Clin Ops Delivery Associate Iii

hace 7 meses

Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

**Purpose**:
Provides administrative and technical support to the Project Team. Coordinates and facilitates project activities and may serve as a study lead acting as a cross-functional liason for the project team. Acts as a buddy during onboarding phase and provides training to new staff as needed. Supports departmental and cross-functional initiatives for process improvements/enhancements.

**Essential Functions**:
According to the specific role (Central or Local), coordinates, oversees and

completes functions on assigned trials activities detailed on the task matrix.
- Performs department, Internal, Country and Investigator file reviews as assigned

and documents findings in appropriate system.
- Ensures allocated tasks are performed on time, within budget and to a high

quality standard. Proactively communicates any risks to project leads and line

manager as appropriate.
- Supports the maintenance of study specific documentation and global support

with specific systems, tools and trackers including but not limited to: study team

lists, tracking of project specific training requirements, system access

management for organization/vendor/clients, and tracking of project level

activity plans in appropriate system. Ensures (e)TMF is up to date by following

file review schedules and documents findings in appropriate system.
- Provides system support (i.e. GoBalto & eTMF).
- Supports RBM activities.
- Performs administrative tasks on assigned trials including but not limited to:
timely processing of documentssent to Client (e)TMF as assigned, performing

(e)TMF reviews, performing mass mailings and communications as needed,

providing documents and reports to internal team members.
- Supports scheduling and organization of client and/or internal meetings with

completion of related meeting minutes.
- Reviews and tracks local regulatory documents.
- Transmits documents to client and centralized IRB/IEC.
- Analyzes and reconciles study metrics and findings reports. Assists with

clarification and resolution of findings related to site documentation.
- Maintains vendor trackers.
- Assists with coordination, compilation and distribution of Investigator Site File

(ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
- Assists with study-specific translation materials and translation QC upon request.
- May attend Kick off meeting and take notes when required.

**Education and Experience**:

- High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
- Bachelor ´s degree preferred.
- Experienced finance profile.
- ** Knowledge, Skills and Abilities**:

- Ability to work in a team or independently as required
- Strong organizational skills and attention to detail, with proven ability to handle multiple tasks
- efficiently and effectively
- Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
- Strong customer focus
- Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet
- changing project timelines
- Demonstrated ability to attain and maintain a good working knowledge of applicable Country
- Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout
- Excellent English language and grammar skills and proficient local language skills as needed
- Good presentation skills
- Excellent computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain
- knowledge and master all clinical trial database systems
- Ability to successfully complete PPD clinical training program
- Self-motivated, positive attitude with effective strong interpersonal skills

  • Clin Ops Delivery Associate Iii

    hace 8 meses

    Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

    Please see JD of Sr. CTC-L

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