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 Global Start-Up Assistant to join our A-team!The Global Start-up Assistant (GSUA) provides administrative support to all activities within Allucent's Study Start-Up & Site Intelligence unit.
This may include tasks related to essential document review, regulatory submission preparation, site contracting activities and Start-up management/oversight.
The GSUA is a member of the Study Start-Up & Site Intelligence unit.In this role your key tasks will include: Pre-populate global templates and forms (incl.
study plans) Pre-populate study level documents, forms and templates Write, control and distribute meeting minutes during GSSU (study) meetings Assist study teams in submission preparation Assist in set-up of start-up tracking systems in CTMS Assist in tracking relevant information and data in CTMS and/or other tracking tools Assist in (CTMS) report generation and review Check completeness of CTMS for all GSSU areas and follow-up with involved stakeholders where required.
Initiate and control signature process of study specific GSSU documents Assist in document redaction for EU CTR submissions Assist other Study Start-Up team members with filing documents in (e)TMF for which they are document owner Assist in transferring changes from Study Master site contracts into country- and/or site specific site contracts Assist in arranging translations as applicable Requirements Life science, healthcare, biological science and/or business degree; or equivalent combination of education, training, and experience Previous experience in drug development and/or clinical research preferred Basic knowledge of GxP, GDPR, and applicable (local) regulatory requirements Good 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 Administrative excellence Proficiency with various computer applications such as CTMS, Word, Excel, and PowerPoint required BenefitsEmployees will receive an internship salary and other benefits through their employment*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-JC1