Clinical Trials Associate CTA Support mwd - Admin Operations Assistance

Company:

We are Immutep an emerging international biotechnology company developing immunotherapeutic products for cancer and autoimmune diseases. With operations based in Australia Germany and France Immutep is dedicated to bringing innovative treatment options to patients. The company is publicly traded on the ASX and NASDAQ.

Location: Berlin Germany; fulltime hybrid role (office/remote)

Summary:

As a result of our continuous progress in our projects we are looking to expand our team and are therefore seeking a highly motivated and experienced Clinical Trial Associate to join our dynamic team. You will play a crucial role in supporting the Clinical Trial Manager (CTM) and other team member as needed in the daytoday clinical operations activities involved in the planning execution and management of assigned clinical trial(s). Ideal candidates will have a solid background in trial and study site management vendor management and handson experience with the full study lifecycle from startup to close out.

Tasks

Clinical Operations Support: Collaborate with the CTM in admin & management tasks (e.g.):

• Investigator Meetings: support CTM with agenda minutes communication coordination.
• Assist the CTM with Sponsor oversight.
• Adhoc 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.

Documentation and Record Keeping: Collaborate with the CTM in admin & management tasks (e.g.):

• 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 studyrelated plans & form/logs.
• Develop tracking tools and processes along with the management of information in those tools.

Site Management: Collaborate with the CTM in admin & management tasks (e.g.):

• 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.

CrossFunctional Collaboration: Collaborate with the CTM in admin & management tasks (e.g.):

• 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

Essential

• 25 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 (ICHGCP) 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 fastpaced environment.
• Sound analytical and problemsolving 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.

Preferable

• 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

What we offer:

• 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.

Contract Type:

• Oneyear fixedterm contract with the potential for extension based on company needs and performance.