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1.0 - 3.0 years

2 - 6 Lacs

Bengaluru

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Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Associate Qualifications: BE/BTech/Masters in actuarial science Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be 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 accuracyThe 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. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skillsAbility to establish strong client relationshipAgility for quick learningCandidates who have completed B.Tech or B.E in Computer science in 2024 & 2025 (if all semester s results are available) 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,Masters in actuarial science

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1.0 - 3.0 years

2 - 6 Lacs

Bengaluru

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Skill required: Clinical Data Operations - Clinical Database Testing Designation: Clinical Data Svs Associate Qualifications: Masters in actuarial science Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world s leading biopharma companies bring their vision to life and enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Testing Team is dedicated to conduct through validation of all clinical trial database components ensuring that database meets quality standards while remaining cost effective. Their responsibilities include reviewing requirement specification, developing test scripts for carious testing types, performing data entry according to these scripts, executing test steps, documenting results and maintaining comprehensive records of all tested components in compliance with regulatory requirements.Design and test EDC databases, create and maintain User Acceptance Testing (UAT) procedures for EDC systems, including the creation of test plans, verification of requirements for databases, eCRFs, edit checks, extractions, and reports. What are we looking for Candidates who have completed Master s or Post graduate degree in Life Science domain (Biology, Genetics, Microbiology, Biochemistry, Biotechnology, and Ecology) in 2024 & 2025 (if all semester s results are available).Adaptable and flexibleAbility to perform under pressureProblem-solving skillsAbility to establish strong client relationshipAgility for quick learningExperience with Clinical testing, Understanding of clinical Trials, Phases and clinical domain. Familiarity with clinical data management concepts and terminologies, Knowledge of regulatory guidelines such as GCP, ICH, 21 CRF Part 11 and GDRP. Experience in test script development and strong documentation skills for test cases, validation reports and audit trials. 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 Masters in actuarial science

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1.0 - 3.0 years

2 - 6 Lacs

Bengaluru

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Skill required: Clinical Data Operations - Clinical Database Testing Designation: Clinical Data Svs Associate Qualifications: Masters in actuarial science Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world s leading biopharma companies bring their vision to life and enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Testing Team is dedicated to conduct through validation of all clinical trial database components ensuring that database meets quality standards while remaining cost effective. Their responsibilities include reviewing requirement specification, developing test scripts for carious testing types, performing data entry according to these scripts, executing test steps, documenting results and maintaining comprehensive records of all tested components in compliance with regulatory requirements.Design and test EDC databases, create and maintain User Acceptance Testing (UAT) procedures for EDC systems, including the creation of test plans, verification of requirements for databases, eCRFs, edit checks, extractions, and reports. What are we looking for Candidates who have completed Master s or Post graduate degree in Life Science domain (Biology, Genetics, Microbiology, Biochemistry, Biotechnology, and Ecology) in 2024 & 2025 (if all semester s results are available).Adaptable and flexible.Ability to perform under pressure.Problem-solving skills.Ability to establish strong client relationship.Agility for quick learning.Experience with Clinical testing, Understanding of clinical Trials, Phases and clinical domain. Familiarity with clinical data management concepts and terminologies, Knowledge of regulatory guidelines such as GCP, ICH, 21 CRF Part 11 and GDRP. Experience in test script development and strong documentation skills for test cases, validation reports and audit trials. 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 Masters in actuarial science

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5.0 - 8.0 years

3 - 7 Lacs

Mumbai

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Skill required: Marketing Operations - Medical Affairs Designation: Copywriting Senior Analyst Qualifications: Any Graduation Years of Experience: 5 to 8 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do Help balance increased marketing complexity and diminishing marketing resources. Drive marketing performance with deep functional and technical expertise, while accelerating time-to-market and operating efficiencies at scale through Data and Technology, Next Generation Content Services, Digital Marketing Services & Customer Engagement and Media Growth Services.Role requires Digital Marketing Ads & Promotion creation/designDesign, develop and deliver business solutions related to the medical affairs group of pharmaceutical companies, including thought leadership development, medical publications, education and information, medical grants, advisory boards and advocacy. What are we looking for Medical ReviewMedical MonitoringContent CreationProblem-solving skillsAgility for quick learningResults orientationCommitment to qualityWritten and verbal communicationClinical Data Review Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualification Any Graduation

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1.0 - 3.0 years

2 - 6 Lacs

Bengaluru

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Skill required: Clinical Data Services - SDTM Mapping Designation: Clinical Data Svs Associate Qualifications: BE/Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.A standard structure for human clinical trial data tabulations and for nonclinical study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA). What are we looking for Adaptable and flexibleAgility 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,Bachelor of Pharmacy,Master of Pharmacy

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1.0 - 3.0 years

5 - 9 Lacs

Chennai

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Skill required: Com.Bkg- Commercial Real Estate - Real Estate Due Diligence Designation: Banking Advisory Associate Qualifications: BCom/MCom/Master of Business Administration Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do We help clients address quality and productivity issues, keep pace with customer expectations, navigate regulatory and operational pressures and ensure business sustainability by transforming their banking operations into an agile, resilient operating model.The Corporate banking /Wholesale banking team is responsible for helping clients and organizations processes trade finance transactions by providing superior service delivery to trade customers whilst safeguarding the bank from risks associated with this business.Identify and assess, prevent and mitigate and account to provide reasonable measures to adapt before executing an agreement in relation to the real estate and immovable property. Valuation of commercial real estate using software like Argus, extracting key information from lease agreements (including amendments) and rent rolls. What are we looking for Agility for quick learningAbility to work well in a teamAbility to perform under pressureCommitment to qualityDetail orientation 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 BCom,MCom,Master of Business Administration

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12.0 - 15.0 years

10 - 14 Lacs

Bengaluru

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Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : SAP HCM Payroll Good to have skills : NAMinimum 12 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure that application requirements are met, overseeing the development process, and providing guidance to team members. You will also engage in problem-solving activities, ensuring that solutions are effectively implemented across multiple teams, while maintaining a focus on quality and efficiency in application delivery. Roles & Responsibilities:- Expected to be an SME.- Collaborate and manage the team to perform.- Responsible for team decisions.- Engage with multiple teams and contribute on key decisions.- Expected to provide solutions to problems that apply across multiple teams.- Facilitate knowledge sharing sessions to enhance team capabilities.- Monitor project progress and ensure alignment with strategic goals. Professional & Technical Skills: - Must To Have Skills: Proficiency in SAP HCM Payroll.- Strong understanding of payroll processing and compliance regulations.- Experience with SAP HCM modules and integration with other systems.- Ability to troubleshoot and resolve application issues effectively.- Familiarity with project management methodologies. Additional Information:- The candidate should have minimum 12 years of experience in SAP HCM Payroll.- This position is based at our Bengaluru office.- A 15 years full time education is required. Qualification 15 years full time education

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2.0 - 8.0 years

20 - 25 Lacs

Mumbai

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At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional All Job Posting Locations: Hong Kong, Hong Kong, Hsinchu City, Hsinchu County, Taiwan, Mumbai, India, North Ryde, New South Wales, Australia, Petaling Jaya, Selangor, Malaysia, Singapore, Singapore Job Description: Johnson & Johnson is currently seeking a Senior Regulatory Affairs Professional to join our Regulatory Affairs APAC team. POSITION SUMMARY: The Senior RA Professional is a member of the Global Regulatory Affairs organization. The position resides in the AP Region and is responsible for working with local regulatory affairs departments, AP regional cross-functional teams, Global Regulatory Teams and other global functions to define and implement the regional strategy for assigned products. The position, under supervision, is accountable for leading and providing region or country strategic input into the global regulatory strategy and identifying regional requirements to optimize registration, and lifecycle management of marketed products, taking into consideration current and proposed changes in regulatory requirements and standards. This position provides regional affiliates with timely responses to Health Authority enquiries and gives general regulatory support to all affiliates in the region for the pharmaceutical sector business. RESPONSIBILITIES: Regulatory Strategy and Expertise Understands regional and local requirements and advises the Global Regulatory Team (GRT) and Compound Development Team (CDT) on applicable regulatory requirements, guidelines and processes, region-specific regulatory issues with impact on the product strategy or deliverables. Keeps up-to-date on understanding of regional/regulatory environment. Participates as a standing member of the project related GRT if applicable; supports the GRT by providing strategic regional input into registration and life cycle management. Expedites commercialization of new indications and line extension by providing regional regulatory inputs to identify barriers and needs. Provides guidance to local affiliates on development of strategies to accelerate submissions/approvals Provides input in post-registration activities, including labeling changes Provide regional implementation and regulatory-based advice on new and updated Core Data Sheets. Maintains expert knowledge in regional regulatory requirements and ensure that staff is expert in country and product-specific regulatory requirements Provides AP evaluation in licensing activities Health Authority, Operating Companies, and Business Partner Interactions Manages regulatory interactions with local operating companies and regional functions Serves as point of contact with local operating companies Ensures excellent collaborative relationship with key stakeholders including staff in the region and global R&D partners. Interacts with local operating companies on individual products/processes Facilitates discussions with local operating companies on regional or global regulatory issues, as required Provides guidance to local operating companies to determine timing and strategy for regional HA meetings. Participates in preparations for interactions with HAs and assist operating company with these interactions. Regulatory Submissions Provides input to submission tactical planning and timelines including lifecycle submissions (labeling changes, renewals and safety reports). Ensures maintenance of generic content plans for submissions in the region, including clinical trials and registration submissions Coordinates and follows-up on post-approval submissions to ensure that product remains in compliance Reviews and provides input to critical submission documents Delivers on business critical regulatory submissions in accordance with development and/or post marketing priorities and timelines Participates in Rapid Response Teams to ensure appropriate and timely responses to HA questions. Provides clarification regarding HA questions and provides input to the strategy for responding to HA questions. Ensures tracking of submission and approval milestones Ensures tracking of regional post-approval commitments and ensures appropriate follow-up actions ADDITIONAL RESPONSIBILITIES: Participates in the development of department processes and procedures. Ensures that defined processes are developed and implemented within the regional regulatory office to track and communicate key regulatory product activities and milestones Updates global regulatory staff regarding changes in regional regulatory requirements and provides support to VP, Regulatory Affairs AP as requested on initiatives. REQUIRED TECHNICAL COMPETENCIES AND KNOWLEDGE: Regulatory Strategy Good understanding of the pharmaceutical industry Detailed knowledge of local laws, regulations and guidance in the region related to full drug life cycle. Understanding of how laws, regulations and guidance apply to specific projects. Ability to interpret them and understand them in the context of the scientific and commercial environment. Good understanding of and experience in drug development and/or marketed products. Ability to anticipate and influence regulatory developments in the region and assess business impact Ability to communicate AP regulatory strategy to global teams and assess impact on global/regional drug development Understanding of the scientific and medical principles applicable to the therapeutic area and specific products. Awareness of pricing and reimbursement issues in AP Understanding of how supply chain decisions impact registrations in AP HA and Operating Company Interactions Detailed knowledge of HA structures, how those agencies operate, and how and when to interact with them to generate a successful outcome. Ability to work with and influence HA actions and outcomes. Project-related knowledge of commercial/medical business needs. Broad understanding of scientific data (CMC, clinical and non-clinical) Regulatory Input into Other Functions Comprehensive understanding of the needs of regional business partners. Submissions Detailed knowledge of laws, regulations, and guidance as they apply to submissions in the region. Knowledge of what is needed for dossier components and submissions, how to obtain regional components and how long it will take to gather it. Understanding of documentation requirements. Ability to analyze reports to determine whether they meet regulatory requirements, and are consistent with the regional regulatory strategy. Labeling Knowledge of local labeling requirements. Under the supervision, and supported by a supervisor, critically review labeling development/labeling revisions and assess impact on relevant countries Knowledge of competitive landscape and how other companies are dealing with similar issues in labeling. Under the supervision, and supported by a supervisor, undertake labeling negotiations with health authorities Decision Making and Problem-Solving Operates in a competitive, complex, and rapidly changing environment. Must make proposals and negotiate on prioritization and trade-offs on a project level. Independence on decision-making regarding regional product strategies with supervisor approval. Defines operational priorities and tactics in the region. Resolves conflicts in priorities in consultation with supervisor, regional business partners, and head office-based team members and other internal customers. Determines risk-management strategies for projects. Makes informed decisions by soliciting input from others where needed. Makes complex decisions in situations with multiple, ambiguous objectives and constraints. Decisions and problem-solving require interpretation of applicable country-specific and company procedures, policies, standards, and regulations in drug regulation and personnel practices, but will not be explicitly circumscribed by these. Independence/Autonomy Operates independently in a complex environment. Independent in daily activities, with /limited managerial oversight. Sets long-term work priorities for self in consultation with supervisor. Position makes determination of routine work issues. KNOWLEDGE, EDUCATION, EXPERIENCE, COMMUNICATION SKILL REQUIREMENTS: Minimum of bachelor s degree or equivalent in pharmacy or life-science or health-related discipline. 2 - 8 years of overall experience in relevant pharmaceutical industry and preferably with regulatory experience Hands on experience in pharmaceutical product registration in AP countries and familiarity with AP regulatory systems and product registration requirements preferred. Previous experience in preparing documents for health authority submissions (Chemistry & Manufacturing, and /or Registration dossiers) also preferred. Demonstrated ability to handle multiple projects. Demonstrated organizational skills Ability to communicate to senior level management. Working knowledge of regulations in the region Experience in HAs interactions. Excellent verbal and written communication skills - proficiency in written and oral English and [Mandarin/Asian (Asia) languages is preferred.] Must be able to develop and maintain excellent working relationships, work successfully within a team environment and as an individual contributor. Cultural sensitivity and ability to work and thrive in a multi-cultural environment, as well as an ability to work in a matrix environment are required Proactive team player, able to take charge and follow-through. Achievement-oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment. Proficient use of technology including MS office programs and Internet resources. Minimal regional business travel (1 or 2 times per year) may be required. Occasional international travel may be required. Must be able to work flexible hours to accommodate early morning/evening meetings/ teleconferences with different time zones.

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1.0 - 6.0 years

1 - 4 Lacs

Varanasi

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Deva Institute of Healthcare and Research Pvt Ltd is looking for Clinical Research Coordinator to join our dynamic team and embark on a rewarding career journey. Coordinate and manage clinical trials from initiation to completion, ensuring compliance with regulatory guidelines and study protocols Recruit, screen, and enroll study participants while maintaining accurate documentation and records Monitor patient safety, manage informed consent, and schedule follow-ups Communicate with investigators, sponsors, and regulatory authorities to ensure timely updates and reporting Maintain study supplies, track data collection, and support data analysis, ensuring high-quality and ethical research practices throughout the study

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3.0 - 7.0 years

3 - 7 Lacs

Mumbai

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IVL India Environmental RD is looking for Quality Expert to join our dynamic team and embark on a rewarding career journey. Develop and implement quality assurance policies and procedures. Conduct quality audits and inspections. Analyze data to identify areas for improvement. Provide training on quality standards and processes. Ensure compliance with regulatory requirements.

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2.0 - 7.0 years

7 - 11 Lacs

Ahmedabad

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Statistical Programmer II Location: Ahmedabad, Gujarat, India Requisition Number 690 On-site Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research approaching each opportunity with foresight, character, resilience and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions. The Statistical Programmer II ( Programmer ) will have experience in all required areas of a Statistical Programmer I. The Statistical Programmer II is responsible for providing programming support for clinical trials. Responsibilities: Exceed expectations and responsibilities of a Statistical Programmer I Understand and implement CDISC and other regulatory standards Follow internal SAS programming conventions May serve as programming lead with responsibility for coordination of activities and timelines May prepare programming specifications for SDTM, ADaM and other derived datasets Apply knowledge of SAS programming to program/develop and/or validate statistical outputs according to the statistical analysis plan and other specifications; including but not limited to: SDTM, ADaM or other derived datasets Tables, listings and figures Review and provide input on case report form design Work effectively with other programmers, statisticians, data managers, database programmers and other cross-functional team members to ensure accurate and high-quality statistical outputs Standard Operating Procedures (SOPs) Strong understanding of departmental and company procedures; ability to guide others on procedures Additional Responsibilities Perform other duties as requested by management Qualifications: The ideal candidate should have a degree in Statistics, Computer Science, or a closely related field; work experience may be substituted for degree Minimum of 2 years direct SAS programming experience in pharmaceutical development or CRO environment Good knowledge of medical terminology and conduct and analysis of clinical trials Knowledge of relevant industry data standards (e.g. CDISC SDTM, ADaM, etc.) Excellent oral and written communication skills, organizational skills, and attention to detail are required

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4.0 - 9.0 years

8 - 12 Lacs

Ahmedabad

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On-site Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research approaching each opportunity with foresight, character, resilience and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions. The Senior Statistical Programmer ( Programmer ) will have experience in all required areas of a Statistical Programmer II. The Senior Statistical Programmer is responsible for providing programming support for clinical trials. Responsibilities: Exceed expectations and responsibilities of a Statistical Programmer II Understand and implement CDISC and other regulatory standards Follow internal SAS programming conventions Serve as programming lead on assigned studies Coordinate and ensure the accuracy and completeness of activities for assigned support programmers Create and maintain project timelines Support the development of tools and macros to improve quality and efficiency of processes Prepare programming specifications for SDTM, ADaM and other derived datasets Apply knowledge of SAS programming to program/develop and/or validate statistical outputs according to the statistical analysis plan and other specifications; including but not limited to: Analysis datasets (SDTM, ADaM, other derived datasets) Tables, listings and figures xml/Reviewer s Guide Integrated summaries Analysis datasets (SDTM, ADaM, other derived datasets) Tables, listings and figures xml/Reviewer s Guide Integrated summaries Perform ad hoc analyses of current and legacy databases Review and provide input on case report form design Serve as a mentor to other programmers Maintain awareness of scope of work to actual work, alerting management of potential change orders or resourcing needs Work effectively with other programmers, statisticians, data managers, database programmers and other cross-functional team members to ensure accurate and high-quality statistical outputs Standard Operating Procedures (SOPs) Strong understanding of departmental and company procedures; ability to guide others on procedures May participate in the development and revision of department SOPs Business Development May support the business development process; RFI completion, proposal development, bid defense participation, attendance at industry/scientific meetings, etc. Additional Responsibilities May assist in the preparation and review of monthly financial reporting May promote visibility outside of the functional area and effectively interact cross-functionally and in industry May participate in candidate interviews Perform other duties as requested by management Qualifications: The ideal candidate should have a degree in Statistics, Computer Science, or a closely related field; work experience may be substituted for degree Minimum of 4 years direct SAS programming experience in pharmaceutical development or CRO environment Good knowledge of medical terminology and conduct and analysis of clinical trials Knowledge of relevant industry data standards (e.g. CDISC SDTM, ADaM, etc.) Excellent oral and written communication skills, organizational skills, and attention to detail are required At Advanced Clinical, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Clinical in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience. Equal Employment Opportunity It is Advanced Clinical s practice not to discriminate against any Employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or veteran status, or any other basis protected by applicable federal, state, or local law. This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your Recruiter so that we can meet to discuss the appropriate alternatives available.

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4.0 - 9.0 years

20 - 25 Lacs

Hyderabad

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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. The Associate Director, Advertising Procurement role will support dynamic Marketing business strategies and collaborate across a matrix-team to position BMS brands to win. This role will focus on enabling our new Agency roster and ensuring sustained value of our new Agency model. 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:

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3.0 - 5.0 years

7 - 11 Lacs

Kolkata

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At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Job Function: R&D Operations Job Sub Function: Clinical Trial Project Management Job Category: Professional All Job Posting Locations: Bangalore, Karnataka, India, Delhi, Delhi, India, Hyderabad, Andhra Pradesh, India, Kolkata, West Bengal, India, Mumbai, India Job Description: Global Clinical Operations (GCO) Senior Site Contract Manager, Global Site Contracting (CCS) *: (*Title may vary based on Region or Country requirements) Position Summary: Responsible for the development and analysis of contractual relationships including investigator grants including but not limited to drafting, negotiating, and finalizing agreements related to clinical trials and/or overseeing a Clinical Research Organization responsible for contract negotiations. Provide support to the clinical team in the pricing, planning, execution and control of grants and contracts. Principal Responsibilities: Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company sponsored and/or investigator-initiated studies through direct negotiation with clinical trial sites or via oversite of a Clinical Research Organization responsible for contract negotiations. Responsible for delivery on established targets/measurements. Responsible for analyzing contract requests/needs from operating companies and translating into appropriate contracts/budgets for company sponsored and investigator initiated clinical trial agreements and other relevant legal documents as they relate to various clinical projects. Ensure that contractual terms and provisions are in compliance with corporate process, systems, and strategies. Provide specialized support for negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents as required. Analyze investigator grants for fair market value aligned with regional knowledge and the J&J grant pricing guidelines, and based on adequate scope of work, clinical trial protocol and other clinical trial information. Participate in and/or lead the approval escalation of grants as appropriate. Work with the global CCS team as necessary to review and analyze contractual terms and conditions in order to reach acceptable language. Assess risks of budget and legal provisions in conjunction with members of the CCS team and support functions and communicate such to stakeholders. Liaise with CCS management and functional CCS support teams, legal, Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and escalate issues as appropriate. Work proactively to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites. Mentor and train new contract coordinators and analysts. Assume responsibility for all aspects of legal document and metrics tracking. Determine potential needs for contract amendments and manage amendment lifecycle. Exemplary customer focus with vision to drive solutions This is not an exhaustive, comprehensive listing of job functions. Other duties may be performed as assigned. Principal Relationships: This position reports to Manager, Site Contracting Internal: Internal Business Partners (CCS, TA, MAF, MAO, GD, HCC, Risk Management, Legal, etc.) outside parties External: Clinical Investigator Sites Commercial Suppliers Clinical Research Organizations (when applicable). Education and Experience Requirements: Bachelor s degree in appropriate scientific or business disciplines 3 to 5 years-experience and/or equivalent competencies in pharmaceutical industry/clinical research Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.) a plus Must have a working knowledge of the clinical development process with two (2) years of negotiation and contract experience Familiarity with clinical research processes Ability to work effectively in cross function teams Strong and proven negotiation and problem resolution skills Working knowledge of PCs (MS Office suite at a minimum) and database management Must demonstrate innovative spirit, have strong interpersonal skills, and ability to manage a high volume of work Previous experience working in virtual teams preferred. DECISION-MAKING AND PROBLEM-SOLVING: Adhere to SOPs, ethics and departmental compliance as determined by GD management as well as operating companies, corporate, HCC and QA guidelines. Ensure familiarity with departmental and corporate processes including but not limited to the relevant processes associated with CCS, GD and operating companies. Comply with requests from QA and auditors. Able to work independently as well as in a collaborative team environment. Other: Fluency in English required. Travel Percentage: 10%

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5.0 - 10.0 years

10 - 14 Lacs

Bengaluru

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Key Responsibilities: Collaborate with business stakeholders to understand data needs and reporting requirements specific to the pharmaceutical domain. Design and develop Power BI dashboards and reports that provide actionable insights. Connect to various data sources (e.g., clinical trials data, sales data, SAP, LIMS, etc.). Perform data cleansing, transformation, and modeling using Power Query and DAX. Work with cross-functional teams including data engineers, analysts, and domain experts. Ensure data accuracy, reliability, and performance optimization of BI solutions. Provide training and support to business users on Power BI reports and dashboards. Maintain documentation of reports, dashboards, data sources, and business logic. Ensure compliance with pharmaceutical regulations (e.g., FDA, GxP, 21 CFR Part 11) in all data-related activities. Required Qualifications: Bachelor s or Master s degree in Computer Science, Data Analytics, Life Sciences, or a related field. 5+ years of hands-on experience in Power BI development and business intelligence. Proven experience working within the pharmaceutical industry (R&D, manufacturing, supply chain, commercial, etc.). Strong knowledge of SQL, DAX, Power Query (M language), and data modeling. Experience working with data from clinical trials, regulatory systems, pharmacovigilance, or commercial pharma data is highly desirable. Familiarity with data governance and compliance frameworks relevant to the pharma industry. Strong analytical, problem-solving, and communication skills. Preferred Qualifications: Experience with Azure Data Services, Snowflake, or other cloud data platforms. Knowledge of statistical or clinical data standards (e.g., CDISC, SDTM). Power BI certification is a plus.

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3.0 - 8.0 years

1 - 2 Lacs

Noida

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Job description Medtek is a data science driven company to support faster drug development and healthcare solutions.It support growing Biotech and Pharma companies. Assist clients with Data Technologies, Data Analysis, Data Mining, CDISC, Visualisation and Regulatory reporting. Support end to end Biostatistics, Programming and Data Management work. ESSENTIAL DUTIES AND RESPONSIBILITIES OF PRINCIPAL STATISTICAL PROGRAMMER- Able to independently Lead statistical programming activities for Phase 2/3 studies Able to multitask and work in a matrix environment 8 years experience in SAS programming and Reporting Able to program and deliver in independently with minimum guidance 6+ year of SDTM/ADaM and TLF Programming experience Able to write specification Independently validate others programs Able to work in multitasking environment and lead studies Proactive, multitask and able to work in matrix environment Pay attention to data and provide daily details Able to work in clinical domain with Clinician, Statistician and Scientist. In-depth knowledge of clinical trial design, statistical analysis, and regulatory guidelines. Strong SAS data manipulation, analysis and reporting skills- with strong output programming experience Development and execution of statistical analysis and reporting deliverables (e.g.safety and efficacy analysis datasets, tables, listings, figures) Provide technical guidance to other statistical programmers, and ensure training and development of team members. SUPERVISORY RESPONSIBILITIES: None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: Master in Statistics, computer science or analytics field with 7+ year experience Knowledge/Skills: Eight + year of Statistical programming experience Six year of experience with CDISC Two year Experience with SQL programming Experience in CDISC SDTM/ADaM domain Good communication skills Job Type: Full-time Pay: 25-30 Lacs P.A. Schedule: 8 hour shift Application Question(s): Can you write ADaM, SDTM specificaiton and programs ? Experience: statistical programming: 7 years (Required)

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2.0 - 5.0 years

11 - 15 Lacs

Hyderabad

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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. Scope The Global Customs Trade Compliance analyst is responsible for supporting BMS Customs Trade coordination, management and data generation for locations where BMS imports and exports. Responsibilities may include, but are not limited to, the following: Determination, management, automation advancement for the intake of assignment and recordkeeping of commodity codes for various markets Support various markets on process implementation for valuation adjustments/reconciliation programs Facilitate the maintenance of files, data, and other supporting information for imports and exports for an audit-ready state and coordinate with internal customers in response to audits or other requests for information pertaining to company import / export activities. Support Customs Trade as needed with Analytics - analytical data gathering and management support for the Customs Classification database, volume/value/audit metrics, drawback, special projects, and other needs as determined Perform other duties that may be assigned or required to support Global Customs and Trade Compliance Skills/Knowledge Required: Knowledge of International Trade Laws and Regulations Must have strong interpersonal skills, be a team player and be willing to work in an environment where individual initiative and accountability to the team are required. Must be able to work independently with limited day-to-day supervision. Must be detail- and compliance-oriented with technical writing skills. Strong technical skills Self-starter, proactive, flexible are essential to effectively interact with all teams, areas and levels of business Strong communication, presentation and skills. PREREQUISITES: 2-5 years of experience in a pharmaceutical environment and expertise on International Trade regulations and requirements for import / export shipments of specialty pharmaceuticals 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:

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4.0 - 8.0 years

9 - 15 Lacs

Hyderabad, Pune, Bengaluru

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Hi, We are hiring for the ITES Company for the Clinical SAS + SQL Programmer Profile. Job Description: Minimum 4 years of experience in any CDMS application. To perform a wide range of Clinical Data Management activities resulting in high quality database within stipulated timelines. To provide expertise in programming concepts to the Data Management team Must be able to develop the connection with the stake holders by pro-actively communicating over the calls and handling the queries by resolving them on the spot or later depending on the nature of the problem. Must be able to contribute the solutions to the DMs or Medical scientist for their New requirements either programmatically or convincing them with the technical limitations, if any, along with providing alternative solution. Must have capability to develop new Macros in SAS or modify any SAS Macros that are used globally throughout studies as a part of automation. Preferred Skills: Excellent interpersonal and communication skills Capability to lead by motivation and exle. Strong knowledge in SAS macros is required. General knowledge of Clinical Trials and Pharmaceutical Industry Oracle/PL SQL, CDMS like SAS, Inform etc Key Skills: a) Minimum 4 years of experience in any Clinical Data Management application. b) Should have Oracle/PL SQL, CDMS like SAS, Inform etc c) Any Medical 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 ( Pune ) Type : Job Code # 483 b) To Apply for above Job Role ( Bangalore ) Type : Job Code # 484 b) To Apply for above Job Role ( Hyderabad ) Type : Job Code # 485

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7.0 - 12.0 years

9 - 15 Lacs

Pune, Mumbai (All Areas)

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Hi We are Hiring For Leading ITES Company for the position of PV Aggregate Reporting Role Job Description To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation Aggregate Safety Reports (PBRER, DSUR etc.) Eligibility: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) Working knowledge of MS Office applications Flexibility to work as per business requirements. Understands and interprets data/information and its practical application. Knowledge of industry and business principles related to biopharmaceutical products and combination products. Good interpersonal, verbal, and written communication skills 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 # 54 b) To Apply for above Job Role ( Pune ) Type : Job Code # 55

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3.0 - 8.0 years

10 - 15 Lacs

Pune, Mumbai (All Areas)

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Hi We are hiring for Leading ITES Company for PV Aggregate Reporting Profile. Skills a) Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing b) Experience is documents i.e., PBRER,PSUR,DSUR, ICH Guidelines b) Qualifications - Health Care Professional OR Masters/bachelors degree in Life Sciences/Physician Job Responsibility Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation Aggregate Safety Reports (PBRER, DSUR etc.) Eligibility: Minimum 2 years of medical writing work experience including 1 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) Working knowledge of MS Office applications Flexibility to work as per business requirements. Understands and interprets data/information and its practical application. Knowledge of industry and business principles related to biopharmaceutical products and combination products. Good interpersonal, verbal, and written communication skills Qualifications Health Care Professional OR Masters/bachelors degree in Life Sciences/Physician 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 # 54 b) To Apply for above Job Role ( Pune ) Type : Job Code # 55

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3.0 - 8.0 years

10 - 15 Lacs

Pune, Mumbai (All Areas)

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Hi We are hiring for Leading ITES Company for PV Aggregate Reporting Profile. Skills a) Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing b) Experience is documents i.e., PBRER,PSUR,DSUR, ICH Guidelines Job Responsibility Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation Aggregate Safety Reports (PBRER, DSUR etc.) Eligibility: Minimum 2 years of medical writing work experience including 1 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) Working knowledge of MS Office applications Flexibility to work as per business requirements. Understands and interprets data/information and its practical application. Knowledge of industry and business principles related to biopharmaceutical products and combination products. Good interpersonal, verbal, and written communication skills Qualifications Health Care Professional OR Masters/bachelors degree in Life Sciences/Physician 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 # 54 b) To Apply for above Job Role ( Pune ) Type : Job Code # 55

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5.0 - 10.0 years

15 - 20 Lacs

Bangalore Rural, Mumbai (All Areas)

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Hi, We are hiring for Leading ITES Company for Lead Data Manager Profile. Job Description Perform day to day Clinical Data Management activities. Work and coordinate with the team to perform data management activities and deliver an error free quality database in accordance with the data management plan and regulator standards. Read and understand the study protocol and the timelines. Perform test data entry in TEST environment, data listing review, data reconciliation and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate. Perform external checks to handle manual discrepancies and action the same. Ensure an error free, quality data with no open queries. Escalate any discrepancy in the clinical data to the study lead as appropriate. Timely completion of trainings Any other tasks deemed appropriate To perform medical data collection and analysis of Prostate Cancer Data using databases like HIS/ EMR (Electronic Medical Record) and Cases Rave, CDM (startup, close out, conduct) Client interaction and meetings. Bringing up new ideas and executing new plans to cope with the back-log. Training to new team members as and when required. Key Skills: a) Minimum 3 years of Experience in leading clinical studies/ Clinical Data Management b) Hands on experience of Study Conduct and Close Out is must c) Any Graduate To Apply, WhatsApp 'Hi' @ 9151555419 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 # 95 b) To Apply for above Job Role ( Bangalore ) Type : Job Code # 98

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5.0 - 10.0 years

15 - 20 Lacs

Nagpur, Bangalore Rural, Bengaluru

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

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5.0 - 10.0 years

15 - 20 Lacs

Pune, Mumbai (All Areas)

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Hi , We are hiring for Leading ITES Company for SAS Programmer & CDB Programmer ( J Reviewer/Python/SAS) Role & responsibilities: 1.Create data cleaning reporting solutions study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. 2. Develop library of reusable checks working closely with data engineers and config specialists. 3. Collaborate with cross functional teams in creating business rules and automated check library across TAU. 4. Serves as a technical resource for creating data analytics to help with data validation and cleaning. 5. Provide programming expertise for data cleaning to efficiently ensure high quality data. 6. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. 7. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. 8. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. 9. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) 10. Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable 11. Technical skills and experience using relational databases (e.g. MS SQL Server, Redshift, or Oracle), 12. EDC build and/or clinical data management experience preferred 13. Experience in AWS preferred 14. Experience setting up automated validation is preferred 15. Knowledge of Data lake and creating interactive Dashboards are preferred 16. Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) To Apply, WhatsApp 'Hi' @ 9151555419 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 # 83 b) To Apply for above Job Role ( Pune ) Type : Job Code # 84

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3.0 - 7.0 years

15 - 20 Lacs

Nagpur, Pune

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

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