213 Clinical Data Jobs - Page 5

The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of serious adverse event reports within the context of the product s safety profile as well as other products within the same therapeutic area. Also, this position plays a greater role as a senior technical leader and participate in matrix management activities including preparation or participation in evaluating safety issues and preparation of aggregate reports in collaboration with the Post-Marketing Safety Experts and Safety Surveillance Group and be responsible for surveillance activities for selected products. Essential Functions Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported Perform medical safety review of the protocol, Investigative Brochure, and/or Case Report Forms (CRFs) for appropriate safety content and data capture, as applicable Provide aggregate reviews of safety information, including but not limited to clinical data, postmarketing, literature review and observational studies to maintain oversight of a product s safety profile (e.g: DSUR, RMP, PBRER, ad hoc regulatory reports etc) Ensure service delivery from productivity, compliance and quality perspective within regulatory /contracted timelines. Lead and participate in the initiatives taken for the same from team delivery perspective Provide therapeutic area/pharmacovigilance issue guidance in the context of leading/managing other safety team members in single case assessment. Ensure update of watch list, list of expectednsess, labeling list/RSIs etc for the assigned products and develop such additional capabilities within the team Lead, drive and participate in training activities, product transitions, audit preparation and knowledge exchange initiatives Review and sign off on the Project Safety Plan and Medical Monitoring Plan per medical safety scope agreed in contract, as applicable Attend project meetings, medical safety team meetings, and represent safety and clinical data review findings during client meetings, as applicable Act as Lead Safety Physician, or additional team support, and/or back up on assigned projects as applicable Provide medical escalation support for medical information and EU Qualified Persons for Pharmacovigilance projects, as applicable 24 hour medical support as required on assigned projects Maintain awareness of medical safety-regulatory industry developments Provide support and participate in signal detection efforts, e.g. strategy meetings etc. as applicable Qualifications Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education. Req Three (3 years) experience practicing clinical medicine after award of medical degree. Graduate, and/or Residency training can qualify for clinical practice experience Req Two (2) years of pharma experience Pref Sound knowledge of Medicine In-depth knowledge of applicable global, regional and local clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Knowledge of Pharmacovigilance- ICSR and Aggregate reports In-depth knowledge of departmental standard operating procedures (SOPs) Skill in use of multiple safety databases Adequate Computer skills, especially Microsoft word, excel & PowerPoint Good communication skills- verbal and written Ability to establish and maintain effective working relationships with managers, co-workers, investigative site staff, clients and regulatory agency representatives Ability to establish and maintain effective working relationships with coworkers, managers and clients A valid medical license, or equivalent, from the country or region in which he/she resides and works Pref

Hi, We are hiring for Leading ITES Company for Lead Study Data Manager Profile Skills: a) Minimum 5 Years of Core Clinical Data Management Experience with minimum 1 year of experience of leading a clinical trial. . b) Experience on Study Conduct and Close Out c) Any Graduate JOB DECSRIPTION: Need exposure of Inform or Medidata Rave database Responsible & Accountable for the assigned study conduct activities, in clinical trials Validate clinical trial data to ensure consistency, integrity and accuracy based on project specific guidelines. Generate data queries based on validation checks or raise Manual queries to resolve data inconsistencies. To perform reconciliation of data from external sources (e.g. Serious Adverse Events, IWRS, Central Laboratory). SPOC for the study communications Proactively highlight any risks associated with the study along with the mitigation plan. Establish a partnership with the stakeholders at operational level to work seamlessly to deliver the assigned project/activity as per timelines. Identify process Improvement opportunities and to ensure learning is shared Ensure deliverables and/or agreed activities/tasks with customer. are completed with the expected quality. Have worked on Study set-up, Study Conduct and Study Close out for various therapeutic areas. Have also worked on writing edit check specification, CRF completion guidelines and review and corrections of set up documents for different versions. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 184 b) For Position in Pune Search : Job Code # 185 c) For Position in Bangalore Search : Job Code # 186

Hi We are hiring for Leading ITES Company for Clinical Data Manager Profile. Role & responsibilities: Candidate should have 2-5 years of experience of CDM with experience in Conduct Scope of work Perform day-to-day Clinical Data Management activities. Work and coordinate with the team to perform data management activities and deliver an error-free quality database in accordance with the data management plan and regulator standards. Read and understand the study protocol and the timelines. Perform test data entry in the TEST environment, data listing review, data reconciliation, and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate. Perform external checks to handle manual discrepancies and action the same. Ensure an error-free, quality data with no open queries. Escalate any discrepancy in the clinical data to the study lead as appropriate. Timely completion of training Any other tasks deemed appropriate To perform medical data collection and analysis of Prostate Cancer Data using databases like HIS/ EMR (Electronic Medical Record) and Caisis, Rave, CDM (startup, closeout, conduct) Client interaction and meetings. Bringing up new ideas and executing new plans to cope with the backlog. Training new team members as and when required. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 205 b) For Position in Pune Search : Job Code # 206 C) For Position in Bangalore Search : Job Code # 207

Hi We are hiring for Leading ITES Company for Clinical Data Manager Profile. Role & Responsibilities: Candidate should have 2-5 years of experience of CDM with experience in Conduct Scope of work Perform day-to-day Clinical Data Management activities. Work and coordinate with the team to perform data management activities and deliver an error-free quality database in accordance with the data management plan and regulator standards. Read and understand the study protocol and the timelines. Perform test data entry in the TEST environment, data listing review, data reconciliation, and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate. Perform external checks to handle manual discrepancies and action the same. Ensure an error-free, quality data with no open queries. Escalate any discrepancy in the clinical data to the study lead as appropriate. Timely completion of training Any other tasks deemed appropriate To perform medical data collection and analysis of Prostate Cancer Data using databases like HIS/ EMR (Electronic Medical Record) and Caisis, Rave, CDM (startup, closeout, conduct) Client interaction and meetings. Bringing up new ideas and executing new plans to cope with the backlog. Training new team members as and when required. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 205 b) For Position in Pune Search : Job Code # 206 C) For Position in Bangalore Search : Job Code # 207

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

Develop and maintain interactions with Thought Leaders, appropriate HCPs, and access stakeholders, within a given geography to answer scientific, unsolicited product and HEOR related questions. MSLs will use various channels for interactions (1:1, group presentation; remote, etc). Develop and execute a medical interaction plan with Key accounts (Army, Railways, CGHS etc.) as per the needs of the stakeholders and the overall medical strategy. Effectively present information to HCPs and be able to respond to questions, ensuring medical accuracy and compliance with local procedures, ethical and legal guidelines and directives. Actively assess the medical landscape by meeting with Thought Leaders to understand their needs and expertise. Continuously update their own knowledge in treatment strategies, products, unmet medical needs, clinical trials and scientific activities. Understand the competitive landscape and actively prepare to address informational needs of customers. Collect and provide meaningful medical insights back to the medical and commercial organizations to be actioned in support of the strategy development. Report safety information, including adverse events, in accordance with BMS Standard Operating Procedures. Contribute to the Country Medical Plan Develop territory Field Medical plan and TL Interaction plans based on therapeutic area objectives and TLs needs. Execute certain medical plan activities as assigned. Adopt institution/account planning approach and contribute to cross-functional institution/account plans. Contribute to development and delivery of scientifically meaningful medical programs/projects in line with the local Medical and Field Medical plan. Provide Medical Support As necessary and appropriate, support the initial and ongoing medical/scientific area and product specific training and provide key scientific updates to internal stakeholders (e.g. Commercial, Regulatory, Pharmacovigilance, Legal, HEOR, Market Access). Provide scientific support at promotional meetings by presenting unbiased scientific and clinical data, by evaluating speakers and by giving support to BMS-contracted speakers. Support Clinical Trial Activities Support Interventional and Non-Interventional Research (NIR) studies (e.g. identification and assessment of potential study sites) to support patient recruitment and/or discussions around the safe and effective use of BMS investigational products, as agreed with local medical management and as defined by the study scope document. Provide recommendations and insights to clinical development team on study and site feasibilities within the therapeutic area based on knowledge of the field and through direct contacts with potential investigators, as agreed with local medical management. Actively support CRO sponsored studies as agreed with local medical management and as defined by the study scope document. Support HCPs in the ISR submission process as agreed with local medical management. Ensure that BMS Pharmacovigilance procedural documents are understood and applied by investigators of local studies, and alert appropriate BMS personnel to any identified Adverse Events. Contribute towards the Patient advocacy programs Support the implementation of the patient education programs in collaboration with the patient advocacy groups. Support the creation of patient education materials. Report safety information, including adverse events, in accordance with BMS Standard Operating Procedures Qualifications MBBS, MD, BDS, MDS 1-2 years of Field Medical experience in medical affairs is preferred. Candidates with experience in the Oncology and Haematology therapy area will be preferred. Languages Excellent English language skills - spoken and written. Experience And Knowledge Working in a scientific and/or clinical research environment Ability to work independently and act as a team player. Have an innovative mindset and approach. Translating scientific or clinical data into an understandable and valuable form to help physicians best serve their patients. Good communication and presentation skills to present scientific and/or clinical data to research or healthcare professionals Developing peer-to-peer relationships with TLs, scientists and other healthcare professionals Ability to quickly and comprehensively learn about new subject areas and environments. Disease area knowledge and an understanding of scientific publications Knowledge of clinical trial design and process Knowledge of the national healthcare and access environment Knowledge of HEOR core concepts (Health economic and outcome research) is a plus.

Primary Job Function Responsible for the integrity of the programming/computing solutions for multiple clinical trials (or equivalent) and/or publication activities. In collaboration with the Biostatistician and Senior Programmer, provide programming support to project-level programming deliverables and other adhoc programming requests. Roles and Responsibilities Ensure understanding and compliance with study and project programming standards. Responsible for development of programming specification. Create and Validate Safety and Efficacy Analysis Datasets in adherence with CDISC and client specific standards and maintain quality and accuracy. Create and Validate Safety and Efficacy Tables, Listings and Figures with high quality and accuracy. Create Study specific or general macros and finalize programming specifications/mock-ups. Adhere to programming specifications and study specific requirements, including completion and filing of required documentation. Plan and organize workload to ensure effective time management and adherence to project specific timelines. Proactively plan for and implement effective resource planning, task allocation and tracking of workload in accordance with agreed KPIs and quality standards Trouble-shoot and resolve programming issues in a timely and efficient manner. Ability to work independently and as part of a team environment. Strong problem solving and organizational skills, attention to detail, verbal and written communications skills Desired Candidate Profile Create and Validate Safety and Efficacy Tables, Listings and Figures with high quality and accuracy. Very strong SAS programming skills required in SAS/Base, PROC SQL,SAS/Stat, SAS Macros and SAS/Graph (Base and Advance SAS). Good communications and negotiation skills, ability to work well with others globally.

Should have 3+ experience in Clinical SAS.experience in Macros & ProcSQLknowledge of clinical trials.work in Shift.No WFH.Education Life Science Graduates( Bpharm, Mpharm, Pharm D, Bsc ( Biotechnology), BE (Biotechnology).Domain:Life Science

Hi, We are hiring for leading ITES Company for Narrative Medical Writing Profile . Job Description Graduate or post graduate in Pharmacy, Nursing or life sciences. Certification in Medical writing or Diploma in clinical research would be desirable. Preferred experience for the Author role: Preferably 1 to 2 years of experience in medical writing domain. Life science graduate with 1 to 3 years of experience Responsibilities of Author: 1. As per process requirement and assigned primary responsibility, support CSR patient narratives (draft and QC) 2. Ensure that the narratives are in accordance with the client SOPs, guidelines and agreed timelines and comply with client quality standards 3. Perform Quality check of the narratives according to the project specific checklist and against the source documents such as patient listing, concomitant medication listing, CIOMS form etc. and log defect in the defect tracker after analyzing the defect category 4. Attention to detail, work under stringent timelines on a need basis, and switch between different projects, as required 5. Be responsible for the quality and timelines of the deliverables as designated/allocated in the project. 6. Proactive communication with lead narrative writers to meet the narrative writing quality and timelines 7. Complete assigned training within stipulated timelines 8. Provide timely data (study tracker, quality metrics, billing numbers/effort hours) for preparing relevant (e.g. quality, TAT, effort hours, etc.) and project status updates, as defined by the client requirements Key Skills: a) Grad or PG in Nursing, Pharmacy or Life Sciences b) 1 to 2 years of experience in medical writing To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Noida Search : Copy and Paste the link below https://outpace.in/job/narrative-medical-writing-4/

Hi, We are hiring for Leading ITES Company for Lead Data Manager Profile. Job Description Perform day to day Clinical Data Management activities. Work and coordinate with the team to perform data management activities and deliver an error free quality database in accordance with the data management plan and regulator standards. Read and understand the study protocol and the timelines. Perform test data entry in TEST environment, data listing review, data reconciliation and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate. Perform external checks to handle manual discrepancies and action the same. Ensure an error free, quality data with no open queries. Escalate any discrepancy in the clinical data to the study lead as appropriate. Timely completion of trainings Any other tasks deemed appropriate To perform medical data collection and analysis of Prostate Cancer Data using databases like HIS/ EMR (Electronic Medical Record) and Cases Rave, CDM (startup, close out, conduct) Client interaction and meetings. Bringing up new ideas and executing new plans to cope with the back-log. Training to new team members as and when required. Key Skills: a) Minimum 3 years of Experience in leading clinical studies/ Clinical Data Management b) Hands on experience of Study Conduct and Close Out is must c) Any Graduate To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Pune Search : Job Code # 96 b) For Position in Nagpur Search : Job Code # 97

Hi We are hiring for Leading ITES Company for Clinical Data Manager Profile. Role & Responsibilities: Candidate should have 2-5 years of experience of CDM with experience in Conduct Scope of work Perform day-to-day Clinical Data Management activities. Work and coordinate with the team to perform data management activities and deliver an error-free quality database in accordance with the data management plan and regulator standards. Read and understand the study protocol and the timelines. Perform test data entry in the TEST environment, data listing review, data reconciliation, and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate. Perform external checks to handle manual discrepancies and action the same. Ensure an error-free, quality data with no open queries. Escalate any discrepancy in the clinical data to the study lead as appropriate. Timely completion of training Any other tasks deemed appropriate To perform medical data collection and analysis of Prostate Cancer Data using databases like HIS/ EMR (Electronic Medical Record) and Caisis, Rave, CDM (startup, closeout, conduct) Client interaction and meetings. Bringing up new ideas and executing new plans to cope with the backlog. Training new team members as and when required. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 205 b) For Position in Pune Search : Job Code # 206 C) For Position in Bangalore Search : Job Code # 207

Provide basic and some comprehensive data management expertise to the Clinical Data Management (CDM) team to provide efficient, quality data management products that meet customer needs. May also undertake team leadership activities under the supervision of the Data Operations Coordinator (DOC), Data Team Lead (DTL), or Functional Manager. Essential Functions Serve as a Data Operations Coordinator (DOC) for one protocol with less then 5 operations staff (excludes DE) or 15+ easy to moderately complex central laboratory studies, or serve in a leadership role in a specific data management task (eg, coder, tester or database designer for technologies that dont require extensive programming expertise) with guidance. May serve in the role of back-up to a DOC or DTL. May conduct data review. May write and resolve data clarifications. May lead database audit team. May develop and test databases and edit specifications. May perform testing of programming. May perform clinical data coding. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM team. Qualifications Bachelors Degree Clinical, biological or mathematical sciences, or related field Req Equivalent combination of education, training and experience in lieu of degree. Medical terminology exposure Excellent organizational, communication, leadership and computer skills Ability to exercise excellent attention to detail Ability to act independently and with initiative required to resolving problems Ability to establish and maintain effective working relationships with coworkers, managers and clients Medical terminology exposure Excellent organizational, communication, leadership and computer skills Ability to exercise excellent attention to detail Ability to act independently and with initiative required to resolving problems Ability to establish and maintain effective working relationships with coworkers, managers and clients

ql-editor "> Job Summary: The QC Reviewer is responsible for ensuring the accuracy, completeness, and compliance of laboratory and clinical data with regulatory guidelines, company policies, and industry standards. This role is critical in maintaining the integrity of research conducted within the organization, ensuring adherence to Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) guidelines. Key Responsibilities: Review raw data, study documentation, analytical reports, and other records to ensure accuracy and compliance with regulatory standards (FDA, EMA, ICH, etc.). Verify data integrity, consistency, and adherence to protocols, standard operating procedures (SOPs), and regulatory requirements. Ensure proper documentation practices (ALCOA+ principles) are followed in all QC-reviewed data. Identify discrepancies, deviations, and errors in reports and provide recommendations for corrective actions. Collaborate with laboratory analysts, study coordinators, and quality assurance teams to resolve issues related to data accuracy and compliance. Maintain proper documentation of QC reviews and findings, preparing detailed reports for management and regulatory bodies as required. Participate in audits (internal and external) and inspections by regulatory authorities. Provide training and mentorship to junior QC staff and other relevant team members on compliance and quality standards. Stay updated with regulatory changes and industry best practices to enhance the organization s quality standards. Qualifications Experience: Bachelor s/Master s degree in Life Sciences, Pharmacy, Chemistry, or a related field. 2-6 years of experience in a Quality Control/Quality Assurance role within a Contract Research Organization (CRO), pharmaceutical, or biotech industry. Strong knowledge of GLP, GCP, FDA, EMA, and ICH guidelines. Proficiency in reviewing analytical data, clinical study reports, and laboratory documentation. Excellent attention to detail and problem-solving skills. Strong communication and interpersonal skills to work effectively with cross-functional teams. Proficiency in Microsoft Office and Laboratory Information Management Systems (LIMS) is preferred. Preferred Skills: Experience with bioanalytical, clinical, or preclinical study reviews. Knowledge of electronic data capture (EDC) and regulatory submission processes. Ability to handle multiple projects with tight deadlines while ensuring compliance and accuracy.

Skill required: Clinical Data Operations - Clinical Data Management Designation: Clinical Data Svs Associate Qualifications: MSc/Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 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.A critical phase in clinical research that assures collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and analysis of studies across the spectrum of clinical research as defined by the National Institutes of Health (NIH). What are we looking for? Investigator Site PaymentsInvestigator Site Payments Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualifications MSc,Bachelor of Pharmacy,Master of Pharmacy

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 Open to look at MD-Pharmacology freshers

Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e. g. , Trial Master File (TMF)) that track site compliance and performance within project timelines. Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files for completeness. Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information. Coordinate the tracking and management of Case Report Forms (CRFs), queries and clinical data flow. Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation. May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training. May collaborate with the clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Qualifications High School Diploma or equivalent Req 3-4 years administrative support experience. r Equivalent combination of education, training and experience. Minimum one year clinical research experience strongly preferred. Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint. Written and verbal communication skills including good command of English language. Effective time management and organizational skills. Ability to establish and maintain effective working relationships with coworkers, managers, and clients. Basic knowledge of applicable clinical research regulatory requirement, i. e. , Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training. Knowledge of applicable protocol requirements as provided in company training. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs. iqvia. com

Medical Writer I - India, Bangalore - Office or Home-Based 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 Medical Writer I to join our diverse and dynamic team. As a Medical Writer I at ICON, you will play a pivotal role in the development and preparation of clinical trial documents, regulatory submissions, and scientific publications, contributing to the advancement of inNvative treatments and therapies. What you will be doing Collaborating with cross-functional teams to prepare, write, and edit clinical study reports (CSRs), clinical protocols, investigator brochures (IBs), patient narratives, and other regulatory documents in compliance with internal standards and regulatory guidelines. Conducting literature reviews, data analysis, and interpretation of clinical trial results to support the development of scientific manuscripts, abstracts, posters, and presentations for publication in peer-reviewed journals and scientific conferences. Assisting in the review and validation of clinical data, ensuring accuracy, completeness, and consistency with study protocols, standard operating procedures (SOPs), and regulatory requirements. Participating in project meetings, teleconferences, and client interactions to discuss project objectives, timelines, and deliverables, while providing input and feedback on document content, format, and presentation. Keeping abreast of emerging trends, scientific developments, and regulatory updates in relevant therapeutic areas, and applying kNwledge of medical writing principles and best practices to support the successful execution of clinical research projects. Your profile Bachelors degree in Life Sciences, Pharmacy, Medicine, or related field, with a keen interest in medical writing, clinical research, and drug development processes. Excellent written and verbal communication skills, with the ability to translate complex medical and scientific information into clear, concise, and engaging content tailored to diverse audiences. Strong attention to detail and organizational skills, with the ability to manage multiple tasks simultaneously, prioritize workload effectively, and meet project deadlines in a fast-paced environment. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with document management systems, reference management software, and statistical analysis tools preferred. Demonstrated ability to work collaboratively as part of a multidisciplinary team, communicate effectively across different functional areas, and adapt to changing project requirements and priorities. Motivated self-starter with a passion for learning and professional growth, committed to delivering high-quality work and contributing to the success of clinical research initiatives. 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.

The Global Product Manager for GE Healthcare s Device Platforms will conceive, define, accept, deliver, monitor, and refine device platform components including operating systems, processing components, and visual toolkits . This individual wi ll work with key stakeholders (including business leaders, finance, marketing, and IT) and the other members of the D i gital Solutions team to develop and convey a product vision. The candidate will also work closely with the product teams to accelerate their product development using shared platform components . The Digital Solutions Platform team is working on GE HealthCare s next generation ecosystem of distributed data platform and related components . It will provide mission critical real-time data about patients and medical devices in acute care settings where patients can be the most vulnerable. The Global Product Manager is a critical and highly visible role within the D igital Solutions organization and will play a key role in developing device components and unifying them with the overall platform strategy. Essential Qualifications: As the Glob al Product Manager, you will be responsible for: Owning the d evice platform product vision and roadmap: Defining the long-term product vision and strategic direction for the platform, aligned with evolving industry trends and customer needs. Developing a deep understanding of the business goals and processes to inform device platform priorities and enablers. Establishing platform roadmaps and release plans that satisfy requirements and support the device product portfolio . Deep understanding of the clinical healthcare landscape: Possessing a strong understanding of healthcare medical device regulations ( FDA, HIPAA, GDPR, etc..), compliance requirements, and the unique challenges faced by healthcare providers and stakeholders. Technical expertise: Demonstrating a solid understanding of emb edded system architecture (e.g., IoT hardware and software technologies ), modern software engineering and IoT cybersecurity best practices . Medical device technology trends and competitive intelligence to inform product strategy and proactively propose new solutions. Product Leadership: Managing platform investment decision making and the overall financial performance of the device platform , taking a return-on-investment approach to increasing the value while minimizing costs. Leading the platform lifecycle, from ideation and requirements gathering to release , post- release monitoring, and iteration. Ensure that the needs of product teams are met and communicated across teams and the organization . Communication and advocacy: Effectively communicating and socializing the value proposition of the Device Platform to internal and external stakeholders, including customers, partners, and industry leaders. Leverage your role to improve d evice platform utilization across the organization, reducing costs and increasing security for devices. Cross-functional collaboration: Building maintaining strong relationships with engineering, data science, finance, sales, and marketing teams to ensure seamless product development and go-to-market strategies. Data-driven decision making: Utilizing data insights to inform platform decisions, measure success, and track key performance indicators (KPIs). Desired Qualifications: 5 + years of experience as a Product Manager, with most of those years specifically in HealthCare and medical device technology. Strong understanding of IoT, medical device development , IoT cyber security, embedded hardware/compute technologies and embedded operating systems. Proven track record of successfully launching and managing medical device products in the healthcare or life sciences industry. Excellent interpersonal and communication skills with the ability to collaborate effectively across diverse teams. Strategic thinker with the ability to analyze market trends, user needs, and business requirements to drive product innovation. Experience with Agile methodologies and product management tools. Strong analytical and problem-solving skills, combined with a passion for improving patient care and clinical research. Experience with design thinking principles and customer experience design. A high degree of empathy: An ability to align and relate to customers. Highly curious and able to deal with uncertainty. Excellent problem-solving and analytical skills, including experience leveraging data to inform decision making and assist in solving engineering problems.

Lead and oversee daily operations for assigned clinical studies, ensuring timely completion within established goals, regulatory guidelines, and project objectives Manage cross-functional study teams (including vendors), collaborating with preclinical development, regulatory affairs, and project management to coordinate clinical study activities Maintain study timelines, proactively addressing and escalating potential delays to project management Conduct and oversee study monitoring visits, providing regular progress updates to stakeholders and resolving study-related issues Implement and maintain quality standards across investigative sites, vendors, and data management, ensuring compliant clinical study files Lead vendor selection and manage vendor relationships, conducting feasibility assessments for country and site selection Oversee clinical data cleaning, analysis, and reporting, participating in data reviews and statistical analysis planning Review and edit data summaries, presentations, training materials, and study documents Develop and implement effective training programs for investigators, site monitors, and internal/external study teams Required Qualifications: BSc Nursing degree with at 15 plus years in the same field Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability

Hi , WE are hiring for Leading ITES Company for SAS Programmer & CDB Programmer ( J Reviewer/Python/SAS) Role & responsibilities: 1.Create data cleaning reporting solutions study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. 2. Develop library of reusable checks working closely with data engineers and config specialists. 3. Collaborate with cross functional teams in creating business rules and automated check library across TAU. 4. Serves as a technical resource for creating data analytics to help with data validation and cleaning. 5. Provide programming expertise for data cleaning to efficiently ensure high quality data. 6. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. 7. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. 8. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. 9. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) 10. Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable 11. Technical skills and experience using relational databases (e.g. MS SQL Server, Redshift, or Oracle), 12. EDC build and/or clinical data management experience preferred 13. Experience in AWS preferred 14. Experience setting up automated validation is preferred 15. Knowledge of Data lake and creating interactive Dashboards are preferred 16. Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Nagpur Search : SAS + CDB Programmer Nagpur (Job Code # 85) b) For Position in Bangalore Search : SAS + CDB Programmer Bangalore (Job Code # 86)

Hi, We are hiring for Leading ITES Company for Lead Study Data Manager Profile Skills: a) Minimum 5 Years of Core Clinical Data Management Experience with minimum 1 year of experience of leading a clinical trial. . b) Experience on Study Conduct and Close Out c) Any Graduate JOB DECSRIPTION: Need exposure of Inform or Medidata Rave database Responsible & Accountable for the assigned study conduct activities, in clinical trials Validate clinical trial data to ensure consistency, integrity and accuracy based on project specific guidelines. Generate data queries based on validation checks or raise Manual queries to resolve data inconsistencies. To perform reconciliation of data from external sources (e.g. Serious Adverse Events, IWRS, Central Laboratory). SPOC for the study communications Proactively highlight any risks associated with the study along with the mitigation plan. Establish a partnership with the stakeholders at operational level to work seamlessly to deliver the assigned project/activity as per timelines. Identify process Improvement opportunities and to ensure learning is shared Ensure deliverables and/or agreed activities/tasks with customer. are completed with the expected quality. Have worked on Study set-up, Study Conduct and Study Close out for various therapeutic areas. Have also worked on writing edit check specification, CRF completion guidelines and review and corrections of set up documents for different versions. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 184 b) For Position in Pune Search : Job Code # 185 c) For Position in Bangalore Search : Job Code # 186

Hi We are hiring for Leading ITES Company for Clinical Data Manager Profile. Role & Responsibilities: Candidate should have 2-5 years of experience of CDM with experience in Conduct Scope of work Perform day-to-day Clinical Data Management activities. Work and coordinate with the team to perform data management activities and deliver an error-free quality database in accordance with the data management plan and regulator standards. Read and understand the study protocol and the timelines. Perform test data entry in the TEST environment, data listing review, data reconciliation, and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate. Perform external checks to handle manual discrepancies and action the same. Ensure an error-free, quality data with no open queries. Escalate any discrepancy in the clinical data to the study lead as appropriate. Timely completion of training Any other tasks deemed appropriate To perform medical data collection and analysis of Prostate Cancer Data using databases like HIS/ EMR (Electronic Medical Record) and Caisis, Rave, CDM (startup, closeout, conduct) Client interaction and meetings. Bringing up new ideas and executing new plans to cope with the backlog. Training new team members as and when required. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 205 b) For Position in Pune Search : Job Code # 206 C) For Position in Bangalore Search : Job Code # 207

Skill required: Clinical Data Operations - Customer Retention Program Implementation Designation: Associate Qualifications: Any Graduation Years of Experience: 1 - 3 Years What would you do? Intelligent Sales and Customer Operations provides an end-to-end, integrated, seamless solution across marketing, sales and service. The solutions enable clients to drive sustainable growth by enhancing their capabilities to deliver consistent, hyper-relevant experiences across the customer lifecycle. In the Inside Sales team you will provide support for lead/opportunity generation:conduct calls / send emails / connect via social media to generate leads, schedule "first meetings" for sales/pre-sales, conduct customer surveys, identify participants for events, and bring awareness of the product or offering on behalf of sales/marketing teams. The Customer Retention Program Implementation team is focused on driving loyalty, deliver customer and brand experiences, and address unmet customer needs that can impact customer perceived value. This team defines the value associated with such a program. What are we looking for? Ability to establish strong client relationship Ability to perform under pressure Adaptable and flexible Detail orientation Problem-solving skills Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Qualifications Any Graduation

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Analyst Qualifications: Any Graduation,BSc Years of Experience: 3 to 5 years Language - Ability: English - Expert What would you do? Exposure to EDC platforms like Medidata RAVE EDC, Inform, Oracle Clinical, Veeva etc. preferred.-Extensive experience in database design, edit check programming, custom function programming and unit testing.-Experienced in various modules such as IVRS/RWS integration and Lab administration.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? 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 Any Graduation,BSc

Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Specialist Qualifications: BE/BTech/MCA 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.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 Oracle Procedural Language Extensions to SQL (PLSQL) Python (Programming Language) R Programming Clinical Database Programming Adaptable and flexible Ability to perform under pressure Problem-solving skills Agility for quick learning Ability to establish strong client relationship 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 BE,BTech,MCA