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 Sr.

Project Specialist (Sr PS) to join our A-team (hybrid*/remote).

As a Sr PS at Allucent, you serve as a key role in project administration to deliver projects within the established budget and timeline in collaboration with Clinical Project Management.

The Sr PS provides support to project management by overseeing and handling global administrative tasks in accordance with the scope of work.

In this role your key tasks will include: 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 templates Attend handover meetings for the CTAs who are joining/leaving the study.

Review handover form and act as Transfer Chair, if delegated by the Line Manager of the Leaver or Replacement Support PMs during audits/inspections.

Ensure follow-up on open action item for resolution within given timelines Responsible for vendor management, as needed Support Clients with ad hoc requests Process subject registration on slot reservation protocols Within the scope of assigned responsibilities resolve study related problems, anticipate risks and offer action plans to avoid critical situations and provide clear guidance to the study team 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 Chair/lead teleconferences as needed Adapt default folders on Share Point 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 Actively support to staff learning & development within the company Mentor and help with on-boarding of new PS Draft and contribute as Subject Matter Expert (SME) in the field of PS activities to the evaluation/improvement of processes and procedures within the Quality Management System Assure good communication and relationships with (future) clients May contribute and take part in client evaluations, visits and bid defenses Requirements Life science, healthcare and/or business degree preferred; High School Diploma/Certificate or equivalent combination of education, training and experience; Minimum 2 years of Project Specialist II work experience for internal candidates Minimum 4 years of experience in drug development and/or clinical research for external candidates Good/ knowledge of Gx P (standards of good practice) 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 Proficiency with various computer applications such as Word, Excel, and Power Point required Administrative excellence Excellent management skills in order to successfully organize and train study teams, to supervise and delegate Excellent organizational skills including prioritization, organizing the workspace and time management Highly efficient problem-solving and decision-making skills Detail oriented Ability to establish and maintain highly effective working relationships with internal and external teams Ability to work independently Ability to work remotely with diverse teams Benefits 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 Good Habitz 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 employee 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.“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.”#LI-BL1