652 Clinical Trials Jobs - Page 11

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

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

Hi We are Hiring for the job role of Medical Writer Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the information is scientifically sound, compliant with industry guidelines, and aligned with the target audiences needs. Attention to detail, strong writing skills, and a solid understanding of medical terminology and research practices are essential in this role. Key Skills: a) Minimum 1 Year experience in - eCTD / NEES / Docubridge b) Should have Experience in making Clinical Study Report and Clinical Summary of Safety c) Any Life Science Graduate To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 396 Job Description: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. Plan and organize project and non-project meetings, as and when required

Role & responsibilities: • Mentors less experienced medical writers on projects, as necessary. • Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision. • Develops or supports a variety of documents that include but not limited to: o Clinical study protocols and clinical study protocol amendments; o Clinical study reports; o Patient narratives; o Annual reports; o Investigator brochures. • Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. • Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables. • Serves as peer reviewer on internal review team. Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format. • Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget. • Performs on-line clinical literature searches, as applicable. • Working knowledge of drug development process and regulatory guidelines. • Continues professional development to keep pace with regulatory guidance and client expectations in medical writing that affect medical writing. • Stays aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership. • Completes required administrated tasks within the specified timeframes. • Performs other work-related duties as assigned.

Leads and mentors a team of Clinical Data Reviewer(CDR). Work closely with study team to meet study milestones. Provide inputs to protocol amendments, review and lead post go live changes to the eCRF, as appropriate. Required Candidate profile 5+ Years of Core Clinical Data Management Experience . Study Data Manager Hands on experience in all phases of Clinical Data Management with minimum 1 year of experience of leading a clinical trial.

• Respond to queries/ clarifications from EC/ IRBs and on sites • Attend drug safety/external meetings/investigator meetings • Patient eligibility review • Review AE/ SAEs • Protocol training of site staff, CRAs etc

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Associate Qualifications: BE/BTech/BCA Years of Experience: 1 to 3 years What would you do? You will be part of our Life Sciences R&D division, which offers a comprehensive range of services across the life sciences sector. This includes Clinical Data Management, regulatory services, pharmacovigilance, and patient services solutions. Employees within this clinical capability will join one of our sub-offerings, such as Clinical Database build and Clinical Reporting. In these roles, you will support leading biopharma companies in realizing their vision, enhancing outcomes by focusing on the patient and integrating scientific expertise with unique insights into the patient experience.The Clinical Reports Programming team is dedicated to developing and maintaining clinical reports for clinical trials. This involves utilizing PL/SQL, SQL, and Clinical SAS programming skills to create these reports. The team also integrates data from various sources such as EDC, Labs, and IRT. Ensuring that all reports comply with regulatory standards and guidelines is a crucial part of their work. They implement stringent quality assurance processes to uphold the highest levels of data integrity and report accuracy. Additionally, the team collaborates closely with clinical operations, biostatistics, and other departments to ensure the reports meet the needs of all stakeholders, facilitating informed decision-making based on accurate and timely data.Develop and review complex reports, 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? Oracle Procedural Language Extensions to SQL (PLSQL) Structured Query Language (SQL) Experience in writing programs using Clinical SAS Clinical Database Programming Clinical Data Management SAS Clinical Adaptable and flexible Ability to perform under pressure Problem-solving skills Ability to establish strong client relationship Agility for quick learning 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 Qualification BE,BTech,BCA

Skill required: Clinical Data Services - Clinical EDC Build Designation: Clinical Data Svs Associate Qualifications: BE/BTech/BSc Years of Experience: 1 to 3 years What would you do? You will be part of our Life Sciences R&D division, which offers a comprehensive range of services across the life sciences sector. This includes Clinical Data Management, regulatory services, pharmacovigilance, and patient services solutions. Employees within this clinical capability will join one of our sub-offerings, such as Clinical Database build and Clinical Reporting. In these roles, you will support leading biopharma companies in realizing their vision, enhancing outcomes by focusing on the patient and integrating scientific expertise with unique insights into the patient experience.The Clinical Database Management team is committed to developing and maintaining databases for clinical trials, which includes creating Case Report Forms (CRFs) and developing Edit and Validation Checks using programming skills like C# and PL/SQL. They also support data integration from various external sources such as labs and Interactive Response Technology (IRT). The team ensures compliance with regulatory standards and guidelines, maintaining high levels of data quality and security. Additionally, they continuously seek to improve database processes and tools by leveraging the latest technologies and best practices to enhance efficiency and accuracyDevelop clinical study databases by building electronic case report forms and program edit checks as per specifications. Support any updates or changes to the study database (e.g. Protocol amendments) through the change control process. What are we looking for? Oracle Procedural Language Extensions to SQL (PLSQL) Structured Query Language (SQL) C, C++, C# Programming Skills Experience in writing programs using Javascript Clinical Database Programming Clinical Data Management SAS Clinical Adaptable and flexible Ability to perform under pressure Problem-solving skills Ability to establish strong client relationship Agility for quick learning 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 Qualification BE,BTech,BSc

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years What would you do? Experience working in Client On-boarding, Account Maintenance, Customer Identification Program (CIP) and Know Your Customer (KYC) processes. Conducting PEPs (Politically Exposed Persons) screening and adverse media checks Proven analytical skills, problem solving ability, and a control mentality paired with meticulous attention to detail. Aptitude for building relationships and ability to communicate complex issues to a wide array of internal clients with differing levels of product experience. Self-motivated and proactive team player who takes ownership and accountability & has strong organizational skills as well as the ability to effectively manage competing priorities. Flexible and able to work well under pressure, manage high volumes, and collaborate with a global team while maintaining a positive attitude.Looking for someone with KYC experience along with ECDD/OCDD knowledgeBusiness and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving customer identification, customer due diligence & enhanced due diligence. What are we looking for? Know Your Customer (KYC) Operations Roles and Responsibilities: Educated to Degree Level Familiar with a wide range of external data sources and third-party systems to be covered as a part of the due diligence process. Relevant financial service experience, ideally within risk, compliance or financial crime. A good understanding of effective risk management Experience of working with high-risk client groups Knowledge of the regulatory environment is highly desirable Strong analytical ability and attention to detail and strong research skills and experience with the Internet and on-line research systems Detail oriented, with the ability to work independently and multi-task effectively Excellent written and verbal communication skills Flexible to work in rotation shifts, time management, and ability to prioritize and work effectively to tight deadlines Qualification Any Graduation

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years What would you do? Required Skills: Strong coping, emotional resilience, and stress-management skills Excellent comprehension and communication Ability to perform duties objectively, devoid of inherent biases or personal beliefs, in the best interest of client policies Strong attention to detail Comfort synthesizing and analyzing information from multiple streams Strong critical thinking and decision-making skillsLooking for someone with KYC experience along with ECDD/OCDD knowledgeBusiness and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving customer identification, customer due diligence & enhanced due diligence. What are we looking for? Good Communication Skills Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years What would you do? Strong coping, emotional resilience, and stress-management skills Excellent comprehension and communication Ability to perform duties objectively, devoid of inherent biases or personal beliefs, in the best interest of client policies Strong attention to detail Comfort synthesizing and analyzing information from multiple streams Strong critical thinking and decision-making skillsLooking for someone with KYC experience along with ECDD/OCDD knowledgeBusiness and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving customer identification, customer due diligence & enhanced due diligence. What are we looking for? Good Communication Skills In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years What would you do? Strong coping, emotional resilience, and stress-management skills Excellent comprehension and communication Ability to perform duties objectively, devoid of inherent biases or personal beliefs, in the best interest of client policies Strong attention to detail Comfort synthesizing and analyzing information from multiple streams Strong critical thinking and decision-making skillsLooking for someone with KYC experience along with ECDD/OCDD knowledgeBusiness and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving customer identification, customer due diligence & enhanced due diligence. What are we looking for? Know Your Customer (KYC) Operations In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Bachelor in Physiotherapy/BSc. Nursing 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.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? Ability to work well in a team Adaptable and flexible Agility for quick learning 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 Bachelor of Pharmacy,Bachelor in Physiotherapy,BSc. Nursing

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Specialist Qualifications: MBBS 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.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.In this role, you will be expected to create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? Agility for quick learning Adaptable and flexible Ability to work well in a team 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 MBBS

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Specialist Qualifications: MBBS Years of Experience: 0 to 2 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.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? Agility for quick learning Ability to work well in a team Adaptable and flexible 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 Qualification MBBS

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Sr Analyst Qualifications: BE/BTech/MCA Years of Experience: 5 to 8 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings, helping the world s leading biopharma companies bring their vision to life and enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The clinical automation team focuses on the development and implementation of innovative concepts and application for our client across different accounts in operations. The team is responsible for designing and implementing highly interactive scalable web apps and prototypes at enterprise level.You will be expected to develop and implement complex APIs based on requirements using different tools/techs such as .Net, Java, PL/SQL, Python, Full- Stack Developer. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Agility for quick learning Ability to work well in a team Bachelor's degree in Computer Science, Information Technology, Engineering or any computer related discipline. Work experience of at least 3 year in relevant industries (Financial Services, Network, Utilities, Health Care, Marketing, Pharma, Retail etc.). Work experience of at least 4 years in designing, coding, APIs, testing, debugging, documenting, and implementing enhancements and fix solutions. Work experience in Implementing APIs based architecture frameworks. Aptitude to learn, think creativity to solve real world business problems, and work in a global collaborative team environment. Proficient verbal and written communication skills in English. Roles and Responsibilities: Work as a technical lead to architect and develop innovative concepts and applications for our clients across different accounts in Operations. Design and implement highly interactive, scalable web apps and prototypes at Enterprise level. Build and modify high-performance APIs and Monitor API performance and troubleshoot issues promptly. Implement APIs based on architecture frameworks and guidelines. Work with DevOps engineers to integrate new code into existing continuous integration (CI) and continuous delivery/deployment (CD) pipelines. Able to lead Automation initiatives within his account. Work closely with the team and client to understand requirements and guiding them to deliver the most effective solution. Participate in the development of automation solutions, from prototyping new functionality and technologies to integrating them in our overall products and offerings, thus developing expertise and skills in this domain. Collaborate with frontend and backend developers to define API requirements and Ensure API security and authentication mechanisms are robust. You should be able to pilot and deploy automation solutions at scale. Partner with the testing team to ensure applications/components are fully functional. Oversee and fix any defects or performance problems discovered in testing. Participating in analyses of requirements as well as functional design whenever necessary. Be involved in the design of the solution. Performing design, coding, application maintenance and testing activities. Take ownership of the successful implementation of the solution. Qualifications BE,BTech,MCA

Job Summary Join our dynamic team as a Pharmacovigilance Specialist where you will leverage Generative AI to enhance drug safety processes. This hybrid role offers the opportunity to work on cutting-edge projects in Research and Development and PV Case Processing ensuring the well-being of patients worldwide. With a focus on innovation you will contribute to the companys mission of improving healthcare outcomes. Responsibilities Utilize Generative AI tools to analyze and interpret pharmacovigilance data ensuring accurate and timely reporting. Collaborate with cross-functional teams to develop strategies for effective PV case processing and management. Conduct thorough research and development activities to improve drug safety protocols and procedures. Implement innovative solutions to streamline pharmacovigilance processes and enhance efficiency. Monitor and evaluate the impact of AI-driven methodologies on drug safety outcomes. Provide insights and recommendations based on data analysis to support decision-making in pharmacovigilance. Ensure compliance with regulatory requirements and industry standards in all pharmacovigilance activities. Participate in the development and maintenance of pharmacovigilance databases and systems. Support the preparation and submission of safety reports to regulatory authorities. Assist in the identification and assessment of potential safety signals and trends. Contribute to the continuous improvement of pharmacovigilance practices through research and innovation. Engage in knowledge sharing and training sessions to enhance team capabilities in AI and pharmacovigilance. Foster a collaborative environment that encourages creativity and problem-solving in drug safety initiatives. Qualifications Demonstrate proficiency in Generative AI and its application in pharmacovigilance processes. Possess a strong understanding of research and development methodologies in drug safety. Exhibit experience in PV case processing and management. Show familiarity with regulatory requirements and industry standards in pharmacovigilance. Display excellent analytical and problem-solving skills. Have the ability to work effectively in a hybrid work model. Demonstrate strong communication and collaboration skills. Certifications Required Certification in Generative AI applications in healthcare or pharmacovigilance.

Core Objectives The Quality Management (QM) Team is passionate about improving the quality of patient care by building intelligence into our athenaClinicals Electronic Health Record service. This is accomplished through the addition of point of care alerts around standards of care as well as identifying and building support for payer-based compensation and/or quality incentive programs. Our team is responsible for leveraging clinical data in the patient chart to improve our clients ability to successfully demonstrate improvements in the quality of care. The Quality Management (QM) Analyst is a critical contributor to this process. As a QM Analyst, you will work closely with teams across our data-driven company to research, prioritize, and build payforperformance programs and clinical guidelines into our expanding quality management library. You will work with the quality management tools in our Electronic Health Record service, athenaClinicals, to support client participation on pay-for-performance and pay-for-value initiatives. To succeed you will need to be a strong analytical problem solver, have excellent attention to detail and be able to work with a vast amount of information in a fast paced setting. You will have the capacity to plan and take responsibility for small projects independently and large projects collectively. You should be able to strive in both independent and team environments and be comfortable communicating between the business and development teams. You will act as a trusted advisor to internal and possibly external clients. Essential Duties And Responsibilities Responsibilities may include, but are not limited to: Develop knowledge on quality improvement trends in the healthcare industry, sharing this knowledge with multiple stakeholders Learn the Quality Management tools, workflows and reporting capabilities of our Electronic Health Record, athena Clinicals Understand, assist with inputs to develop and implement QM analysis and reporting processes, tools and metrics Work closely with team members to evaluate and prioritize new quality program development, including analysis of the clinical and financial impact to clients using these programs Understanding of business escalations and provide satisfactory responses. Manage internal and external stakeholder relationships through clear and concise communication and reporting, specific and measurable goals, aligned incentives, and clear expectations Ability to execute assigned projects with cross-functional teams using your excellent written and verbal communication skills to achieve success Become an active participant in athenahealths teaching and learning culture Key Skills And Abilities Technical Skills Strong computer literacy, including advanced Excel, Word, Power Point knowledge and web/internet tools Strong aptitude for developing and understanding big-picture QM use cases with attention to detail required to identify potential obstacles and mitigate risks Demonstrated success in using data and adding knowledge-based insight when making business decisions Soft skills Professional attitude comfortable working in a corporate setting populated by diverse types of people and able to maintain poise and a sense of humor in stressful situations Demonstrated success in managing projects with cross-functional interdependencies Excellent organizational skills, analytical ability, and strong attention to detail Flexibility and willingness to take on new tasks and challenges Understanding of medical terminology and EMRs as well as an understanding of measuring clinical quality and outcomes Flexibility and the ability to handle rapidly changing priorities as needed Excellent communication skills, including listening, writing and relationship development Enthusiasm, idealism, creativity, dedication, a sense of humor and an open mind Project Management Skills Ability to learn and work with project owners and above on the projects Basic project management skills and the desire to become more effective helping towards project success Capacity to plan and take responsibility to own mini-projects independently and collectively on large scale projects Professional attitude comfortable working in a corporate setting populated by diverse types of people as you become stronger in timely and efficient stakeholder communication Work Experience And Education Bachelors degree - Preferred Life Science background. Minimum 3 + years professional experience, healthcare experience preferred Work experience with athenaNet preferred Work hours are 1 to 10pm IST

Challenging. Meaningful. Life-changing. Those aren t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers. bms. com/working-with-us . Position: Internal Audit Analyst II, Global Internal Audit & Assurance (EG 90) Location : Hyderabad, India Reports To : Associate Director, IT Audit At Bristol Myers Squibb, we are inspired by a single vision - transforming patients lives through science. Across oncology, hematology, immunology, neuroscience, and cardiovascular disease, with one of the most diverse and promising pipelines in the industry, each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. Position Summary The Internal Audit Analyst II in GIA will work in a team environment to plan and execute dynamic risk-based audits and identify value-added recommendations to strengthen Company processes and controls. Audits will include U. S. -based operations, international Company subsidiaries, strategic initiatives, critical business processes, and key third-party outsourcing arrangements. Throughout the audits, the Senior Internal Audit Analyst will have the opportunity to interact with senior management and enhance oral and written communication skills. Key Responsibilities Key responsibilities include, but are not limited to: Work collaboratively with audit teams to execute financial, operational, compliance, and integrated IT audits. Actively participate in planning activities to identify significant risks and develop appropriate risk-based audit procedures. Research applicable policies, guidance, and regulations to drive assigned sections of the audit with high quality and within deadlines. Leverage existing data analytics AI use cases and assist with build and enhancement projects, when assigned. Interview key personnel to assess business processes and the strength of their control environments. Identify meaningful value-added recommendations for management to improve the adequacy, effectiveness, and efficiency of controls and related processes. Actively participate in meetings involving various levels of management to effectively communicate audit status, align on significant audit issues and recommended corrective actions. Prepare clear, detailed audit documentation evidencing the results of actual testing procedures in accordance with BMS and the Institute of Internal Auditors (IIA) standards. Prepare audit reports, including clearly written, concise audit observations that effectively communicate identified issues and their related corrective actions to key stakeholders. Participate with the team in trainings and regular departmental meetings that include sharing best practices. Participate in departmental projects as assigned (e. g. , audit lessons learned, training, continuous improvement, etc. ). Qualifications & Experience A BA/BS degree in Data Science, Computer Science, Information Systems, Accounting, Finance, or other business discipline. A minimum of 3 years prior public accounting or internal audit experience, including experience in financial, operational, IT or compliance auditing. Knowledge of U. S. GAAP and IIA standards. English fluency. Strong verbal and written communication skills. Proficiency with Excel/Word/PowerPoint. AI and Data analytics experience (specifically with visualization tools such as Tableau) and ERPs. Desirable Qualifications & Experience MBA or other advanced degree. Professional certification (i. e. , CPA, CA, CIA, CISA or equivalent). Experience with a Big Four firm. Experience in developing written reports and delivering presentations. Multilingual (verbal and written). Key Capabilities of Focus Leadership : Pursues tasks with a sense of urgency. Shows accountability by taking ownership of assigned responsibilities and completing them on time, with the highest quality. Demonstrates speed and innovation to get things done; can simplify complex processes; knows of and can leverage resources to drive tasks/projects forward across functions and within the function. Able to identify risk and quickly develop an understanding of complex processes. Works effectively in ambiguous situations and adapts quickly in a rapidly changing environment. Collaboration: Works well in a team environment, fostering inclusion and building effective relationships with both team members and customers. Displays excellent ability to communicate across various levels of management, including with executives, to explain identified issues and related corrective actions. Digital Proficiency: Actively works toward improving data analytics capabilities and developing digital acumen. Gathers relevant information and critically evaluates it to define next steps and propose a solution. Business Acumen: This role requires strong and proven ability to understand local and micro business dynamics, identify risks and opportunities. Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to adastaffingsupport@bms. com . Visit careers. bms. com/eeo-accessibility to access our complete Equal Employment Opportunity statement. If you come across a role that intrigues you but doesn t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. With a single vision as inspiring as Transforming patients lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms. com . Visit careers. bms. com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers. bms. com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

The Project Research Scientist II (Non-Medical) plays a crucial role in shaping the direction and success of clinical and health services research projects. This position requires expertise in scientific research, good organizational skills, and the ability to navigate complex regulatory environments. Primary Responsibilities: Develop and refine study designs to ensure scientific rigor and alignment with research objectives. Analyse data according to study statistical plan tailored to the studys specific needs, ensuring that data collection methods align with intended analysis strategies. Compile comprehensive reports for relevant committees and funding agency, that summarize the study progress, challenges encountered, and future directions. Organize project meetings to manage progress and timelines Preparing manuscripts for scientific communication. Site Audits: Conduct regular site visits to ensure compliance with study protocols and Good Clinical Practice (GCP) guidelines. Address any deviations or concerns related to study execution. Data Audits: Perform thorough audits of collected data to verify accuracy, completeness, and adherence to the study design and ethical standards. Team Collaboration: Work closely with a multidisciplinary team, including data managers, statisticians, other researchers, and clinical staff, to ensure that all aspects of the study are Minimum required qualifications/experience: First class post-graduate degree, including integrated PG degrees, with three years experience or Desirable: Experience in clinical or health services research, including expertise in study design and research methodology. Experience in conducting/managing operational feasibility studies Excellent written and oral communication skills, capable of effectively presenting research findings and writing complex reports. Demonstrated ability to lead and manage research projects, including coordination of Knowledge of regulatory standards and ethical guidelines pertinent to clinical research. Strong attention to detail and commitment to accuracy. Good organizational skills and ability to manage multiple tasks.

Primary Responsibilities: Develop and refine study designs to ensure scientific rigor and alignment with research objectives. Analyse data according to study statistical plan tailored to the studys specific needs, ensuring that data collection methods align with intended analysis strategies. Compile comprehensive reports for relevant committees and funding agency, that summarize the study progress, challenges encountered, and future directions. Organize project meetings to manage progress and timelines. Preparing manuscripts for scientific communication. Site monitoring visits and audits: manage the monitoring visits and address any deviations or concerns related to study execution. Execute action points as indicated by the study monitor during the visit and generate closure reports. Data Audits: Perform thorough audits of collected data to verify accuracy, completeness, and adherence to the study design and ethical standards. Team Collaboration: Work closely with a multidisciplinary team, including data managers, statisticians, other researchers, and clinical staff, to ensure that all aspects of the study are Minimum Essential Qualifications: First Class Post Graduate Degree, including the integrated PG degrees, with PhD Second Class Post Graduate Degree, including the integrated PG degrees, with PhD and with For Engineering/IT/CS- First Class Graduate Degree of four years with three years experience Desirable Qualifications/experience: Experience in clinical or health services research, including expertise in study design and research methodology. Experience in conducting/managing operational feasibility studies Minimum 3 years of experience in clinical data analysis, statistical analysis of large datasets, or Experience in statistical methods, exploratory data analysis, multivariate data analysis, linear, logistic, Poission regression with diagnostic checking, survival analysis, and their implementation in R, SAS, Graphpad prism, or other statistical software. Excellent written and oral communication skills, capable of effectively presenting research findings and writing complex reports. Demonstrated ability to lead and manage research projects, including coordination of Knowledge of regulatory standards and ethical guidelines pertinent to clinical research. Strong attention to detail and commitment to accuracy. Good organizational skills and ability to manage multiple tasks.

PURPOSE Performs and oversees data management activities in order to provide high quality data that meets client/project needs. Ensures that data is processed and tracked in alignment with regulatory and quality standards. RESPONSIBILITIES Serve as main point of contact for Data Management for 5 to 10 studies, or serve in a leadership role to a specific DM Task. Manage delivery of projects through full eCOA data management study life-cycle. Manage eCOA DM project timelines and quality; determine resource needs; identify out-of-scope work. Perform comprehensive data management tasks including data review, writing and resolving data clarifications. Provide support in database design activities for technologies not requiring extensive programming. Perform comprehensive quality control procedures. Independently bring project solutions to the eCOA team. Solve issues through using the global issue escalation/communication plan. Consult with eCOA ops Group for process issues; communicate ideas for process improvement. Assist in developing and implementing new technology. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with eCOA team. Interact with other study team members to negotiate timelines and responsibilities. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES Good understanding of clinical drug development process and Data Management activities. Background in, medical terminology, Pharmacology, Anatomy, and Physiology. Excellent organizational, communication, and data management skills (detailed oriented). Ability to establish and maintain effective working relationships with coworkers, managers and clients. Ability to work within a team and with a good level of autonomy. MINIMUM REQUIRED EDUCATION AND EXPERIENCE Bachelor s degree, or educational equivalence, in clinical, biological, or mathematical sciences or related field or nursing qualification with 2-4 year clinical trials experience in function similar to DM; or equivalent combination of education, training and experience. PHYSICAL REQUIREMENTS Extensive use of telephone and face-to-face communication requiring accurate perception of speech Extensive use of keyboard requiring repetitive motion of fingers Regular sitting for extended periods of time

PURPOSE Performs and oversees data management activities in order to provide high quality data that meets client/project needs. Ensures that data is processed and tracked in alignment with regulatory and quality standards. RESPONSIBILITIES Serve as main point of contact for Data Management for 5 to 10 studies, or serve in a leadership role to a specific DM Task. Manage delivery of projects through full eCOA data management study life-cycle. Manage eCOA DM project timelines and quality; determine resource needs; identify out-of-scope work. Perform comprehensive data management tasks including data review, writing and resolving data clarifications. Provide support in database design activities for technologies not requiring extensive programming. Perform comprehensive quality control procedures. Independently bring project solutions to the eCOA team. Solve issues through using the global issue escalation/communication plan. Consult with eCOA ops Group for process issues; communicate ideas for process improvement. Assist in developing and implementing new technology. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with eCOA team. Interact with other study team members to negotiate timelines and responsibilities. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES Good understanding of clinical drug development process and Data Management activities. Background in, medical terminology, Pharmacology, Anatomy, and Physiology. Excellent organizational, communication, and data management skills (detailed oriented). Ability to establish and maintain effective working relationships with coworkers, managers and clients. Ability to work within a team and with a good level of autonomy. MINIMUM REQUIRED EDUCATION AND EXPERIENCE Bachelor s degree, or educational equivalence, in clinical, biological, or mathematical sciences or related field or nursing qualification with 2-4 year clinical trials experience in function similar to DM; or equivalent combination of education, training and experience. PHYSICAL REQUIREMENTS Extensive use of telephone and face-to-face communication requiring accurate perception of speech Extensive use of keyboard requiring repetitive motion of fingers Regular sitting for extended periods of time . 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

: Provide basic and some comprehensive data management expertise to the eCOA Data Management (DM) team to deliver efficient, quality data management products that meet customer needs. May also undertake eCOA Data Management activities under the supervision of the Data Team Lead (DTL)/ Sr DTL, or Functional Manager. Essential Functions: - Undertake eCOA Data Management activities for assigned studies, with/without supervision. - May serve in the role of back-up to a DTL. - Perform testing of programming and data transfers. - Understand and comply with core operating procedures and working instructions. - Meet objectives as assigned and develop and maintain good communications and working relationships within eCOA DM team. - Database Design and Maintenance: Create and maintain clinical databases to ensure they are efficient and meet the needs of the clinical trials. - Data Querying and Reporting: Manage queries and generate reports for analysis. - Data Validation: Analyze and resolve discrepancies from Recon/CTMS inquiries. - Study Close-out: Execute end-to-end study close-out activities, include Archival. - Identify opportunities to automate and improve data collection and management processes. Qualifications: - Bachelor s degree in pharmacy or equivalent preferred. - 3-6 years of direct data management experience, preferably a minimum of 1 year as a CDM project lead. - Good to have experience in electronic Clinical Outcome Assessment (eCOA) or Decentralized Clinical Trials (DCT). - Advanced proficiency in English, both spoken and written. - Advanced skills in computer applications like Microsoft Excel, Word, Outlook, etc. - Advanced understanding of the drug development lifecycle and overall clinical research process.

Job Summary The Sr Product Specialist (ISG) will play a crucial role in enhancing and managing our Veeva CTMS and Veeva systems within the Research and Development domain. With a hybrid work model and day shifts the candidate will collaborate with cross-functional teams to ensure seamless integration and functionality of these systems. This role requires a deep understanding of Veeva technologies and R&D processes to drive innovation and efficiency. Responsibilities Lead the implementation and optimization of Veeva CTMS and Veeva systems to support R&D activities. Oversee system configurations and ensure alignment with business requirements. Collaborate with stakeholders to gather and analyze system needs and translate them into technical specifications. Provide technical expertise and support to end-users ensuring smooth operation of Veeva systems. Develop and maintain documentation for system processes and configurations. Conduct regular system audits to ensure data integrity and compliance with industry standards. Coordinate with IT teams to troubleshoot and resolve system issues promptly. Facilitate training sessions for users to enhance their understanding and utilization of Veeva systems. Monitor system performance and implement improvements to enhance efficiency. Engage with vendors and external partners to stay updated on the latest Veeva technologies and best practices. Drive continuous improvement initiatives to optimize system functionality and user experience. Ensure compliance with regulatory requirements and company policies in all system-related activities. Support project management activities including planning execution and monitoring of system-related projects. Qualifications Possess a strong background in Veeva CTMS and Veeva systems with hands-on experience. Demonstrate expertise in Research and Development processes and requirements. Exhibit excellent problem-solving skills and the ability to work independently. Have a proven track record of managing and optimizing enterprise systems. Show proficiency in collaborating with cross-functional teams and stakeholders. Display strong communication skills to effectively convey technical information to non-technical audiences. Certifications Required Veeva Certified Administrator Veeva Vault Certification