Data Management Trial Manager
hace 2 semanas
Position Overview:
The Trial Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific drug/vaccine program.
Collaborates with appropriate functional areas to align resources and ensure all aspects of the project plan are executed on time and with appropriate quality.
Agrees/arbitrates deliverable-based commitments based on detailed knowledge of trial complexity and requirements. Manages change, customer, and stakeholder expectations, facilitates cross-functional decision making, and performs risk management. Represents functional areas and GDMS on cross-functional trial teams and in other trial-level development forums.
Under the guidance of more senior staff, may serve as the data management lead or perform a support role for filing programs.
Primary activities include but are not limited to:
- Develops detailed project plans for the collection, review, and cleaning of all clinical data for assigned trials within a specific drug / vaccine program. Data includes, but is not limited to, case report form (CRF) data, lab data, other external data, biomarker data, and clinical outcomes assessments.
- Serves as project manager of all clinical data management activities for trials as assigned.
- Project planning, initiation, execution, change control, and closing.
- Project team development, project team leadership, meeting management, and resource coordination.
- Risk management planning (i.e., risk identification, analysis, response planning, monitoring, and control), including escalation as necessary.
- Management of customer / stakeholder expectations; facilitation of crossfunctional decisions.
- Defines trial-level requirements for quality data collection and validation at the trial level.
- Reads and interprets the clinical protocol from a clinical data management perspective.
- Provides clinical data management input into trial design, as appropriate, ensuring operational feasibility.
- Ensures appropriate use of standards and projectlevel consistency of database design, data collection, and validation.
- Facilitates assessment and processing of standards and change requests.
- Approves triallevel data validation plan (including project and protocol specific data validation elements).
- Monitors overall status and quality of data being collected during the in-life portion of a trial.
- Ensures activities required to achieve database lock (or data extraction) are completed by appropriate, responsible functional area.
- Ensures timely archival of trial data and documentation.
- Ensures timely decommissioning of clinical data management technologies.
- Accountable for ensuring the successful execution of delivery of data management services provided by external partners engaged for outsourced trials, as assigned
- Supports site and sponsor audits, as appropriate
- Identifies and supports improvements to data collection and data management processes and tools.
ONEGDMS
Position Qualifications:
OR
Associates Degree with at least 5 years' professional experience in clinical data management. Medical research, or database design and development, with at least 1 year experience working with formal project management tools and processes
OR
High School Diploma (or equivalent) with at least 8 years' professional experience in clinical data management;
Knowledge and Skills:
- Understanding of the clinical research process with in-depth knowledge of the Clinical Data Management lifecycle.
- Familiar and comfortable with database concepts and tools to manage, extract, and report data.
- Strong organization, leadership, and management skills.
- Exceptional communication skills (oral and written) with the ability to communicate with both the technical and business areas.
Search Firm Representatives Please Read Carefully
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Requisition ID:
R285944
-
Data Management Trial Manager
hace 2 semanas
Bogotá, Bogotá D.E., Colombia MSD A tiempo completoJob Description:Position Overview:The Trial Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific drug/vaccine program. Develops and manages project plans which span from protocol development through database lock, archiving, and submission deliverables where applicable....
-
Clinical Data Manager
hace 2 semanas
Bogotá, Bogotá D.E., Colombia MSD A tiempo completoJob Description:Position Overview: Under the direction of the applicable management, the Clinical Data Manager is responsible for executing end to end data management activities pertaining to clinical trials, including but not limited to; data management tool and system development, validation and maintenance, data collection, data integrity review and...
-
Clinical Data Management Analyst
hace 2 semanas
Bogotá, Bogotá D.E., Colombia MSD A tiempo completoJob Description:Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.Position Overview:Under the direction of the applicable...
-
Clinical Data Manager
hace 2 semanas
Bogotá, Bogotá D.E., Colombia MSD A tiempo completoJob Description:Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.Position Overview:Under the direction of the applicable...
-
Lead Clinical Data Manager
hace 2 semanas
Bogotá, Bogotá D.E., Colombia MSD A tiempo completoJob Description: Position Overview:_ Under the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management activities pertaining to clinical trials, including but not limited to: data management tool and system development, validation and maintenance, data integrity review and...
-
Lead Clinical Data Manager
hace 2 semanas
Bogotá, Bogotá D.E., Colombia MSD A tiempo completoJob Description:_ #ONEGDMS __Under the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management activities pertaining to clinical trials, including but not limited to: data management tool and system development, validation and maintenance, data integrity review and reconciliation,...
-
Sr. or Clinical Trial Manager, Oncology, Columbia
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Novasyte A tiempo completoIQVIA Biotech is committed and dedicated to the small biotech & biopharma companies we support.Opportunities available for an experienced Clinical Trial Manager II or Senior Clinical Trial Manager.Previous clinical trial management and CRO experience preferred.Therapeutic requirements/preference: any of the following Oncology/Hematology/CAR T/Cell & Gene...
-
Data Center Ops Senior Associate
hace 2 semanas
Bogotá, Bogotá D.E., Colombia NTT DATA A tiempo completoJob Description Req ID: NTT DATA Services se encuentra en la búsqueda de un Operador de Centro de Cómputo con nivel de inglés intermedio - avanzado que se incorpore a nuestro equipo en Colombia, Bogotá.ResponsabilidadesProveer el Soporte y gestión a los requerimientos elevados para Colombia en sus operaciones en línea y en Batch, por Correo, Teléfono...
-
Jr Infrastructure Project Manager
hace 2 semanas
Bogotá, Bogotá D.E., Colombia NTT DATA A tiempo completoWe are currently seeking a IT Infrastrucutre Project Manager Junior to join our team in Bogotá, Colombia- Job Description: Support Infrastructure project multicountry. Working in virtual teams, working remotely or for a remote manager. Support projects endtoend (planning, execution, monitoring and closure) Basic support in project financial management...
-
Gdo Principal Clinical Data Manager
hace 2 semanas
Bogotá, Bogotá D.E., Colombia MSD A tiempo completoJob Description:Under the direction of the applicable management, the Principal Clinical Data Manager (PCDM) is responsible and accountable, for ensuring quality and consistent end to end data management deliverables which can include trial and standards level data collection specification authoring. He/she is also accountable for providing comprehensive...
-
Data Center Ops Senior Associate
hace 2 semanas
Bogotá, Bogotá D.E., Colombia NTT DATA A tiempo completoReq ID: 250918We are currently seeking a Data Center Ops Senior Associate to join our team in BOGOTA D.C., Distrito Capital de Bogotá (CO-DC), Colombia (CO). Proveer el Soporte y gestión a los requerimientos elevados por los países en sus operaciones en línea y en Batch, por Correo, Teléfono o Casos Service now. Dar respuesta a los requerimientos...
-
Data Center Ops Senior Associate
hace 2 semanas
Bogotá, Bogotá D.E., Colombia NTT DATA A tiempo completoReq ID: 278244NTT DATA Services se encuentra en la búsqueda de un Operador de Centro de Cómputo con nível de inglés intermedio - avanzado que se incorpore a nuestro equipo en Colombia, Bogotá.Responsabilidades Proveer el Soporte y gestión a los requerimientos elevados para Colombia en sus operaciones en línea y en Batch, por Correo, Teléfono o Casos...
-
Clinical Trial Coordinator
hace 2 semanas
Bogotá, Bogotá D.E., Colombia MSD A tiempo completoJob Description:Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable.The...
-
Clinical Data Management Analyst
hace 2 semanas
Bogotá, Bogotá D.E., Colombia MSD A tiempo completoJob Description:ONEGDMS Under the direction of the applicable management, the Clinical Data Manager is responsible for executing end to end data management activities pertaining to clinical trials, including but not limited to; data management tool and system development, validation and maintenance, data collection, data integrity review and reconciliation,...
-
Data Center Ops Senior Associate
hace 2 semanas
Bogotá, Bogotá D.E., Colombia NTT DATA A tiempo completoReq ID: 278244We are currently seeking a Data Center Ops Senior Associate to join our team in BOGOTA D.C., Distrito Capital de Bogotá (CO-DC), Colombia (CO).ResumenRealizar la ejecución de los trabajos diarios y de cierre del back end de nuestro cliente del sector financiero.Responsabilidades Proveer el Soporte y gestión a los requerimientos elevados por...
-
Data Architect
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Data Meaning A tiempo completoDATA ARCHITECTPosition Type: Long-term ContractLocation: Latin America, RemoteData Meaning Services Group is a leading Business Intelligence and Data Analytics consulting firm dedicated to empowering organizations with meaningful data-driven insights. As a company at the forefront of the data revolution, we specialize in transforming raw data into actionable...
-
Data Center Ops Senior Associate
hace 2 semanas
Bogotá, Bogotá D.E., Colombia NTT DATA Services A tiempo completoReq ID: NTT DATA Services se encuentra en la búsqueda de un Operador de Centro de Cómputo con nivel de inglés intermedio - avanzado que se incorpore a nuestro equipo en Colombia, Bogotá.ResponsabilidadesProveer el Soporte y gestión a los requerimientos elevados para Colombia en sus operaciones en línea y en Batch, por Correo, Teléfono o Casos Service...
-
Clinical Trial Coordinator
hace 2 semanas
Bogotá, Bogotá D.E., Colombia MSD A tiempo completoJob Description:We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a...
-
Data Center Ops Senior Associate
hace 2 semanas
Bogotá, Bogotá D.E., Colombia NTT Data Services A tiempo completoReq ID: 230811We are currently seeking a Data Center Ops Senior Associate to join our team in Bogota, Distrito Capital de Bogotá (CO-DC), Colombia (CO).Position overviewRealizar la ejecución de los trabajos diarios y de cierre del back end de nuestro cliente del sector financiero.Position's General Duties and Tasks: Proveer el Soporte y gestión a los...
-
Data Center Ops Senior Associate
hace 2 semanas
Bogotá, Bogotá D.E., Colombia NTT Data Services A tiempo completoReq ID: 228428We are currently seeking a Data Center Ops Senior Associate to join our team in Bogota, Distrito Capital de Bogotá (CO-DC), Colombia (CO).Position overviewRealizar la ejecución de los trabajos diarios y de cierre del back end de nuestro cliente del sector financiero.Position's General Duties and Tasks: Proveer el Soporte y gestión a los...