virtual team in a matrix structure Excellent communication and interpersonal skills Ability to establish and maintain effective working relationships with coworkers, and stakeholders Critical thinking abilities to take complex, ambiguous, abstract project details and break them into smaller components, patterns, views, and features Problem solver with the ability to conceptualize and think creatively Experience in Tools like - Jira, HP PPM Must have flexibility to attend few calls in the evening hours Limited travel may be required Good to have: Knowledge of Clinical Trial or related processes Experience in the Healthcare Industry with Life Science, Contract Research Organization (CRO), or a Healthcare regulatory environment Experience of working in a SAFe best practice is a strong plus

Designs and builds software - tools, libraries, automation, services, and the scripts. Performs maintenance, upgrades, and migrations. Provides tools and best practices to support the entire software development lifecycle. Essential Functions Technical Configured Build and Deploy process using Azure DevOps. Build and Release pipelines for all Front end, Middleware and Backend applications. Design deployment strategies and deploy node, Springboot, and other services to Azure cloud Configure Azure Build and Release Pipelines using Azure DevOps Configure Kubernetes Clusters with High Availability. Configure Azure infrastructure using Terraform Configure Jenkins as a central service to build, test, scan and deploy applications using Continuous Integration and Continuous Delivery model (CI/CD). Implement Kubernetes Infrastructure Monitoring using Prometheus and Grafana Host applications using Microservices architecture in Microsoft Azure. Build Azure infrastructure - App Gateway, Azure Active Directory, VNet, ACR, Key vault, SQL Servers using Terraform Configure and Maintain Kubernetes (AKS) High Available Infrastructure in Azure Monitoring and troubleshooting production issues using App Dynamics, Splunk, Azure Application Insights. Authored YAML scripts for deploying Deployments, Replica Sets, PODs for the Kubernetes infrastructure using Helm. Design and deploy Docker Containers from Dockerfiles and Docker Images to host several Microservices on Cloud native platforms. Lead the effort of designing and configuring Kubernetes Architecture on Azure Cloud for container orchestration to build and deploy reliable and scalable distributed applications. Configure Nginx servers and apply SSL certificates Others Coordinate the development, integration, and production deployments Take ownership of tasks and Work independently Debug and understand the project s IAC codebase with minimal help Highlight issues/improvements Follows coding best practices and writes well commented and readable code Communicate and articulate effectively. Explain technical issues succinctly and precisely Work in an agile setup with knowledge of tools like Jira, Confluence, etc Qualifications Bachelors Degree Computer Science, a related field, or equivalent experience Req

Independently manage end-to-end delivery of data management services for single/multi-service projects, 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 and vision to the team in the areas of project planning, execution, and close-out; financial management; communications; and milestone deliverables. May perform role of Data Team Lead (DTL), Program Lead, Customer Site Manager, and/or a leadership role in a specific CDM task (e.g. Subject Matter Expert (SME). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents. Should have experience in study setup (all DM activities ). Did setup of minimum 2-3 studies on Rave Platform. Experience in writing URS for Data review reports. Screens and Edit Checks UAT experience. Essential Functions Client Management: Serve as primary point of contact for customer on data management deliverables manage multiple large studies or program of studies (possibly global) Provide leadership and senior support to DTLs on multiple large global studies/programme of global studies Provide leadership and senior support to DTLs on multiple large global studies/programme of global studies. 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 Lead direct negotiations with customer, e.g., timelines, financial, process, resources. Maintain strong customer relationships Ensure open communications with customer and IQVIA management to independently manage and meet contractual obligations 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 provide training and development on data management expertise to junior team members Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders Independently manage DM service delivery with comprehensive DM process and technical expertise in executing projects Serve as the escalation point for unresolved data issues independently work with client data managers, vendors, internal team members for resolution Ensure appropriate resources are assigned to meet project deliverables Create and/or review and sign-off on all data management plan (DMP) documents Ensure service and quality meet agreed upon specifications per the DMP and contract/SOW Implement proactive quality management plans across multiple projects/programmes/customer account. Manage service performance and provide leadership to identify root causes of issues and implement remedial actions Continuously look for opportunities to improve service develop and work with team to implement plan to re-organise and drive change (possibly across a customer account) Ensure timely follow-up and resolution of compliance issues Serve as Subject Matter Expert (SME) Provide leadership and expertise in a specific CDM task or technology Serve as customer site lead for one or more customers Train and mentor junior DTL staff in DM expertise may coordinate the work of more junior DTL staff Independently maintain internal tracking databases and systems Financial Management/Business Development Support: Independently manage SOW/budget Review financial reports on a monthly basis and participate in project reviews as requested Identify out of scope tasks and track change orders to completion Participate in pricing discussions across customer account Serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing Independently support RFP process (review RFP documents, pricing, attend bid defense) Other: Independently bring process improvements and solutions to the CDM team/CDM department Lead a focus team or global or local best practice team Communicate lessons learned and/or present in CDM workshop(s) Manage the development and implementation of new technology or tool Present at professional conferences and/or publish articles in professional journals Provide review and expert opinion in developing, revising, and maintaining core operating procedures and work instructions Perform other duties as directed by the functional manager Qualifications Bachelors Degree Health, clinical, biological or mathematical sciences, or related field Req 7 years direct Data Management experience, including 5 or more years as a CDM project lead. Equivalent combination of education, training and experience. Previous experience and proven competence in managing delivery of multiple global trials through full DM life-cycle (i.e. large trials of at least 1000 patients). Demonstrated expert data management skills and advanced 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). Previous experience and proven competence in handling complex customer negotiations and bid defense meetings independently. 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 relevant regulatory guidelines. Excellent communication, interpersonal, customer service, and teamwork skills. Excellent organizational and problem-solving skills. Excellent project management skills. Ability to work independently. 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 delivery of multiple global trials through full DM life-cycle (i.e. large trials of at least 1000 patients). Demonstrated expert data management skills and advanced 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). Previous experience and proven competence in handling complex customer negotiations and bid defense meetings independently. 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 relevant regulatory guidelines. Excellent communication, interpersonal, customer service, and teamwork skills. Excellent organizational and problem-solving skills. Excellent project management skills. Ability to work independently. Comprehensive understanding of clinical drug development process. Ability to establish and maintain effective working relationships with coworkers, managers and customers.

Let s do this. Let s change the world. Job Description The Manager, CSAR - Electronic Data Interchange and Acquisition will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting Electronic Data Interchange/Acquisition programming activities. The Manager, CSAR - Electronic Data Interchange and Acquisition will develop the Data Acquisition Requirements Specification (DARS) document to outline metadata transfer requirements, establish and validate vendor integration criteria, and manage the processing of electronic data from vendors. The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality deliverables, internal and external clinical systems, and other CSAR activities related to the use electronic data capture technology. The position will be responsible for quality and deliverables at the study and portfolio level. Manager, CSAR - Electronic Data Interchange and Acquisition will also be expected to help deliver large system transformation projects, with a focus on project management, contribution of subject matter expertise, partner engagement, and change management. The successful candidate will be a strong leader with demonstrated ability to influence partners, while also acting as an individual contributor on study specific and general CSAR/Global Development Operations projects or operational work. Proven capability of providing support for study deliverables. Has operational experience with clinical database management systems and allied technologies (e. g. , Rave EDC, Veeva EDC). Responsibilities include, but are not limited to, the following: Support of clinical trial platform technologies Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Coordinating and providing programming support to Clinical Study Teams Works collaboratively with Clinical Data Management to meet study deliverables and timelines Acting as a technical point of contact for systems deliverables on defined programs Experience in writing the Data Acquisition Requirements Specification (DARS) document to specify metadata transfer requirements, setting up and testing RWS integration requirements supporting study closure with final data loads and transfer discontinuation, configuring data upload gateways between external vendors and Amgen. Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Assist in preparing for and responding to audit findings (internal or external). What we expect of you We are all different, yet we all use our unique contributions to serve patients. Knowledge Good Clinical Practice Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking. Drug development and clinical trials processes Data management processes Programming of clinical trial databases and applications Experienced in collecting, maintaining, aggregating, and supporting data cleaning controls for external (non-EDC) data, importing clinical study data from various sources including central labs and imaging vendors. Systems development lifecycle Programming Languages Project planning and management Collaborating with global cross-functional teams (team/matrix environment) Quality management and Risk Analysis Regulatory filings and inspections Process improvement methodologies Preferred Qualifications Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related field with 9-13 years of experience Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena Proven experience in managing teams General project management and planning experience Experience in oversight of outside vendors (CRO s, central labs, imaging vendors, IRT vendors, etc. ) Basic Qualifications Bachelor s degree or equivalent in life science, computer science, business administration or related field with 9-13 years of experience. Proven experience in managing teams Specialist knowledge / experience in life sciences or a medically related field General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)

>To connect top practitioner doctors of different specialist all over India >To structure a proper process to establish & conduct medical survey for research & strategy purpose > Establish a proper compliance & register for conducting clinical trials

Perform triage & intake of ICSR received daily in ARGUS databases Should have hands On Experience On ARGUS Safety Database Should Have hands on Experience on MEDDRA Applicants Should Complete Certification in Pharmacoviiglance Required Candidate profile B.Pharm / M.Pharm/Pharm D/Life sciences degree With Hands On Experience On Argus Safety Database and Med DRA coding, Argus, Narrative Writing, Triage

Job description Should have knowledge in clinical research studies Perform Site visits (i.e. Site Selection Visit, Site Initiation Visits, Site monitoring visits and site close-out visits) should have knowledge in ICH GCP Guidelines Required Candidate profile Strong understanding of clinical trial processes and regulatory requirements. Excellent clinical assessment skills and a commitment to patient safety and ethical research practices.

Should have knowledge in clinical research studies Monitoring of Clinical studies conducted at various CROs located globally as per ICH/GCP, applicable regulatory requirements, protocols and SOPs. Perform Site visits (i.e. Site Selection Visit) Required Candidate profile Strong understanding of clinical trial processes and regulatory requirements. Excellent clinical assessment skills and a commitment to patient safety and ethical research practices.

Responsibilities: Review operative reports to abstract information and apply CPT, HCPCS, and ICD-10-CM codes Verify LCD/NCD information as appropriate Utilize NCCI edits, AMA CPT Assistant, AHA Coding Clinic, and other resources as needed Initiate physician queries as needed Escalate coding/documentation problems when appropriate Participate in ongoing coding education Perform other related duties as required/assigned Other responsibilities as assigned Requirements Coding certification 2+ years outpatient surgical coding Extensive knowledge of medical terminology, anatomy and physiology Ability to work independently and as part of a team Flexibility to assume new tasks or assignments as needed Preferred Knowledge, Skills, Abilities & Education: University certificate in healthcare related field 2+ years Ambulatory Surgical Center coding experience

Entry Level Role for Freshers. This role involves collecting, managing, and analyzing adverse drug reaction data, ensuring compliance with regulatory guidelines. Maintain and update safety databases Required Candidate profile Only for Freshers/candidates in their final year

About the job: Key responsibilities: 1. Conduct psychotherapies and record proper documentation in a case file 2. Treat OPD patients as well as indoor admissions 3. Conduct ECT Requirements: 1. In-depth understanding of mental health disorders, their symptoms, and treatments 2. High levels of emotional intelligence to connect with patients experiencing distress 3. Strong analytical skills to interpret symptoms, behavior patterns, and test results 4. Precision in diagnosing and differentiating between overlapping mental health conditions 5. Ability to provide non-judgmental, supportive care in difficult emotional situations 6. Familiarity with psychiatric diagnostic tools 7. Ability to prescribe and manage psychotropic medications responsibly Who can apply: Only those candidates can apply who: have minimum 1 years of experience Salary: ₹ 2,00,000 /year Experience: 1 year(s) Deadline: 2025-06-20 23:59:59 Other perks: Informal dress code, 5 days a week Skills required: Analytical Thinking, Problem Solving, Clinical Research and Emotional intelligence Other Requirements: 1. Qualification: MD Psychiatry 2. Experience: 1 to 3 years About Company: Mindbliss Hospital is a dedicated mental health care facility committed to providing comprehensive psychiatric and psychological services for individuals of all ages. Located in [City/Country], our hospital offers a safe, supportive, and confidential environment for the diagnosis, treatment, and management of a wide range of mental health conditions.Our team of experienced psychiatrists, clinical psychologists, counselors, and psychiatric nurses work collaboratively to deliver personalized care through evidence-based practices. We specialize in treating disorders such as depression, anxiety, bipolar disorder, schizophrenia, personality disorders, PTSD, substance abuse, and more.

Role & responsibilities Study Site Management & Regulatory Compliance Conducting initiation visits to ensure sites are prepared for the trial. Regularly visiting study sites to ensure compliance with the protocol, Good Clinical Practice (GCP), and regulatory requirements. Ensuring that the study is conducted in accordance with the approved protocol and amendments. Verifying that informed consent is obtained from all study participants. Data Quality and Integrity Risk Management Implementing corrective and preventive actions (CAPA) to resolve issues and prevent recurrence. Documentation and Reporting - Ensuring all trial-related documentation is complete, accurate, and up-to-date. Preparing monitoring reports, site visit reports, and other required documentation. Patient Safety and Rights - Monitoring and reporting adverse events and serious adverse events (SAEs) in accordance with regulatory requirements. Ensuring the safety and well-being of study participants throughout the trial. Preferred candidate profile Masters in Science / PHD / Relevant qualification in Clinical Research Mandatory to have: Should have lead a team of CRC in past for minimum 3 - 4 years Perks and benefits Best in Industry

Department- Commercial, GBS Are you passionate about taking your competitive intelligence journey to next level? Do you want to work for a globally renowned organization Novo Nordisk? We are seeking a Global Competitive Intelligence Associate Lead to join our vibrant and fast-moving Commercial-GBS team in Bangalore, India. If that sounds like you, read on and apply today for a life-changing career. The position As a Global Competitive Intelligence Associate Lead at Novo Nordisk, you will be responsible for: Consistently track and monitor activities of pharmaceutical competitors and man-aging news on competitors from key scientific and clinical congresses within the TA, relevant for research, development projects, and brand strategies. Ensure timely monitoring, analysis, and communication of all relevant competitor activities to the stakeholders and establish comprehensive and up-to-date snap-shots of competitive landscapes in all areas, including competitor pipelines, projected approval timelines, and existing products. Provide regular updates with strategic implications for the company, highlighting new trends, market events, assessing landscapes, and unmet needs. Also, delivering focused deep dives on specific topics. Drive process to establish an overview of near, medium, and long-term challenges and opportunities posed to Novo Nordisk and offering ongoing assistance to relevant project teams. Lead coverage of major scientific congresses pertinent to therapy area for competitor activities. Qualifications We are looking for candidates with the following qualifications: A Masters degree in Life Sciences, Medicine, or Pharmaceutical Sciences. Over 8 years of experience in the Competitive Intelligence sector, specifically within the pharmaceutical industry. Ability to carry out daily responsibilities autonomously and skilled in staying updated with industry trends and therapy area knowledge, while adapting quickly. A strong understanding of essential aspects related to drug development and marketing. This includes knowledge in therapy areas, drug landscapes, disease comprehension, market insights, clinical and regulatory aspects, and recognizing forthcoming opportunities. Proven competence in effectively communicating scientific, technological, and commercial information to different organizational levels paired with a strategic mindset and analytical capabilities. A highly self-driven, proactive and organized approach, with excellent collaboration and communication skills when interacting with stakeholders across the global NN organization (Denmark and Bangalore). About the department The Commercial- GBS unit is responsible for driving deliverables for multiple Corporate Vice President (CVP) areas within Commercial- GBS. This includes Insulin, GLP-1 and Obesity Marketing, Market Access, Insights, and Commercial Operations. Located in Bangalore, India, our team is dynamic and fast-paced, working together to make a difference in the lives of patients worldwide.

Department- CMR (Clinical, Medical, Regulatory & Pharmacovigilance) Location- Bangalore / Hyderabad Are you an experienced medical professional and passionate about Clinical Medical? Does being part of a growing, yet dynamic environment excite you? If yes, then you may be the one we are looking for as Clinical Medical Manager for Novo Nordisk India. Apply now! The position As a Clinical Medical Manager, you will be responsible for : Facilitate the execution of clinical trials related to New Therapy Areas (including CVD, CKD, NASH) by providing medical/scientific expertise and advice. Identify and map KOLs, investigators, and research centres within the relevant therapy areas. Collect early scientific insights and guidance by discussing relevant early development data with external medical and scientific experts. Contribute to delivering successful clinical trials (phase I-IV) in collaboration with clinical operations. Provide timely medical guidance and internal training to clinical staff. Engage in extensive scientific communication both internally and externally, requiring strong presentation skills. Performing ad hoc visits, Supporting attendance at investigator meetings, ensuring KOL inclusion in clinical trials and engaging key investigators to communicate trial results. Qualifications To be successful in this role, you should have the following qualifications: MD in any discipline with a strong clinical research/medical affairs background. 5 years of clinical or pharmaceutical industry experience with strong experience in human healthcare research either from university, CROs, or pharmaceutical industry. Expertise in therapeutic areas of relevance (CVD, CKD, NASH), preferably with authorship in peer-reviewed journals. Understanding of pharmaceutical drug development. Open to domestic and international travel in connection with site visits, congresses, and company events. Experience as a clinical trial investigator or sub-investigator. Understanding the specificities and nuances of the local healthcare infrastructure. About the department The CMR (Clinical, Medical, Regulatory & Pharmacovigilance) team based in Bangalore. Our team is dedicated to driving clinical trials and providing medical/scientific expertise in New Therapy Areas. We work closely with KOLs, independent professional associations, and patient advocacy associations to ensure the successful execution of clinical trials. The atmosphere is collaborative and dynamic, with a strong focus on scientific excellence and patient outcomes.

Department-Centralised Monitoring Unit (CMU) Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives? Then we might have the right position for you. Apply now and join a growing team, working in an international environment. About the department The Centralised Monitoring Unit (CMU)- Bangalore, is a department within the Clinical Drug Development area. It is a perfect blend of skilled medical professionals (Medical reviewers) and technical programmers (Functional programmers, statistical monitors). Medical reviewers are actively involved in Risk-based medical monitoring in collaboration with the medical specialists from Denmark, with a focus on ensuring overall patient safety and wellbeing of all clinical trial participants, by ensuring compliance to protocol and identifying potential clinically significant outliers that require medical attention and medical data cleaning. The Functional Programmers develop operational visualizations in data visualization tools to support the trial teams on proactive centralized monitoring and Statistical Monitors perform the detection of unusual data patterns, systematic errors, and potential lack of compliance or fraud across trials. The Position: (NoteThis is not a role within Pharmacovigilance) The Senior Medical Reviewer is responsible for conducting comprehensive medical reviews of clinical trial data across various therapy areas within the drug development portfolio. This role ensures the highest quality and consistency of medical data, with a strong emphasis on patient safety, protocol adherence, and compliance with Good Clinical Practice (GCP), ICH guidelines, local regulations, and Standard Operating Procedures (SOPs). Key responsibilities include collaborating closely with study team members"”such as Data Managers, Trial Managers, and Medical Specialists"”throughout the trial process, providing timely updates on the status of medical reviews, and escalating any issues to maintain trial integrity and compliance. Responsible for contribution to or participation in trial planning activities related to medical review. Perform the quality check measure for the medical review. Responsible for clarifying and if possible, resolving issues of medical concern and inconsistencies in clinical trial data with staff at investigational sites. Responsible for presenting findings of Medical Review to relevant Medical Specialists to enable decision-making. Responsible for documenting medical reviews in the sponsor TMF. Ensure close collaboration with relevant study group members, especially the Data Manager, Trial Manager(s), and Medical Specialist during trial conduct. Provide training on the project and process to the new team members. Review and provide inputs to MMP as well as Medical Monitoring, Displays or other data listing required to perform Medical review. The input should ensure unambiguous monitoring requirements as well as medical monitoring displays and data listing to enable efficient medical review. Qualifications: A graduate degree in Medicine or a related field is required (MBBS & MD in Pharmacology preferred; MBBS & MD in other clinical or paraclinical areas with relevant experience in clinical patient management or clinical research will also be considered). Preferably 3-5 years of relevant experience in Clinical Drug Development (Medical Data Review, Medical Monitoring, Investigator, Safety Surveillance, Scientific Clinical Drug Development etc). 1-2 years of project management experience is essential. Solid understanding of ICH (International Council for Harmonisation) guidelines and GCP (Good Clinical Practice) principles. Proficient in computer applications, including MS Office, MS Project, and PowerPoint. Strong grasp of medical terminology and clinical trial processes. Demonstrated analytical skills with a results-oriented approach. Exceptional proficiency in written and spoken English.