Job Description:
-Execute end to end data management activities pertaining to clinical trials, including but not limited to: data management tool and system development, data validation and maintenance, data collection, data integrity review and reconciliation, query management, medical coding, database lock preparation, protocol review, CRF development, database set-up activities and SAE reconciliation in compliance with Standard Operating Procedures (SOPs) and ICH-GCP guidelines. -Design, create, validate, review, approve and maintain data management tool specifications. -Ensure completeness, accuracy and consistency of clinical data and data structure across all projects. -Address Regulatory Submission issues within Biometrics and with other related departments. -Utilize appropriate CDM concepts and resources to solve moderately complex technical CDM issues. Qualifications: 1. A minimum of B.A. or B.S. degree, preferably in Bioinformatics, Biological Sciences, Medicine, Pharmacy, Nursing, or health care related discipline, master’s degree preferred. Knowledge and Skills: 1. Proficiency on all related regulations, GCP, and Good Clinical DM Practice. 2. Knowledge of Medidata Rave, InForm, or Oracle Clinical Data Management preferred. 3. Excellent work planning and time management skills. 4. Fluent oral and written English skills. 5. Able to work under pressure and in a changing environment with flexibility. 6. Good communication skills with the ability to communicate with both the technical and business areas.
Additional Info:
Company Description: Our Profession is our Passion! We at RangTechnologies specialize in planning, implementing, managing, and staffing InformationTechnology Solutions and Services. Our goal is to help our clients define their investments in technology, optimize processes that bring fast-track success, and deliver business-critical applications to improve performance. We value diversity. We operate as one team, bringing highly qualified and experienced software and management professionals with advanced degrees in Computer Science, Management, Engineering, Statistics and Bioinformatics. The values that drive our success are: • Strategy: We help our clients’ growth by achieving competitive advantage and creating value. • Quality: We believe in ‘Quality First’ and ‘Quality Must’ in solutions we deliver. • Support: We bring ideas and talent to empower business performance with new-age technologies. We take pride in building strategic long-term relationship with our clients. All your information will be kept confidential according to EEO guidelines.[Click Here to Access the Original Job Post]
-Execute end to end data management activities pertaining to clinical trials, including but not limited to: data management tool and system development, data validation and maintenance, data collection, data integrity review and reconciliation, query management, medical coding, database lock preparation, protocol review, CRF development, database set-up activities and SAE reconciliation in compliance with Standard Operating Procedures (SOPs) and ICH-GCP guidelines. -Design, create, validate, review, approve and maintain data management tool specifications. -Ensure completeness, accuracy and consistency of clinical data and data structure across all projects. -Address Regulatory Submission issues within Biometrics and with other related departments. -Utilize appropriate CDM concepts and resources to solve moderately complex technical CDM issues. Qualifications: 1. A minimum of B.A. or B.S. degree, preferably in Bioinformatics, Biological Sciences, Medicine, Pharmacy, Nursing, or health care related discipline, master’s degree preferred. Knowledge and Skills: 1. Proficiency on all related regulations, GCP, and Good Clinical DM Practice. 2. Knowledge of Medidata Rave, InForm, or Oracle Clinical Data Management preferred. 3. Excellent work planning and time management skills. 4. Fluent oral and written English skills. 5. Able to work under pressure and in a changing environment with flexibility. 6. Good communication skills with the ability to communicate with both the technical and business areas.
Requeriments :
Skills :
Areas :
Additional Info:
Company Description: Our Profession is our Passion! We at RangTechnologies specialize in planning, implementing, managing, and staffing InformationTechnology Solutions and Services. Our goal is to help our clients define their investments in technology, optimize processes that bring fast-track success, and deliver business-critical applications to improve performance. We value diversity. We operate as one team, bringing highly qualified and experienced software and management professionals with advanced degrees in Computer Science, Management, Engineering, Statistics and Bioinformatics. The values that drive our success are: • Strategy: We help our clients’ growth by achieving competitive advantage and creating value. • Quality: We believe in ‘Quality First’ and ‘Quality Must’ in solutions we deliver. • Support: We bring ideas and talent to empower business performance with new-age technologies. We take pride in building strategic long-term relationship with our clients. All your information will be kept confidential according to EEO guidelines.[Click Here to Access the Original Job Post]