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0 - 1 years
3 - 5 Lacs
Pune
Work from Office
About Krishagni Founded in 2009, Krishagni is a "software product company" specialising in developing software for medical research. Our flagship product, OpenSpecimen, is trusted by over 100 customers across 20 countries. We are a close-knit team of 15+ professionals, operating with a flat hierarchy and a culture free from office politics. At Krishagni, we value performance and innovation and reward excellence generously. Role & responsibilities * Work closely with customers and internal teams to master the OpenSpecimen product. * Responsible for configuring, customizing, and supporting the product * Should be able to use JSON, JavaScript, SQL, R, Python, and other similar tools. * This position is ideal for someone with a technical mindset, a passion for problem-solving, and an interest in delivering excellent end-user support. Preferred candidate profile B.Sc or M.Sc in any bio science or info stream with a flair for programming in SQL, Java Script, R, etc. Perks and benefits * Salary and performance bonus * Rewarding environment to learn and prosper * Liberal and stressfree work culture * Five days a week
Posted 3 months ago
3 - 5 years
7 - 11 Lacs
Mumbai
Work from Office
We are seeking a highly skilled and motivated Clinical Research Medical Advisor (CRMA) to join our team. The CRMA will be accountable for all country clinical or medical aspects associated with Development and prioritized Research programs/trials. This role involves providing clinical strategic and tactical leadership, optimizing clinical trial implementation, and ensuring adherence to safety standards and clinical data quality. Job Description Key Responsibilities: - Provide clinical development and indication expertise specific to the country/cluster. Validate study designs and make final decisions on clinical/medical trial feasibility. Contribute to scientific/clinical/medical aspects of the start-up phase to ensure fast clinical trial site start-up. Provide clinical/medical expertise to clinical trial operations team members and clinical trial sites for IRB/EC interactions. Develop clinical/medical trial plans to ensure successful trial implementation. Provide robust indication, compound, and protocol training to the clinical operations team and externally as needed. Support and partner with internal stakeholders regarding clinical trials. Essential Requirements:- Scientific degree MD/M.B.B.S Ability to manage a study from the scientific/medical/clinical perspective. Demonstrated capability to problem solve and mediate complex issues. Effective leadership and communication skills. Agility to move quickly across different therapeutic areas and indications. Ideally, 3 years of clinical development experience in the pharmaceutical industry or clinical practice. Sound understanding of the overall clinical development process and ICH/GCP principles.
Posted 3 months ago
4 - 7 years
11 - 15 Lacs
Hyderabad
Work from Office
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Clin Eval Med Writer Specialist-II Careers that Change Lives Career growth and development is about learning and stretching yourself to grow your expertise and navigate your career. Medtronic offers award-winning programs to accelerate your development and growth. Our size, scope and market leadership give you the chance to explore career opportunities and grow as we grow. A Day in the Life Responsibilities may include the following and other duties may be assigned. Review and summarize scientific literature. Reports instances of complaints/adverse events from literature to GCH. Create responses for audit/submission queries. Maintains database of peer-reviewed literature. Appraise, analyze, summarize, and discuss clinical evidence from all the available sources. Conducts comprehensive literature searches and performs a critical evaluation of clinical evidence. Develop state of the art on product family for its intended purpose. Create maintain plans and reports for regulatory authorities Review/approve other documentation for device development Knowledge of regulatory agencies guidelines on clinical evaluation requirements. Ability to independently ascertain and analyze relevant clinical data from scientific publications SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects - from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education. DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Minimum Qualifications Bachelor degree in Medical, Mechanical, Electric Life Science or Masters in Pharmaceutical 4-7 years experiences as a medical/clinical writer in medical device and or pharmaceutical industry. A mix is preferred in case of pharma Excellent written, organizational, and communication skills is required, and have a flexible and team-oriented attitude. Strong attention to details and ability to handle multiple tasks, good at planning and can work under pressure; Good at English, including reading, writing, and speaking; Good Learning attitude About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let s work together to address universal healthcare needs and improve patients lives.Help us shape the future. Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. Benefits Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission to alleviate pain, restore health, and extend life unites a global team of 95,000+ passionate people. We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the RD lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here
Posted 3 months ago
2 - 6 years
2 - 6 Lacs
Pune, Hyderabad
Work from Office
Key Skills: Experience in CDM and hands on with Medidata RAVE Company Name: IQVIA Job Location: Hyderabad/Pune Experience: 2+ Years Interview Mode: V irtual Interview Rounds: 2-3 rounds Notice Period: Any Generic job description: Develop and maintain data management documentation, including study protocols, case report forms and data management plans. Design case report forms (CRFs) and electronic data capture (EDC) systems for data collection. Perform data entry and cleaning activities, including discrepancy management and query resolution. Conduct data validation checks and implement quality control measures to ensure accuracy and completeness.
Posted 3 months ago
0 years
0 - 0 Lacs
Chennai, Ahmedabad, Kochi
Work from Office
We are seeking a highly motivated and compassionate recent graduate to join our clinical team as an Entry-Level Clinical Assistant/Clinical Associate. This is an excellent opportunity to gain hands-on experience in a clinical setting and contribute to patient care or clinical research. You will work closely with physicians, nurses, and other clinical staff, assisting with various tasks related to patient care, data collection, and administrative support. This role is ideal for individuals with a strong interest in healthcare and a desire to learn and grow in a dynamic environment. Responsibilities: Patient Care Support: Assist with patient intake and vital sign measurements. Prepare examination rooms and ensure they are clean and stocked with supplies. Provide basic patient support and comfort. Assist with the administration of basic medical procedures under supervision. Clinical Data Management: Accurately collect and record patient data in electronic health records (EHR) or clinical research databases. Assist in the preparation of clinical reports and data summaries. Maintain accurate and organized clinical records. Ensure data integrity and confidentiality. Administrative Support: Schedule patient appointments and manage patient flow. Answer phone calls and respond to patient inquiries. Assist with filing, photocopying, and other administrative tasks. Maintain inventory of clinical supplies. Clinical Research Support (if applicable): Assist with the recruitment and screening of clinical trial participants. Assist in the administration of study procedures and data collection. Maintain study documentation and regulatory files. Ensure adherence to study protocols and ethical guidelines. General Support: Assist clinical staff as needed. Participate in team meetings and training sessions. Maintain a clean and organized work environment. Any other duties as assigned. Qualifications: Bachelor's degree in a Life Science, Healthcare, or related field (e.g., Biology, Nursing, Psychology, Public Health). Strong interest in patient care or clinical research. Excellent communication and interpersonal skills. Strong attention to detail and accuracy. Ability to work independently and as part of a team. Strong organizational and time-management skills. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint). Must be a recent graduate.
Posted 3 months ago
7 - 11 years
9 - 13 Lacs
Bengaluru
Work from Office
Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Specialist Qualifications: Bachelor of Pharmacy Years of Experience: 7 to 11 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. The role may require you to identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The role may also need expertise in managing clinical data management projects. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualifications Bachelor of Pharmacy
Posted 3 months ago
10 - 15 years
27 - 33 Lacs
Bengaluru
Work from Office
As part of the Science and Technology Organization, we develop the services that drive the next generation of healthcare applications and enable developers to build new and innovative solutions that seamlessly span clinical devices sensors, local compute and storage hubs, and a global footprint of cloud resources. We are looking for a talented and creative expert to help define, create and evolve a new generation of world-class cloud-based healthcare solutions AI applications across our business portfolios powered by hundreds of existing and new purpose-built services. GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. Job Description Roles and Responsibilities Work backwards from customers to define the strategy for one of our leading digital AI products. Identify target user personas and markets for integration of applications and AI into customer workflows. Clearly articulate value-propositions to drive adoption and relevance. Build cost/pricing models, partner vs build vs buy strategy. Work closely with customers, architects, engineers, and external vendors to prioritize deliverables and ensure releases meet roadmap content and timelines. Work with cross-functional teams to innovate and change the way software is deployed and commercialized to rapidly bring to market new solutions that help unlock, correlate, and analyze the clinical data that powers todays intelligent, precision healthcare. Be equally comfortable digging into business and commercial requirements and digging into operational and deployment strategies with service, architecture and design teams Be flexible, excel when faced with ambiguity and thrive in a fast-paced environment. Have a bias for acting now - then iterate. Required Qualifications Bachelors degree in Engineering, Computer Science or related field 10+ years of managing and/or activating products in a related industry including hands-on management of large, cross-functional software and system efforts Proven experience in identifying customer s business and strategic needs, concerns, and desires to drive value-adding product capabilities Desired Characteristics Master s Degree in Engineering, Computer Science or related field 3+ years of hands-on software engineering experience Experience leading and/or managing efforts in a distributed systems environment Hands-on experience with Service-Oriented Architecture (SOA) and Cloud solutions Familiarity with Healthcare workflows and deployment scenarios Real world experience with portfolio and investment decisions to balance customer needs, existing product requirements and long term enterprise differentiation Strong written and verbal communication skills Ability to excel in a fast-paced, startup-like environment
Posted 3 months ago
5 - 9 years
11 - 15 Lacs
Chennai, Trivandrum, Bengaluru
Work from Office
Senior Clinical Data Science Lead- Office based- Chennai 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 Senior Clinical Data Science Lead to join our diverse and dynamic team. As a Senior Clinical Data Science Lead at ICON, you will play a pivotal role in leading the analysis, interpretation, and management of clinical data to drive the success of our clinical trials. You will contribute to the advancement of innovative treatments and therapies by overseeing data science initiatives and ensuring data quality and integrity across studies. What You Will Be Doing: Leading the development and implementation of clinical data management strategies to optimize data collection, analysis, and reporting. Collaborating with cross-functional teams to ensure the accurate integration of data science techniques into clinical trial designs. Overseeing the analysis of clinical data to provide actionable insights that inform study decisions and outcomes. Providing strategic guidance on data governance, quality control, and compliance with regulatory requirements. Establishing partnerships with key stakeholders to leverage the latest advancements in data science and technology in clinical research. Your Profile: Advanced degree in a relevant field such as data science, biostatistics, or life sciences. Extensive experience in clinical data science, with a strong focus on data management and analysis in clinical trials. Strong leadership skills and a proven ability to manage cross-functional teams in a fast-paced, matrix environment. Expertise in data analysis tools, statistical software, and data visualization techniques. Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive change in a complex organization. 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, diversity, inclusion belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. Were proud of our diverse workforce and the work we ve done to become a more inclusive organisation. 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 requirementsWe 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 EmployeePlease click here to apply
Posted 3 months ago
4 - 8 years
10 - 14 Lacs
Chennai, Trivandrum, Bengaluru
Work from Office
Senior Clinical Data Science Lead- Office based- Chennai 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 Senior Clinical Data Science Lead to join our diverse and dynamic team. As a Senior Clinical Data Science Lead at ICON, you will play a pivotal role in leading the analysis, interpretation, and management of clinical data to drive the success of our clinical trials. You will contribute to the advancement of innovative treatments and therapies by overseeing data science initiatives and ensuring data quality and integrity across studies. What You Will Be Doing: Leading the development and implementation of clinical data management strategies to optimize data collection, analysis, and reporting. Collaborating with cross-functional teams to ensure the accurate integration of data science techniques into clinical trial designs. Overseeing the analysis of clinical data to provide actionable insights that inform study decisions and outcomes. Providing strategic guidance on data governance, quality control, and compliance with regulatory requirements. Establishing partnerships with key stakeholders to leverage the latest advancements in data science and technology in clinical research. Your Profile: Advanced degree in a relevant field such as data science, biostatistics, or life sciences. Extensive experience in clinical data science, with a strong focus on data management and analysis in clinical trials. Strong leadership skills and a proven ability to manage cross-functional teams in a fast-paced, matrix environment. Expertise in data analysis tools, statistical software, and data visualization techniques. Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive change in a complex organization. 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, diversity, inclusion belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. Were proud of our diverse workforce and the work we ve done to become a more inclusive organisation. 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 requirementsWe 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 EmployeePlease click here to apply
Posted 3 months ago
0 years
0 Lacs
Delhi NCR, Bengaluru, Kolkata
Hybrid
We are seeking a highly organized and detail-oriented Clinical Trial Coordinator (Fresher) to join our dynamic clinical research team. In this role, you will play a crucial part in ensuring the successful execution of our clinical trials from start to finish. You will collaborate with a multidisciplinary team of researchers, investigators, and study personnel to coordinate all aspects of clinical trial operations. Key Responsibilities: Study Coordination: Coordinate the day-to-day activities of assigned clinical trials, ensuring adherence to protocols, timelines, and regulatory requirements. Site Management: Assist in site selection, initiation, monitoring, and close-out activities. Documentation: Maintain accurate and complete study records, including case report forms, source documents, and regulatory binders. Communication: Facilitate effective communication between study sites, sponsors, investigators, and internal team members. Data Management: Ensure timely and accurate data collection, entry, and query resolution. Regulatory Compliance: Ensure compliance with all applicable regulations, guidelines, and standard operating procedures. Patient Recruitment: Support patient recruitment and retention efforts. Training: Provide training and support to study staff on study protocols and procedures. Quality Assurance: Participate in quality control activities and internal audits. Qualifications and Skills: Education: Bachelor's degree in life sciences, nursing, or a related field. Experience: Fresher or recent graduate with a strong interest in clinical research. Knowledge: Basic understanding of clinical research principles and Good Clinical Practice (GCP). Skills: Excellent organizational, communication, and interpersonal skills.
Posted 3 months ago
0 years
0 Lacs
Ahmedabad, Kochi, Kolkata
Hybrid
Job Type- Fresher or Internship level Clinical Research Associates manage clinical trials and studies pertaining to biotechnological and pharmaceutical products, drugs and procedures. A Clinical Research Associate, also known as a CRA, conducts research to ensure these products are safe. Responsibilities: 1. Assist in Protocol Development: Collaborate with the clinical research team to contribute to the development and review of clinical trial protocols. 2. Site Identification and Selection: Participate in the process of identifying and selecting clinical trial sites by conducting feasibility assessments. 3. Regulatory Compliance: Support the team in ensuring regulatory compliance throughout the clinical trial process. Assist in the preparation and submission of regulatory documents to appropriate health authorities. 4. Site Initiation: Assist in the initiation of clinical trial sites by coordinating site training activities and ensuring that all necessary documentation is in place. 5. Monitoring and Data Collection: Work closely with clinical research associates and investigators to monitor and collect data during the clinical trial. Assist in ensuring data accuracy, completeness, and adherence to protocol. 6. Adverse Event Reporting: Contribute to the process of monitoring and reporting adverse events, ensuring compliance with regulatory requirements. 7. Study Close-Out: Participate in the close-out activities of clinical trials, including the collection of essential documents and finalizing study reports. 8. Collaboration and Communication: Work collaboratively with cross-functional teams, including clinical operations, data management, and regulatory affairs. Communicate effectively with investigators, site staff, and study sponsors. 9. Documentation and Record Keeping: Maintain accurate and up-to-date documentation of all activities performed during the internship. Contribute to the development and organization of the trial master file. 10. Learning and Development: Actively engage in learning opportunities provided during the internship to enhance knowledge of clinical research processes and industry regulations. Qualifications: Currently enrolled in a Bachelor's or Master's degree program in a related field (e.g., Life Sciences, Pharmacy, Nursing, etc.). Excellent communication and interpersonal skills. Detail-oriented with strong organizational and time management abilities. Ability to work independently and as part of a team.
Posted 3 months ago
1 - 6 years
4 - 9 Lacs
Bengaluru
Work from Office
This project is based in the neonatal intensive care unit. It recruits neonates (later preterm and term) who are at risk of acute kidney injury and monitors them using a near-infrared spectroscopy device (NIRS). The machine is attached to the neonate and the readings are recorded and stored. Other demographic and clinical data variables are documented. All neonates enrolled in the study are followed up at 3, 6 and 12 months for kidney function parameters. Project Research Scientist-1 (Non Medical) Position Starting: 15th March, 2025 No. of Vacancy: one Preferred Qualifications: First class post graduate degree including integrated PG degrees Second class postgraduate degree including integrated PG degrees with PhD Basic computer operating skills Salary: 56,000 +16,800 HRA (total 72,800 pm) Language : English, Kannada, Hindi Preferable Tamil, Telugu Experience: At least 1 year experience of working in a biomedical research project Last Day for Receiving Application: 10th March, 2025 Roles and Responsibilities: To ensure all eligible neonates are included in the study To ensure complete data collection of all neonates recruited in the study. To maintain the research documents of every enrolled subject. Data entry of all the data related to the study To communicate with families during the hospital stay, and at discharge and liaise between the research team and the patient s families To communicate with families and liaise with them to ensure follow-up during the first year after discharge To support families with getting appointments for follow-up and the investigations to be done at follow-up To support timely report submission to ICMR and IEC. To maintain the documents and bills related to the expenses of the study Interested candidates may send their Resume to: The Principal Investigator ICMR NIRSneo Project
Posted 3 months ago
2 - 3 years
5 - 6 Lacs
Bengaluru
Work from Office
A Multicentre multi-method study for development and Validation of a Deprescribing Tool, followed by Implementation and evaluation of its impact, facilitators and barriers. The study will be done in three main steps 1. Formative research using Systematic/Rapid Review, Mixed methods study and a qualitative study. The intervention components will be then prioritized using Delphi process and will be locally customised. 2. The IP will be evaluated through a cluster RCT for effectiveness, implementation research outcomes and cost effectiveness. 3. In this step, we will disseminate the findings and learnings of the study through symposia s and we will conduct effective policy dialogues with key stakeholders. Project Technical Support- II Position Starting: 15th March, 2025 No. of Vacancy: one Preferred Qualifications: Three years Graduate in relevant subject / field + three years experience or PG in relevant subject / field For Engineering / IT /CS first class four years Graduate Degree + Three years Experience Salary: Rs.35,560 /- (Including HRA of 27%) Language : Good communication in English Experience: Two to three years experience in a recognized institute/hospital Knowledge of Computer Applications Experience in prescription data collection/analysis or research project Experience in Clinical data collection, including interviews/surveys Last Day for Receiving Application: 10th March, 2025 Roles and Responsibilities: Overall coordinate the study; closely work with the Project Scientist and investigators.
Posted 3 months ago
0 - 3 years
2 - 5 Lacs
Vijayawada
Work from Office
anutech solutions is looking for CLINICAL DATA EXECUTIVE to join our dynamic team and embark on a rewarding career journey. An Engineer in End User Support (EUS) is responsible for providing technical support and assistance to end users within an organization. They play a crucial role in ensuring that end users have the necessary tools, resources, and technical guidance to effectively carry out their work. Here is a general job description for an Engineer - EUS : Responsibilities : Technical Support : Provide technical support and assistance to end users via various channels, including in-person, remote support tools, and helpdesk ticketing systems. Respond to user inquiries, troubleshoot hardware and software issues, and resolve technical problems in a timely manner. Hardware and Software Setup : Install, configure, and maintain end-user hardware, including desktop computers, laptops, peripherals (printers, scanners), and mobile devices. Install and configure software applications, operating systems, and updates as needed. User Account Management : Create, manage, and maintain user accounts, permissions, and access rights for various systems and applications. Assist with password resets, account provisioning, and access requests. System Monitoring and Maintenance : Monitor system performance, availability, and security. Perform routine maintenance tasks, such as software updates, system backups, and antivirus scans, to ensure system stability and data protection.
Posted 3 months ago
5 - 7 years
7 - 9 Lacs
Chennai, Pune, Delhi
Work from Office
We are looking for a Team lead/ Manager/ senior medical advisor/reviewer proficient in all aspects of clinical and post-marketing drug safety. Responsibilities: Clinical Phase: Lead as a medical monitor/Medical expert Medical Monitoring experience is a must and the ability to effectively communicate with the clients, attend investigator meetings as required and provide support to sites regarding protocol or possible drug interactions is essential. Review and provide feedback on study protocols as needed. Deliver therapeutic area training for all case processing team. May require 24/7 availability depending on the client needs for possible queries or protocol deviations resulting in potential harm to patients. Drafting medical monitoring plans (MMP) and ensuring compliance. Reviewing adverse events (AEs) reported by study sites, assessing their severity, and determining appropriate actions (like dose adjustments or trial discontinuation). Make assessments on SUSAR reportability. Perform the review and interpret clinical data, ensure protocol compliance and draft monthly reports for the clients (with presentation at periodic meetings if required). Develop and update current training materials in line with GCP and GVP requirements for medical review of all cases. Post-Marketing (Pharmacovigilance): Lead the medical reviewers Medical review of the ICSRs (Spontaneous, literature) Support in causality, medical assessment, benefit-risk evaluation of the medicinal product. Mentor junior medical reviewers and perform additional review of cases to ensure competency. Provide feedback and ongoing workshops to develop the medical reviewers. Participate in audits and inspections as required Ensure understanding of client needs, conventions and ensure expectations are met and exceeded Training and mentoring other team members Required Education: MBBS, or MD (Doctor of Medicine) Required Experience : Experience in leading medical review teams Client communications Safety Database experience Minimum 10 years experience working for service providers or pharmaceutical company At least 5-7 years of experience as a Medical Monitor or clinical phase Required Technical Skills: Microsoft package Pharmaceutical background - strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety. Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment. Working knowledge of EDC systems Good Medical knowledge and Pharmacology understanding
Posted 3 months ago
5 - 11 years
12 - 16 Lacs
Bengaluru
Work from Office
At GE Healthcare, we are dedicated to revolutionizing healthcare through advanced data-driven solutions. Our Data Platform team is building a state-of-the-art Data Lakehouse to empower acute care providers with actionable insights. We are seeking an Engineering Manager who will lead this critical initiative and be instrumental in shaping the future of healthcare analytics. The Acute Care Data Platform team is working on GE HealthCare s next generation distributed data platform. It will provide mission critical real-time data about patients and medical devices in acute care settings where patients can be the most vulnerable. As the Engineering Manager for the Data Lakehouse team, you will lead a talented group of Data Engineers and Analysts focused on designing and implementing a cloud-based, scalable, and performant Data Lakehouse tailored for acute care settings. You will promote Agile methodologies, foster a culture of continuous improvement, and champion DevOps practices, all while embodying the principles of Servant Leadership. Key Responsibilities: As the Engineering Manager for our Acute Care Data Platform, Data Lakehouse team you will be responsible for: Team Leadership: Lead, mentor, and manage a full-stack team of data professionals (including data engineers, architects, product owners and others), fostering an exciting, collaborative and innovative environment. Recruit top talent and support career development through coaching, performance feedback, and professional growth opportunities. Data Lakehouse Development: Oversee the architecture, design, and implementation of the Acute Care Data Lakehouse which integrates structured and unstructured acute care data from multiple internal and external sources. Ensure data quality transparency, compliance to various geo-political data laws and regulations as well as consistency, discoverability and reliability throughout the data lifecycle. Agile Practices: Advocate for Agile methodologies within the team, facilitating sprint planning, daily stand-ups, retrospectives, and continuous feedback cycles. Develop / Implement Agile KPIs to demonstrate adherence and show team performance improvements over time. Collaborate closely with product owners and stakeholders to define, prioritize, and deliver features that meet business needs. DevOps and Automation: Implement and refine DevOps practices to streamline integration and deployment pipelines in order to enhance operational efficiency. Champion automation of data workflows, CI/CD, and monitoring processes to ensure high availability and performance. Servant Leadership: Serve as an advocate for your team, removing obstacles and empowering team members to take ownership of their work. Foster a safe environment where team members feel valued and encouraged to innovate, share ideas, and contribute to decision-making processes. Practice active listening and provide support to team members in both professional and personal challenges, emphasizing a people-first approach. Stakeholder Collaboration: Work closely with cross-functional teams, including data scientists, product managers, and clinical healthcare professionals, to understand data requirements and inform decision-making. Communicate effectively with technical and non-technical stakeholders to ensure alignment and transparency. Continuous Improvement: Foster a culture of continuous improvement, encouraging experimentation and adoption of best practices in data engineering and analytics. Stay current with industry trends, technologies, and best practices related to data platforms and acute care systems. Desired Qualifications: Bachelor s or master s degree in computer science, Data Engineering, Information Systems, or a related field. 5+ years of experience in Data Engineering or Analytics, with a proven track record of delivering large-scale data solutions. 2+ years of experience in a management role, successfully leading engineering teams in an Agile environment. Strong knowledge of data technologies, including data warehousing, ETL processes, and cloud platforms (e.g., AWS, Azure, GCP). Proficiency in programming languages such as Java, Python, SQL, or Scala. Solid understanding of DevOps principles, CI/CD pipelines, and automation tools. 3+ years experience in HealthCare, life sciences, or clinical data technology. Excellent communication, interpersonal, and problem-solving skills. Passion for healthcare data, analytics, and improving patient outcomes. Why Join Us: Be part of a mission-driven team dedicated to enhancing the quality of acute care through data. Opportunity to shape and influence the future of healthcare analytics and decisions. Collaborative and supportive work culture that values personal and professional growth. Competitive salary, comprehensive benefits, and flexible work arrangements.
Posted 3 months ago
2 - 8 years
4 - 10 Lacs
Chennai, Pune, Delhi
Work from Office
Description Statistical 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 Uses SAS or other software to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. Works to ensure that outputs meet quality standards and project requirements. Performs validation programming and works with other Statistical Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings. Keeps project team members informed of programming progress and issues requiring their attention. Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs ensuring inspection readiness. Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. May develop specifications for datasets and outputs according to statistical and Sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming, accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others. Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. Completes project programming activities within timeframe allotted by Lead Statistical Programmer and/or management. May act as the Lead Statistical Programmer, directs the programming activities of other programming personnel and monitors progress on programming deliverables. Assists with the transfer of deliverables. Performs other work-related duties as assigned. Minimal travel may be required. Qualifications What we re looking for Undergraduate Degree, preferably in a scientific or statistical discipline; In lieu of degree, an equivalent combination of education and demonstrated programming experience. Proficiency in programming in SAS or other required software, preferably in a clinical trial environment. Requirement - R Programmer(s): External Anonymized Dataset production Require Statistical Programmer II (2-4yrs); Sr Statistical Programmer (5-8yrs); Principal Stat Programmer (8yrs above) relevant experience in Clinical SAS SAS/SQL, R programming skills Hand on experience in Anonymization of Clinical Datasets will be given weightage Experience in Github / GitLab preferred SDTM / ADaM Theoretical knowledge and SDTM hands on experience will be value added. Excellent written and verbal communications skills. Capable Programmer(s) with proven R (R Studio) skills. SQL experience will be useful to write conditions for data redactions. As code is managed using Git\Gitlab any experience in this area will also be useful. Some knowledge of Python may be useful e.g. to look at code / outputs. Good eye for detail to review clinical data pre- and post-processing from the anonymization ruleset tool. This includes review for Personal Protected Information (PPI) based on the ruleset provided or variables/observations do not present in the ruleset. Knowledge of the drug development process (Phase I through IV) and general regulatory requirements. study lead experience and capable of managing multiple studies. Excellent written and verbal communication skills. Ability to read, write, speak, and understand English. .
Posted 3 months ago
1 - 2 years
3 - 4 Lacs
Bengaluru
Work from Office
What you ll do As a Regional Medical Advisor, you will be responsible to engage medical / scientific experts in in-depth medical / scientific product or disease area discussions, and deliver presentations in a non-promotional scientific context as determined by global / local Medical Affairs plans (and in line with the TA and brand strategy). You also act as an educational resource to internal stakeholders, providing medical / scientific knowledge, training, and support to internal stakeholders on AZs marketed products and compounds in development. Key Duties and Accountabilities Develop a strong local KOL network Jointly develop the market/local KOL engagement plan with other MSLs, identify and segment KOLs according to their scientific interest and related affiliations and build the KOL network pre- and post-launch. Engage with KOLs using deep scientific expertise and knowledge of AZs marketed products and compounds in development. Support clinical trials and investigator engagement Provide support to the Global Medicines Development (GMD) team on clinical site identification and patient recruitment for Phase I, II & III studies. Create opportunities to complement existing flow of clinical data for AZs products in line with stakeholder needs, i.e., by identifying pre-clinical, clinical and post-marketing study investigators in alignment with the Development Plan, and engaging in discussions on the ISS Program with potential investigators. Provides support to the internal Global Medicines Development (GMD) team on clinical site identification Engage in scientific exchange Engage with the medical / scientific community in a highly credible, balanced/objective way, representing AZs dedication to and excellence in science Prepare and give relevant high level medical science presentations at congresses, symposia and scientific meetings Provide support for content development, agreeing agendas and delivery of effective clinical presentations e.g., advisory boards Help to develop medical science literature, i.e., write, edit and publish scientific articles and papers Build capability of other internal and external stakeholders Act as a subject matter expert for external clinical / scientific stakeholders Help to build stakeholders understanding about potential solutions to their needs, e.g., extended access programs , approaches to diagnostic testing, etc. Respond to unsolicited stakeholder inquiries and provide focused, balanced and objective clinical / scientific information that supports the safe and appropriate use of AstraZeneca s currently available products, including questions regarding off-label uses, and products under development, when appropriate to do so Act as an educational resource to internal stakeholders Support the sales force and other departments with medical science information (e.g., disease and treatment) and training Effectively gather, analyze , synthesize and forward relevant new knowledge and meaningful insights about the external scientific / medical / regulatory environment to internal colleagues Provide internal stakeholders with actionable items related to brand strategy and GMD based on stakeholders perspectives Review promotional and scientific documents for content accuracy and compliance Be compliant Successfully complete all training requirements, including product examinations and certifications Comply with all external regulations and internal policies Ensure understanding of the AZ Global MSL Guide, AZ Code of Ethics, External Interactions Policy and Standards, and Publications Policy along with relevant local industry codes of conduct. Essential for the role MBBS/MD-Pharmacology Sound knowledge of basic research, drug discovery, drug development, clinical environment Experience in pharmaceutical industry, health care or research environment Proven ability to understand, assimilate and communicate scientific information Proven track record to engage and develop lasting relationships with key thought leaders in complex clinical environments Existing network within the TA ecosystem, with proven ability to influence decision making processes in an ecosystem with multiple influential stakeholders Proven demonstration of successful working in complex cross functional teams Good Planning and Organizational Skills Excellent Scientific knowledge Problem solving and Decision making skills Ability to develop Strategic Partnerships Demonstrate AZ Values consistently Desirable for the role Relevant 1-2 years of experience in Pharma industry preferably in Oncology. Open to look at MD-Pharmacology freshers
Posted 3 months ago
2 - 7 years
5 - 10 Lacs
Chennai, Pune, Delhi
Work from Office
Description Principal Statistical Programmer 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. WhyBecause 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 Uses SAS, or other software, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. Works to ensure that outputs meet quality standards and project requirements. Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings. Keeps project team members informed of programming progress and issues requiring their attention. Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness. Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus. Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. Accountable for on-time delivery across concurrent programming deliverables. Negotiates programming timelines and provides risk mitigation plans for projects or programs, as needed. Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions. Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables. Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities. Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor. Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process. Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for complex programming questions. Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs), guidelines, policies, and/or procedures. Contributes technical expertise to the development of programming tools and macros for standardization and efficiency. When serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents. (i.e. DEFINE.XML) When serving as a subject matter expert for CDISC and other industry and regulatory requirements, actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards. Transfers deliverables. Performs other work-related duties as assigned. Minimal travel may be required Qualifications What we re looking for Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience. Extensive programming experience in SAS or other required software, preferably in a clinical trial environment as demonstrated by the ability to lead multiple complex and/or global projects with teams of statistical programmers. Requirement - R Programmer(s): External Anonymized Dataset production Require Statistical Programmer II (2-4yrs); Sr Statistical Programmer (5-8yrs); Principal Stat Programmer (8yrs above) relevant experience in Clinical SAS SAS/SQL, R programming skills Hand on experience in Anonymization of Clinical Datasets will be given weightage Experience in Github / GitLab preferred SDTM / ADaM Theoretical knowledge and SDTM hands on experience will be value added. Excellent written and verbal communications skills. Capable Programmer(s) with proven R (R Studio) skills. SQL experience will be useful to write conditions for data redactions. As code is managed using Git\Gitlab any experience in this area will also be useful. Some knowledge of Python may be useful e.g. to look at code / outputs. Good eye for detail to review clinical data pre- and post-processing from the anonymization ruleset tool. This includes review for Personal Protected Information (PPI) based on the ruleset provided or variables/observations do not present in the ruleset. Knowledge of the drug development process (Phase I through IV) and general regulatory requirements. study lead experience and capable of managing multiple studies
Posted 3 months ago
3 - 6 years
5 - 9 Lacs
Chennai, Pune, Delhi
Work from Office
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. WhyBecause 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 Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. Per the Clinical Monitoring/Site Management Plan (CMP/SMP): o Assesses site processes o Conducts Source Document Review of appropriate site source documents and medical records o Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records o Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines o Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture o Verifies site compliance with electronic data capture requirements May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. Understands project scope, budgets, and timelines for own and others activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets. May act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements. Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates, and may, with supervision, lead, global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. May provide training or mentorship to more junior level CRAs. May perform training and sign off visits for junior CRA staff, as assigned. May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead (COL), or operational line manager. For Real World Late Phase (RWLP), the Sr. CRA I will use the business card title of Sr. Site Management Associate I. Additional responsibilities include: o Site support throughout the study lifecycle from site identification through close out o Knowledge of local requirements for real world late phase study designs o Chart abstraction activities and data collection o As required, collaborate and build relationships with Sponsor and other affiliates, medical science liaisons and local country staff o Identify and communicate out of scope activities to Lead CRA/Project Manager o Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations o Identify operational efficiencies and process improvements o Develop country level informed consent forms o Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared o Participate in bid defense meetings Qualifications QUALIFICATION REQUIREMENTS Bachelor s degree or RN in a related field or equivalent combination of education, training and experience Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements Must demonstrate good computer skills and be able to embrace new technologies Excellent communication, presentation and interpersonal skills. Basic level of critical thinking skills expected. Ability to manage required travel of up to 75% on a regular basis
Posted 3 months ago
5 - 8 years
4 - 8 Lacs
Bengaluru
Work from Office
Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Sr Analyst Qualifications: BE/BTech/MCA Years of Experience: 5 to 8 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, Clinical Automation, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Automation Team focuses on the development and implementation of innovative concepts and application for out clients across different accounts in Operations. The team is responsible for designing and implementing highly interactive, scalable web apps and prototypes at Enterprise level. The team is responsible for collaborate with frontend and backend developers to define API requirements and Ensure API security and authentication mechanisms are robust.You will be expected to develop and implement complex APIs based on requirements using different tools/techs such as .Net, Java, PL/SQL, C# or any other applicable systems. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Agility for quick learning Ability to work well in a team Bachelor's degree in computer science, Information Technology, Engineering or any computer related discipline. Work experience of at least 3 years in relevant industries (Financial Services, Network, Utilities, Health Care, Marketing, Pharma, Retail etc.). Work experience of at least 4 years in designing, coding, APIs, testing, debugging, documenting, and implementing enhancements and fix solutions. Work experience in Implementing APIs based architecture frameworks. Aptitude to learn, think creativity to solve real world business problems, and work in a global collaborative team environment. Proficient verbal and written communication skills in English. Roles and Responsibilities: Work as a technical lead to architect and develop innovative concepts and applications for our clients across different accounts in Operations. Design and implement highly interactive, scalable web apps and prototypes at Enterprise level. Build and modify high-performance APIs and Monitor API performance and troubleshoot issues promptly. Implement APIs based on architecture frameworks and guidelines. Work with DevOps engineers to integrate new code into existing continuous integration (CI) and continuous delivery/deployment (CD) pipelines. Able to lead Automation initiatives within his account. Work closely with the team and client to understand requirements and guiding them to deliver the most effective solution. Participate in the development of automation solutions, from prototyping new functionality and technologies to integrating them in our overall products and offerings, thus developing expertise and skills in this domain. Collaborate with frontend and backend developers to define API requirements and Ensure API security and authentication mechanisms are robust. You should be able to pilot and deploy automation solutions at scale. Partner with the testing team to ensure applications/components are fully functional. Oversee and fix any defects or performance problems discovered in testing. Participating in analyses of requirements as well as functional design whenever necessary. Be involved in the design of the solution. Performing design, coding, application maintenance and testing activities. Take ownership of the successful implementation of the solution. Interact with the end client as required to ensure the solution is implemented as per requirements. Deliver code to time and quality expectations. Fully unit test developed solutions. Qualifications BE,BTech,MCA
Posted 3 months ago
5 - 8 years
7 - 10 Lacs
Bengaluru
Work from Office
Skill required: Clinical Data Services - Clinical eTMF Management Designation: Clinical Data Svs Sr Analyst Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 5 to 8 years Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects. You will be expected to use strategies, methods and tools used throughout the lifecycle of the clinical trial regulated content. Includes data review and accuracy checks of trial master file table of contents, head quarters, initial full protocol package and amended FPP checklists, end of trial checklists, essential document reconciliation, and clinical study report appendices. What are we looking for? Clinical eTMF Management Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualifications Bachelor of Pharmacy,Master of Pharmacy
Posted 3 months ago
8 - 10 years
10 - 15 Lacs
Bengaluru
Work from Office
Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Specialist Qualifications: Any Graduation Years of Experience: 8-10 Yrs What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.You will be expected to develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for? You will be expected to develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualifications Any Graduation
Posted 3 months ago
3 - 5 years
5 - 7 Lacs
Bengaluru
Work from Office
Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Analyst Qualifications: BE,MCA,BTech Years of Experience: 3 - 5 Years Language - Ability: English - Advanced What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.In this role, you will be expected to develop clinical trial reports using SAS/ J-review / Congnos / SQL / PLSQL as per the study requirement. What are we looking for? SAS Clinical SQL Databases Strong analytical skills Collaboration and interpersonal skills Written and verbal communication Ability to meet deadlines Adaptable and flexible Clinical Database Programming Experience in any clinical report development using PL/SQL or SAS JReview experience is added advantage. Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualifications BE,MCA,BTech
Posted 3 months ago
7 - 11 years
9 - 13 Lacs
Bengaluru
Work from Office
Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Specialist Qualifications: Bachelor of Pharmacy Years of Experience: 7 to 11 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. The role may require you to identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The role may also need expertise in managing clinical data management projects. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Roles and Responsibilities: Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred. o Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. o Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders. o Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery. o Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred. o Good analytical and communication skills. Qualifications Bachelor of Pharmacy
Posted 3 months ago
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The job market for clinical data professionals in India is experiencing a significant growth as the healthcare industry continues to expand and evolve. With the increasing importance of data-driven decision making in healthcare, the demand for skilled individuals who can analyze and interpret clinical data is on the rise.
These cities are known for their thriving healthcare and pharmaceutical industries, making them hotspots for clinical data job opportunities.
The average salary range for clinical data professionals in India varies based on experience and location. Entry-level positions typically start at around INR 3-5 lakhs per annum, while experienced professionals can earn upwards of INR 10-15 lakhs per annum.
A typical career path in clinical data might involve starting as a Clinical Data Analyst, then progressing to roles such as Clinical Data Manager, Senior Data Scientist, and eventually reaching positions like Director of Data Science or Chief Data Officer.
In addition to proficiency in clinical data analysis, professionals in this field are often expected to have skills in data visualization, statistical analysis, programming languages such as R or Python, and knowledge of healthcare regulations and standards.
As you explore opportunities in the clinical data field in India, remember to showcase your expertise, stay updated with industry trends, and practice your technical skills. With the right preparation and confidence, you can excel in your job search and secure a rewarding career in clinical data. Good luck!
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