Project Specialist II

Summary

Join Allucent™ as a Project Specialist and contribute to bringing life-changing therapies to patients globally. This hybrid/remote role supports the project management team by overseeing global administrative tasks. Key responsibilities include managing study trackers, attending meetings, handling access requests, creating and maintaining various documents, generating reports, and supporting the study team. The ideal candidate possesses at least two years of experience in a similar role, strong communication and organizational skills, and proficiency in Microsoft Office. Allucent offers a comprehensive benefits package, including competitive salaries, flexible working hours, professional development opportunities, and various incentive programs.

Requirements

• High School Diploma/Certificate or equivalent combination of education, training and experience
• Experience of at least 2 years as Project Specialist I or within a similar role
• Fluency in English (spoken and written)
• Strong verbal and written communication skills
• Computer literacy, proficiency in Microsoft Office
• Excellent interpersonal and organizational skills
• Ability to work independently and to effectively prioritize tasks
• Ability to manage multiple tasks within a project or multiple projects
• Attention to detail
• Ability to work in an environment that changes rapidly to fit client needs
• Ability to establish and maintain effective working relationships with co-workers, managers and vendors
• Excellent management skills in order to successfully train and organize study team, to supervise, prioritize and delegate
• Ability to meet deadlines
• Effective problem-solving skills
• Excellent presentation skills
• Ability to work remotely with diverse teams

Responsibilities

• Prepare and maintain study trackers
• Attend study teleconferences, prepare TC minutes and track TC minutes in CTMS
• Attend F2F meetings (KoM, IM)
• Plan and attend handover meetings for CTAs joining/leaving the study
• Submit and track access requests for the Allucent study team
• Adapt default folders on ePOI Cloud / Active studies for working documents to facilitate study needs
• Create and maintain Global Contact List
• Create and maintain Trial Responsibilities Log for Allucent study team
• Upload and assign trainings in QPulse for the study team. Follow-up with study team on training completions
• Create Project Specific Training Matrix and its upload to QPulse
• Create study specific Correspondence Management Plan
• Sort 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
• Review reports in CTMS to ensure completeness, consistency and information is up to date prior to their distribution
• Generate and distribute daily or weekly reports from various systems
• Follow-up with CRAs for CTMS updates if data is missing for reports
• Customize and distribute study logs/forms templates
• Organize centralized printing for study material
• Support with centralized IMP/lab kits distribution
• Support CTAs with study related questions/issues
• Submit trial level documents to Veeva Vault eTMF Document Inbox. Resolve rejections
• Work with TMFL on reconciliation of TMF Trial Level Documents
• Allucent study team CVs reconciliation and follow-up and submission to eTMF
• Assist in preparation of eTMF Plan with the TMFL
• Support PMs during audits/inspections. In cooperation with QA/Compliance follow-up on open items/cases in QPulse and delegation to responsible parties for resolution
• Distribute Newsletters to the sites and support with formatting, if required
• Prepare weekly CTMS project status reporting and distribution to internal study team as a reminder on pending actions
• Provide administrative support for DSMB activities for assigned studies
• Provide other administrative ad hoc support to PM not mentioned above
• Mentor and train Project Specialists
• Chair/lead teleconferences upon request of PM
• Manage investigator payments in CTMS
• Enter protocol level milestones 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 milestones are being updated regularly
• Make resource requests for team development
• Support with setting up study Zoom account and organization of study related meetings and webex trainings, as needed
• Assist PM with Vendor management, as needed

Preferred Qualifications

Bachelor’s degree or equivalence (BS/BA)

Benefits

• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Opportunity for remote/hybrid* working depending on location
• Leadership and mentoring opportunities
• Participation in our enriching Buddy Program as a new or existing employee
• Internal growth opportunities and career progression
• Financially rewarding internal employee referral program
• Access to online soft-skills and technical training via GoodHabitz and internal platforms
• Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
• Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees