Empleos actuales relacionados con Data Management Trial Manager - Bogota - MSD

  • Clinical Data Manager

    hace 2 semanas

    Bogota, Colombia MSD A tiempo completo

    **Job 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...

  • Clinical Data Manager

    hace 1 semana

    Bogota, Colombia MSD A tiempo completo

    **Job 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...

  • Lead Clinical Data Manager

    hace 2 semanas

    Bogota, Colombia MSD A tiempo completo

    **Job 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...

  • Sr. or Clinical Trial Manager, Oncology, Columbia

    hace 2 días

    Bogota, Colombia Novasyte A tiempo completo

    IQVIA 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 &...

  • Clinical Trial Coordinator

    hace 2 días

    Bogota, Colombia MSD A tiempo completo

    **Job 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...

  • Principal Clinical Data Manager

    hace 1 semana

    Bogota, Colombia Labcorp A tiempo completo

    **Essential Job Duties**: *** - Lead studies including (but not limited to) a combination of healthy volunteer and patient populations, multi-site, complex protocol design, strong client management required or reduced timelines. - As the lead data manager, be accountable for all DM deliverables as assigned per the established timeline; providing instruction...

  • Gdo Principal Clinical Data Manager

    hace 2 días

    Bogota, Colombia MSD A tiempo completo

    **Job 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...

  • Clinical Data Management Analyst

    hace 2 días

    Bogota, Colombia MSD A tiempo completo

    **Job 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...

  • Data Center Ops Senior Associate

    hace 3 días

    Bogota, Colombia NTT DATA A tiempo completo

    **Req ID**: 278244 We 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). **Resumen** Realizar 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...

  • Project Manager

    hace 1 semana

    Bogota, Colombia PepsiCo A tiempo completo

    Overview: **We Are PepsiCo** Join PepsiCo and dare to transform! We are the perfect place for curious people, thinkers and change agents. From leadership to front lines, we're excited about the future and working together to make the world a better place. Being part of PepsiCo means being part of one of the largest food and beverage companies in the world,...

Data Management Trial Manager

hace 2 semanas

Bogota, Colombia MSD A tiempo completo

**Job 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. 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. Participates in the development of, and ensures adherence to, Merck clinical data management procedures. Interacts with staff across sites, countries, and time zones.

Primary activities include but are not limited to:
1. 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.

2. Serves as project manager of all clinical data management activities for trials as assigned. Under the guidance of more senior staff when appropriate, uses excellent interpersonal, negotiating, and project management skills to perform and manage the following tasks:

- 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 cross-functional decisions.

3. 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 project-level consistency of database design, data collection, and validation.
- Facilitates assessment and processing of standards and change requests.
- Approves trial-level data validation plan (including project and protocol specific data validation elements).

4. Manages trial-level data quality and completion of database lock and post-database lock activities:

- 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.

5. Accountable for ensuring the successful execution of delivery of data management services provided by external partners engaged for outsourced trials, as assigned

6. Supports site and sponsor audits, as appropriate

7. 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**:
1. Understanding of the clinical research process with in-depth knowledge of the Clinical Data Management lifecycle.
2. Familiar and comfortable with database concepts and tools to manage, extract, and report data.
3. Strong organization, leadership, and management skills.
4. 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**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R225963