Project Specialist II (Europe)

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Project Specialist to join our A-team (hybrid*/remote). As a Project Specialist at Allucent, you are responsible for supporting the project management team by overseeing and handling global administrative tasks in accordance with the scope of work.

In this role your key tasks will include:

• 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.
• Submission and tracking of access requests for the Allucent 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 Allucent 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
• 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.

• Allucent 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.
• 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 meetings and webex trainings, as needed
• Assisting PM with Vendor management, as needed

• High School Diploma/Certificate or equivalent combination of education, training and experience; Bachelor’s degree or equivalence (BS/BA) preferred
• 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

Benefits of working at Allucent include:

• 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

Disclaimers:

*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”

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