Assoc Lab Project Set-up Manager, Q2 Solutions

hace 1 semana

Buenos Aires, Argentina IQVIA A tiempo completo

Manage the process of designing and launching clinical research studies; manage activities of the Sponsor/Clinical Research Organization (CRO); lead colleagues in the design and organization of project components during Start-Up; develop and maintain best practices within the organization; Accountability and ownership for the quality of all start-up work and sponsor deliverables.

**Essential Functions**
- Develop the database design requirements which include configuration definition for full protocols, protocol amendments and sponsor study changes
- developing and maintaining client design standards as applicable in accordance with the Clinical Protocol
- Manage study database configuration. Support internal/external stakeholders in the development of sponsor standards and as a Set-up point of contact
- Collaborate with colleagues during planning meetings regarding project timelines, and project-related issues focusing on capabilities within, but not limited to, Data Management, Logistics, Clinical Trial Materials, Laboratory Testing, and Specimen Management
- Responsible for updates to the project, including the action/issues logs, status sheets and timelines during the startup phase, where applicable
- Communicate and coordinate set-up activities with clients and internal customers to ensure that all milestones are achieved
- Proactively manage changes in study related project scope, identify potential risks, and devise contingency plans
- As required, prepare and present study-specific materials and services at Investigator, Kick-off meetings. Participate in external and internal audits as required
- Provide day to day guidance to more junior staff assigned to project or within a specific program area
- may act as a mentor as well as assist in the training and development of more junior staff
- Participate in improvement projects as defined by the relevant process improvement management team. Conduct project lesson learn sessions and create a recommendations report in order to identify successful and unsuccessful project elements, when applicable
- Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice.

**Qualifications**
- Bachelor's Degree Science or related field Pref
- Other Equivalent combination of education, training and experience may be accepted in lieu of degree. Req
- Minimum 2 years of clinical or research industry experience, including 1 year project management / project set up experience Pref Or
- Equivalent combination of education, training and experience Req
- Possess strong interpersonal skills.
- Demonstrated ability to meet deadlines.
- Some experience in leading Phase I-IV clinical trials would be advantageous. Some technical and therapeutic expertise would be advantageous, in addition to significant experience with key customers.
- Demonstrated computer proficiency with Microsoft Office. Working knowledge of Clinical Trials Management Systems would be an advantage.
- Possess an understanding of medical and clinical research terminology.
- Demonstrated ability to work in a fast-paced environment.
- Knowledge of Project Management processes and terminology.
- Excellent organizational and time management skills.
- Excellent accuracy and attention to detail skills.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.

  • Assoc Lab Project Set-up Manager, Q2 Solutions

    hace 1 semana

    Buenos Aires, Argentina Novasyte A tiempo completo

    Manage the process of designing and launching clinical research studies; manage activities of the Sponsor/Clinical Research Organization (CRO); lead colleagues in the design and organization of project components during Start-Up; develop and maintain best practices within the organization; Accountability and ownership for the quality of all start-up work and...

  • Laboratory Project Set-up Coordinator

    hace 6 días

    Buenos Aires, Argentina Novasyte A tiempo completo

    Provide pre-launch database support; assist with designing, loading, and validation of Lab databases using Clinical Trials Management System [examples QLIMs, NewLIMs, TOPCAT, Encompass]; ensure work is conducted in line with standard operating procedures, policies and good practice. RESPONSIBILITIES- Configure project databases.- Input data into the...

  • Laboratory Project Set Up Manager

    hace 6 días

    Buenos Aires, Argentina Novasyte A tiempo completo

    Job Overview Manage the process of designing and launching clinical research studies; manage activities of the Sponsor/Clinical Research Organization (CRO); lead colleagues in the design and organization of project components during Start-Up; develop and maintain best practices within the organization; Accountability and ownership for the quality of all...

  • Lab Project Services Coordinator, Q2 Solutions

    hace 6 días

    Buenos Aires, Argentina Novasyte A tiempo completo

    Provide support to the Project Manager and related team members by performing routine procedures and tasks associated with the day to day running of projects throughout the entire study lifecycle (e.g. start-up, maintenance and close-out). Ensure work is conducted in line with standard operating procedures, policies and good practices. Essential Functions -...

  • Lab Project Services Coordinator, Q2 Solutions

    hace 3 días

    Buenos Aires, Argentina IQVIA A tiempo completo

    Provide support to the Project Manager and related team members by performing routine procedures and tasks associated with the day to day running of projects throughout the entire study lifecycle (e.g. start-up, maintenance and close-out). Ensure work is conducted in line with standard operating procedures, policies and good practices. **Essential...

  • Associate Laboratory Project Set-up Manager

    hace 6 días

    Buenos Aires, Argentina Novasyte A tiempo completo

    Job Overview Manage the process of designing and launching clinical research studies; manage activities of the Sponsor/Clinical Research Organization (CRO); lead colleagues in the design and organization of project components during Start-Up; develop and maintain best practices within the organization; Accountability and ownership for the quality of all...

  • Assoc/site Activation Manager

    hace 4 semanas

    Buenos Aires, Argentina Novasyte A tiempo completo

    Assoc/site Activation Manager - All Latam Novasyte Internal Job Description- Calling all experienced Site Activation Managers- The Site Activation Manager (SAM) position within GSA team in IQVIA is our project manager for the start-up phase in charge of design and implementation of our strategy towards sites activation from award until open to enrolment. The...

  • Project Services Lab Qc Analyst in Argentina

    hace 6 días

    Buenos Aires, Argentina IQVIA A tiempo completo

    **Job Overview** In accordance with the process of designing and launching global clinical research studies, perform an independent QC review and ensure study set-up process and procedures are adhered to during the start-up and amendment phase; review of source documentation and database configuration versus sponsor protocol; provision of guidance in the...

  • Lab Project Services Manager

    hace 2 semanas

    Buenos Aires, Argentina IQVIA A tiempo completo

    **Job Overview** Under general direction, manage all laboratory aspects of assigned clinical trial projects for a Customer or a specific program for a Customer. May have responsibility for a specific Customer, drug program, indication or drug compound. Acts as the main point of contact for the Customer after study award and throughout the entire study...

  • Lab Project Services Manager

    hace 2 semanas

    Buenos Aires, Argentina IQVIA A tiempo completo

    **Job Overview** Under general direction, manage all laboratory aspects of assigned clinical trial projects for a Customer or a specific program for a Customer. May have responsibility for a specific Customer, drug program, indication or drug compound. Acts as the main point of contact for the Customer after study award and throughout the entire study...