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0.0 - 3.0 years
0 Lacs
karnataka
On-site
As a Clinical Research Coordinator at Analytical Project, St. John's Research Institute in Bangalore, you will be responsible for interacting with patients, sponsors, IEC, lab staff, and other departments to conduct studies following ICH GCP Guidelines, SOPs, and study protocol guidelines. You will act as the main communication line between patients, Investigators, and CROs during study conduct activities. **Key Responsibilities:** - Coordinate in screening, Audio-Video consenting, enrolment, periodic study visits, and close out visits. - Ensure the protection of the rights and well-being of research participants throughout the study duration. - Coordinate with finance, legal, and regulatory teams to prepare CTAs specific to the trials. - Maintain study documentation by completing source documents for each patient and updating Site Master Files. - Complete CRFs and e-CRFs on time, as well as resolve data queries. - Handle EDC, Inform & Medidata data capture. - Maintain inventory of study consumables including Investigational product handling, storage, dispensing, accountability, temperature tracking, equipment calibration, sample centrifugation, courier of documents, and lab sample shipment. - Prepare, notify, and track Ethics committee submissions in a timely manner. - Submit study progress, amendments, Protocol Deviations, AE's, and SAEs to the ethics committee and sponsor promptly. - Coordinate with the investigator and safety monitoring team during SAEs. - Assist in resolving IEC, DCGI, and FDA queries. - Coordinate and participate in monitoring visits with sponsor/CRO and facilitate inspections/audits. - Follow up with patients, document telephone contacts, conduct study closeout visits, and archive documents. - Maintain records of closeout studies and resolve post-closeout queries. **Qualifications Required:** - Degree with a life Science background. - Trained in Clinical research e.g. Diploma in Clinical research or MSc Clinical research and Pharm D. - Experience: 0-6 months. - Language proficiency in English, Kannada, Hindi, and Telugu. Interested candidates are encouraged to send their resume to The Principal Investigator at Analytical Project, St. John's Research Institute by emailing a cover letter and curriculum vitae with 3 references (names, email addresses, and phone numbers) to molly.j@sjri.res.in & cc to hr@sjri.res.in by or before 28th August 2025. [Please note: For more information, please visit our website www.sjri.res.in],
Posted 1 day ago
7.0 - 11.0 years
3 - 7 Lacs
bengaluru
Work from Office
About The Role Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Specialist Qualifications: BE/BTech/BSc Years of Experience: 7 to 11 years Language - Ability: English(Domestic) - Intermediate 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.Develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for? Commitment to qualityAbility to perform under pressureProblem-solving skillsCollaboration and interpersonal skillsClinical SAS, SQL, J-Review, CDW Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualification BE,BTech,BSc
Posted 4 days ago
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, FDA). Identify and resolve data inconsistencies and protocol deviations. Collaborate with clinical operations to ensure accuracy and completeness of source documentation. Support audit readiness through rigorous documentation practices and participation in quality reviews. Assist in creating source documents from protocols, CRFs, and lab manuals. Drive timely completion of data cleaning and database lock activities. Track and report key metrics for data quality and operational efficiency. Process Development & Compliance Develop SOPs, training guides, and implement process improvements. Identify inefficiencies and propose solutions to enhance workflow and team productivity. Participate in audits and collaborate on regulatory responses. Promote adherence to industry and internal standards. Cross-Functional Collaboration Serve as the point of contact for clinical data inquiries across assigned studies. Coordinate timelines and deliverables with project managers, monitors, and external stakeholders. Support all phases of the clinical study lifecycle from initiation to close-out. Qualifications and Experience Bachelor's degree in life sciences, health sciences, nursing, or a related field. Minimum 12 years of relevant experience, with at least 7 years in a Clinical Research Coordinator or Clinical Data Management role. Prior Managerial experience is a plus; must exhibit ability and willingness to take on supervisory responsibilities. Strong knowledge of CTMS (e.g., CRIO) and EDC systems such as RAVE, Veeva Vault, Clinical One, and Inform. Solid understanding of GCP, HIPAA, ALCOA-C, and clinical trial protocol standards. Must demonstrate ability to read, interpret, and operationalize clinical protocols. Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint). Ability to work independently while building processes and guiding others. Willingness to align with US operating hours.
Posted 5 days ago
2.0 - 7.0 years
6 - 10 Lacs
kochi, hyderabad, bengaluru
Work from Office
Designation: Clinical Data Manager Full Time Opportunity Location: Full Time Job Description: - Tasks have been carried out independently and the status is communicated back to all relevant parties. - Ensuring that the electronic data generated is transferred to the customer as per the Data Specifications - Configure, QC, and Test Study EDT and obtain client sign off on approved DTS. - Ensure EDT is delivered in accordance with the required frequency and specifications. - Control the receipt and integration of partner or 3PL data, as per scope of study. - Perform data reconciliations within the context of the assigned team, [and service], as appropriate to ensure a clean data set. - Perform approved data cleaning functions in order to maintain a clean data set. - Adherence to all written and authorized SOPs and/or work instructions. - Understand data structures, e.g, CDISC, LOINC - Experience of SAS programming to produce derived analysis datasets. - Collaborate with internal departments to make sure data is collected, managed and reported clearly, accurately and securely. - Support client and internal audits. - Takes on mentoring newer Data Management team members. Location - Bangalore,Cochin,Kochi, Hyderabad,Karnataka,Kerala,Telangana
Posted 5 days ago
3.0 - 5.0 years
2 - 6 Lacs
bengaluru
Work from Office
About The Role Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Analyst Qualifications: Any Graduation Years of Experience: 3-5 Yrs 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.In this role, you will be expected to develop clinical trial reports using SAS/ J-review / Congnos / SQL / PLSQL as per the study requirement. What are we looking for? SAS ClinicalOracle Procedural Language Extensions to SQL (PLSQL)Python (Programming Language)R ProgrammingClinical Database ProgrammingAdaptable and flexibleAbility to perform under pressureProblem-solving skillsAgility for quick learningAbility to establish strong client relationship Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualification Any Graduation
Posted 6 days ago
5.0 - 8.0 years
4 - 8 Lacs
bengaluru
Work from Office
About The Role Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Sr Analyst Qualifications: Any Graduation,BE,MCA Years of Experience: 5-8 Yrs 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.In this role, you will be expected to develop clinical trial reports using SAS/ J-review / Congnos / SQL / PLSQL as per the study requirement. What are we looking for? SAS ClinicalOracle Procedural Language Extensions to SQL (PLSQL)Python (Programming Language)R ProgrammingClinical Database ProgrammingAdaptable and flexibleAbility to perform under pressureProblem-solving skillsAgility for quick learningAbility to establish strong client relationship Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualification Any Graduation,BE,MCA
Posted 6 days ago
3.0 - 5.0 years
2 - 6 Lacs
bengaluru
Work from Office
About The Role Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Analyst Qualifications: Any Graduation Years of Experience: 3-5 Yrs 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.In this role, you will be expected to develop clinical trial reports using SAS/ J-review / Congnos / SQL / PLSQL as per the study requirement. What are we looking for? SAS ClinicalOracle Procedural Language Extensions to SQL (PLSQL)Python (Programming Language)R ProgrammingClinical Database ProgrammingAdaptable and flexibleAbility to perform under pressureProblem-solving skillsAgility for quick learningAbility to establish strong client relationship Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualification Any Graduation
Posted 6 days ago
7.0 - 12.0 years
10 - 14 Lacs
pune
Work from Office
About The Role 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 : Infor M3 Process Manufacturing & Distro Good to have skills : NA Minimum 7.5 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 day will involve overseeing the application development process and ensuring successful implementation. 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- Provide solutions to problems for their immediate team and across multiple teams- Lead the application development process effectively- Ensure timely delivery of projects- Provide guidance and mentorship to team members Professional & Technical Skills: - Must To Have Skills: Proficiency in Infor M3 Process Manufacturing & Distro- Strong understanding of software development lifecycle- Experience in leading application development projects- Knowledge of agile methodologies- Excellent communication and leadership skills Additional Information:- The candidate should have a minimum of 7.5 years of experience in Infor M3 Process Manufacturing & Distro- This position is based at our Pune office- A 15 years full-time education is required Qualification 15 years full time education
Posted 6 days ago
3.0 - 6.0 years
5 - 8 Lacs
mumbai
Work from Office
We are looking for a highly skilled and experienced Specialist to join our team at Jones Lang LaSalle Property Consultants (India) Pvt. Ltd., located in the Real Estate industry, with a strong background in Engineering Services. Roles and Responsibility Collaborate with cross-functional teams to deliver high-quality results. Provide expert advice and guidance on property-related matters. Conduct site visits and inspections to assess property conditions and potential issues. Develop and implement effective solutions to address complex problems. Analyze data and prepare reports to inform business decisions. Build and maintain relationships with clients and stakeholders. Job Requirements Strong understanding of real estate principles and practices. Excellent communication and interpersonal skills. Ability to work independently and as part of a team. Proficiency in relevant software and tools. Strong problem-solving and analytical skills. Ability to adapt to changing priorities and deadlines.
Posted 6 days ago
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 problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression supportive and engaged line management technical and therapeutic area training peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities Job Summary This position is responsible for leading other Clinical Data Associates (CDA) in collection of Non-CRF data/data management activities, during study set-up, conduct and closeout activities for multiple studies, providing support and may function as a backup for the Project Data Manager (PDM) on a study as required for global clinical trials. Core Responsibilities Maintains awareness of the pertinent elements of contract and scope of work for assigned project(s) and communicates status updates to the Project Manager (PM) and/or Biometrics Project Manager (BPM) as necessary. Reviews and adheres to the requirements of study-specific DMP for assigned project(s) and updates as required. Creates and enters test data for User Acceptance Testing (UAT) Performs User Acceptance Testing (UAT) for data entry screens, edits and data review listings, all different roles used in the study and Targeted Source Data Verification (SDV) configuration and matrices. Receives and enters lab normal ranges. Completes and submits Clinical Database Management System (CDMS)-specific access forms and/or spreadsheets. Performs reviews of discrepancy (edit check) output and validation listings based on data entered into the clinical database. Based on this review, queries or applies self-evident corrections or other global rulings permitted in cases where queries are not required, per the DVS and/or Data Management Plan (DMP) for the assigned projects. Resolves answered queries and re-queries where appropriate. For paper studies, takes receipt of, and reviews, Data Clarification Forms (DCFs) that have been answered by sites and where appropriate, edits the CRF database accordingly. For paper studies, performs internal QC checks via listing output from database against CRFs and DCFs. Serves as QC Coordinator for paper studies. For paper studies, ensures all CRFs and DCFs received are returned for filing in the Document Control Room per the Data Tracking Guidelines for the assigned projects. For EDC studies, performs DM quality review and/or other internal QC checks as required per applicable Electronic Data Capture (EDC) systems. Participates/Leads in internal meetings. Attends in-process review meetings. Participates in internal/external audits as required. Files documentation in the Data Management Study File (DMSF). Maintains proficiency in Data Management systems and processes through regular trainings (CDA Knowledge College) Performs SAS mapping QC whereby discrepancies are noted on the SAS mapping test logs. Oversees the work of other CDAs as required. This may involve on-the-job training, review of work, as well as ensuring the quality of work performed. Ensures that data from external databases/datasets such as central and/or local laboratory data, electronic diary data, pharmacokinetic (PK) data, or Interactive Response Technology (IRT) are consistent with data in the clinical database. Uses the specified process to document and query any such discrepancies found with the appropriate party. Completes tasks within timeframe by appropriately prioritizing multiple tasks within or across projects and adapts to timeline or priority changes by reorganizing daily workload. Proactively communicates to project team and management accurate estimates on time to complete tasks, availability to take on new assignments and resourcing conflicts. Minimizes rework by following study instructions, seeking understanding of assignments prior to performing task and anticipating the effect changes may have on data when issuing and resolving queries. Runs data cleaning and/or status reports. Performs Serious Adverse Event (SAE) reconciliations. Liaises with other groups such as Clinical Programming (CP), Biostatistics and Clinical Operations. Creates ad-hoc data cleaning reports used to determine if a validated listing is required including creation of the specification for the validated listing (updates DVS with the listing requirements). Perform post-migration testing on screens, edit checks, matrices and role changes as required. Participates in customer and third party meetings distributing relevant information in advance, ensures minutes are promptly and accurately distributed to internal team for review and subsequent edits are applied in order to maintain established currency for sponsor distribution. Reviews database design specifications (including configuration, data structures, annotated CRFs). Designs and/or reviews CRF/eCRF including eCRF visit structure co-coordinating with team members responsible for the associated database design. Provides input into the Data Validation Specification (DVS) including creation of edit checks for assigned forms including any post-production updates to the DVS and listings under guidance. Provides support to the PDM on a study as required. May involve soliciting support from and coordinating with other CDAs, taking full responsibility for an aspect of the study delivery, or producing study metrics reports. PDM's back up for specific activities (including attend sponsor's meetings to provide updates). Creation of Discoverer, BOXI, J-Review Reports Creates, updates and reviews study-specific documents such as CRF/eCRF DMP, data import/export agreements, CRF/eCRF Completion Guidelines. Fills-in the Data Transfer Request Form required for delivering the data to sponsor or vendor. Reviews queries and self-evident corrections proposed by less experienced DM staff. Understands the coding process Understands the purpose of interim, dry run, data cut Trains and mentors DM staff providing timely feedback to trainee and management as appropriate. Trains project team in project specific requirements. Provides EDC training to internal and external team members via Teleconference. Serves as a platform or process-specific Subject Matter Expert (SME). Performs QC of DMSF after QuickStart Camp (QSC) and ongoing during the study conduct. May be required to participate in client, internal or agency audits and inspections May represent the department at business development related meetings. Implement, maintain, and approve non CRF Vendor Transfer Agreements/plans/ specifications and confirm non CRF vendor specifications can be met and provide expertise on testing/results. Effectively communicates non-CRF data collection deliverables, status of work and data issues to the Client study lead and other study team members. Coordinates cross-functional non-CRF tasks with good understanding of downstream processes and stakeholder needs and impacts. Receive, process, and deliver non CRF test and production data. Implementation of patient enrollment and randomization strategy responsible for set up of IXRS UAT. Provide comprehensive assessment to identify all non CRF data types defined in the study protocol via protocol review and team discussion (including amendments) Communicate independently, proactively, and clearly to internal and external stakeholders. Able to lead all the Non CRF activities of study independently Able to act as Non CRF POC for Customer leading Cross functional communication and Vendor collaboration Additional Qualifications. BA/BS degree in the biological sciences or related disciplines in the natural science/health care field. Must have 5 to 7years of experience in Clinical Data Management. Must have experience into external vendor data setup and non-CRF setup activities Must have experience in central lab. Experience into eCOA, ePRO, patient diaries, Device testing, sensor testing , Data transfer agreement, external data setup, Lab, ECG, IWRS/IVRS testing Data management startup, study setup. Experience with DM practices and relational database management software systems preferred. Oracle Clinical, Rave, or Inform systems preferred. Knowledge of clinical data, and ICH/Good Clinical Practices. Knowledge of medical terminology preferred. Proficiency in navigating MS Windows, as well as use of MS Word, Excel, and email applications. Excellent speed and accuracy of keyboard skills. Work experience in clinical research, drug development, data management, or other healthcare environment preferred. Familiarity with medical terminology Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade Good organizational, planning, and time management skills preferred. Ability to multitask under tight deadlines while providing attention to detail. Ability to be flexible and adapt to change. Ability to work independently as well as part of a multi-disciplinary team. Ability to perform a leadership functions in DM including effective mentoring skills, and the ability to deal effectively with sponsors and internal customers. Responsible for performing activities that are in compliance with applicable Corporate Business Practices, Standard Operating Procedures and Working Instructions and performing other duties as assigned by management. Minimal travel may be required (up to 25%). Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Non CRF Set-up , Leads the collection of non-CRF data, during study set-up, conduct and close out activities for multiple studies
Posted 6 days ago
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 problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression supportive and engaged line management technical and therapeutic area training peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities Job Summary This position is responsible for leading other Clinical Data Associates (CDA) in collection of Non-CRF data/data management activities, during study set-up, conduct and closeout activities for multiple studies, providing support and may function as a backup for the Project Data Manager (PDM) on a study as required for global clinical trials. Core Responsibilities Maintains awareness of the pertinent elements of contract and scope of work for assigned project(s) and communicates status updates to the Project Manager (PM) and/or Biometrics Project Manager (BPM) as necessary. Reviews and adheres to the requirements of study-specific DMP for assigned project(s) and updates as required. Creates and enters test data for User Acceptance Testing (UAT) Performs User Acceptance Testing (UAT) for data entry screens, edits and data review listings, all different roles used in the study and Targeted Source Data Verification (SDV) configuration and matrices. Receives and enters lab normal ranges. Completes and submits Clinical Database Management System (CDMS)-specific access forms and/or spreadsheets. Performs reviews of discrepancy (edit check) output and validation listings based on data entered into the clinical database. Based on this review, queries or applies self-evident corrections or other global rulings permitted in cases where queries are not required, per the DVS and/or Data Management Plan (DMP) for the assigned projects. Resolves answered queries and re-queries where appropriate. For paper studies, takes receipt of, and reviews, Data Clarification Forms (DCFs) that have been answered by sites and where appropriate, edits the CRF database accordingly. For paper studies, performs internal QC checks via listing output from database against CRFs and DCFs. Serves as QC Coordinator for paper studies. For paper studies, ensures all CRFs and DCFs received are returned for filing in the Document Control Room per the Data Tracking Guidelines for the assigned projects. For EDC studies, performs DM quality review and/or other internal QC checks as required per applicable Electronic Data Capture (EDC) systems. Participates/Leads in internal meetings. Attends in-process review meetings. Participates in internal/external audits as required. Files documentation in the Data Management Study File (DMSF). Maintains proficiency in Data Management systems and processes through regular trainings (CDA Knowledge College) Performs SAS mapping QC whereby discrepancies are noted on the SAS mapping test logs. Oversees the work of other CDAs as required. This may involve on-the-job training, review of work, as well as ensuring the quality of work performed. Ensures that data from external databases/datasets such as central and/or local laboratory data, electronic diary data, pharmacokinetic (PK) data, or Interactive Response Technology (IRT) are consistent with data in the clinical database. Uses the specified process to document and query any such discrepancies found with the appropriate party. Completes tasks within timeframe by appropriately prioritizing multiple tasks within or across projects and adapts to timeline or priority changes by reorganizing daily workload. Proactively communicates to project team and management accurate estimates on time to complete tasks, availability to take on new assignments and resourcing conflicts. Minimizes rework by following study instructions, seeking understanding of assignments prior to performing task and anticipating the effect changes may have on data when issuing and resolving queries. Runs data cleaning and/or status reports. Performs Serious Adverse Event (SAE) reconciliations. Liaises with other groups such as Clinical Programming (CP), Biostatistics and Clinical Operations. Creates ad-hoc data cleaning reports used to determine if a validated listing is required including creation of the specification for the validated listing (updates DVS with the listing requirements). Perform post-migration testing on screens, edit checks, matrices and role changes as required. Participates in customer and third party meetings distributing relevant information in advance, ensures minutes are promptly and accurately distributed to internal team for review and subsequent edits are applied in order to maintain established currency for sponsor distribution. Reviews database design specifications (including configuration, data structures, annotated CRFs). Designs and/or reviews CRF/eCRF including eCRF visit structure co-coordinating with team members responsible for the associated database design. Provides input into the Data Validation Specification (DVS) including creation of edit checks for assigned forms including any post-production updates to the DVS and listings under guidance. Provides support to the PDM on a study as required. May involve soliciting support from and coordinating with other CDAs, taking full responsibility for an aspect of the study delivery, or producing study metrics reports. PDM's back up for specific activities (including attend sponsor's meetings to provide updates). Creation of Discoverer, BOXI, J-Review Reports Creates, updates and reviews study-specific documents such as CRF/eCRF DMP, data import/export agreements, CRF/eCRF Completion Guidelines. Fills-in the Data Transfer Request Form required for delivering the data to sponsor or vendor. Reviews queries and self-evident corrections proposed by less experienced DM staff. Understands the coding process Understands the purpose of interim, dry run, data cut Trains and mentors DM staff providing timely feedback to trainee and management as appropriate. Trains project team in project specific requirements. Provides EDC training to internal and external team members via Teleconference. Serves as a platform or process-specific Subject Matter Expert (SME). Performs QC of DMSF after QuickStart Camp (QSC) and ongoing during the study conduct. May be required to participate in client, internal or agency audits and inspections May represent the department at business development related meetings. Implement, maintain, and approve non CRF Vendor Transfer Agreements/plans/ specifications and confirm non CRF vendor specifications can be met and provide expertise on testing/results. Effectively communicates non-CRF data collection deliverables, status of work and data issues to the Client study lead and other study team members. Coordinates cross-functional non-CRF tasks with good understanding of downstream processes and stakeholder needs and impacts. Receive, process, and deliver non CRF test and production data. Implementation of patient enrollment and randomization strategy responsible for set up of IXRS UAT. Provide comprehensive assessment to identify all non CRF data types defined in the study protocol via protocol review and team discussion (including amendments) Communicate independently, proactively, and clearly to internal and external stakeholders. Able to lead all the Non CRF activities of study independently Able to act as Non CRF POC for Customer leading Cross functional communication and Vendor collaboration Additional Qualifications. BA/BS degree in the biological sciences or related disciplines in the natural science/health care field. Must have 5 to 7years of experience in Clinical Data Management. Must have experience into external vendor data setup and non-CRF setup activities Must have experience in central lab. Experience into eCOA, ePRO, patient diaries, Device testing, sensor testing , Data transfer agreement, external data setup, Lab, ECG, IWRS/IVRS testing Data management startup, study setup. Experience with DM practices and relational database management software systems preferred. Oracle Clinical, Rave, or Inform systems preferred. Knowledge of clinical data, and ICH/Good Clinical Practices. Knowledge of medical terminology preferred. Proficiency in navigating MS Windows, as well as use of MS Word, Excel, and email applications. Excellent speed and accuracy of keyboard skills. Work experience in clinical research, drug development, data management, or other healthcare environment preferred. Familiarity with medical terminology Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade Good organizational, planning, and time management skills preferred. Ability to multitask under tight deadlines while providing attention to detail. Ability to be flexible and adapt to change. Ability to work independently as well as part of a multi-disciplinary team. Ability to perform a leadership functions in DM including effective mentoring skills, and the ability to deal effectively with sponsors and internal customers. Responsible for performing activities that are in compliance with applicable Corporate Business Practices, Standard Operating Procedures and Working Instructions and performing other duties as assigned by management. Minimal travel may be required (up to 25%). Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Non CRF Set-up , Leads the collection of non-CRF data, during study set-up, conduct and close out activities for multiple studies
Posted 6 days ago
5.0 - 10.0 years
5 - 8 Lacs
mohali
Work from Office
*Strong understanding of payment industry processes: Offline product EDC SD, DQR, and Payment gateway, Business development, growth and key account management Pre Sales, Post Sale Handling, Strategic partnerships and collaborations * Individual Contributor Role. *Acting as the main point of contact between the merchant and the internal team. *Communicating and collaborating with the team to meet merchant requirements. Requirements: * 5+ yrs of experience in Offline product EDC SD, DQR and Payment gateway, fintech, Banking / Insurance Sales. * Set and track sales targets. *Motivated and results-driven professional with a proven track record in business development, key account management, partnership development, and business growth. Why join us: * The team follows a process-driven structure with low ambiguity, built on the foundation of merit and mutual respect. * We are proud of the culture we've built, and fitment within this culture is more important than competence. * This is a large and high-growth business, and involves dealing with multiple stakeholders across levels both within and outside the organization. * The candidate will have a free hand to innovate within the boundaries of compliance, ethics and profitability.
Posted 1 week ago
3.0 - 8.0 years
5 - 9 Lacs
pune
Work from Office
About The Role Project Role : Business Function Implement Practitioner Project Role Description : Support the implementation of activities for a specific business function to improve performance for a function end to end. Activities include analyzing and designing/re-designing business processes and/or defining parts of an organization. Must have skills : Infor M3 Process Manufacturing & Distro, Technical Writing Good to have skills : Technical Documentation Minimum 3 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Business Function Implement Practitioner, you will support the implementation of activities for a specific business function aimed at enhancing overall performance. A typical day involves collaborating with various stakeholders to analyze current business processes, identifying areas for improvement, and designing or redesigning processes to optimize efficiency. You will engage in discussions to gather insights, facilitate workshops, and document findings to ensure that the proposed changes align with organizational goals. Your role will also require you to monitor the implementation of these processes, ensuring that they are effectively integrated into the business function. Roles & Responsibilities:- Expected to perform independently and become an SME.- Required active participation/contribution in team discussions.- Contribute in providing solutions to work related problems.- Facilitate workshops and meetings to gather requirements and feedback from stakeholders.- Develop and maintain comprehensive documentation of business processes and changes. Professional & Technical Skills: - Must To Have Skills: Proficiency in Infor M3 Process Manufacturing & Distro, Technical Writing.- Good To Have Skills: Experience with Technical Documentation.- Strong analytical skills to assess business processes and identify improvement opportunities.- Ability to communicate complex ideas clearly and effectively to diverse audiences.- Experience in process mapping and redesign methodologies. Additional Information:- The candidate should have minimum 3 years of experience in Infor M3 Process Manufacturing & Distro.- This position is based at our Pune office.- A 15 years full time education is required. Qualification 15 years full time education
Posted 1 week ago
3.0 - 8.0 years
5 - 9 Lacs
pune
Work from Office
About The Role Project Role : Business Function Implement Practitioner Project Role Description : Support the implementation of activities for a specific business function to improve performance for a function end to end. Activities include analyzing and designing/re-designing business processes and/or defining parts of an organization. Must have skills : Infor M3 Process Manufacturing & Distro Good to have skills : NA Minimum 3 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Business Function Implement Practitioner, you will support the implementation of activities for a specific business function aimed at enhancing performance across the entire function. Your typical day will involve collaborating with various stakeholders to analyze current processes, identify areas for improvement, and design effective solutions that align with organizational goals. You will engage in discussions to gather insights, facilitate workshops, and contribute to the overall strategy for process optimization, ensuring that the changes implemented are sustainable and beneficial for the organization. Roles & Responsibilities:- Expected to perform independently and become an SME.- Required active participation/contribution in team discussions.- Contribute in providing solutions to work related problems.- Facilitate workshops and meetings to gather requirements and feedback from stakeholders.- Analyze existing business processes and identify opportunities for improvement. Professional & Technical Skills: - Must To Have Skills: Proficiency in Infor M3 Process Manufacturing & Distro.- Strong understanding of business process modeling and analysis.- Experience with change management methodologies.- Ability to work collaboratively in a team environment.- Familiarity with project management tools and techniques. Additional Information:- The candidate should have minimum 3 years of experience in Infor M3 Process Manufacturing & Distro.- This position is based at our Pune office.- A 15 years full time education is required. Qualification 15 years full time education
Posted 1 week ago
5.0 - 8.0 years
4 - 8 Lacs
bengaluru
Work from Office
About The Role Skill required: Clinical Data Services - Clinical EDC Build Designation: Clinical Data Svs Sr Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 5 to 8 years Language - Ability: English(International) - Expert 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.You will be expected to develop clinical study databases by building electronic case report forms and program edit checks as per specifications. Support any updates or changes to the study database (e.g. Protocol amendments) through the change control process. What are we looking for? Adaptable and flexibleAbility to perform under pressureProblem-solving skillsDetail orientationAbility to establish strong client relationship Roles and Responsibilities: Overall experience of 4+ years with exposure to EDC platforms like Medidata RAVE EDC, Inform, Oracle Clinical, Veeva etc. preferred.Extensive experience in database design, edit check programming, custom function programming and unit testing.Experienced in various modules such as IVRS/RWS integration and Lab administration. Medidata RAVE study builder certified preferred. Qualification BSc,Master of Pharmacy
Posted 1 week ago
3.0 - 5.0 years
2 - 6 Lacs
bengaluru
Work from Office
About The Role Skill required: Clinical Data Services - Clinical EDC Build Designation: Clinical Data Svs Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 3 to 5 years Language - Ability: English(International) - Expert 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.You will be expected to develop clinical study databases by building electronic case report forms and program edit checks as per specifications. Support any updates or changes to the study database (e.g. Protocol amendments) through the change control process. What are we looking for? Adaptable and flexibleAbility to perform under pressureProblem-solving skillsDetail orientationAbility to establish strong client relationship Roles and Responsibilities: Clinical Database Developers:Overall experience of 4+ years with exposure to EDC platforms like Medidata RAVE EDC, Inform, Oracle Clinical, Veeva etc. preferred.Extensive experience in database design, edit check programming, custom function programming and unit testing.Experienced in various modules such as IVRS/RWS integration and Lab administration. Medidata RAVE study builder certified preferred. Qualification BSc,Master of Pharmacy
Posted 1 week ago
7.0 - 11.0 years
3 - 7 Lacs
bengaluru
Work from Office
About The Role Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Specialist Qualifications: Bachelor of Pharmacy Years of Experience: 7 to 11 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.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 flexibleAbility to perform under pressureProblem-solving skills Roles and Responsibilities: Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred. o Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. o Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders. o Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery. o Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred. o Good analytical and communication skills. Qualification Bachelor of Pharmacy
Posted 1 week ago
3.0 - 5.0 years
2 - 6 Lacs
bengaluru
Work from Office
About The Role Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Analyst Qualifications: BE Years of Experience: 3-5 yrs 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, Clinical Automation, 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 Automation Team focuses on the development and implementation of innovative concepts and application for out clients across different accounts in Operations. The team is responsible for designing and implementing highly interactive, scalable web apps and prototypes at Enterprise level. The team is responsible for collaborate with frontend and backend developers to define API requirements and Ensure API security and authentication mechanisms are robust.You will be expected to develop and implement complex APIs based on requirements using different tools/techs such as .Net, Java, PL/SQL, C# or any other applicable systems. What are we looking for? Adaptable and flexibleAbility to perform under pressureProblem-solving skillsAgility for quick learningAbility to work well in a teamBachelors degree in computer science, Information Technology, Engineering or any computer related discipline.Work experience of at least 3 years in relevant industries (Financial Services, Network, Utilities, Health Care, Marketing, Pharma, Retail etc.).Work experience of at least 4 years in designing, coding, APIs, testing, debugging, documenting, and implementing enhancements and fix solutions.Work experience in Implementing APIs based architecture frameworks.Aptitude to learn, think creativity to solve real world business problems, and work in a global collaborative team environment.Proficient verbal and written communication skills in English. Roles and Responsibilities: Work as a technical lead to architect and develop innovative concepts and applications for our clients across different accounts in Operations.Design and implement highly interactive, scalable web apps and prototypes at Enterprise level.Build and modify high-performance APIs and Monitor API performance and troubleshoot issues promptly.Implement APIs based on architecture frameworks and guidelines.Work with DevOps engineers to integrate new code into existing continuous integration (CI) and continuous delivery/deployment (CD) pipelines.Able to lead Automation initiatives within his account.Work closely with the team and client to understand requirements and guiding them to deliver the most effective solution.Participate in the development of automation solutions, from prototyping new functionality and technologies to integrating them in our overall products and offerings, thus developing expertise and skills in this domain.Collaborate with frontend and backend developers to define API requirements and Ensure API security and authentication mechanisms are robust.You should be able to pilot and deploy automation solutions at scale.Partner with the testing team to ensure applications/components are fully functional.Oversee and fix any defects or performance problems discovered in testing.Participating in analyses of requirements as well as functional design whenever necessary.Be involved in the design of the solution.Performing design, coding, application maintenance and testing activities.Take ownership of the successful implementation of the solution.Interact with the end client as required to ensure the solution is implemented as per requirements.Deliver code to time and quality expectations.Fully unit test developed solutions. Qualification BE
Posted 1 week ago
5.0 - 8.0 years
4 - 8 Lacs
bengaluru
Work from Office
About The Role Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Sr Analyst Qualifications: BE/BTech/MCA 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? 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.In this role, you will be expected to develop clinical trial reports using SAS/ J-review / Congnos / SQL / PLSQL as per the study requirement. What are we looking for? Clinical Database ProgrammingClinical Data ManagementOracle Procedural Language Extensions to SQL (PLSQL)Adaptable and flexibleAbility to perform under pressureProblem-solving skillsAgility for quick learningAbility to work well in a teamSAS ClinicalStructured Query Language (SQL) 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 BE,BTech,MCA
Posted 1 week ago
7.0 - 11.0 years
3 - 7 Lacs
bengaluru
Work from Office
About The Role Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Specialist Qualifications: BE Years of Experience: 7 to 11 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.Develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for? SDTM ProgrammingStatistical ProgrammingPython (Programming Language)Ability to establish strong client relationshipAbility to handle disputesAbility to manage multiple stakeholdersClinical EDC Design Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualification BE
Posted 1 week ago
7.0 - 11.0 years
3 - 7 Lacs
bengaluru
Work from Office
About The Role Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Specialist Qualifications: BE Years of Experience: 7 to 11 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.Develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for? SDTM ProgrammingStatistical ProgrammingPython (Programming Language)Ability to establish strong client relationshipAbility to handle disputesAbility to manage multiple stakeholdersClinical EDC Design Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualification BE
Posted 1 week ago
3.0 - 5.0 years
2 - 6 Lacs
bengaluru
Work from Office
About The Role Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical data SVS Analyst Qualifications: Any Graduation,BE,MCA Years of Experience: 3-5 Yrs 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.In this role, you will be expected to develop clinical trial reports using SAS/ J-review / Congnos / SQL / PLSQL as per the study requirement What are we looking for? Clinical Database ProgrammingClinical Data ManagementOracle Procedural Language Extensions to SQL (PLSQL)Adaptable and flexibleAbility to perform under pressureProblem-solving skillsAgility for quick learningAbility to work well in a teamSAS ClinicalStructured Query Language (SQL 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,BE,MCA
Posted 1 week ago
2.0 - 6.0 years
12 - 16 Lacs
noida
Work from Office
-Lead and manage the end-to-end deployment of EDC and DQR devices across PAN India for enterprise merchants. -Develop deployment strategies, timelines, and resource plans to achieve target rollouts efficiently. -Coordinate with regional teams, vendors, logistics, technical support, and enterprise merchants to ensure smooth installations and activations. -Monitor deployment progress, identify challenges, and drive corrective actions to meet deployment SLAs and quality standards. -Collaborate with Product, Engineering, and Operations teams to ensure devices and solutions meet enterprise security, compliance, and performance benchmarks. -Manage vendor relationships, including performance monitoring, issue resolution, and escalations related to device supply and installation. -Oversee deployment analytics and reporting, providing regular updates to senior management on rollout status, issues, and improvements. -Drive continuous process improvements to optimize deployment efficiency and customer satisfaction. -Lead and mentor a distributed deployment team, fostering accountability and operational excellence. -Ensure adherence to regulatory and compliance requirements in all deployment activities. Preferred : -Proven experience leading teams and coordinating with multiple stakeholders across geographies. -Excellent project management and organizational skills with a track record of meeting deadlines and SLAs. -Strong analytical and problem-solving skills to address deployment challenges proactively. -Excellent communication and negotiation skills. Willingness to travel frequently across India for on-ground coordination and support. -Experience working in the fintech or payments industry, especially with merchant acquiring or POS deployment. Knowledge of supply chain, logistics, and vendor management related to device rollouts. -Understanding of digital payment technologies and integrations.
Posted 1 week ago
3.0 - 8.0 years
5 - 9 Lacs
pune
Work from Office
Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Infor M3 Process Manufacturing & Distro Good to have skills : NA Educational Qualification : 15 years full time education is required Summary :As an Application Developer, you will engage in the design, construction, and configuration of applications tailored to fulfill specific business processes and application requirements. Your typical day will involve collaborating with team members to understand project needs, developing innovative solutions, and ensuring that applications function seamlessly within the existing infrastructure. You will also participate in testing and troubleshooting to enhance application performance and user experience, contributing to the overall success of the projects you are involved in. Roles & Responsibilities:- Expected to perform independently and become an SME.- Required active participation/contribution in team discussions.- Contribute in providing solutions to work related problems.- Assist in the documentation of application processes and workflows to ensure clarity and consistency.- Engage in continuous learning to stay updated with the latest technologies and methodologies relevant to application development. Professional & Technical Skills: - Must To Have Skills: Proficiency in Infor M3 Process Manufacturing & Distro.- Strong understanding of application design principles and methodologies.- Experience with software development life cycle and agile methodologies.- Ability to troubleshoot and resolve application issues effectively.- Familiarity with integration techniques and tools to connect various applications. Additional Information:- The candidate should have minimum 3 years of experience in Infor M3 Process Manufacturing & Distro.- This position is based at our Pune office.- A 15 years full time education is required. Qualification 15 years full time education is required
Posted 1 week ago
2.0 - 4.0 years
14 - 19 Lacs
bengaluru
Work from Office
Position - Area Manager - Payments - Merchant Acquiring/Senior Area Manager - Payments - Merchant Acquiring Culture Anchor:Work Hard - Consistently puts in effort. plans and tracks daily progress to achieve targetsExecute with Rigor - Takes responsibility for meeting targets with focus and effortOwn It - Maintains honesty and fairness in all interactions in line with organizations policiesAct with Integrity Duties and Responsibilities FOS Management:- Recruit, train and motivate the team- Manage the FOS productivity Distribution development:-Acquire merchant - Drive QR deployment, SB deployment and POS/EDC Deployment -Build distribution for the business (business development).-Initiating and developing relationships with key decision makers in the relationships managed for business development. Distribution management:-Ensure proper distribution coverage through proper FOS mapping.-Manage channel relationships. - Drive sales numbers & retailer payment recon. - Work with partner on Sales promotion ideas and execution to drive sales.-Ensure process rigor and controllership.-Visibility @ point of sale-Drive Store activation every month (as per company defined definitions) Required Qualifications and Experience a)Qualifications Graduation/MBA with 2-4 years of experience.b)Work Experiencec)Should be an MBA with 1-4 years of experience OR Graduate with minimum 3-6 yrs of experienced)Prior exposure to Payments / FMCG / Telecom Pre-paid sales is mandatory. e)For internal candidates, people with Distribution handling roles in Consumer Durables, Digital & LSF roles are preferred.f)Good communication and interpersonal sg)Experience of handling merchant relationships directly in the pasth)Should be high on energy & a self starteri)Should have a passion for being out on the field and meeting Retailers.
Posted 1 week ago
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