Project Specialist (I Or Ii)

Description
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. At Allucent, our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies.
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:
We currently looking for an experienced Project Specialist I and II to join our team in Canada, Brazil, or the UK! The Project Specialist (PS) 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. In general, PS I and PS II have equivalent skill sets and responsibilities. The main factor which differentiates PS I from PS II is a level of knowledge, and, consequently, level of required supervision and decision-making ability.
Location: Canada, Brazil, or the UK
Experience: 3+ years in Clinical Research
Workplace options: Hybrid/Remote/On-site
Language: excellent professional level of English required
The Project Specialist is responsible for the following tasks:
Project team continuous support includes, but is not limited to work with the PM and the project team and assist with the tasks, including:

• Support in creation of Project Plan and other study plans including associated templates
• Support Clients with ad hoc requests
• Support PMs during audits/inspections. Ensure follow-up on open action item for resolution within given timelines
• Within the scope of assigned responsibilities resolve study related problems, and offer action plans
• Coordinate, prepare, handle, and distribute clinical trial support materials if done centrally
• Create and/or maintain tracking tools for clinical data management
• Review reports in applicable systems to ensure completeness, consistency and information is up to date prior to their distribution
• Enter data into systems and tools per required processes
• Assist PM with vendor management, as needed
• Process subject registration on slot reservation protocols
• 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
• Attend handover meetings for the CTAs who are joining/leaving the study and review handover form

Communication:

• Prepare Study Correspondence Management Plan (SCMP)
• Coordinate internal and external project team conference calls, process agendas, meeting minutes, and action log or equivalent
• Process Public Folders (PF) for study level as per SCMP Ensure study PFs are maintained by the trial team to accomplish inspection readiness
• Facilitate team communication and liaise with sponsors, sites and third parties

Filing:

• 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
• Provide clear guidance to CRAs / CTAs and coordinate setup of investigator site files
• Work with TMFL on reconciliation of TMF trial level documents
• Coordinate and support the project team with the final reconciliation and off-site archival of project documentation
• Support TMF Lead (TMFL) with the setup of Trial Master File (TMF)
• Adapt default folders on SharePoint
• Customize and distribute study logs/forms/templates
• 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

Other:

• Create Contracted FTE by Month files
• 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
• Administrative support for Trial Committees activities for assigned studies
• With the PM, ensure all activities included in the project scope of work are completed and project timelines are met
• Support PMs with budget related activities, as needed

Requirements
Qualifications:

• Basic knowledge of GxP
• GDPR and applicable regulatory requirements
• Minimum 4 years of experience in drug development and/or clinical research
• Minimum 2 years of relevant work experience in similar positions
• Life science, healthcare and/or business degree preferred. High School Diploma/Certificate or equivalent combination of education, training and experience required

Skills

• Effective problem-solving and decision-making based on the established procedures and working instructions
• Ability to work remotely with diverse teams
• Representative, outgoing and client focused
• Detail oriented
• Proficiency with various computer applications such as Word, Excel, and PowerPoint required
• Ability to work independently
• Ability to establish and maintain effective working relationships with internal and external team
• Ability to work in a fast-paced challenging environment of a growing company
• Strong written and verbal communication skills including good command of English language
• Excellent organizational skills including prioritization, organizing the workspace and time management
• Administrative excellence

Benefits

• Departmental Study/Training Budget for furthering professional development
• More task variety
• Access to online soft-skills and technical training via GoodHabitz and internal platforms
• Comprehensive benefits package
• Financially rewarding internal employee referral program
• Flexible Working hours (within reason)
• Competitive salaries per location
• Internal growth opportunities and career progression
• Leadership and mentoring opportunities

To all recruitment agencies: Allucent does not accept agency resumes. Please do not forward resumes to our careers alias or other Allucent employees. Allucent is not responsible for any fees related to unsolicited resumes.
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