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7.0 - 12.0 years

0 - 3 Lacs

pune, bengaluru, mumbai (all areas)

Work from Office

TCS is hiring for Clinical Data Management!!! Job Location Mumbai Experience Range – 7 to 12 Years Skillset Required- Knowledge of medical device risk classification Interested candidates are requested share updated CV with below details on the mail id – Babeeta.shahi@tcs.com Key Responsibilities Review and understand the study protocol and the timelines. Perform data review, data reconciliation and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate. Implement study team feedback as required on the data. Perform external checks to handle manual discrepancies and action the same. Develop specifications, implementation and testing for the edit checks and li...

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12.0 - 15.0 years

22 - 25 Lacs

chennai

Work from Office

Team Leadership & Oversight Support and mentor a team of Clinical Data Specialists, promoting consistency, quality, and productivity. Collaborate on training plans, performance goals, and team development. Provide day-to-day guidance and technical support related to data issues. Help manage team capacity, workload distribution, and scheduling across studies. Foster effective collaboration with cross-functional teams. Data Management & Quality Assurance Accurate data maintenance, quality control, and discrepancy resolution in CTMS and EDC systems (e.g., RAVE, Veeva Vault, Clinical One, Inform). Review source documents for adherence to ALCOA-C principles and regulatory guidelines (GCP, HIPAA, ...

Posted 6 days ago

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5.0 - 7.0 years

0 Lacs

india

On-site

Description Sr CDA (Data Acquisition Specialist-Non-CRF) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate pr...

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5.0 - 7.0 years

0 Lacs

pune, maharashtra, india

On-site

Description Sr CDA (Data Acquisition Specialist-Non-CRF) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate pr...

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5.0 - 7.0 years

0 Lacs

india

On-site

Description Sr CDA (Data Acquisition Specialist-Non-CRF) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate pr...

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15.0 - 24.0 years

20 - 35 Lacs

bengaluru

Work from Office

JD: Skills : CDM- clinical data management,PV- pharmacovigilance ,statistical Data,Discrepancy management- Domain- Life science,Clinical trial design -Leading training teams Good to have : SAS,statistical programming Exp : End to end CDM exp||TL exp for 15-20 PPL US UK shift- should be flexible - WFO What are we looking for? •Commitment to quality • Education Graduate from an accredited college or university; or an equivalent level of education. • 12-16 years of experience, with at least 6-8 years in end-to-end clinical data management and Pharmacovigilance and 4-6 years of training experience on process/language/soft skills • Prior experience in managing teams directly and indirectly. • Exc...

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1.0 - 5.0 years

5 - 7 Lacs

chennai, tamil nadu, india

On-site

Tools Required Rave Oracle Inform Veeva Studio Roles and Responsibilities Protocol reading and understanding Design the eCRF layout and the database corresponding to the eCRFs to hold the data from the EDC system Setup Core Configurations Implementing the Dynamic rules as per the Sponsor requirements Experienced in writing the Data Validation Specification (DVS) Create, test, and maintain trial-specific plausibility and consistency Edit Checks as per Data Validation Specification Analyze complex checks and Develop Custom Functions using C# for Rave studies or other EDC Expertise in performing Technical and Functional Review Incorporate internal feedback and update programs as required Must H...

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1.0 - 5.0 years

5 - 7 Lacs

delhi, india

On-site

Tools Required Rave Oracle Inform Veeva Studio Roles and Responsibilities Protocol reading and understanding Design the eCRF layout and the database corresponding to the eCRFs to hold the data from the EDC system Setup Core Configurations Implementing the Dynamic rules as per the Sponsor requirements Experienced in writing the Data Validation Specification (DVS) Create, test, and maintain trial-specific plausibility and consistency Edit Checks as per Data Validation Specification Analyze complex checks and Develop Custom Functions using C# for Rave studies or other EDC Expertise in performing Technical and Functional Review Incorporate internal feedback and update programs as required Must H...

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1.0 - 5.0 years

5 - 7 Lacs

kolkata, west bengal, india

On-site

Tools Required Rave Oracle Inform Veeva Studio Roles and Responsibilities Protocol reading and understanding Design the eCRF layout and the database corresponding to the eCRFs to hold the data from the EDC system Setup Core Configurations Implementing the Dynamic rules as per the Sponsor requirements Experienced in writing the Data Validation Specification (DVS) Create, test, and maintain trial-specific plausibility and consistency Edit Checks as per Data Validation Specification Analyze complex checks and Develop Custom Functions using C# for Rave studies or other EDC Expertise in performing Technical and Functional Review Incorporate internal feedback and update programs as required Must H...

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1.0 - 5.0 years

5 - 12 Lacs

bengaluru

Remote

Atorus industry-leading clinical trial analytics experts build tools and solutions that efficiently facilitate data management and biometrics activities. We carry this out by automating and applying advancing services and technology to maximize trial efficiency, ease interpretation, and prepare your clinical trial data to quickly deliver actionable insights. Job Overview The Electronic Data Capture (EDC) Programmer is responsible for providing support in creating, deploying, and maintaining clinical databases and provides EDC programming support to the study team in accordance with Atorus and/or sponsor standard operating procedures (SOPs), Good Clinical Practice (GCP), ICH Guidelines and sp...

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5.0 - 10.0 years

15 - 30 Lacs

bengaluru

Hybrid

Position: Data Engineer, Sr - I *** JOB DESCRIPTION *** OVERVIEW The Data Engineer, Sr - I will work closely with clients and provide high level technical consulting services, configuration of the elluminate platform, development and oversight for specific projects that include trial configuration, quality control, project management, assessing new technologies, process improvements, system validation, SOP development, custom analytics development, clinical software implementations and integrations, platform configuration, ETL and custom analytics development. As a Data Engineer, Sr - I, you will serve as the primary technical lead, spearheading consulting efforts related to clinical systems...

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10.0 - 14.0 years

0 Lacs

pune, maharashtra

On-site

As a Clinical Data Management (CDM) professional, you will be responsible for overseeing the full lifecycle of clinical data management processes. Your role will involve ensuring the quality and integrity of clinical trial data, developing and implementing data management plans, and monitoring data entry and validation processes. You will coordinate with clinical teams to ensure timely data collection and conduct data cleaning and review activities. Additionally, you will be preparing data for statistical analysis and reporting while ensuring compliance with regulatory requirements and industry standards. Participating in protocol development and study design, utilizing data management softw...

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2.0 - 5.0 years

4 - 9 Lacs

kochi, kolkata

Hybrid

Job Title / Primary Skill: Clinical DB Designer Years of Experience: 2-5 Years Job Location: Kochi/Kolkata Must Have Skills: Clinical data management, rave, study startup activities, Edit Specification Documents, and EDC build specifications Good To Have Skills: Rave Job Description: • 2-5 years of relevant clinical DB Testing experience in CDMS Platforms • Conduct testing activities in CDMS environment and provide comprehensive testing expertise to the team to produce efficient, quality database that meets customer requirements. • Independently conduct testing activities to validate edit checks, system settings, SAS listings, Transfer Programming and custom reports in platforms including, I...

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12.0 - 16.0 years

19 - 25 Lacs

kochi

Hybrid

Job Title / Primary Skill: Manager Clin Data Mgmt Years of Experience: 12-16 Years Job Location: Kochi Must Have Skills: Clinical data management, data management, rave, Line management Good To Have Skills: Rave Job Description Manage and support team of Data Management professionals to efficiently produce databases that meet customer requirements. Essential Functions • Provide expert review and guidance for production of Data Management deliverables including CRF/e-CRF, database design and set-up, validation definition and programming, Data Management Plan and database deliverables to internal and external customers. Provide technical advice and solutions with internal and external customer...

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3.0 - 6.0 years

5 - 8 Lacs

hyderabad, pune

Work from Office

o Develop and maintain clinical trial applications using Rave. o Configure and customize Rave EDC (Electronic Data Capture) systems. o Work with clinical data management teams to ensure data quality and integrity. o Provide support for Rave-related issues and system updates.

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8.0 - 10.0 years

0 Lacs

pune, maharashtra, india

Remote

ZS is a place where passion changes lives. As a management consulting and technology firm focused on improving life and how we live it, we transform ideas into impact by bringing together data, science, technology and human ingenuity to deliver better outcomes for all. Here you'll work side-by-side with a powerful collective of thinkers and experts shaping life-changing solutions for patients, caregivers and consumers, worldwide. ZSers drive impact by bringing a client-first mentality to each and every engagement. We partner collaboratively with our clients to develop custom solutions and technology products that create value and deliver company results across critical areas of their busines...

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2.0 - 6.0 years

0 Lacs

hyderabad, telangana

On-site

You should have at least 2 years of experience in Clinical Trial EDC, preferably with systems like Veeva, RAVE, or Oracle, and/or Reporting experience, preferably with tools like JReview, Spotfire, Jupyter Labs, or SQL. You should be familiar with common troubleshooting tools and technologies such as JIRA, Dynamics, and have a good understanding of Microsoft Office products like Office, Excel, PowerPoint, and Dynamics. It would be ideal if you have an understanding of web technologies and web services like RESTful APIs, SOAP, and experience with database technologies such as Java, Python, and SQL, for troubleshooting issues related to cloud-based software systems. In addition to technical sk...

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7.0 - 11.0 years

0 Lacs

karnataka

On-site

At EY, you'll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture, and technology to become the best version of you. And we're counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. As a Manager in Clinical Data & Technology within Life Sciences Consulting at EY, you will be part of our Life Sciences sector team, assisting clients in reimagining their clinical data strategies and implementing cutting-edge solutions across trial data capture, management, and analytics. You will play a strategic role in shaping next-gener...

Posted 3 weeks ago

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5.0 - 9.0 years

0 Lacs

hyderabad, telangana

On-site

You will be responsible as a Rave Programmer for a duration of 12 months in a hybrid role based in either Hyderabad or Pune. Your primary responsibilities will include hands-on end-to-end Rave study build experience, including CRF, edit check creation, custom functions, dynamics/matrix programming, migration planning and execution, and module connections/integrations programming. You will also be tasked with overseeing the work of Database Developer I & 2, training and mentoring them as needed, and ensuring the quality of programming and attention to detail in the database build process. As a Rave Programmer, you must have at least 5 years of experience in Rave study build, a Bachelor's degr...

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1.0 - 2.0 years

1 - 4 Lacs

bengaluru

Hybrid

Job Title / Primary Skill: Assoc Clin Data Coord Years of Experience: 1-2 Years Job Location: Bangalore Must Have Skills: Clinical data management, data management, rave, conduct, closeout, start up Good To Have Skills: Rave Job Description Provide basic and some comprehensive data management expertise to the Clinical Data Management (CDM) team to provide efficient, quality data management products that meet customer needs. May also undertake team leadership activities under the supervision of the Data Operations Coordinator (DOC), Data Team Lead (DTL), or Functional Manager. Essential Functions • Serve as a Data Operations Coordinator (DOC) for one protocol with less then 5 operations staff...

Posted 4 weeks ago

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4.0 - 5.0 years

7 - 12 Lacs

chennai

Work from Office

Responsibilities: * Collaborate with cross-functional teams on study setup, data cleaning, and reporting. * Manage clinical data from CRFs using RAVE software following ICH-GCP guidelines. Health insurance Annual bonus Provident fund Accidental insurance Life insurance Mobile bill reimbursements

Posted 4 weeks ago

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7.0 - 10.0 years

10 - 15 Lacs

kochi, thane, bengaluru

Hybrid

Roles and Responsibilities Manage data reconciliation activities to ensure accuracy and completeness of clinical trial data. Develop and implement effective data management plans, including database lock procedures. Collaborate with cross-functional teams to resolve issues related to query management and UAT (User Acceptance Testing). Conduct regular listing reviews to maintain high-quality datasets. Ensure compliance with regulatory requirements throughout the entire lifecycle of a clinical trial.

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8.0 - 12.0 years

0 Lacs

thiruvananthapuram, kerala

On-site

At EY, you will have the opportunity to shape your future with confidence, succeed in a globally connected powerhouse of diverse teams, and take your career wherever you desire. Join EY to help build a better working world. As a Data Integration Architect with 8+ years of experience in clinical or life sciences domains, you will lead the integration of Medidata platforms into enterprise clinical trial systems. Your role will involve designing scalable, compliant data integration solutions, collaborating across global R&D systems, and contributing to data-driven innovation in the healthcare and life sciences space. You will play a crucial part in aligning integration efforts with organization...

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6.0 - 11.0 years

0 - 0 Lacs

bangalore, hyderabad, kolkata

On-site

6-8 years of experience in Clinical Data Management/Clinical Data base programming or relevant field. Location: Mumbai Pune, Bangalore, Hyderabad, Kolkata Good technical experience on EDC systems (Rave/Veeva) Ability to provide technical expertise. Proactively communicate ownership of studies. Critical thinking to identify root causes and best practices. Knowledge of create high quality EDC specification. Knowledge of both SDTM and C-DASH (Clinical Data Acquisition Standards Harmonization) Knowledgeable of study protocols and create specifications that align to key deliverables. Knowledge of creation of Edit check specification and knowledge of programming edit check Knowledge of EDC design ...

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9.0 - 12.0 years

10 - 16 Lacs

Kochi, Kolkata, Bengaluru

Hybrid

Job Title / Primary Skill: Data Team Lead Years of Experience: 9-12 Years Job Location: Bangalore/Kochi/Kolkata Must Have Skills: Clinical data management, conduct, closeout, start up, SSU, Study lead Good To Have Skills: Rave Job Description 9+ of direct Data Management experience with a minimum of 2 year as a CDM project lead Pref Manage end-to-end delivery of data management services for single/multi-service projects with minimal guidance, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Data Management (DM) team to provide high quality data management products that meet customer needs. Provide leadership...

Posted 1 month ago

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