1120 Clinical Research Jobs - Page 42

Tablets India Ltd. is looking for Marketing Executive (Medical Representative) to join our dynamic team and embark on a rewarding career journey Develop and maintain relationships with healthcare professionals and organizations Promote and sell our medical products and services to targeted customers Provide product demonstrations and education to customers Attend industry events and conferences to network and stay up to date on industry trends Maintain accurate records of sales activities and customer interactions Achieve sales targets and quotas Marketing Executive role is to promote Tablets India Ltd products to Medical professionals (doctors/ chemists etc.) and responsible for the generation of prescriptions to achieve given sales objective.

Tablets India Ltd. is looking for Marketing Executive (Medical Representative) to join our dynamic team and embark on a rewarding career journey Develop and maintain relationships with healthcare professionals and organizations Promote and sell our medical products and services to targeted customers Provide product demonstrations and education to customers Attend industry events and conferences to network and stay up to date on industry trends Maintain accurate records of sales activities and customer interactions Achieve sales targets and quotas Marketing Executive role is to promote Tablets India Ltd products to Medical professionals (doctors/ chemists etc.) and responsible for the generation of prescriptions to achieve given sales objective.

Tablets India Ltd. is looking for Marketing Executive (Medical Representative) to join our dynamic team and embark on a rewarding career journey Develop and maintain relationships with healthcare professionals and organizations Promote and sell our medical products and services to targeted customers Provide product demonstrations and education to customers Attend industry events and conferences to network and stay up to date on industry trends Maintain accurate records of sales activities and customer interactions Achieve sales targets and quotas Marketing Executive role is to promote Tablets India Ltd products to Medical professionals (doctors/ chemists etc.) and responsible for the generation of prescriptions to achieve given sales objective.

Tablets India Ltd. is looking for Marketing Executive (Medical Representative) to join our dynamic team and embark on a rewarding career journey Develop and maintain relationships with healthcare professionals and organizations Promote and sell our medical products and services to targeted customers Provide product demonstrations and education to customers Attend industry events and conferences to network and stay up to date on industry trends Maintain accurate records of sales activities and customer interactions Achieve sales targets and quotas Marketing Executive role is to promote Tablets India Ltd products to Medical professionals (doctors/ chemists etc.) and responsible for the generation of prescriptions to achieve given sales objective.

Tablets India Ltd. is looking for Marketing Executive (Medical Representative) to join our dynamic team and embark on a rewarding career journey Develop and maintain relationships with healthcare professionals and organizations Promote and sell our medical products and services to targeted customers Provide product demonstrations and education to customers Attend industry events and conferences to network and stay up to date on industry trends Maintain accurate records of sales activities and customer interactions Achieve sales targets and quotas Marketing Executive role is to promote Tablets India Ltd products to Medical professionals (doctors/ chemists etc.) and responsible for the generation of prescriptions to achieve given sales objective.

Tablets India Ltd. is looking for Marketing Executive (Medical Representative) to join our dynamic team and embark on a rewarding career journey Develop and maintain relationships with healthcare professionals and organizations Promote and sell our medical products and services to targeted customers Provide product demonstrations and education to customers Attend industry events and conferences to network and stay up to date on industry trends Maintain accurate records of sales activities and customer interactions Achieve sales targets and quotas Marketing Executive role is to promote Tablets India Ltd products to Medical professionals (doctors/ chemists etc.) and responsible for the generation of prescriptions to achieve given sales objective.

Tablets India Ltd. is looking for Marketing Executive (Medical Representative) to join our dynamic team and embark on a rewarding career journey Develop and maintain relationships with healthcare professionals and organizations Promote and sell our medical products and services to targeted customers Provide product demonstrations and education to customers Attend industry events and conferences to network and stay up to date on industry trends Maintain accurate records of sales activities and customer interactions Achieve sales targets and quotas Marketing Executive role is to promote Tablets India Ltd products to Medical professionals (doctors/ chemists etc.) and responsible for the generation of prescriptions to achieve given sales objective.

Tablets India Ltd. is looking for Marketing Executive (Medical Representative) to join our dynamic team and embark on a rewarding career journey Develop and maintain relationships with healthcare professionals and organizations Promote and sell our medical products and services to targeted customers Provide product demonstrations and education to customers Attend industry events and conferences to network and stay up to date on industry trends Maintain accurate records of sales activities and customer interactions Achieve sales targets and quotas Marketing Executive role is to promote Tablets India Ltd products to Medical professionals (doctors/ chemists etc.) and responsible for the generation of prescriptions to achieve given sales objective.

Tablets India Ltd. is looking for Marketing Executive (Medical Representative) to join our dynamic team and embark on a rewarding career journey Develop and maintain relationships with healthcare professionals and organizations Promote and sell our medical products and services to targeted customers Provide product demonstrations and education to customers Attend industry events and conferences to network and stay up to date on industry trends Maintain accurate records of sales activities and customer interactions Achieve sales targets and quotas Marketing Executive role is to promote Tablets India Ltd products to Medical professionals (doctors/ chemists etc.) and responsible for the generation of prescriptions to achieve given sales objective.

Tablets India Ltd. is looking for Marketing Executive (Medical Representative) to join our dynamic team and embark on a rewarding career journey Develop and maintain relationships with healthcare professionals and organizations Promote and sell our medical products and services to targeted customers Provide product demonstrations and education to customers Attend industry events and conferences to network and stay up to date on industry trends Maintain accurate records of sales activities and customer interactions Achieve sales targets and quotas Marketing Executive role is to promote Tablets India Ltd products to Medical professionals (doctors/ chemists etc.) and responsible for the generation of prescriptions to achieve given sales objective.

To support the development, dissemination, and maintenance of Value & Access evidence generation deliverables for selected key strategic asset/s for a specific disease/condition. Deliverables: Targeted literature review, systematic literature review, Global value dossier, Manuscripts and other activities as directed by stakeholders. Key Responsibilities: Develop optimal knowledge and experience in V&A/ HEOR evidence generation Develop and maintain the qualitative and/or quantitative deliverables as per the client requirements in accordance with the agreed standard process and timelines Support clients to conduct evidence generation activities. Liaise with clients on project schedule/planning of deliverables Ensure that the new associates/junior colleagues deliver quality deliverables by providing guidance and performing QC/review Deliver adhoc and cross-functional requests and activities Support the development of additional guidance and training materials (ie checklists, QA processes etc) Contribute to the continual improvement of the assigned deliverables and the guidance template Develop long-term, peer-level relationships with key clients Train and ensure functional development of new associates/junior colleagues within V&A team Complies with and support group s project management tool, standards and policies. Maintains records for all assigned projects including archiving. Maintains audit, SOP and training compliance Essential Requirements: 5+ years conducting HEOR evidence generation (health economic and outcomes research) for pharmaceutical products in pharma industry, contract research organization, or academic institute; or experience in a closely related discipline within the pharma industry (eg clinical research, statistics, epidemiology, pricing analytics) Undergraduate degree in a relevant scientific discipline plus graduate degree (Masters or PhD) in relevant discipline (including health economics, epidemiology, health services research, public health, or business management) Proficiency in English is a pre-requisite; while knowledge of other in-scope country languages would be an advantage Pharmaceutical domain knowledge MS-Office skills (MS-Excel, MS-Word, and MS-Power-point) Ability to work, prioritize, and drive projects independently

About The Role #body.unify div.unify-button-container .unify-apply-now:focus, #body.unify div.unify-button-container .unify-apply-now:hover{color:rgb(0,0,0) !important;}#body.unify div.unify-button-container .unify-apply-now:focus, #body.unify div.unify-button-container .unify-apply-now:hover{background:rgba(230,231,232,1.0) !important;} Apply now Account Development Representative Job Location (Short): Mumbai, India Workplace Type: Onsite Business Unit: ALI Req Id: 1629 .buttontextb0d7f9bdde9da229 a{ border1px solid transparent; } .buttontextb0d7f9bdde9da229 a:focus{ border1px dashed #5B94FF !important; outlinenone !important; } Responsibilities At Hexagon, we know that the key to growth is a high-performing sales team. That’s why we’re seeking a qualified Account Development Representative (ADR) to find and screen potential customers who could benefit from our products and services. As the first line of communication with a prospect, the ideal ADR has a strong understanding of the sales process and excels at researching leads, starting new relationships, and setting up sales closers for success. The ADR should be a quick learner who has strong communication skills and an ability to showcase our offerings in a compelling way. Every potential customer is an opportunity for boosting top-line revenue growth, customer acquisition levels, and profitability. Utilize Salesforce, cold calls, and email to generate new sales opportunities Identify the needs of prospects, and suggest appropriate products or services Proactively seek new business opportunities in the market Build long-term, trusting relationships with prospects to qualify leads as sales opportunities Set up meetings or calls between (prospective) customers and sales executives Collaborate with the sales team to develop strategies for reaching sales targets Use customer relationship management (CRM) software to manage leads and sales activities Research accounts, identify key players, generate interest, and successfully manage and overcome prospect objections to secure qualified meetings and expand Hexagon's presence. Stay up-to-date on market trends, competition, and industry developments Provide regular reports on sales activities and results to management. Education / Qualifications Experience in the engineering industry and engineering education/bachelor’s degree is preferred 4-6 years of experience in inside sales and/or sales, with a track record of exceeding lead targets Skills Required Proficiency with Salesforce or other CRM software Strong verbal and written communication skills Ability to build and maintain relationships with potential clients Proven, creative problem-solving approach and strong analytical skills Experience using ADR engagement platforms like Salesloft/Outreach and Demandbase Strong understanding of ADR and lead development best practices and procedures Proven ability to perform successfully and self-motivated Positive can-do attitude and tireless work ethic. Driven and self-sufficient. About Hexagon Hexagon is the global leader in digital reality solutions, combining sensor, software and autonomous technologies. We are putting data to work to boost efficiency, productivity, quality and safety across industrial, manufacturing, infrastructure, public sector, and mobility applications. Our technologies are shaping production and people related ecosystems to become increasingly connected and autonomous – ensuring a scalable, sustainable future. Hexagon (Nasdaq StockholmHEXA B) has approximately 24,500 employees in 50 countries and net sales of approximately 5.4bn EUR. Learn more at?hexagon.com?and follow us?@HexagonAB. Hexagon’s R&D Centre in India Hexagon’s R&D Centre in India is the single largest R&D centre for the company globally. More than 2,000 talented engineers and developers create innovation from this centre that powers Hexagon's products and solutions. Hexagon’s R&D Centre delivers innovations and creative solutions for all business lines of Hexagon, including Asset Lifecycle Intelligence, Autonomous Solutions, Geosystems, Manufacturing Intelligence, and Safety, Infrastructure & Geospatial. It also hosts dedicated service teams for the global implementation of Hexagon’s products. R&D India – MAKES THINGS INTELLIGENT Asset Lifecycle Intelligence Produces insights across the asset lifecycle to design, construct, and operate more profitable, safe, and sustainable industrial facilities. Everyone is welcome At Hexagon, we believe that diverse and inclusive teams are critical to the success of our people and our business. Everyone is welcome—as an inclusive workplace, we do not discriminate. In fact, we embrace differences and are fully committed to creating equal opportunities, an inclusive environment, and fairness for all. Respect is the cornerstone of how we operate, so speak up and be yourself. You are valued here. .buttontext1c1d8f096aaf95bf a{ border1px solid transparent; } .buttontext1c1d8f096aaf95bf a:focus{ border1px dashed #0097ba !important; outlinenone !important; } #body.unify div.unify-button-container .unify-apply-now:focus, #body.unify div.unify-button-container .unify-apply-now:hover{color:rgb(0,0,0) !important;}#body.unify div.unify-button-container .unify-apply-now:focus, #body.unify div.unify-button-container .unify-apply-now:hover{background:rgba(230,231,232,1.0) !important;} Apply now

Image Data Processing Technologist _ Office Based _ Chennai/Trivandrum 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 an Image Data Processing Technologist to join our diverse and dynamic team. You will collaborate with cross-functional teams to enhance the efficiency and effectiveness of imaging data in clinical research. What you will be doing Maintain a positive, results-oriented work environment by building partnerships, modeling teamwork as well as communicating in an open, balanced, and objective manner Verifying incoming documentation and data for GCP/HIPAA violations and responding according to outlined procedures in a timely manner to rectify them Preparing / loading / demographically reviewing data for analysis Managing and filing documentation associated with projects Identifying issues with received data and notify project specific sites, customers and internal staff following internal processes to open, monitor, and resolve queries May represent Incoming Data Processing in internal meetings Compliance with internal SOPs Your Profile: Bachelor s degree in radiologic technology, medical imaging, or a related field; relevant certifications preferred. 1 - 4 years of experience in medical imaging or related roles, preferably within a clinical research environment. Strong knowledge of imaging techniques and technologies, as well as regulatory guidelines governing imaging in clinical trials. Excellent organizational and problem-solving skills, with a keen attention to detail. Effective communication and interpersonal skills, with the ability to work collaboratively with diverse teams. What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the 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

Image Data Processing Technologist _ Office Based _ Chennai/Trivandrum . We are currently seeking an Image Data Processing Technologist to join our diverse and dynamic team. You will collaborate with cross-functional teams to enhance the efficiency and effectiveness of imaging data in clinical research. What you will be doing Maintain a positive, results-oriented work environment by building partnerships, modeling teamwork as well as communicating in an open, balanced, and objective manner Verifying incoming documentation and data for GCP/HIPAA violations and responding according to outlined procedures in a timely manner to rectify them Preparing / loading / demographically reviewing data for analysis Managing and filing documentation associated with projects Identifying issues with received data and notify project specific sites, customers and internal staff following internal processes to open, monitor, and resolve queries May represent Incoming Data Processing in internal meetings Compliance with internal SOPs Your Profile: Bachelor s degree in radiologic technology, medical imaging, or a related field; relevant certifications preferred. 1 - 4 years of experience in medical imaging or related roles, preferably within a clinical research environment. Strong knowledge of imaging techniques and technologies, as well as regulatory guidelines governing imaging in clinical trials. Excellent organizational and problem-solving skills, with a keen attention to detail. Effective communication and interpersonal skills, with the ability to work collaboratively with diverse teams. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the 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

Roles and Responsibilities Your primary responsibility will be to integrate with the existing laboratory workflow and maintain good (a) Identifying patients eligible for the study (b) Check availability of samples from biobank (c) Isolation and Quality Control of DNA and RNA required for the RADICAL workflow (d) Active participation in library preparation and optimisation of the high-throughput workflows that (e) Proper documentation of regular experiments carried out and troubleshooting if required. (f) Participation in SOP preparation and helping out with preparation of annual reports. (g) Basic data analysis skills Minimum required qualifications/experience (ICMR Guidelines) 1. Three Years Graduate in relevant subject/field + three years experience Post-Graduate in relevant subject/field 2. For Engineering/IT/CS- First Class Four Years Graduate Degree + Three Years Experience. Desired qualifications/experience (a) M.Sc. (with 1-2 years of experience) in Biological Sciences with expertise in Molecular Biology and (b) Expertise in DNA extraction, qPCR, Sanger Sequencing, NGS library preparation and sequencing using (c) Soft skills: MS Office, Excel, Laboratory and clinical data documentation, Data analysis tools using R packages, PRISM, SPSS etc. (preferable) (a) Integrity, motivation, enthusiasm, responsibility and reliability (b) Focus and commitment in carrying out tasks and duties (c) Critical analytical and problem-solving skills, capable of independent work (d) Ability to work effectively as part of a multidisciplinary team Knowledge/ Aptitude/Skills, Requirements Essential / desirable a. Integrity b. Flexibility c. Motivated d. Committed e. Willing to learn new skills f. Works as part of a team g. Receptive to new ideas h. Capable of independent work & to an agreed plan i. Good time management j. Organized, able to prioritize responsibilities k. Works to high technical and Essential i. Essential 2. Education / Qualifications M.Sc. in Biological Science (1-4 yrs experience) 3. Experience a. Good laboratory practice b. DNA and RNA technology c. Library preparation for sequencing d. Handling Illumina sequencer a. Essential b. Essential c. Desirable d. Desirable Application form CV Interview & References 4. Skills and ability a. Critical thinking b. Problem solving skills c. Readiness to evaluate, develop and test new approaches and strategies d. Mentoring junior team members a. Essential b. Essential c. Essential d. Desirable

The IQVIA Global Oncology team has primary responsibility for curating anonymous patient-level data for a wide array of tumors on a global scale, analyzing the data and providing insights and recommendations to cancer care stakeholders. As a Client Service Representative in Oncology Market Research, you will be ensuring high-quality deliverables, data-driven insights, and continuous engagement to maximize client value in using our syndicated Oncology patient tracker study. You will play a pivotal role in the Global Oncology Service team, focusing on Client Support, Internal Customer Support, and Product Expertise. In this role, you will Actively acquiring and applying expertise in IQVIA proprietary databases, methodologies, and analytical frameworks to generate client deliverables and internal reports. Developpe comprehensive data analyses and delivering tailored reports to precisely address client requests. (This could be in collaboration directly with clients or with colleagues working on behalf of the clients) Ensure seamless client onboarding and enhance service delivery workflows to achieve maximum efficiency and drive client satisfaction. Diligently train clients, delivering comprehensive training materials, and conducting client workshops ( Ie: presentation of the deliverables) as needed. Conduct thorough desk research based on specific briefs, utilizing both internal and external sources to support project deliverables and enhance internal oncology knowledge. Develop expertise on our visualization tools (e.g., MicroStrategy or any other tool as relevant) to provide customized analytics to specific client needs. Strengthen support in IQVIA countries that lack Oncology expertise and client service resources. This involves delivering comprehensive training crafting detailed reports to effectively meet clients needs and ensure successful deliveries. Support commercial teams to achieve revenue and growth by providing comprehensive guidance on data usage, offering expert advice on product capabilities, and providing services prices recommendations. This includes Engage with clients through calls, showcasing the database, addressing client-specific inquiries, and evaluating feasibility for Request for Proposals. Support the internal new countries or existing IQVIA countries involved in lacking Oncology expertise and client service resources, including training, service pricing, and report creation to support clients needs and deliveries. Contribute to questionnaire enhancement and improvement by performing data validations through secondary research and collaboration with Legacy Quintiles medical teams. Work closely with our operation and product management team to Support the launch of new Oncology products/deliverables. Work closely with a diverse range of peers, project managers and subject matter experts, in offices across the world to better fulfil the need of the role. Partner on webinars organized by the OD marketing team (or other IQVIA teams if required) Maintain specialist therapeutic area knowledge through relevant literature, internet sources, conferences, IMS publications, and share it with the rest of the team. Essential Experience, Skills and Education Required: Master s/Bachelor s degree (or equivalent); preferably in physical, natural or biological science, medicine, mathematics, economics or business Experience/interest in healthcare, life sciences and the pharmaceutical industry, preferably in oncology. Knowledge of key issues and current developments in the pharmaceutical and healthcare industries Good commercial awareness/business judgment Knowledge/interest of consulting methodologies, tools, and techniques Analytical, interpretative, and problem-solving skills. Comfort in conducting analytics using multiple data sources. Attention to detail and ability to deliver high quality work within short timelines. Excellent English verbal (presentation) and written communication skills; additional languages an advantage Strong interpersonal and relationship building skills; able to build credibility with key customers and stakeholders. Ability to multi-task Strong IT literacy e.g. Word, PowerPoint, Excel; experience using MicroStrategy desired (but not critical) A willingness and ability to travel if required, but this will be very limited. . 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

Responsibilities: -Under general supervision, conducts mapping of SDTM and Custom domains. -Understands and reviews requirements, creates plans and/or contributes in estimations. -Performs planning, mapping domains, review domains and Unit testing on planned releases. -Supports and performs defect fix and tracking; coordinates with team. -Works closely with testers, Dev Leads/Managers and other project stakeholders. -Maintains documentation to assist in debugging and modifying software; analyzes results to ensure existing functionality and recommends corrective action. -Coordinates with testing teams in troubleshooting and resolving issues. -Regularly documents, tracks and escalates issues as appropriate. -Seeks necessary managerial support to discuss/flag risks and mitigation plans. Experience: -Individual contributor with 2-6 years of experience who works under close supervision. -Experience to create SDTM datasets of clinical data from raw data -Experience on Clinical domain is preferred. -Experience in any one of ETL tool and concepts is preferred. -Good hands on experience in Oracle/SQL. -Hands on experience in these tools - HP ALM, JIRA, Synapse RT. Education: -Bachelor s or Masters Degree in Computer Science, Information Technology, Clinical Information Management or equivalent qualifications. Knowledge: -Good Strong understanding of SDLC processes. -Good strong understanding of defect lifecycle. -Good knowledge on CDISC concepts and deliverables -Good knowledge on end to end clinical data management activities -Good Understanding on eCRF, protocol & study related documents. . 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

Project Manager - FSA _ Home Based Required: Must have at least 8+ years of strong hands on experinece in site feasibility, budget negotiations, and regulatory submissions. Hands on experinece in global projects & must coordinates with global/regional teams to ensure on-time site initiation. Job Description Recognize, exemplify and adhere to ICONs values which centre around our commitment to People, Clients and Performance. As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs. Travel (approximately 15%) domestic and/or international. Anticipated activities may include attendance at Bid Defences, Kick-Off, Investigator or study team meetings. Attend BID Defence meetings, as directed, to provide strategic study start up advice. Attend Kick Off Meetings, for all assigned studies, to provide strategic input into the study start up discussions Draft CA, EC and contract execution plan (including other local study start up requirements) and monitor the execution of the plan including any revised timelines. Work with key parties to draft mitigation plans against contractual targets for key milestones Responsible for the inclusion of the Study Start Up Plan in to the Project Management Plan to be shared and agreed with the sponsor. Fully accountable for the implementation of the Study Start Up Plan for all assigned studies Responsible for the Study Start Up element of the Project Communication Plan. Responsible for the harmonization of processes and procedures during start up across the region and appropriate training of the team members In collaboration with the Project Managers identify and present interdependencies to the project team and track key deliverables against responsible parties, driving forward strategies to prevent Road Block situations. Plan, coordinate and drive all study start up activities as defined by the SOW from site identification list to IP release to achieve the agreed/contracted deliverables and timelines in all countries including: Accountable for the preparation and coordination of submissions to regulatory, ethics and other bodies in all countries for assigned studies Accountable for the development, finalisation and review Master and Country Specific Subject Information Sheets/Informed Consent Forms (SIS/ICFs) Accountable for the preparation, finalisation and review Master and Country Specific EU Clinical Trial Application Forms (xml file) and corresponding data files in collaboration with other relevant departments (EU Only) Accountable for providing sponsor advice on the content of drug labels including the review and translations of drug labels where costed for. Accountable for ensuring all submission packages receive an independent quality review prior to submission Accountable for co-ordinating the timely negotiation of contracts and budgets with sites Accountable for the co-ordination of translations for documents required for submission for assigned studies Accountable for timely and accurate data entry of all study start up activities in the appropriate clinical trial management system Accountable for the timely follow-up for queries made by CA/EC on assigned studies Accountable for the collection of critical documents required for IP Release on assigned studies Where necessary, ensure implementation of an escalation plan as agreed in the study communication plan. Work directly with PM and ICG legal group to establish a defined Clinical Trial Agreement (CTA) process from fallback text to site execution of the CTA. The sponsor may directly be involved in this process or the ICG legal team may discuss directly with the sponsor. Accountable for the timely tracking and reporting for all assigned studies. Accountable for leading the country study start up team members involved in the study. May serve as a mentor and coach for these team members as required. Ensure adherence to the SOW and the site activation budget as per the costing model. Manage study resources as appropriate per SOW at any phase of the study. Identify out of scope activities and negotiate changes required to SOW and budget as necessary with the PM. Responsible for the overall quality of the start up phase of the project, address quality issues and ensure implementation of action plans in a timely manner. Responsible for establishing format of the standard status report with PM to ensure the sponsor and study management needs are achieved, providing the reports as agreed, to the study management team. Provide regular communication to the project manager identifying issues/targets/resolutions. Innovate, motivate and empower the site activation team to deliver on the timelines milestones with clear measurable objectives. Inform site activation Regional/Country Management teams to mitigate risk as appropriate Provide regular updates to Study Start Up Management team including production of study metrics Attend all relevant study team meetings throughout the start up phase of all assigned studies Ensure effective escalation of issues and feedback including input for Opex (Operational Excellence Meeting) when study is discussed and input into the Global Dashboard for studies in start up Delegate tasks as appropriate to study start up team while retaining accountability for the successful delivery of the study start up plan To be familiar with ICH GCP, relevant country regulations/guidelines and ICON SOPs To be fully trained in all systems Competent in communication skills for timely follow-up, issue resolution and report updates; as outlined in the communication and escalation plan with timely documentation. Comply with all department requirements regarding information provision and status updating and reporting. To undertake other reasonably related duties as may be assigned from time to time Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the 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

Project Manager - FSA _ 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 Required: Must have at least 8+ years of strong hands on experinece in site feasibility, budget negotiations, and regulatory submissions. Hands on experinece in global projects & must coordinates with global/regional teams to ensure on-time site initiation. Job Description Recognize, exemplify and adhere to ICONs values which centre around our commitment to People, Clients and Performance. As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs. Travel (approximately 15%) domestic and/or international. Anticipated activities may include attendance at Bid Defences, Kick-Off, Investigator or study team meetings. Attend BID Defence meetings, as directed, to provide strategic study start up advice. Attend Kick Off Meetings, for all assigned studies, to provide strategic input into the study start up discussions Draft CA, EC and contract execution plan (including other local study start up requirements) and monitor the execution of the plan including any revised timelines. Work with key parties to draft mitigation plans against contractual targets for key milestones Responsible for the inclusion of the Study Start Up Plan in to the Project Management Plan to be shared and agreed with the sponsor. Fully accountable for the implementation of the Study Start Up Plan for all assigned studies Responsible for the Study Start Up element of the Project Communication Plan. Responsible for the harmonization of processes and procedures during start up across the region and appropriate training of the team members In collaboration with the Project Managers identify and present interdependencies to the project team and track key deliverables against responsible parties, driving forward strategies to prevent Road Block situations. Plan, coordinate and drive all study start up activities as defined by the SOW from site identification list to IP release to achieve the agreed/contracted deliverables and timelines in all countries including: Accountable for the preparation and coordination of submissions to regulatory, ethics and other bodies in all countries for assigned studies Accountable for the development, finalisation and review Master and Country Specific Subject Information Sheets/Informed Consent Forms (SIS/ICFs) Accountable for the preparation, finalisation and review Master and Country Specific EU Clinical Trial Application Forms (xml file) and corresponding data files in collaboration with other relevant departments (EU Only) Accountable for providing sponsor advice on the content of drug labels including the review and translations of drug labels where costed for. Accountable for ensuring all submission packages receive an independent quality review prior to submission Accountable for co-ordinating the timely negotiation of contracts and budgets with sites Accountable for the co-ordination of translations for documents required for submission for assigned studies Accountable for timely and accurate data entry of all study start up activities in the appropriate clinical trial management system Accountable for the timely follow-up for queries made by CA/EC on assigned studies Accountable for the collection of critical documents required for IP Release on assigned studies Where necessary, ensure implementation of an escalation plan as agreed in the study communication plan. Work directly with PM and ICG legal group to establish a defined Clinical Trial Agreement (CTA) process from fallback text to site execution of the CTA. The sponsor may directly be involved in this process or the ICG legal team may discuss directly with the sponsor. Accountable for the timely tracking and reporting for all assigned studies. Accountable for leading the country study start up team members involved in the study. May serve as a mentor and coach for these team members as required. Ensure adherence to the SOW and the site activation budget as per the costing model. Manage study resources as appropriate per SOW at any phase of the study. Identify out of scope activities and negotiate changes required to SOW and budget as necessary with the PM. Responsible for the overall quality of the start up phase of the project, address quality issues and ensure implementation of action plans in a timely manner. Responsible for establishing format of the standard status report with PM to ensure the sponsor and study management needs are achieved, providing the reports as agreed, to the study management team. Provide regular communication to the project manager identifying issues/targets/resolutions. Innovate, motivate and empower the site activation team to deliver on the timelines milestones with clear measurable objectives. Inform site activation Regional/Country Management teams to mitigate risk as appropriate Provide regular updates to Study Start Up Management team including production of study metrics Attend all relevant study team meetings throughout the start up phase of all assigned studies Ensure effective escalation of issues and feedback including input for Opex (Operational Excellence Meeting) when study is discussed and input into the Global Dashboard for studies in start up Delegate tasks as appropriate to study start up team while retaining accountability for the successful delivery of the study start up plan To be familiar with ICH GCP, relevant country regulations/guidelines and ICON SOPs To be fully trained in all systems Competent in communication skills for timely follow-up, issue resolution and report updates; as outlined in the communication and escalation plan with timely documentation. Comply with all department requirements regarding information provision and status updating and reporting. To undertake other reasonably related duties as may be assigned from time to time What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the 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

Key Responsibilities Technical Leadership - Lead and manage the Clinical Trial Transparency team to ensure timely, consistent, and accurate delivery of anonymised documents including full protocols, reporting and analysis plans and clinical study reports to external registers e.g., ClinicalTrials.gov, EU Clinical Trials Register and GSK/ViiV Study Register, and to other national registers, as required. Accountable for: (1) establishing priorities for document anonymisation and ensuring proper controls are in place and (2) operational delivery across the therapy areas by ensuring transparency deliverables meet the requirements of Health Authorities/Regulatory Agencies, Industry Associations, and GSK policy transparency commitments, all of which evolve regularly and maintain robust performance as defined by key performance indicators. Additionally, provide strategic direction and leadership in regulated and policy driven clinical transparency to a team of recognized subject matter experts and manage external resources (outsourced, platforms, consultants) to ensure availability of adequate resources in line with workload needs. Digital Innovation - Lead the thinking and implementation of digital content generation systems using AI/ML within CTT to enhance efficiencies associated with development of disclosure summaries, while ensuring compliance to regulation and quality are met. Support the development of digital dashboards (e.g. Power BI) for measuring CTT KPIs and for tracking CTT deliverables. Build strategies for mini automation projects to carry out routine tasks that will result in improved throughput and better resource utilization. Scientific Business Expertise - Provide strategic direction and leadership in regulated and policy driven clinical disclosures to a team of recognized subject matter experts and management of external resources (outsourced, platforms, consultants) to ensure adequate resources to address workload needs. Cross-functional Stakeholder Management - Partner with and lead interactions with senior management in relevant functional areas. Establish strong relationships with internal business partners (Clinical Sciences, Development Operations, Biostatistics, and Regulatory. etc.) and be the primary contact for all regulated and policy disclosures supporting the entire GSK R&D portfolio. Drive key change management initiatives with these teams to enhance ways of working in line with key organizational goals. Identify ways to continuously create awareness on transparency requirements to stakeholders through the appropriate use of digital communication tools (e.g. informercial videos, bulletins, roadshows, etc.). Process Excellence - Drive the processes for transparency activities leading to timely, accurate and high-quality information posted to public websites. Establish and integrate consistent processes for trial transparency activities throughout the portfolio. Maintain oversight for processes improvement/ efficiencies for the transparency function according to evolving requirements. Bring specialized knowledge of global transparency requirements and standards and provide guidance on best practices to ensure quality of information shared publicly and ensure compliance with defined requirements. Work closely with other roles in CTT (e.g. business capability lead) to strengthen the process knowledge of team members and ensure that written standards and document templates are consistent with changes in regulation/policy or current ways of working, synchronized with global changes in transparency requirements and bring in best practices and standards for transparency. Empower other roles within CTT to function as key enablers of clinical trial conduct by ensuring that regulatory/policy commitments for transparency are met ahead of planned timelines, to support critical organizational initiatives. Industry Benchmarking - Monitor, communicate and proactively plan in response to changes in global Clinical Trial Transparency Regulations including new industry trends and translate into GSK s Clinical Trial Transparency strategy. Maintain GSK initiatives of building trust at the highest standards by continuous adaptation of the internal process to be aligned with the external evolving requirements. Collaborate with other roles in CTT (e.g. benchmarking lead) to identify processes to continually scan the external environment for latest industry trends in transparency. Based on this information, develop processes for authoring of smart disclosure documents that will enable GSK to maintain its industry leading position in transparency, while ensuring that GSK also retains its competitive advantage. Work closely with responsible roles for effective management of Company/Critical Confidential Information in public disclosure documents. Transparency Knowledge Management - Provide medical governance advice in the field of anonymisation on a regular basis to stakeholders across therapy area. Assist trial teams with the collection of required information for postings, answer their questions regarding posting requirements and processes, including recommending resolution or workaround to complex issues, with appropriate consideration of possible impacts. Enterprise Risk Management - Ensure implementation of the risk management framework, including risk identification, assessment and prioritization and the definition of mitigation plans. Design and develop risk mitigation strategies while proactively identifying business transparency risks and implementing strategies to manage the impact of these risks on the business. Business Performance Monitoring - Establish and track key performance indicators that demonstrate compliance with applicable transparency regulations and internal policy. Monitor KPIs for continuous improvement in clinical transparency (e.g. through Transparency Dashboard), including KPIs for oversight of vendors performing the services. Systems and Tools - Integrate disclosure systems with other enterprise systems seamlessly to ensure that information flow is accurate, timely and purposeful. Work closely with disclosure system owners to implement enhancements, improvements and leverage the full functionality of such systems. Lead discussions with owners/stakeholders of complementary business systems to set up efficient networking with the disclosure system to allow for timely availability of information (e.g. study milestones, product approval/termination) that are relevant for transparency teams while also lead the thinking around implementation of new technologies. Cross-functional Governance - Bring specialized and advanced knowledge of disclosure requirements and standards to ensure quality of information shared publicly and ensure compliance with defined requirements. Work closely with the Medical Governance Boards, the Head Medical Governance, Head Publications and the Head Bioethics and Policy to ensure that GSK maintains its industry leading transparency ranking through a robust process for following policy including any exceptions or extensions. Strategic Leadership - Provide strategic direction and leadership in external working groups to develop common principles and standards to support clinical transparency and be a leader for GSK with industry-leading strategies in transparency. Maintain knowledge and expertise in Disclosure environment (Publications ethics and Privacy). Partner with key internal and external stakeholders to strengthen GSK practices for Policy requirements in line with relevant internal and external requirements. Develop strategies involving technology implementation and set targets to match the vision of an organization, creation of future business plans and required actions. Develop teams and partners to work with them by leveraging the synergy of wide variety of talent, while building a capacity that allows rapid implementation of tasks in order to achieve complex or cross-functional objectives. Minimum Level of Job-Related Experience Required Broad scientific/ pharmaceutical industry background with >10 years of experience in clinical research and/or in pharmaceutical industry , of which at least 8 years in Clinical Trial Transparency, Publications or Medical Writing. Extensive experience in Clinical Disclosure, Statistics or Programming with exposure to anonymisation techniques. Proficiency in GCP/ICH guidelines and regulations governing clinical trial disclosure (FDAAA 801 Final Rule, European Clinical Trial Directive, European Clinical Trial Regulation), EMA Policy 70, Health Canada PRCI, GDPR, Privacy Laws, PhUSE, TransCelerate. Knowledge of PhRMA/EFPIA principles and related best practices Experience with Clinical Trial Disclosure software solution(s) Knowledge of GSK clinical/EPI/HE development activities and GCP Guidelines. Proven experience of managing and driving complex transversal projects involving senior management Previous line management experience of 5+ years is essential.

Role and Responsibilities: The Lead - Strategic Business Development will play a crucial role in maintaining strong client relationships, handling clients, and acquiring new clients for our Business Development process. They will be responsible for positioning MakroCare's specialized services with strategic planning and implementation for medical devices and diagnostics companies in Europe and the USA. Additionally, the role involves developing and implementing business development strategies, maintaining international contacts, achieving sales targets, and working with the marketing and pre-sales teams for lead generation. Candidate Qualifications: Bachelor's Degree in any Life Science with an MBA/PGDM certification Minimum of 8 - 12 years of experience in the BA BE/CRO industry as a Business Development. Proven success and experience in regulatory projects within the Biotech/Life sciences/pharmaceutical environment Experience in international pharmaceutical projects with excellent communication skills Cooperative and assertive working style with the ability to understand and explain complex relationships Basic knowledge of data fields related to pharmaceutical products Required Skills: Business Development Strategy & Services Client Handling New Client Acquisition HealthCare, Medical Devices, Regulatory Affairs & Clinical Research .

Hi , We are hiring for Leading ITES Company for SDTM Programmer Profile. Please go through the JD and we will get back to the relevant profiles. Job Description: Minimum 3 years of experience for Senior Statistical programming is a mandate. Having strong understanding of SAS Base/Macros/GTL and experience of SDTM/ADAM/TLFs creation as per CDISC standards. Associate should be able to manage communication with customers, track and ensure quality on-time deliverables Implementation of process improvements for enhanced quality and efficiency gains, institute robust processes to ensure consistent outcomes with quicker turn-around time. Experience in SDTM, ADAM & TLF Experience in EDC & VEEVA Expertise in Base and Advance SAS programming. Expertise in developing macros and developing generalized programs. Development of the complex SAS macros that can be utilized across TAs in multiple studies, review of the developed SAS programs. Expertise in SQL, SAS Macros, Functions, SAS GTL, SAS, and other advanced SAS components. Mentor and supervise developers to build generic standard macros, generic listings or other ad-hoc requests in accordance with business requirements To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Statistical Programmer Mumbai (Job Code # 208) b) For Position in Pune Search : Statistical Programmer Pune (Job Code # 209)

Hi We are looking to hire for SAS+R Programming . Please go through the JD and Apply Roles & Responsibilities: Create data cleaning reporting solutions, study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. Contribute to process improvements and development of programming standards using R. Minimum of 3 years of experience in R programming including familiarity with R packages (e.g., Tidyverse, ggplot2, survival) Familiarity with data visualization techniques and tools in R. Write clean, efficient, and well-documented R code, conduct R code reviews, and R programming validation. Strong proficiency in R programming, including data manipulation, statistical analysis, and data visualization. Experience with POSIT Workbench, Connect, and/or Package Manager. Good to have python & SQL knowledge Develop library of reusable checks working closely with data engineers and config specialists. Collaborate with cross functional teams in creating business rules and automated check library across TAU. Serves as a technical resource for creating data analytics to help with data validation and cleaning. Provide programming expertise for data cleaning to efficiently ensure high quality data. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. 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.) Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 373 b) For Position in Pune Search : Job Code # 374

Hi We are hiring for ITES Company Role -Medical Reviewer Qualification : MBBS/MD only (MCI Certification is not mandate**) Experience Range : 1 to 7 Years Preferred Experience: Minimum of 1 years of experience in PV/ Clinical Research (drug safety) Job Description: Author a company clinical comment (CCC) for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: -Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. -Detail any requests for changes to the case, including the narrative. -Detail any follow-up information that is required and not already noted within the Query Manager in the Patient Safety database. Provide product advice as required, especially with regards to case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Review the company causality assessment provided by Medical Advisor. • Review the medical sense including seriousness and coding of the case in the global context of the drug or clinical project, including the narrative, AE/SAE terms, suspect drugs, concomitant medications, laboratory data, and medical history. To provide documentation of the review and case comments in Sapphire in Medical Review workflow. Maintain knowledge of the marketed drug currently under litigation. Maintain knowledge of the company disease and therapeutic areas for marketed drugs and drugs in development through periodic medical review training held by client medical staff. Skills required: Computer Literate (good knowledge of MS Office) Sound understanding of the Drug Safety and Regulatory process Good problem solving and decision-making skills Capability to lead by motivation and example Ability to prioritize schedule and organize Excellent interpersonal and communication skills To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Medical Reviewer Mumbai (Job Code # 47) b) For Position in Pune Search : Medical Reviewer Pune (Job Code # 48) c) For Position in Bangalore Search : Medical Reviewer Bangalore (Job Code # 51)

Hi We are hiring for the leading ITES Company for the Medical Reviewer Role. Qualification - MBBS/MD is Must (Full TIme) Job Overview: The Medical Reviewer is responsible for the evaluation and analysis of clinical data to ensure accuracy, compliance with regulations, and the highest quality standards. This role involves reviewing clinical trial data, medical documentation, and regulatory submissions to support the approval of new medical products and therapies. Key Responsibilities: Clinical Data Review : Evaluate clinical trial data for completeness, accuracy, and adherence to protocols. Ensure data integrity and consistency across various documents and databases Medical Documentation: Review and verify the accuracy of medical documentation, including patient records, case reports, and clinical study reports. Ensure documentation complies with regulatory requirements and company standards. Regulatory Compliance: Stay updated with the latest regulatory guidelines and ensure all reviews align with current regulations. Prepare and review regulatory submissions to ensure timely and successful product approvals. Training and Development: Stay informed about advancements in medical research and regulatory changes. Participate in continuous training and development programs to enhance knowledge and skills. Skills required: Computer Literate (good knowledge of MS Office) Sound understanding of the Drug Safety and Regulatory process Good problem solving and decision-making skills Capability to lead by motivation and example Ability to prioritize schedule and organize Excellent interpersonal and communication skills To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Chennai Search : Medical Reviewer Chennai (Job Code # 52) b) For Position in Indore Search : Medical Reviewer Indore (Job Code # 53)