Gilead Sciences, Inc.
Overview
We are seeking a highly motivated individual to join us as a
Senior Data Management Associate . In this role you will work closely with the Biostatistics, Programming, and Clinical Operations teams. This role will be a hands-on resource, reporting to the Senior Manager, Clinical Data Management or higher. The
Senior Data Management Associate
will be responsible for overseeing all aspects of clinical data management studies from start-up to close-out for Kite’s global clinical development programs. The Senior Data Management Associate will also work with Clinical Operations, Safety, and Regulatory as necessary. In this role you follow data management processes and understand the downstream implications of deviations from processes. This position will be responsible for supporting other data management roles and overseeing CDM vendors (external and/or CRO), creating and maintaining project timelines and data management documents, working with EDC Programming and Clinical Programming to create clinical databases and data quality reports, lead or support clinical data collection and data review activities, and study closure. Responsibilities (include but are not limited to): Works collaboratively with Clinical and Statistical Programming, Clinical Operations, Biostatistics, Clinical Development and others to meet project deliverables and timelines for clinical data collection, quality checking, and reporting. Handle multiple global/regional studies that are complex in scope and volume. Lead studies(s)/projects without supervision oversight. Ensures completeness, accuracy and consistency of clinical data and data structure. Leads the preparation and design of eCRF’s. Reviews study protocols and leads and/or assists in the planning and implementation of the data management portions of clinical studies. Interact with site coordinators, investigators, and field clinical staff in collecting data and resolving queries to meet the protocol requirements in a timely manner. Utilizes reports to track study progress and ensure timeliness and quality expectations are met. Prepare and manage data management timelines to ensure goals of teams are met Proficient in web-based Electronic Data Capture (such as Medidata Rave and other clinical data management systems) Provide CDM expertise for external vendor data coordination, collection, and cleaning to efficiently ensure high quality data Manage CDM deliverables in coordination with internal and external cross functional teams. Review clinical data on an ongoing basis to ensure quality data Assisting in the implementation of routine clinical data management processes with vendors including data entry, data quality checking, data transfer, and reporting. Create and/or support Data Transfer Plans and other pertinent External Data documentation Manage and coordinate external data deliverables. Review, query management, report delivery to study teams, study timeline and database snapshot coordination for analysis including Safety Review Team Flexible to changing priorities, detail-oriented, works well under pressure and able to take on unfamiliar tasks. Ensures adherence to standard business processes within CDM systems to ensure compliance to regulatory bodies. May participate in the design and implementation of clinical data management process. Serves as a point of contact for study management team. Demonstrates proficient English verbal and written communication skills, including the ability to clearly describe critical technical CDM aspects to non-CDM staff Demonstrates meeting facilitation/presentation skills. Demonstrates ability to appropriately delegate tasks to applicable staff members. Demonstrated ability to identify issues, as well as communicate and escalate project level issues including processes, timelines, resourcing, performance, etc. Basic Qualifications
High School diploma and 9+ years of experience in Data Management -OR- BS/BA in life science or related discipline and 5+ years of experience in Data Management -OR- MS/MA in life sciences or related discipline and 3+ years of experience in Data Management Preferred Qualifications
CDM oncology experience and knowledge of hematological cancers / cell therapy. Scientific background and experience with lab data handling Demonstrated knowledge of FDA, EMA, ICH guidelines and regulations covering clinical trials, statistics, and data management. Experience in managing clinical data management deliverables for regulatory submission. Knowledge of industry-leading EDC and data review tools (e.g., Medidata Rave, Veeva EDC, Medrio EDC, Oracle, TrialGrid, JReview, etc.) and well versed in industry trends and emerging technologies supporting data collection Experience with Industry Standards Guidelines (e.g., CDISC) in either the collection (CDASH), tabulation (SDTM), or analysis (ADaM) models Ability to problem solve. Exceptional people/project leadership skills. Familiarity with industry wide thesauri/dictionaries such as MedDRA and WHODD.
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We are seeking a highly motivated individual to join us as a
Senior Data Management Associate . In this role you will work closely with the Biostatistics, Programming, and Clinical Operations teams. This role will be a hands-on resource, reporting to the Senior Manager, Clinical Data Management or higher. The
Senior Data Management Associate
will be responsible for overseeing all aspects of clinical data management studies from start-up to close-out for Kite’s global clinical development programs. The Senior Data Management Associate will also work with Clinical Operations, Safety, and Regulatory as necessary. In this role you follow data management processes and understand the downstream implications of deviations from processes. This position will be responsible for supporting other data management roles and overseeing CDM vendors (external and/or CRO), creating and maintaining project timelines and data management documents, working with EDC Programming and Clinical Programming to create clinical databases and data quality reports, lead or support clinical data collection and data review activities, and study closure. Responsibilities (include but are not limited to): Works collaboratively with Clinical and Statistical Programming, Clinical Operations, Biostatistics, Clinical Development and others to meet project deliverables and timelines for clinical data collection, quality checking, and reporting. Handle multiple global/regional studies that are complex in scope and volume. Lead studies(s)/projects without supervision oversight. Ensures completeness, accuracy and consistency of clinical data and data structure. Leads the preparation and design of eCRF’s. Reviews study protocols and leads and/or assists in the planning and implementation of the data management portions of clinical studies. Interact with site coordinators, investigators, and field clinical staff in collecting data and resolving queries to meet the protocol requirements in a timely manner. Utilizes reports to track study progress and ensure timeliness and quality expectations are met. Prepare and manage data management timelines to ensure goals of teams are met Proficient in web-based Electronic Data Capture (such as Medidata Rave and other clinical data management systems) Provide CDM expertise for external vendor data coordination, collection, and cleaning to efficiently ensure high quality data Manage CDM deliverables in coordination with internal and external cross functional teams. Review clinical data on an ongoing basis to ensure quality data Assisting in the implementation of routine clinical data management processes with vendors including data entry, data quality checking, data transfer, and reporting. Create and/or support Data Transfer Plans and other pertinent External Data documentation Manage and coordinate external data deliverables. Review, query management, report delivery to study teams, study timeline and database snapshot coordination for analysis including Safety Review Team Flexible to changing priorities, detail-oriented, works well under pressure and able to take on unfamiliar tasks. Ensures adherence to standard business processes within CDM systems to ensure compliance to regulatory bodies. May participate in the design and implementation of clinical data management process. Serves as a point of contact for study management team. Demonstrates proficient English verbal and written communication skills, including the ability to clearly describe critical technical CDM aspects to non-CDM staff Demonstrates meeting facilitation/presentation skills. Demonstrates ability to appropriately delegate tasks to applicable staff members. Demonstrated ability to identify issues, as well as communicate and escalate project level issues including processes, timelines, resourcing, performance, etc. Basic Qualifications
High School diploma and 9+ years of experience in Data Management -OR- BS/BA in life science or related discipline and 5+ years of experience in Data Management -OR- MS/MA in life sciences or related discipline and 3+ years of experience in Data Management Preferred Qualifications
CDM oncology experience and knowledge of hematological cancers / cell therapy. Scientific background and experience with lab data handling Demonstrated knowledge of FDA, EMA, ICH guidelines and regulations covering clinical trials, statistics, and data management. Experience in managing clinical data management deliverables for regulatory submission. Knowledge of industry-leading EDC and data review tools (e.g., Medidata Rave, Veeva EDC, Medrio EDC, Oracle, TrialGrid, JReview, etc.) and well versed in industry trends and emerging technologies supporting data collection Experience with Industry Standards Guidelines (e.g., CDISC) in either the collection (CDASH), tabulation (SDTM), or analysis (ADaM) models Ability to problem solve. Exceptional people/project leadership skills. Familiarity with industry wide thesauri/dictionaries such as MedDRA and WHODD.
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