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2.0 - 6.0 years
0 Lacs
karnataka
On-site
Premier Research is seeking a Data Coordinator - DM to join the Clinical Data Sciences team. In this role, you will play a crucial part in assisting biotech, medtech, and specialty pharma companies in translating life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. Your contributions will directly impact saving and improving lives, as we recognize our team members as our most valuable asset in achieving success. As part of our team, you will be supported in your growth and provided with the necessary skills and opportunities to excel at work while maintaining the flexibility and balance needed in your life. Your ideas will shape the way we operate, and your voice will be valued within our organization. Together, we are dedicated to delivering the medical innovation that patients are eagerly awaiting, making a difference in the field of biotech. Your responsibilities will include assisting in testing and maintaining databases, reviewing Case Report Forms (CRFs), data listings, and databases to ensure compliance with protocol guidelines, collaborating with colleagues to ensure database integrity, preparing documentation such as Data Management Plans (DMP) and Data Reports, developing standard test data, performing user acceptance testing, data entry, generating reports for data review, resolving data discrepancies, and supporting various data management processes. To be successful in this role, you should hold a Bachelor's Degree or above, preferably in a Life Science field, and have 2-4 years of experience in Data Management or related clinical research industry. Additionally, knowledge of at least one Clinical Data Management System (CDMS) such as Medidata Rave or Calyx EDC would be beneficial. If you are looking to contribute to impactful projects, grow in your career, and be part of a team dedicated to making a difference in the biotech industry, we invite you to join us at Premier Research and build your future with us.,
Posted 5 days ago
4.0 - 8.0 years
0 Lacs
karnataka
On-site
You will serve as a member of the project team with the primary responsibility of clinical data review, query generation/resolution, and reconciliation to ensure the delivery of clinical data aligns with client quality and integrity specifications, project timelines, and productivity targets. Additionally, there is a potential opportunity to contribute to the development of the project Data Management Plan, including data review guidelines and setting up data management systems according to project requirements. You may also act as the operational data management leader on small projects, providing technical oversight of data management activities to deliver clinical data in line with client quality standards, project timelines, and budgets. Your core responsibilities will include reviewing clinical trial data as per [Global] Data Management Plans and relevant standardized data management processes to identify any erroneous, missing, incomplete, or implausible data. Running ancillary programs to support data review, generating, resolving, and tracking queries for problematic data, performing aggregate reviews of clinical data to identify trends or inconsistencies, applying quality control procedures to ensure data quality standards are met, and reviewing project documents such as protocols, CRFs, and Data Management Plans are also key aspects of your role. Furthermore, you will assist in developing Data Management Plans and Quality Management Plans, reviewing database designs, creating data review guidelines, developing data management system edit checks, and collaborating with the project team to meet milestones and communicate with leads from various disciplines. You will also ensure service quality meets specified requirements, inform the Lead Data Reviewer of budget overages, perform quality control on data management activities, support audits, and train project staff on data management processes. To qualify for this role, you should have a university/college degree in life sciences, health sciences, information technology, or related subjects. Relevant work experience or education equivalent to a bachelor's degree will also be considered. You should have 4 to 6 years of experience in Clinical Data Management, knowledge of clinical trial processes, clinical operations, biometrics, and system applications, strong time management skills, the ability to work in a team, good organizational, communication, and interpersonal skills, knowledge of medical terminology, science background, and proficiency in oral and written communication. Preferred qualifications include in-depth knowledge of Fortrea, Electronic Data Capture experience, and familiarity with the organization's structure and Standard Operating Procedures. The physical demands of this job involve an office and/or home-based work environment. Your role is crucial in ensuring the quality and integrity of clinical data delivery, adhering to project timelines, and collaborating effectively with the project team to achieve set objectives.,
Posted 3 weeks ago
4.0 - 8.0 years
0 Lacs
karnataka
On-site
You will serve as a member of the project team, primarily responsible for clinical data review, query generation/resolution, and reconciliation to ensure the delivery of clinical data meets client quality and integrity specifications, project timelines, and productivity targets. You may also assist in developing project Data Management Plans and setting up data management systems as per project requirements. Additionally, you may lead data management activities on small projects with technical oversight. Your responsibilities will include reviewing clinical trial data based on Data Management Plans and standardized processes to identify errors or inconsistencies, running ancillary programs to support data review, generating and resolving queries, performing aggregate data reviews, ensuring data quality standards are met, reviewing project documents, collaborating on Data Management and Quality Management Plans, reviewing database design, creating data review guidelines, developing data management system checks, assisting in building timelines, and ensuring service and quality standards are achieved. To qualify for this role, you should have a university/college degree in life sciences, health sciences, information technology, or related subjects. Alternatively, relevant work experience may be accepted in lieu of a bachelor's degree. You should have 4 to 6 years of experience in Clinical Data Management, knowledge of clinical trial processes, time management skills, ability to work in a team environment, good organizational, communication, and interpersonal skills, as well as knowledge of medical terminology and science. Preferred qualifications include thorough knowledge of Fortrea, Electronic Data Capture experience, and familiarity with organization SOPs. You will primarily work in an office or home-based environment. Additionally, you may need to support and action client or internal audits, mentor/coach project staff, and perform other related duties as assigned by management.,
Posted 1 month ago
1.0 - 5.0 years
0 Lacs
hyderabad, telangana
On-site
As a Clinical Data Services Associate at Accenture, you will play a crucial role in the Clinical Data Management team. Your responsibilities will include collecting, integrating, and ensuring the availability of data at the appropriate quality and cost. You will be involved in activities such as reviewing discrepancies, generating queries, and resolving them. Additionally, you will create CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. Your expertise will help in identifying and addressing protocol deviations in the database, performing edit check validation, writing test scripts, and conducting database validation (UAT) against specified CRF/ECRF. You will also manage clinical data management projects, ensuring the collection, integration, and availability of data at the required quality and cost to support the conduct, management, and analysis of studies in clinical research. To excel in this role, you should have the ability to establish strong client relationships, handle disputes effectively, manage multiple stakeholders, meet deadlines consistently, and work collaboratively in a team environment. Your role will involve solving routine problems based on established guidelines and seeking guidance from your team and supervisor when needed. You will receive detailed instructions on your daily tasks and new assignments, with the decisions you make impacting your own work within a focused scope. Please be aware that this position may require you to work in rotational shifts. With a Bachelor of Pharmacy or Master of Pharmacy qualification and 1 to 3 years of relevant experience, you will contribute to Accenture's global professional services company. Accenture is known for its expertise in digital, cloud, and security solutions, offering services across various industries to drive value and success for clients worldwide. Join Accenture's Life Sciences R&D vertical, where you will be part of a team dedicated to supporting the world's leading biopharma companies in bringing their vision to life. By converging around the patient and combining scientific expertise with unique insights into the patient experience, you will help improve outcomes and drive innovation in the healthcare sector. Discover a rewarding career at Accenture, where you can leverage your skills in Clinical Data Management to make a meaningful impact on the future of healthcare. Visit www.accenture.com to learn more about our company and explore the opportunities awaiting you in our dynamic and innovative organization.,
Posted 1 month ago
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