Project Specialist

These customers have new therapeutic ideas, but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in patients’ lives.

**Summary**:
The Project Specialist (PS) serves as an essential role in project administration to deliver projects within the established budget and timeline in collaboration with Clinical Project Management. The PS provides support to project management by overseeing and handling global administrative tasks in accordance with the scope of work. Typical duties include coordination of project activities through collaboration with project team members, dissemination of project information and guidance to ensure adequate support for the study team, preparation of agendas for meetings, documenting key decisions and providing relevant updates as needed. This is a full-time, direct hire role for an experience industry professional. Ability to communicate verbally & written in English is required.

**Location: Mexico or **Brazil

**Experience**: 2+ years in PS or similar role with 4+ years industry experience

**Language**: Excellent professional level of English required (**Please submit resumes in English language**)

**Responsibilities**:

- Create and/or maintain tracking tools for clinical data management
- Enter data into systems and tools per required processes
- Review reports in applicable systems to ensure completeness, consistency and information is up to date prior to their distribution
- Coordinate, prepare, handle, and distribute clinical trial support materials if done centrally
- Support with the preparation of the study-related presentation materials (Kick off Meeting, CRA Training and Investigator Meeting, regular and ad hoc meetings) and present as needed
- Support in creation of Project Plan and other study plans including associated templates
- Attend handover meetings for the CTAs who are joining/leaving the study and review handover form
- Support PMs during audits/inspections. Ensure follow-up on open action item for resolution within given timelines
- Assist PM with vendor management, as needed
- Support Clients with ad hoc requests
- Within the scope of assigned responsibilities resolve study related problems, and offer action plans
- Facilitate team communication and liaise with sponsors, sites and third parties
- Prepare Study Correspondence Management Plan (SCMP)
- Process Public Folders (PF) for study level as per SCMP Ensure study PFs are maintained by the trial team to accomplish inspection readiness
- Coordinate internal and external project team conference calls, process agendas, meeting minutes, and action log or equivalent
- Adapt default folders on SharePoint
- Support TMF Lead (TMFL) with the setup of Trial Master File (TMF)
- As a document owner, is responsible for document filing on trial level, and can act as a document submitter for other document owners on trial level as needed
- Work with TMFL on reconciliation of TMF trial level documents
- Coordinate and support the project team with the periodic review of study files for accuracy, quality, and completeness, including tracking of the outstanding issues for proper resolution
- Coordinate and support the project team with the final reconciliation and off-site archival of project documentation
- Provide clear guidance to CRAs / CTAs and coordinate setup of investigator site files
- Customize and distribute study logs/forms/templates
- With the PM, ensure all activities included in the project scope of work are completed and project timelines are met
- If delegated by PM/CTL, enter trial level data in CTMS and conduct monthly reviews to ensure that content is accurate and up to date. Follow up with local study teams to ensure country and site level data is being updated regularly in CTMS
- Support PMs with budget related activities, as needed
- Create Contracted FTE by Month files
- Administrative support for Trial Committees activities for assigned studies
- Other duties as assigned.

**Requirements**:
**Qualifications & Skills**:

- Life science, healthcare and/or business degree preferred. High School Diploma/Certificate or equivalent combination of education, training and experience required
- Relevant work experience in similar positions (drug development and/or clinical research)
- Basic knowledge of GxP
- GDPR and applicable regulatory requirements
- Strong written and verbal communication skills including good command of English language
- Representative, outgoing and client focused
- Ability to work in a fast-paced challenging environment of a growing company
- Administrative excellence
- Excellent organizational skills including prioritization, organizing the workspace and time management
- Effective problem-solving and decision-making based on the