Clinical Trial Assistant to Alligator Bioscience

On behalf of Alligator Bioscience we are currently seeking a proactive and engaged Clinical Trial Assistant to join their team in Lund.
Alligator is a research-based biotechnology company founded in 2001. The company specializes in the development of antibody-based pharmaceuticals for cancer treatment. The company is primarily active in the early phases of drug development, from the idea stage to clinical phase II trials
In this role you will Support the Clinical Operations Department and work closely with our Clinical Trial Managers in the day-to-day work for planning, execution, and reporting of clinical trials. You will also support outsourcing and contracting activities within the assigned projects. This is indeed a role where You will make a difference in the development of safe and efficient cancer treatments for patients based on advanced immune oncology research.
Your essential tasks will be to:
Assist CTM in Sponsor study planning and study oversight activities, e.g., development of study documents, updating, review and monitoring of clinical trial systems such as CTMS, eTMF and EDC, monitoring of CRO compliance with study specific plans, review of monitoring visit reports etc.
Participate and contribute as appropriate in clinical cross-functional meetings led by CTM and project calls led by CRO PM
Efficiently handle document management process and tracking of study activities, e.g. collection, QC and timely filing of Sponsor TMF documents, due diligence documentation etc.
Contribute to development and improvements of processes within the clinical operational area, e.g. SOP writing and/or revisions, development of sponsor oversight tools, checklists, etc.
Provide support in change controls, deviations, CAPAs to ensure GxP compliance according to Alligator’s Quality Assurance System
Ensure to attend and receive ongoing training to relevant clinical and quality regulations and guidelines
Contribute to quality GCP compliance related activities and audit/inspection readiness
You will also assist the Director of Clinical Operations in activities as needed.


OUR EXPECTATIONS
We expect the ideal candidate to have:
An academic degree in life science (molecular biology, biological, chemistry or similar) or other relevant area
Minimum 2 years of relevant work experience in life sciences, either within Pharma/Medical Device, CRO companies or academia, preferably within clinical research, quality assurance or regulatory affairs
Knowledge of GCP and clinical trial regulations
Excellent verbal and written communication skills in English
Excellent experience in Microsoft office suite of applications
Proven ability to work with multiple projects and tasks simultaneously

To succeed in the role, we believe you are:
organized, structured with the ability to work efficiently and with high accuracy, i.e., with attention to relevant details
self-motivated and determined to reach goals
have strong problem solving and technical skills
a true Team Player, but can also work independently
open-minded, embracing diversity and inclusion


APPLICATION
We handle screening and selection ongoing and therefore encourage you to apply as soon as possible. Please upload your CV and cover letter via the attached form. All enquiries are treated confidentially. We don´t accept applications via e-mail.
If you have questions please contact Johanna Isberg, tel +46 705 843383 or email johanna.isberg@islossning.se.
We look forward to your application!