Clinical Trials Associate (CTA) Support (m/w/d) - Admin & Operations Assistance

Intro

Company

The company is publicly traded on the ASX and NASDAQ.

Location: Berlin, Germany; full-time, hybrid role (office/remote)

Summary

Ideal candidates will have a solid background in trial and study site management, vendor management, and hands-on experience with the full study lifecycle, from start-up to close out.

Tasks

• Investigator Meetings: support CTM with agenda, minutes, communication, coordination
• Assist the CTM with Sponsor oversight
• Ad-hoc tasks as requested by the CTM
• Training entry level CTAs
• Support the preparation, conduct, and follow up of audits/inspections
• Participate in Protocol Deviation (PD) reviews and coordinate as necessary in place of the CTM

• Support identification and analysis of potential risks with CTM. Support Follow Up (FU)/coordination as needed
• Possess comprehensive knowledge of the Trial Master File (TMF); ensure the completion and quality control (QC) of the eTMF, including at the Contract Research Organization (CRO) level, and promptly resolve any issues
• Review Change Orders (COs)/Work Orders (WOs) incl. budgets, and invoices along with the CTM
• Manage insurance certificate updates
• Develop & Review/QC core clinical docs (e.g., trial protocol, CSR, PoP, PoR, study-related plans & form/logs
• Develop tracking tools and processes along with the management of information in those tools

• Review Monitoring Visit Reports (MVRs) for any discrepancies. Communicate feedback to CRO
• Coordinate the site selection process internally by circulating trackers, scheduling meetings, and FU with the CRO to address any questions
• Participate in Quality Assessment Visits (QAVs) and perform tasks independently. Support FU, conduct, oversight & plan as delegated by the CTM

• Lead team meetings, prepare meeting agenda, summarize meeting min, & ensure FU/completion of meeting action items
• Support with CRO/Vendor Selection meetings, slides, agendas, coordination etc
• Liaise with CROs and other vendors to ensure deliverables and methods of communication are developed to facilitate efficient workflow
• Can manage and be the main contact person for a particular vendor as delegated by the CTM

Requirements

• 2-5 years’ experience as a CTA or experience in a similar role (g., clinical site, CRO, Sponsor or clinical trial vendor) preferably on the Sponsor/pharma side
• Knowledge and experience in relevant legislation and international guidelines (ICH-GCP) for the performance of clinical trials
• Advanced understanding & demonstration of proficiency in CTA tasks. Experience setting up & maintaining eTMF
• Very good knowledge of standard software (Word, Excel, Outlook, Power Point); knowledge of CTMS/EDC Systems
• Very strong skills in collaboration, communication, organization, prioritization of tasks & attention to detail
• Strong professional and interpersonal communication skills, with the ability to engage effectively with others
• Perform multiple tasks simultaneously and manage changing priorities; must be comfortable working in a fast-paced environment
• Sound analytical and problem-solving skills; able to work under minimal supervision for the tasks assigned
• Critical thinking: able to assess complex information with support from CTM
• Proficient in English (written and spoken). Strong verbal and written communication skills

• Scientific or healthcare field educational background, preferred
• Experience in oncology, immune oncology is a plus
• Experience in large phase II or phase III studies, is an asset

Benefits

• Multifunctional interesting tasks in the emerging field of immune therapeutics
• Be part of the development of a "first in class” immune oncology drug
• Highly motivated, energetic and supportive international team

• One-year fixed-term contract with the potential for extension based on company needs and performance