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1.0 - 3.0 years
2 - 6 Lacs
Bengaluru
Work from Office
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
Posted 2 months ago
1.0 - 3.0 years
2 - 6 Lacs
Bengaluru
Work from Office
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
Posted 2 months ago
1.0 - 3.0 years
2 - 6 Lacs
Bengaluru
Work from Office
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
Posted 2 months ago
2.0 - 5.0 years
15 - 20 Lacs
Nagpur, Bengaluru
Work from Office
Hi, We are hiring for ITES Company for SDTM Programmer Role. Job description: Minimum 2 years of experience for Senior Statistical programming is a mandate. • Having strong understanding of SAS Base/Macros/GTL and experience of SDTM/ADAM/TLFs creation as per CDISC standards. • Associate should be able to manage communication with customers, track and ensure quality on-time deliverables • Implementation of process improvements for enhanced quality and efficiency gains, institute robust processes to ensure consistent outcomes with quicker turn-around time. • Experience in SDTM, ADAM & TLF • Experience in EDC & VEEVA • Expertise in Base and Advance SAS programming. • Expertise in developing macros and developing generalized programs. • Development of the complex SAS macros that can be utilized across TAs in multiple studies, review of the developed SAS programs. • Expertise in SQL, SAS Macros, Functions, SAS GTL, SAS, and other advanced SAS components. • Mentor and supervise developers to build generic standard macros, generic listings or other ad-hoc requests in accordance with business requirements Key Skills: a) Minimum 2 years of Experience in SDTM, ADAM & TLF is must b) 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 ( Bangalore ) Type : Job Code # 91 b) To Apply for above Job Role ( Nagpur ) Type : Job Code # 92
Posted 2 months ago
3.0 - 8.0 years
15 - 20 Lacs
Nagpur, Pune, Bengaluru
Work from Office
Hi, We are hiring for ITES Company for SAS + CDB Programmer Role. Job description: Programming, specifically J Review, SQL, R and GitHub. Good to have Python. • Create data cleaning reporting solutions study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. • Develop library of reusable checks working closely with data engineers and config specialists. • Collaborate with cross functional teams in creating business rules and automated check library across TAU. • Serves as a technical resource for creating data analytics to help with data validation and cleaning. • Provide programming expertise for data cleaning to efficiently ensure high quality data. • Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. • Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. • Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. • Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) • Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable • Technical skills and experience using relational databases (e.g. MS SQL Server, Redshift, or Oracle), • EDC build and/or clinical data management experience preferred • Experience in AWS preferred • Experience setting up automated validation is preferred • Knowledge of Data base and creating interactive Dashboards are preferred • Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) Key Skills: a) Minimum 3 years of Experience in SAS CDB Programmers with R programming. b) Good to have Python knowledge 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 # 84 b) To Apply for above Job Role ( Nagpur ) Type : Job Code # 85 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 86
Posted 2 months ago
7.0 - 11.0 years
9 - 13 Lacs
Bengaluru
Work from Office
Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Specialist Qualifications: Bachelor of Pharmacy Years of Experience: 7 to 11 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. The role may require you to identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The role may also need expertise in managing clinical data management projects. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualifications Bachelor of Pharmacy
Posted 2 months ago
2.0 - 7.0 years
10 - 20 Lacs
Pune, Bengaluru, Mumbai (All Areas)
Work from Office
Hi, We are looking to hire someone for Study Data Manager Please go through the JD, we shall call back the relevant Profiles a) Experience in leading clinical studies. b) Experience on Study Conduct and Close Out JOB DECSRIPTION: Need exposure to Inform or Medidata Rave database Responsible & Accountable for the assigned study conduct activities, in clinical trials Validate clinical trial data to ensure consistency, integrity, and accuracy based on project-specific guidelines. Generate data queries based on validation checks or raise Manual queries to resolve data inconsistencies. To perform reconciliation of data from external sources (e.g. Serious Adverse Events, IWRS, Central Laboratory). SPOC for the study communications Proactively highlight any risks associated with the study along with the mitigation plan. Establish a partnership with the stakeholders at the operational level to work seamlessly to deliver the assigned project/activity as per timelines. Identify process Improvement opportunities and ensure learning is shared Ensure deliverables and/or agreed activities/tasks with customers. are completed with the expected quality. Have worked on Study set-up, Study Conduct, and Study Closeout for various therapeutic areas. Have also worked on writing edit check specifications, CRF completion guidelines, and review and corrections of set-up documents for different versions 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 # 184 b) To Apply for above Job Role ( Pune ) Type : Job Code # 185 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 186
Posted 2 months ago
4.0 - 7.0 years
10 - 14 Lacs
Bengaluru
Work from Office
Assess database design requirements relevant to data capture tool, data extraction, processing and reporting. Design database based on protocol and clinical data manager specifications. Make recommendations to management concerning complex technical issues and provide solutions. Configuration and validation of mapping for datasets export from EDC. Program edit checks according to the specifications defined by the clinical data manager. Provide support in the fixing of any issues or required changes to eCRF and Edit Checks encountered during system testing, User Acceptance Testing (UAT) and deployment testing. Import external data in the EDC based on the Data transfer agreement developed in collaboration with the Clinical Data Manager and process. Able to manage multiple studies and projects simultaneously and deliver on the timelines. Able to provide support or manage edit checks testing and UAT if required. Archive study databases and related documents. Participate in the review and development of Quality documents (SOP and working practices). Qualifications Bachelor of Science degree or related field. Experienced EDC / eCRF design developer to deliver an eCRF based on protocol requirements. Knowledge and understanding of clinical research. Significant experience creating eCRFs using any of the eDC tools (egOracle RDC, Lifesphere, Ennov, Inform,). Proven experience in eCRF development with a cross functional study team to meet timelines and deliverables. Experience with data management tools, technologies and processes. Ability to learn new process, programming languages. Additional Information PERSONAL CHARACTERISTICS Eurofins has a culture of high professional standards, with strong processes, and an eye for details. Candidates will need to be fully aligned with this culture, which implies a structured and analytical approach, pragmatism, and modesty. EVOLUTION About Eurofins Central Laboratory Eurofins Central Laboratory is a dynamic, global organization fully dedicated to providing global central laboratory services to support all phases of clinical trials. At Eurofins Central Laboratory, we are BOLD . We go beyond the expected. Since we are purely a central laboratory, there are no distractions allowing us to remain laser-focused on the best science, technology, and people. We are part of one of the worlds leading laboratory organizations Eurofins Scientific, therefore we offer end-to-end testing solutions which are unsurpassed in the industry. Eurofins Central Laboratory is setting new standards with GLP capabilities embedded within our Central Laboratory. We support our customers with laboratory facilities in the USA, Europe, Singapore, and China, and a back-office in India.
Posted 2 months ago
4.0 - 9.0 years
10 - 20 Lacs
Pune, Bangalore Rural, Mumbai (All Areas)
Work from Office
Hi We're hiring for Leading ITES Company for EDC (Veeva Programmer) Role Experience in EDC & Veeva is Must. Job Description : Create eCRF specifications, design, develop and unit test and functionally validate clinical trial setup process Create edit check specifications and program or modify checks at study level within EDC Setup different instances of study URL (e.g.: UAT (User Acceptance Testing), production, testing etc.,)) Setup and configure user accounts for study teams Setup and manage blinded and unblinded study configurations Be the SME (Subject Matter Expert) for all database related activities Setup, configure, unit test and functionally validate and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc., Familiar with custom functions within EDC systems Work closely with EDC vendors regarding any tool related issues in the system Ability to troubleshoot database setup as per study needs Prepare, test and implement postproduction changes as per study needs Archive and retire the study URL after database lock Partner with appropriate team members to establish technology standards and governance models Establish and support business process SOPs. Oversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT (Information Technology), and Quality organizations Be a primary change agent to ensure adoption of new capabilities and business process Be the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality. Work with leaders to resolve issues affecting the delivery of clinical trials Collaborate with standards team in creating standard CRF libraries for study level consumption Work closely with data engineers and data management programmers at study level integration and delivery Lead technology vendor oversight activities. Be a process expert for operational and oversight models. Partner with appropriate team members, technology vendors, and CRO partners to avoid and resolve risks. Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents Participate in preparing function for submission readiness and may represent Clinical Information Operations (CIO) group in a formal inspection or audit. Track study deliverables and evaluate study metrics to mitigate risk for major data management deliverables. Adaptable to new ways of working using technology to accelerate clinical trial setup Education and Experience Requirements: Bachelor's degree or related experience. Knowledge of drug development process. Minimum of 4+ years experience in Data Management, Programming, Clinical IT, or other Clinical Research related fields. Hands-on experience with at least one EDC system (e.g.: Medidata Rave, Inform, Veeva etc.,) Experience programming in CQL, working with JSON format and/or C# is preferred Experience integrating other clinical trial modules (e.g.: lab, safety, IRT, coding etc.,) with the EDC system Understanding of industry standard technologies to support Clinical Development needs (e.g., CTMS, SAS, R or Python, Data Warehouses, SharePoint) 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 # 181 b) To Apply for above Job Role ( Pune ) Type : Job Code # 182 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 183
Posted 2 months ago
0.0 - 5.0 years
1 - 3 Lacs
Rangareddy, Hyderabad, Bandlaguda
Work from Office
Job Description Excellent Opportunity for job seekers of Entire Hyderabad, Telangana. Walk in on for Bank; 2nd & 3rd JUNE 2025 We hiring for various departments under Relationship Officer Profile of Partners Payroll. - Payroll will be with one of leading partners - Career progression opportunity to Axis Bank payroll for top performers. - Attractive earning opportunity & best incentives schemes in the industry. Job Title: Relationship Officer and Relationship Executive Job Location: Hyderabad Job Specification: Job Type: Full-time Department: Mortgage( Home Loan branch & Open Market, Lap ) Consumer loan( personal loan, Education Loan ) MAB( Merchant Acquiring Onboarding, EDC Sales ) Credit cards( Branch Sales, Store sales ) Wheels( Two wheeler, 4 Wheeler, Tractor loan ) AGRI B2B & B2C Sales Experience: Fresher who are ready to build their careers & Experienced in any sales profile (Field Sales, Branch Sales) Qualification: Intermediate / Graduate/Post Graduate Dress Code : Formals. *Kindly attend the interview on below mentioned location in Formals Note : 1. Female : Branch Sales( Telecaller) 2. Male : Branch & Field Sales Salary Range From Rs.180000/- to Rs.350000/-CTC Per Anum + Incentives. ( Salary based on experience) Interview Location: Axis Pssg branch Quess Corp Limited 2nd floor, Lala 1 Land Mark, Above Nissan showroom, Opp.Ranigunj Bus depot, Secunderabad -500003 Google Map Location:- https://goo.gl/maps/M6Brp5E3Xy8Siyyo7 Contact Person : RENUKA-8978700343 Documents required- All Xerox copies. 1. Resume(updated) 2. Aadhar card 3. PAN Card 4. Educational Documents-10TH/12th/Degree. If you have experience , bring all the 5.Offer Letters 5.Latest 3 months Pay slips 6. Relieving letters NOTE- you can also get your FRIENDS with you who are looking for job and get selected with us. If you have missed this Interview Slot, Please directly come during working days@10:00 am to the same interview venue mentioned above .
Posted 2 months ago
2.0 - 6.0 years
2 - 4 Lacs
Kolkata
Work from Office
BUSINESS DEVELOPMENT MANAGER EMERGING CORPORATES Job Description Acquiring of Current Account Customers in the identified segment and reference generation from the specified catchment area Ensure acquisition of high - quality of current account Proactive registration and activation of acquired customers to direct banking channels. Meet and exceed the defined targets of new customer acquisitions month on month by analyzing transaction banking needs of the customers. Assist and support the Area Sales Manager in the catchment mapping and scoping exercise. Provide regular feedback to Area Sales Manager on opportunities and customer needs Ensure quality sourcing in line with the Bank policy Preferred candidate profile 2-7 years of experience in BFSI. Candidates from other industries having flair for open market sales are welcome. Salary as per industrial norms.
Posted 2 months ago
10.0 - 14.0 years
35 - 50 Lacs
Bengaluru
Work from Office
Description - External Job Summary We are seeking a highly skilled Technical Lead with 10 to 12 years of experience in Informatica SaaS CDI IICS Informatica SaaS CDQ Informatica AXON and Informatica EDC. The ideal candidate will work from our office during day shifts contributing to our data integration and quality initiatives. Responsibilities Lead the design and implementation of data integration solutions using Informatica SaaS CDI and IICSOversee the development and deployment of data quality solutions with Informatica SaaS CDQProvide technical expertise in the use of Informatica AXON for data governance and metadata managementEnsure the effective use of Informatica EDC for enterprise data cataloging and lineage trackingCollaborate with cross-functional teams to understand data requirements and deliver solutions that meet business needsDevelop and maintain best practices for data integration quality and governanceMonitor and optimize the performance of data integration and quality processesTroubleshoot and resolve issues related to data integration and qualityProvide guidance and mentorship to junior team members on Informatica tools and best practicesConduct regular reviews of data integration and quality processes to ensure compliance with industry standardsStay updated with the latest trends and advancements in Informatica tools and technologiesContribute to the continuous improvement of data management practices within the organizationCommunicate effectively with stakeholders to ensure alignment on data initiatives Qualifications Possess extensive experience in Informatica SaaS CDI and IICSDemonstrate strong expertise in Informatica SaaS CDQ for data quality managementHave in-depth knowledge of Informatica AXON for data governanceShow proficiency in using Informatica EDC for data cataloging and lineageExhibit excellent problem-solving and troubleshooting skillsDisplay strong communication and collaboration abilitiesHave a proven track record of leading data integration and quality projects successfullyMaintain a commitment to staying current with industry trends and best practicesDemonstrate the ability to mentor and guide junior team members effectivelyPossess a strong understanding of data management principles and practicesShow a proactive approach to identifying and addressing data-related challengesExhibit a strong attention to detail and commitment to qualityHave a passion for leveraging data to drive business outcomes. Certifications Required Informatica Certified Professional Informatica Data Quality Certification
Posted 2 months ago
5.0 - 10.0 years
7 - 12 Lacs
Kolkata, Mumbai, New Delhi
Work from Office
Who we are We re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit. Why Worldwide We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us! What the Clinical Operations Department does at Worldwide Clinical Research Associates (CRAs) play a vital role in ensuring our clinical research programs are executed with the quality and excellence our sponsors expect and the care and passion patients deserve. These roles are the backbone of every strong CRO, helping drive breakthrough scientific research and playing a lead role on every clinical trial. All CROs will promise you growth, opportunity and maybe even a challenge. But we offer more than that. We offer an uncommon experience - one you can t get anywhere else, with a team unlike anyone else. At Worldwide we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every trial like a patient s life depends on it - because it does. Our leaders are in the trenches with you daily - committed to advancing science and moving mountains for our customers. What you will do Responsible for managing the research activities at sites participating in Worldwide s clinical research projects, which are predominantly registries and other types of non-interventional / observational studies Typically involved in all stages of the clinical study, including identifying potential sites to participate in the research effort, performing various study start-up activities such as working with sites to collect appropriate regulatory documents and supporting the negotiation of contracts and budgets, training the sites to collect data properly and report any potential safety-related events, managing the sites activities during study maintenance, and closing down research activities at the sites once the study has c oncluded Conduct study initiation visits (SIVs) While most of the site management efforts will be performed remotely, will be required to ensure compliance with obtaining informed consent, reporting potential safety-related events, and adhering to all applicable regulatory requirement What you will bring to the role Excellent interpersonal, oral, and written communication skills in English Superior organizational skills with attention to details Ability to work with little or no supervision Proficiency in Microsoft Office, CTMS and EDC Systems Your experience 5+ years of experience as a Clinical Research Associate Demonstrable experience of handling multiple protocols across a range of therapeutic indications Four-year college curriculum in life sciences, OR Two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree) Ability to meet the travel requirements of the job We love knowing that someone is going to have a better life because of the work we do. To view our other roles, check out our careers page at Discover a world of difference at Worldwide ! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn . Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law .
Posted 2 months ago
0.0 - 5.0 years
2 - 3 Lacs
Tambaram, Chennai
Work from Office
Designation: Relationship Officer/Team leader JOB LOCATION: - All over Chennai Open Vacancy: - Home loan Sales Demonstrating/Presenting /Introducing/Selling banking products. New Lead generation & follow-up on leads given, maintain record of sales leads. Willing to travel and convince customer to purchase loan in any retail vertical. Good customer approach. Generating lead and can get the closures completed. Travelling throughout the Rural & Urban area visiting the customer. Completing customers loan proposal & submitting to Bank. Processing of all customer files, maintaining records & reports. Maintaining relationship with customers in pre- sales and post sales Required Candidate profile Good customer approach. Knowledge of local customers and target businesses Age between 18 - 35 years. Graduate Experience in Sales field is an added advantage. 2-wheeler preferable Walk-Ins Interview Venue: - Chennai Location: - 150/151 Alpha Tower, 6th Floor, North Usman Road, T. Nagar, Chennai 600017 HR Contact & Meet to: - You can WhatsApp share your Resume to below Number with your preferred location name: - Dinesh HR - 8056811701 Sarath HR - 9884061383
Posted 2 months ago
3.0 - 7.0 years
7 - 11 Lacs
Bengaluru
Work from Office
Job Title: Senior Clinical Data Science Programmer Location: Bangalore/Chennai [Hybrid Model] As a Senior Clinical Data Science Programmer at ICON, you will be responsible for implementing and maintaining efficient standard content in data collection and delivery tools You will support metadata standards that facilitate the seamless data flow from collection to delivery in alignment with industry standards and regulatory requirements This role will work in close collaboration with clinical data collection and analysis teams to ensure optimal adoption and reuse of standards across trials and therapeutic areas, This Position Has Two Main Focus Areas Data Collection Focusing on CRFs, DTAs, and Rave eDC standards Data Delivery Focusing on SDTM, controlled terminology, and metadata mapping Standards Development & Configuration Design, implement, and manage clinical data standards across collection and delivery tools to enhance trial efficiency and data consistency, Tailor standards to meet the scientific and operational needs of specific disease or therapeutic areas, Ensure robust traceability from master standards through to study-specific implementations, maintaining detailed metadata lineage, Data Collection Focus (if Applicable) Implement standard content in Medidata Rave eDC, including: CRF mockups Standard questionnaires and COAs Validation rule specifications Standard integrations (e-g, IWRS) Data Delivery Focus (if Applicable) Annotate CRFs with SDTM-compliant metadata to support regulatory submissions and operational excellence, Support content such as: SDTM and define xml creation Annotated CRFs Data Transfer Agreement standards Metadata mapping (CRF/DTA to DRM, DRM to SDTM) Collaboration & Support Act as a standards expert and advisor to clinical data management and clinical programming teams, as well as CRO partners, Provide guidance on effective adoption and implementation of standards across global studies, Key Interfaces Primary: Standards leads (data collection and delivery), Data Managers, Technical Data Architects Secondary: Clinical teams (statisticians, physicians), Clinical Analysis Standards, CDISC working groups For Data Collection Focus Strong hands-on experience with Rave eDC (Medidata Solutions) SAS programming knowledge preferred For Data Delivery Focus Experience with SAS programming for clinical data standards Exposure to Rave eDC is advantageous Common Requirements Solid understanding of CDISC standards (SDTM, CDASH, Controlled Terminology, define xml) Experience with SAS LSAF and Pinnacle 21 is a plus Bachelors degree in Life Sciences, Computer Science, or equivalent professional experience Minimum of 2 years in clinical data management, standards, or related functions Strong organizational skills and the ability to manage multiple priorities Excellent written and verbal communication skills in English What ICON Can Offer You Our success depends on the quality of our people Thats why weve made it a priority to build a diverse culture that rewards high performance and nurtures talent, In addition to your competitive salary, ICON offers a range of additional benefits Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family, Our Benefits Examples Include Various annual leave entitlements A range of health insurance offerings to suit you and your familys needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your familys well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: https://careers iconplc,com/benefits At ICON, inclusion & belonging are fundamental to our culture and values Were dedicated to providing an inclusive and accessible environment for all candidates ICON is committed to providing a workplace free of discrimination and harassment All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below, https://careers iconplc , com / reasonable-accommodations Interested in the role, but unsure if you meet all of the requirementsWe would encourage you to apply regardless theres every chance youre exactly what were looking for here at ICON whether it is for this or other roles,
Posted 2 months ago
1.0 - 3.0 years
4 - 7 Lacs
Hyderabad
Work from Office
Conversion to Franchisee Stores jointly with Sales team Shortlisting top dealers jointly with Sales team for conversion to Franchise partners. Develop and maintain list of potential Franchise partners Build pipeline for conversion to Franchise stores and upgradation of franchise partners to higher tier Evaluating Retail Excellence Score (RES) and working on driving the same Track and drive Retail excellence through DDE for various parameters like store hygiene, visibility, Customer feedback capture, POS Billing adherence, etc, Audit of Franchise retail excellence score on quarterly basis Creating awareness and importance of RES among franchise Support Delivery of All Marketing, VM Campaigns and focused product sales Support sales of Focussed products via placement, display and promotion through colour consulting and painting services Monitors effectiveness of VM arrangement at stores and recommends changes. Executes Marketing/ promotional campaigns for the Franchise Partner Plan Franchise Launch & coordinate Upgrade Coordinate the store launch plan and monitor the launch / opening process for smooth operations Monitor Business Performance of Franchise Stores. Monitor new store performance with required handholding for first 6 months Drive various measures/ plan to improve the underperforming stores Drive sales of Focused Value-added Products / Services through Franchise Stores Track ROI of Franchise Stores through keeping a close watch on sales and cost implications Relationship Management and Conflict Management with Franchise Partners Building Relationship with Top Franchise Partners in the territory Conflict Management within Franchise and non-Franchise stores Coordination with sales team for quick resolution of conflict and escalated issues Training Training of Franchise Dealer staff on Company systems and processes Train the staff on increasing conversions, upselling, cross selling and improving customer handling Tally & EDC Installation & Adoption Ensure all the stores get Tally installed after readiness and EDC machine also gets installed. Consent form for EDC to be collected from all finalized stores during agreement signing. Drive integration & Adoption for EDC & Tally across all stores Paint Consultant Hiring of PCs in a coordination with RD Zonal Associate hiring team Drive productivity for PCs across all the stores ensure they are filing the required CRM data on time Manage performance of PCs though regular follow ups and review Qualifications: Master of Business Admin Report to: Manager
Posted 2 months ago
1.0 - 3.0 years
4 - 7 Lacs
Nagar
Work from Office
Conversion to Franchisee Stores jointly with Sales team Shortlisting top dealers jointly with Sales team for conversion to Franchise partners. Develop and maintain list of potential Franchise partners Build pipeline for conversion to Franchise stores and upgradation of franchise partners to higher tier Evaluating Retail Excellence Score (RES) and working on driving the same Track and drive Retail excellence through DDE for various parameters like store hygiene, visibility, Customer feedback capture, POS Billing adherence, etc, Audit of Franchise retail excellence score on quarterly basis Creating awareness and importance of RES among franchise Support Delivery of All Marketing, VM Campaigns and focused product sales Support sales of Focussed products via placement, display and promotion through colour consulting and painting services Monitors effectiveness of VM arrangement at stores and recommends changes. Executes Marketing/ promotional campaigns for the Franchise Partner Plan Franchise Launch & coordinate Upgrade Coordinate the store launch plan and monitor the launch / opening process for smooth operations Monitor Business Performance of Franchise Stores. Monitor new store performance with required handholding for first 6 months Drive various measures/ plan to improve the underperforming stores Drive sales of Focused Value-added Products / Services through Franchise Stores Track ROI of Franchise Stores through keeping a close watch on sales and cost implications Relationship Management and Conflict Management with Franchise Partners Building Relationship with Top Franchise Partners in the territory Conflict Management within Franchise and non-Franchise stores Coordination with sales team for quick resolution of conflict and escalated issues Training Training of Franchise Dealer staff on Company systems and processes Train the staff on increasing conversions, upselling, cross selling and improving customer handling Tally & EDC Installation & Adoption Ensure all the stores get Tally installed after readiness and EDC machine also gets installed. Consent form for EDC to be collected from all finalized stores during agreement signing. Drive integration & Adoption for EDC & Tally across all stores Paint Consultant Hiring of PCs in a coordination with RD Zonal Associate hiring team Drive productivity for PCs across all the stores ensure they are filing the required CRM data on time Manage performance of PCs though regular follow ups and review Qualifications: Master of Business Admin Report to: Manager
Posted 2 months ago
2.0 - 6.0 years
4 - 7 Lacs
Nanded
Work from Office
Conversion to Franchisee Stores jointly with Sales team Shortlisting top dealers jointly with Sales team for conversion to Franchise partners. Develop and maintain list of potential Franchise partners Build pipeline for conversion to Franchise stores and upgradation of franchise partners to higher tier Evaluating Retail Excellence Score (RES) and working on driving the same Track and drive Retail excellence through DDE for various parameters like store hygiene, visibility, Customer feedback capture, POS Billing adherence, etc, Audit of Franchise retail excellence score on quarterly basis Creating awareness and importance of RES among franchise Support Delivery of All Marketing, VM Campaigns and focused product sales Support sales of Focussed products via placement, display and promotion through colour consulting and painting services Monitors effectiveness of VM arrangement at stores and recommends changes. Executes Marketing/ promotional campaigns for the Franchise Partner Plan Franchise Launch & coordinate Upgrade Coordinate the store launch plan and monitor the launch / opening process for smooth operations Monitor Business Performance of Franchise Stores. Monitor new store performance with required handholding for first 6 months Drive various measures/ plan to improve the underperforming stores Drive sales of Focused Value-added Products / Services through Franchise Stores Track ROI of Franchise Stores through keeping a close watch on sales and cost implications Relationship Management and Conflict Management with Franchise Partners Building Relationship with Top Franchise Partners in the territory Conflict Management within Franchise and non-Franchise stores Coordination with sales team for quick resolution of conflict and escalated issues Training Training of Franchise Dealer staff on Company systems and processes Train the staff on increasing conversions, upselling, cross selling and improving customer handling Tally & EDC Installation & Adoption Ensure all the stores get Tally installed after readiness and EDC machine also gets installed. Consent form for EDC to be collected from all finalized stores during agreement signing. Drive integration & Adoption for EDC & Tally across all stores Paint Consultant Hiring of PCs in a coordination with RD Zonal Associate hiring team Drive productivity for PCs across all the stores ensure they are filing the required CRM data on time Manage performance of PCs though regular follow ups and review Qualifications: Post Graduate Report to: Manager
Posted 2 months ago
2.0 - 8.0 years
1 - 4 Lacs
Tiruchirapalli
Work from Office
Conversion to Franchisee Stores jointly with Sales team Shortlisting top dealers jointly with Sales team for conversion to Franchise partners. Develop and maintain list of potential Franchise partners Build pipeline for conversion to Franchise stores and upgradation of franchise partners to higher tier Evaluating Retail Excellence Score (RES) and working on driving the same Track and drive Retail excellence through DDE for various parameters like store hygiene, visibility, Customer feedback capture, POS Billing adherence, etc, Audit of Franchise retail excellence score on quarterly basis Creating awareness and importance of RES among franchise Support Delivery of All Marketing, VM Campaigns and focused product sales Support sales of Focussed products via placement, display and promotion through colour consulting and painting services Monitors effectiveness of VM arrangement at stores and recommends changes. Executes Marketing/ promotional campaigns for the Franchise Partner Plan Franchise Launch & coordinate Upgrade Coordinate the store launch plan and monitor the launch / opening process for smooth operations Monitor Business Performance of Franchise Stores. Monitor new store performance with required handholding for first 6 months Drive various measures/ plan to improve the underperforming stores Drive sales of Focused Value-added Products / Services through Franchise Stores Track ROI of Franchise Stores through keeping a close watch on sales and cost implications Relationship Management and Conflict Management with Franchise Partners Building Relationship with Top Franchise Partners in the territory Conflict Management within Franchise and non-Franchise stores Coordination with sales team for quick resolution of conflict and escalated issues Training Training of Franchise Dealer staff on Company systems and processes Train the staff on increasing conversions, upselling, cross selling and improving customer handling Tally & EDC Installation & Adoption Ensure all the stores get Tally installed after readiness and EDC machine also gets installed. Consent form for EDC to be collected from all finalized stores during agreement signing. Drive integration & Adoption for EDC & Tally across all stores Paint Consultant Hiring of PCs in a coordination with RD Zonal Associate hiring team Drive productivity for PCs across all the stores ensure they are filing the required CRM data on time Manage performance of PCs though regular follow ups and review Qualifications: Post Graduate Report to: Manager
Posted 2 months ago
3.0 - 8.0 years
2 - 5 Lacs
Bengaluru
Work from Office
Conversion to Franchisee Stores jointly with Sales team Shortlisting top dealers jointly with Sales team for conversion to Franchise partners. Develop and maintain list of potential Franchise partners Build pipeline for conversion to Franchise stores and upgradation of franchise partners to higher tier Evaluating Retail Excellence Score (RES) and working on driving the same Track and drive Retail excellence through DDE for various parameters like store hygiene, visibility, Customer feedback capture, POS Billing adherence, etc, Audit of Franchise retail excellence score on quarterly basis Creating awareness and importance of RES among franchise Support Delivery of All Marketing, VM Campaigns and focused product sales Support sales of Focussed products via placement, display and promotion through colour consulting and painting services Monitors effectiveness of VM arrangement at stores and recommends changes. Executes Marketing/ promotional campaigns for the Franchise Partner Plan Franchise Launch & coordinate Upgrade Coordinate the store launch plan and monitor the launch / opening process for smooth operations Monitor Business Performance of Franchise Stores. Monitor new store performance with required handholding for first 6 months Drive various measures/ plan to improve the underperforming stores Drive sales of Focused Value-added Products / Services through Franchise Stores Track ROI of Franchise Stores through keeping a close watch on sales and cost implications Relationship Management and Conflict Management with Franchise Partners Building Relationship with Top Franchise Partners in the territory Conflict Management within Franchise and non-Franchise stores Coordination with sales team for quick resolution of conflict and escalated issues Training Training of Franchise Dealer staff on Company systems and processes Train the staff on increasing conversions, upselling, cross selling and improving customer handling Tally & EDC Installation & Adoption Ensure all the stores get Tally installed after readiness and EDC machine also gets installed. Consent form for EDC to be collected from all finalized stores during agreement signing. Drive integration & Adoption for EDC & Tally across all stores Paint Consultant Hiring of PCs in a coordination with RD Zonal Associate hiring team Drive productivity for PCs across all the stores ensure they are filing the required CRM data on time Manage performance of PCs though regular follow ups and review Qualifications: Post Graduate Report to: Manager
Posted 2 months ago
5.0 - 7.0 years
1 - 5 Lacs
Mumbai, Nagpur, Thane
Work from Office
Conversion to Franchisee Stores jointly with Sales team Shortlisting top dealers jointly with Sales team for conversion to Franchise partners. Develop and maintain list of potential Franchise partners Build pipeline for conversion to Franchise stores and upgradation of franchise partners to higher tier Evaluating Retail Excellence Score (RES) and working on driving the same Track and drive Retail excellence through DDE for various parameters like store hygiene, visibility, Customer feedback capture, POS Billing adherence, etc, Audit of Franchise retail excellence score on quarterly basis Creating awareness and importance of RES among franchise Support Delivery of All Marketing, VM Campaigns and focused product sales Support sales of Focussed products via placement, display and promotion through colour consulting and painting services Monitors effectiveness of VM arrangement at stores and recommends changes. Executes Marketing/ promotional campaigns for the Franchise Partner Plan Franchise Launch & coordinate Upgrade Coordinate the store launch plan and monitor the launch / opening process for smooth operations Monitor Business Performance of Franchise Stores. Monitor new store performance with required handholding for first 6 months Drive various measures/ plan to improve the underperforming stores Drive sales of Focused Value-added Products / Services through Franchise Stores Track ROI of Franchise Stores through keeping a close watch on sales and cost implications Relationship Management and Conflict Management with Franchise Partners Building Relationship with Top Franchise Partners in the territory Conflict Management within Franchise and non-Franchise stores Coordination with sales team for quick resolution of conflict and escalated issues Training Training of Franchise Dealer staff on Company systems and processes Train the staff on increasing conversions, upselling, cross selling and improving customer handling Tally & EDC Installation & Adoption Ensure all the stores get Tally installed after readiness and EDC machine also gets installed. Consent form for EDC to be collected from all finalized stores during agreement signing. Drive integration & Adoption for EDC & Tally across all stores Paint Consultant Hiring of PCs in a coordination with RD Zonal Associate hiring team Drive productivity for PCs across all the stores ensure they are filing the required CRM data on time Manage performance of PCs though regular follow ups and review Qualifications: Post Graduate Report to: Manager
Posted 2 months ago
2.0 - 4.0 years
3 - 6 Lacs
Bengaluru
Work from Office
Premier Research is looking for a Data Coordinator - DM to join our Clinical Data Sciences team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for Biotech . Join us and build your future here. What youll be doing: Assists in testing of databases (DBs) and maintenance of study data, including the processing of discrepancies and queries. Reviews Case Report Forms (CRFs), data listings, and DBs to ensure that all captured data follow the rules outlined by the protocol, CRF Completion Guidelines (CCGs) and departmental plans. Collaborates cross-functionally with colleagues to ensure the integrity of clinical databases. Prepares documentation, such as CCGs, Data Management Plan (DMP), Data Report Assists in developing standard test data for testing screens and listings and provides feedback on the results of the testing Performs user acceptance testing on studies, including testing of edit checks, etc. Assists in maintaining DBs and supports DB updates Performs data entry Generates reports for data review Reviews CRFs, data listings, and DBs to ensure all data captured follow protocol, CCGs, DMP, etc. Generates queries to appropriate internal or external personnel (e.g., investigational sites, Clinical Research Associates and client representatives) to resolve problematic data identified during various aspects of the data management (DM) process Reviews responses to queries and resolves discrepancies Performs external data and/or serious adverse event reconciliation Acts as a Lead Data Coordinator and/or Safety Reviewer on multiple studies Performs document submission to Trial Master File (TMF) Supports TMF Quality Control (QC) activities Performs database QC activities Performs QC of study reports, CRF archive files Supports the Data Scientist and/or PM in reporting financial project stats, study metrics, dashboard updates, project status What we are looking for: Bachelor s Degree or above (preferably in a Life Science) Typically requires 2 -4 years of DM mastery or related clinical research industry experience Knowledge of at least one Clinical Data Management System (CDMS) (e.g. Medidata Rave, Calyx EDC, etc.)
Posted 2 months ago
7.0 - 12.0 years
7 - 10 Lacs
Lucknow
Work from Office
Role & responsibilities - Handled large team size across multiple cities, Minimum 50 FOS & 6-7 TL - Experience in building ciites from ground zero in offline vertical i.e QR, SB & EDC - Worked with Fintech (General Trade & Oil and Gas), FMCG & Telecommunications - Minimum 7-8 yrs of experience - Strong analytical mindset with detailed focus on data driven productivity - Experience working with agencies to onboard manpower within TAT( 48 hrs )
Posted 2 months ago
6.0 - 8.0 years
6 - 9 Lacs
Kolkata, Mumbai, New Delhi
Work from Office
We are seeking an experienced Clinical Trial Manager (CTM) to lead the execution of Phase I, II and III oncology studies at key national institutions in India. This role is pivotal in driving site activation, regulatory compliance, and clinical delivery in alignment with global sponsor expectations. Key Responsibilities: Lead clinical operations and site-level engagement for assigned Phase s studies in India Manage relationships with Principal Investigators (PIs), CRCs, and Institutional stakeholders at government hospitals Oversee timely and compliant PSSV, site initiation visits (SIV), patient recruitment, and data collection Ensure study milestones are met, including First Patient First Visit (FPFV) and clean database targets Collaborate with sponsor teams, regulatory consultants, and third-party vendors to streamline dossier submissions and audit readiness Coordinate regulatory submissions and ethics committee (EC) approvals; ensure alignment with CDSCO, ICMR, and local EC timelines Conduct ongoing risk assessment and drive mitigation strategies across sites Provide oversight to field CRAs and monitor site compliance Contribute to internal SOP development and quality initiatives Key Qualifications: bachelors degree in life sciences or related field; advanced degree preferred Minimum 6-8 years of clinical research experience with at least 3 years in an independent CTM role Demonstrated experience in oncology or immunotherapy trials, preferably with exposure to AIIMS or government research centers Strong working knowledge of GCP, ICH, and CDSCO guidelines Proven track record managing multi-site studies and remote monitoring teams Excellent interpersonal, communication, and problem-solving skills Proficiency in CTMS, EDC, and eTMF systems is a plus Willingness to travel across India as needed (up to 25%)
Posted 2 months ago
4.0 - 8.0 years
6 - 10 Lacs
Hyderabad
Work from Office
The Manager, CSAR - SAS Clinical Data Reporting and Spotfire Programmer will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting SAS Clinical Data Reporting and Spotfire programming activities. The Manager, CSAR - SAS Clinical Data Reporting and Spotfire Programmer will create patient data reports and dashboards, adhering to Amgen standards, procedures, and best practices using SAS for programming and Spotfire for visualization. The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality deliverables, internal and external clinical systems, and other CSAR activities related to the use electronic data capture technology. The position will be responsible for quality and deliverables at the study and portfolio level. The Manager, CSAR - SAS Clinical Data Reporting and Spotfire Programmer will also be expected to help deliver large system transformation projects, with a focus on project management, contribution of subject matter expertise, stakeholder engagement, and change management. The successful candidate will be a strong leader with demonstrated ability to influence stakeholders, while also acting as an individual contributor on study specific and general CSAR/Global Development Operations projects or operational work. Proven capability of providing support for study deliverables. Has operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC). Responsibilities include, but are not limited to, the following Support of clinical trial platform technologies? Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Coordinating and providing programming support to Clinical Study Teams ? Works collaboratively with Clinical Data Management to meet study deliverables and timelines Acting as a technical point of contact for systems deliverables on defined programs Experience in creating complex Spotfire visualizations and dashboards, with the ability to justify or suggest charts based on business scenarios. Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Assist in preparing for and responding to audit findings (internal or external). Knowledge Good Clinical Practice ? Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking. Drug development and clinical trials processes? Data management processes? Programming of clinical trial databases and applications? Proficient in SAS programming and Spotfire data visualization software Systems development lifecycle? Programming Languages ? Project planning and management? Collaborating with global cross-functional teams (team/matrix environment) Quality management? and Risk Analysis Regulatory filings and inspections Process improvement methodologies Preferred Qualifications Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related discipline? Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena? General project management and planning experience ? Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.) Basic Qualifications Bachelor’s degree or equivalent in life science, computer science, business administration or related discipline ?with 9 to 13 yrs of experience. Specialist knowledge / experience in life sciences or a medically related field? General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)
Posted 2 months ago
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