Data Management Trial Manager

hace 1 semana

Munro, Argentina MSD A tiempo completo

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 theclinical data management procedures. Interacts with staff across sites, countries, and time zones.

**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. 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.

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).

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.

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.

**Education/Experience**: B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline, with at least 3 years’ 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

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

Fluent English

**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.

ONEGDMS

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
No relocation

**VISA Sponsorship**:
No

**Travel Requirements**:
No Travel Required

**Flexible Work Arrangements**:
Hybrid

**Shift**:
Not Indicated

**Valid Driving License**:
No

**Hazardous Material(s)**:
N/A
**Requisition ID**:R290962

  • Clinical Trial Coordinator

    hace 2 semanas

    Munro, Argentina MSD A tiempo completo

    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 role is...

  • Clinical Trial Coordinator

    hace 2 semanas

    Munro, Argentina MSD A tiempo completo

    **Job Description**: Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill,...

  • (Finance) Clinical Trial Coordinator

    hace 2 semanas

    Munro, Argentina MSD A tiempo completo

    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 role is critical to meet planned Site Ready dates. The role will collaborate at local level closely with COM, CRM and CRA. And the person collaborates with...

  • Quality Control Analyst

    hace 3 semanas

    Munro, Argentina MSD A tiempo completo

    **Job Description**: Our Quantitative Sciences team use big data to analyze the safety and efficacy claims of our potential medical breakthroughs. We review the quality and reliability of clinical studies using deep scientific knowledge, statistical analysis and high-quality data to support decision making in clinical trials. **Primary...

  • Cra Manager

    hace 1 semana

    Munro, Argentina MSD A tiempo completo

    This role will be key to ensure strong monitoring in our clinical trials. Under the oversight of the Clinical Research Director, the person is responsible to manage a team of 6-14 CRAs and to ensure excellent study and site performance with strict adherence to local regulations, company SOPs and ICH GCP. As line manager the role is critical to continuously...

  • Cra Junior

    hace 2 semanas

    Munro, Argentina MSD A tiempo completo

    With support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites. - Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. - Performs clinical study site management/monitoring...

  • Cra Manager

    hace 3 semanas

    Munro, Argentina MSD A tiempo completo

    This role will be key to ensure strong monitoring in our clinical trials. Under the oversight of the CRD or Head of Site Management and Monitoring, the person is responsible to manage a team of 6-14 CRAs and to ensure excellent study and site performance with strict adherence to local regulations, company SOPs and ICH GCP. As line manager the role is...

  • Senior Technical Project Manager

    hace 2 semanas

    Munro, Argentina MSD A tiempo completo

    **Job Description**: The Sr. Technical PM is responsible for the oversight and management of the end-to-end delivery of technical data management components for one or more drug/vaccine programs. Provides technical consultation on the data management strategy, collaborates with appropriate functional areas to secure and align resources, and ensures all...

  • Lead Clinical Database Testing Analyst

    hace 4 semanas

    Munro, Argentina MSD A tiempo completo

    #ONEGDMS **Position Overview** Under the direction of the Director/Associate Director, the Lead CDT Analyst creates and executes Quality Control (QC) testing and User Acceptance Testing (UAT) procedures for electronic data capture (EDC) systems. This includes: internet based EDC, electronic devices, electronic diaries, IVRS/IWRS, etc. along with reporting...

  • Cra Junior

    hace 1 semana

    Munro, Argentina MSD A tiempo completo

    With support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites. - Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. - Performs clinical study site management/monitoring...

  • Cdt Analyst Ii

    hace 2 semanas

    Munro, Argentina MSD A tiempo completo

    **Position Overview** Under the direction of the Director/Associate Director, the CDT Analyst II creates and executes Quality Control (QC) testing and User Acceptance Testing (UAT) procedures for electronic data capture (EDC) systems. This includes: internet based EDC, electronic devices, electronic diaries, IVRS/IWRS, etc. along with reporting and...

  • Cdt Analyst Ii

    hace 2 semanas

    Munro, Argentina MSD A tiempo completo

    Under the direction of the Director/Associate Director, the CDT Analyst II creates and executes Quality Control (QC) testing and User Acceptance Testing (UAT) procedures for electronic data capture (EDC) systems. This includes: internet based EDC, electronic devices, electronic diaries, IVRS/IWRS, etc. along with reporting and documenting testing results....

  • QA & Compliance (Cdt Analyst Ii)

    hace 2 semanas

    Munro, Argentina MSD A tiempo completo

    50% Same responsibilities as the CDT Analyst - 15% Responsible for the creation of Test Plans and Test Summary documentation for a clinical trial - 5% Responsible for the creation/modification of standard and trial specific test scripts - 10% Responsible for the facilitation and coordination of testing activities related to the tool/system being tested - 10%...

  • Cra

    hace 2 semanas

    Munro, Argentina MSD A tiempo completo

    The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, company´s policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as...

  • Clinical Research Associate

    hace 3 semanas

    Munro, Argentina MSD A tiempo completo

    Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and...

  • Clinical Research Associate

    hace 2 semanas

    Munro, Argentina MSD A tiempo completo

    **Job Description**: Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill,...

  • Clinical Research Associate

    hace 2 semanas

    Munro, Argentina MSD A tiempo completo

    Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and...

  • Sr. Spclst, Clinical Research

    hace 3 semanas

    Munro, Argentina MSD A tiempo completo

    **Job Description**: Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill,...

  • Edao Analyst

    hace 2 semanas

    Munro, Argentina MSD A tiempo completo

    **Job Description**: **Reporting directly to Head/Manager of eClinical Technologies, the EDAO Analyst** will create, review, and facilitate approval of external data format specification documents including, but not limited to; Data Transfer Specifications (DTS) & Electronic Data Transfer (eDT). Coordinate with external vendors, Information Technology (IT),...

  • Regional Vendor

    hace 2 semanas

    Munro, Argentina Givaudan A tiempo completo

    Step into our world of creativity and joy! Regional Vendor & Quality Systems Manager - Join us and celebrate the beauty of human experience. Create for happier, healthier lives, with love for nature. Together, with passion and creativity, we deliver food innovations, craft inspired fragrances and develop beauty and wellbeing solutions. There’s much to...