Clinical Research and Biology Affais Associate

Vor 3 Tagen

Lausanne, Schweiz Volumina Medical Vollzeit

**associate - Pharma/Medical devices
- Full time, 100%
- Based in Lausanne (Biopôle Epalinges and EPFL) - travel time: up to 30%
- 1-year contract, possibly renewable for a total of 2.5 years

Volumina Medical is a start-up, spin-off of the Swiss Federal Institute of Technology (EPFL), active in the
field of medical devices. The company develops breakthrough innovations for plastic and reconstructive
surgery. The first product is an implantable biomaterial and targets the regeneration of soft parts of the
human body which are damaged due to ageing, tumor excision, genetic malformation, or trauma. In the
framework of a collaborative project together with the CIBM (Center for Biomedical Imaging) at EPFL, we
are looking for a highly motivated **clinical research and biology affairs associate** to join our clinical and
biology team and contribute directly to the clinical validation of our products for tissue regeneration.

projects in collaboration between the CIBM and Volumina Medical. You will participate to in vivo
experiments, analysis of biological samples. Your missions will also include the writing of biology reports,
white papers and scientific documents, as well as clinical documents to be submitted to competent
regulatory and medical authorities for conducting clinical research. You will perform clinical literature
searches, literature searches about biological mechanisms and interact with KOLs and plastic surgeons and
dermatologists. You will also participate to the optimal implementation of the clinical studies under the
supervision of the clinical affairs manager.

**The primary activities include but are not limited to**:
**Biology activities**:

- Perform _in vivo_ experiments to understand the _in vivo _biological process taking place in the

biomaterial (including participation in animal experiments, sample collection and processing,
collection and analysis of technical and scientific data)
- Perform cell culture experiments
- Manage biology projects, interact with different teams to achieve the objectives of the project in

a timely manner
- Perform literature research
- Write experimental plans and implement them
- Document all results according to guidelines and present results to the team

**Clinical research activities**:

- Perform clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor

SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents
- Perform remote and on-site monitoring & oversight activities to ensure that the data generated at

site is complete, accurate and unbiased;
- Conduct site visits (validation visits, initiation visits, monitoring visits, close-out visits, etc.) and

document activities in reports in a timely manner.
- Collect, review and monitor the required regulatory documentation for study maintenance and

study close-out
- Communicate with Investigators and site staff on issues related to protocol conduct, recruitment,

retention, protocol deviations, regulatory documentation, site audits/inspections and overall site
performance
- Write clinical reports
- Participate to literature watch in the field of dermatology and aesthetic medicine

**Other activities**:

- Participate to preclinical validations on ad hoc basis, to support the preclinical affairs team when

needed.
- Interact with external suppliers and identify new stakeholders for specific activities in relation with

biological and/or clinical affairs.

**Qualifications**:

- Master’s Degree of PhD in Biology (immunology, cell biology, animal experimentation, large
- Animal experimentation license is required
- Initial direct site management (monitoring) experience in a (bio)pharmaceutical company or CRO

is a plus
- Ability to travel approximately up to 30% of working time
- Good understanding of clinical research, phases of clinical trials, current GCP/ICH & swiss clinical

research laws and guidelines
- Good knowledge of dermatology and aesthetic medicine clinical studies
- Ability to understand and analyze data/metrics and act appropriately
- Fluent English knowledge, both written and spoken. French or Portuguese knowledge is

advantageous
- Strong patient focus; demonstrated ability to translate science into an easy to communicate

language
- Effective time management skills and problem-solving skills
- Ability to work highly independently across multiple protocols
- You are disciplined and care about details
- You enjoy working in a multidisciplinary team and having interactions with others

**We offer**:

- A dynamic and stimulating work environment, between a leading institution of EPFL and an

innovative start-up clinical stage Company
- The opportunity to collaborate with internationally recognized experts in the field of dermatology,

plastic and reconstructive surgery in Europe, US and other countries
- The opportunity to express your talents and grow with the team
- The integration into an interactive team, where you can pro

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