Project Support Specialist II
New
Remote, Mexico
We’re expanding across
Mexico, Brazil, Argentina, Colombia, Chile, and PeruFull-TimeMiddle
Salary not disclosed
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Job Details
- Experience
- Minimum 2 years relevant experience
- Required Skills
- SharePointMicrosoft ExcelMicrosoft OfficePowerPoint
Requirements
- 4-year college degree or international equivalent; or equivalent experience ideally in a business, scientific or healthcare discipline
- Minimum 2 years relevant experience or demonstrated competencies in the key requirements of the role.
- Fluency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint).
- Customer service demeanor; demonstrate flexibility, teamwork, and a keen attention to detail.
- Ability to communicate both verbally and in writing at the English proficiently (Professional level).
- Working knowledge of ICH-GCP, Precision SOPs, and regulatory guidance.
- Demonstrates solid interpersonal skills.
- Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment.
- Strong written and verbal communication skills
Responsibilities
- Manages the meeting lifecycle including scheduling internal and external meetings, preparing, and circulating agendas, taking meeting minutes, circulating, and updating meeting minutes based on team member input, and filing meeting agendas and minutes in the Trial Master File.
- Assists with creation and maintenance of the project timeline in MS Project or similar system. Collects updates from team members, captures and documents these updates, and ensures updates are communicated to the cross-functional study team.
- Performs an array of activities and tasks in clinical systems applicable to their role and project scope.
- Manages study-specific training lifecycle by collecting, tracking, and loading training materials, assigning team members to appropriate training, and documenting completion of study-specific training in appropriate systems. Manages the maintenance of training records and files records in the Trial Master File.
- Establishes a study-level Share Point site or similar shared working space and ensures appropriate access to study team, sponsors, and others as appropriate.
- Creates project-specific email boxes and maintains appropriate access to study team members.
- Manages user access to study systems by submitting user requests to the Helpdesk or similar, by reviewing team member access on a defined periodic basis, and documenting access reviews. Ensure rapid removal of system access for team members no longer affiliated with the study.
- Orders study supplies and addresses queries on study supplies.
- Prepares study binder materials and works with vendor to ensure proper binder creation and shipping to study sites. Works with vendor to obtain project-related cost estimates. Ensures vendor quotes align with invoices for completed binders and consults directly with Project Manager to approve vendor payments.
- Maintains various study trackers as needed and directed by the Project Manager, Clinical Trial Manager, or other project leader.
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