Sr. Project Specialist
Allucent, Slovakia
Job Description
CATO SMS and Pharm-Olam, LLC have merged to form Allucent!
Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment.
We are looking for a Senior Project Specialist to join our team in Central amp;/or Eastern Europe with the option to work remotely! The Senior Project Specialist provides support to project management to deliver projects within the established budget and timeline. 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. They write and disseminate work plans and project documents, including procedures, progress reports and presentations
Location: Central/Eastern Europe (Poland, Hungary, Slovakia, Czech Republic)
Key Responsibilities:
Provides continuous support to Project Managers (PM), Clinical Trial Leaders (CTL) and study team throughout the course of the clinical trial. Daily support includes, but is not limited to:
- Preparation and maintenance of study trackers
- Attendance to the study teleconferences, preparation of TC minutes and tracking TC minutes in CTMS
- Attendance to F2F meetings (KoM, IM)
- Planning and attendance of handover meetings for the CTAs who are joining/leaving the study. Reviews HO form and signs off as Transfer Chair, as needed.
- Submission and tracking of access requests for the Pharm-Olam study team
- Adaptation of default folders on ePOI Cloud / Active studies for working documents to facilitate study needs
- Creation and maintenance of Global Contact List
- Creation and maintenance of Trial Responsibilities Log for Pharm-Olam study team.
- Upload and assignment of trainings in QPulse for the study team. Follow-up with study team on training completions.
- Creation of Project Specific Training Matrix and its upload to QPulse.
- Creation of study specific Correspondence Management Plan
- Sorting out Public Folders for study level and usually Vendors and Sponsor correspondence
- Follow-up and reminders to the study team to sort out Public Folders regularly and escalating backlogs to PM in a timely manner
- Review reports in CTMS to ensure completeness, consistency and information is up to date prior to their distribution
- Generation and distribution of daily or weekly reports from various systems
- Follow-up with CRAs for CTMS updates if data is missing for reports.
- Customization and distribution of study logs/forms templates
- Organization of centralized printing for study material
- Support with centralized IMP/lab kits distribution
- Supporting CTAs with study related questions/issues.
- Submission of trial level documents to Veeva Vault eTMF Document Inbox. Resolving rejections.
- Working with TMFL on reconciliation of TMF Trial Level Documents.
- Pharm-Olam study team CVs reconciliation and follow-up and submission to eTMF.
- Assistance in preparation of eTMF Plan with the TMFL.
- Supporting PMs during audits/inspections. In cooperation with QA/Compliance follow-up on open items/cases in QPulse and delegation to responsible parties for resolution. Ensuring all resolutions are provided to the PM /Sponsor within given timelines. Following-up with study team to resolve TMF related findings and work with TMFL to ensure documents are provided by the study team for filing in the eTMF.
- Distribution of Newsletters to the sites and support with formatting, if required
- Preparation of weekly CTMS project status reporting and distribution to internal study team as a reminder on pending actions
- Administrative support for DSMB activities for assigned studies.
- Other administrative ad hoc support to PM not mentioned above.
- Mentoring and training of Project Specialists
- Chairing/leading teleconferences upon request of PM
- Management of investigator payments in CTMS
- Entering protocol level milestones in CTMS and conducting monthly reviews to ensure that content is accurate and up to date. Following up with local study teams to ensure country and site level milestones are being updated regularly.
- Resource requests for team development
- Support with setting up study Zoom account and organization of study related