Job description

Affivant Science is a Swiss- & US-based immuno-oncology biotechnology company (current staff: 12 employees) actively dedicated to developing novel immune-oncology approaches to activate and enable the innate immune system to fight cancer.

Affivant’s lead candidate (AFVT-2101), a tetravalent, bispecific Innate Cell Engager (ICE®) designed to target specific patient populations as powerful monotherapies and combination treatments, is currently in IND-enabling studies and the FIH study is planned to start in Q2 2023.
Affivant is therefore looking for a reliable and motivated Clinical Study Manager to be based in Switzerland for a 9-months contract (hybrid home-working and office-based) with the aim to become a permanent role.
You will have the opportunity to work in a dynamic, multi-cultural, multi-lingual environment, with possibilities to shape the company’s growth and success in a multidisciplinary team environment. Reporting to the Sr. Director, Clinical Operations.

Main responsibilities and tasks:
The Clinical Study Manager will be responsible for the day-to-day operations and oversight of clinical trials, overall or at the assigned country/site level, to ensure completion through all phases (from start up to closure) on time, within budget and of high quality in compliance with all applicable regulations, ICH-GCP guidelines and standard operating procedures (SOPs).
- Oversee and monitor the deliverables of the clinical activities on the assigned country/site levelor trial(s) towards the CROs and External Service Providers (ESPs) selected for the trial(s), toensure compliance with study protocol and in accordance with scope of work/budget
- Contribute to the operational trial related activities in close collaboration with other functions
- Proactively identify deficiencies and new risks in trial conduct, suggest corrective actions intimely fashion and escalate internally, as required
- Participate in the development and review of clinical trial-related documents and manuals
- Consolidate and provide regular updating on operational clinical trial level activities for internalreporting
- Contribute actively to the development and management of study timelines, risk and qualityplans including tracking of trial budget
- Contribute to prepare and formulate critical decisions, mapping out options and obtain internal
approval
- Oversight of all trial files, including the Trial Master File completeness for audit/inspectionreadiness and investigator site files
- Partake in the selection and training of ESPs
- Contribute and assist in forecasting drug supply needs
- Ensure and support feasibility activities as needed
- Support in the coordination and actively participate to study-related meetings and trainingsessions
- Review invoices

Qualifications and Experience:
- Bachelor degree in Life Sciences / Healthcare or equivalent. MSc is advantageous

- Minimum of 3 years of experience in the Clinical Trial field either in CRO or industry/biotech experience (site start-up, study management)

- Fluent in both written and spoken English. Any additional language is an asset

- Relevant working/residency permit or Swiss/EU-Citizenship is preferred

Skills/Knowledge:
- Minimum 3 years’ experience in managing all operational aspects of clinical trials from initiation to closure

- Experience with site set-up activities including budget negotiation with clinical sites; having dealt with US sites is preferred

- Experience with the management of ESPs and Third Party Vendors/Central Labs

- Previous exposure to working on oncology Phase I and II trials is a major asset

- Very good knowledge of ICH-GCP and clinical trial process

- Previous experience working with electronic data capture, electronic Trial Master File (eTMF), and Clinical Trial Management Systems (CTMS) is preferred

- Ability to work independently and in a highly organized way

- Self-motivated way of working and “hands-on” and “can-do” attitude

- Detail-oriented and well-organized: can prioritize multiple tasks and goals

- Ability to work well in a team environment

- Strong critical thinking and problem-solving skills

- Proficiency in common MS Office packages

- Willingness to travel on ad-hoc basis (e.g., site visits USA and EU)

Location

Viaduktstrasse, Basel, Switzerland

Contact information