Sr. Clinical Data Manager

1 semana atrás

Rondônia, Brasil Alimentiv Tempo inteiro

**JOB SUMMARY**:
Responsible for leading, planning and execution of all data management activities for assigned projects, ensuring focus on data integrity, validity, reliability in accordance with standard processes, sponsor guidelines, industry best practices and regulatory standards. Act as coach, mentor and/or Subject Matter Expert within the department, aiding Manager in process improvements, issue escalation and training development and delivery. Support the department and company in achieving objectives and strategic goals.

**Project Support**:

- Serve as the Lead Data Manager and primary contact responsible for overseeing day-to-day data management activities from study start-up through final database lock, including, but not limited to:

- Creation and maintenance of the Data Management Plan
- Development and design of Case Report Forms (CRFs)
- Develop Database Build specifications and coordinate database build and testing activities with database programmers
- Define and test edit checks
- Perform data review and query generation/resolution
- Track study progress and issue periodic status reports
- Process/reconcile electronic data received from other data sources, e.g. CIMS, Safety database, labs, IRT
- Oversee database lock and transfer process.
- Coordinate and supervise the day-day work of Data Management (DM) staff assigned.
- Train and mentor assigned employees on data management procedures and guidelines.
- Participate/lead internal/sponsor meetings as required, working directly with the assigned project manager and team to provide data management support.
- Ensure approved study documentation is maintained and properly stored in the trial master files.
- Manage project resources per budget and within expected timeframes.
- Develop or assist with the project training development and delivery, for investigators, clinical sites, project teams and sponsors on data collection processes, tools and/or equipment as required.
- Act as point of escalation for data related issues and queries.

**Department Support**:

- Contribute to the continuous improvement of DM and the wider organization through information sharing, training and education.
- Promote and be an advocate of DM internally and externally.
- Coach, mentor and/or train peers, contribute to peer selection, performance evaluation, peer orientation and project communications.
- May participate in and/or lead the development, review and implementation of processes, policies, SOPs/WI’s and associated documents affecting DM.
- May participate in and/or lead DM and cross functional working groups.
- May supervise Data Management staff.

**QUALIFICATIONS**:

- Applicants should have a minimum of a one to two year post-secondary certification in a relevant field of study, and 3-5 years of related work experience in Clinical Data Management with ongoing training. CCDM designation is considered an asset.

**WORKING CONDITIONS**:

- Home-based

  • Clinical Data Coder

    2 semanas atrás

    Rondônia, Brasil Indero Tempo inteiro

    The Clinical Data Coder is primarily responsible for providing support to activities related to coding of Clinical data for ongoing clinical studies. The Clinical Data Coder will also participate in various clinical data management activities required to ensure that data captured are collected, managed and reported clearly, accurately and securely. In...

  • Lead Clinical Trials Data Specialist

    Há 2 dias

    Rondônia, Brasil beBeeClinical Tempo inteiro R$120.000 - R$140.000

    **Lead Clinical Trials Data Specialist Role Summary**">The ideal candidate will be responsible for leading single and/or multiple clinical trials, ensuring the development, maintenance, and validation of annotated Case Report Forms (aCRFs) as well as specifications and statistical programming of Standard Data Tabulation Model (SDTM) datasets, Analysis Data...

  • Clinical Research Vendor Manager

    Há 2 dias

    Rondônia, Brasil beBeeVendor Tempo inteiro R$1.080.000 - R$1.320.000

    Lead Vendor CoordinatorThe Lead Vendor Coordinator oversees the evaluation and integration of vendors that support clinical services. This encompasses a diverse array of central lab vendors, drug depots, and technology providers for end-to-end clinical trial management.Main ResponsibilitiesDevelop vendor requirements in collaboration with stakeholders.Drive...

  • Clinical Operations Lead

    Há 3 dias

    Rondônia, Brasil Alimentiv Tempo inteiro

    Responsible for the clinical operations of a project within a defined regional/global level. Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations. The COL acts as a primary liaison...

  • Sr. Vendor Manager

    Há 2 dias

    Rondônia, Brasil Alimentiv Tempo inteiro

    The Sr. Vendor Manager (SVM) is accountable for the evaluation, integration, oversight, and performance of all vendors that support Alimentiv’s clinical services, including a wide array of central lab vendors, central/local drug depots, and goods and technology vendors that support end-to-end clinical trial management. In consultation with Quality...

  • Senior Clinical Research Project Lead

    Há 2 dias

    Rondônia, Brasil beBeeClinicalProjectManagement Tempo inteiro R$80.000 - R$150.000

    Clinical Project ManagerOverview:The Clinical Project Manager will oversee the strategic planning, execution, and completion of assigned clinical research projects.Responsibilities:Manage project planning, execution, progress, and completion to ensure timely delivery and quality outcomes.Collaborate with functional experts to ensure compliance with...

  • Clinical Project Manager

    4 semanas atrás

    Rondônia, Brasil Alimentiv Tempo inteiro

    **Project Management**:- Manage the planning, execution, progress and completion of assigned clinical research projects.- Work with functional experts to ensure all project activities comply with applicable regulations, guidelines, and corporate policies.- Maintain operational, financial and regulatory integrity and safety.- Develop and/or participate in the...

  • Clinical Project Manager

    Há 2 dias

    Rondônia, Brasil Alimentiv Tempo inteiro

    **Project Management**: - Manage the planning, execution, progress and completion of assigned clinical research projects. - Work with functional experts to ensure all project activities comply with applicable regulations, guidelines, and corporate policies. - Maintain operational, financial and regulatory integrity and safety. - Develop and/or participate...

  • Clinical Project Manager

    Há 3 dias

    Rondônia, Brasil Alimentiv Tempo inteiro

    **Project Management**: - Manage the planning, execution, progress and completion of assigned clinical research projects. - Work with functional experts to ensure all project activities comply with applicable regulations, guidelines, and corporate policies. - Maintain operational, financial and regulatory integrity and safety. - Develop and/or participate...

  • Senior Risk Manager

    Há 6 dias

    Rondônia, Brasil Indero Tempo inteiro

    The Senior Risk Manager plays a pivotal role in developing and executing risk-based monitoring strategies, ensuring data quality and integrity in clinical research projects. This position involves cross-functional collaboration to identify, assess, and mitigate risks throughout the clinical trial lifecycle, supporting the seamless implementation of...