Clinical Project Associate

**Division**:GC Aesthetics

**Location**: Apt, France

**Job Title**:Clinical Project Associate

**Department**: Clinical

**Responsible to**:Clinical Affairs Manager

**Purpose of Job (Summary)**

To support the Clinical Affairs function of GC Aesthetics to ensure relevant data is collected and reported in line with business, regulatory and customer needs. Maintain technical documentation, specifically the clinical evaluation process, to ensure compliance with the applicable regulations. Manage clinical data in ‘live’ clinical studies and manage and maintain all scientific documentation in your areas of responsibility.

**Key Responsibilities**
- Generation and update of scheduled clinical evaluation reports in accordance with applicable regulations/regulatory guidance documents
- Preparation and maintenance of the clinical evaluation schedule after completion of the current schedule
- Generation of a transition plan to support the clinical evaluation requirements in accordance with the new Medical Device Regulation
- Preparation of clinical evaluation reports and reviews to support key projects within the business
- Manage all GC Aesthetics clinical study data entry and data cleaning in your area of responsibility
- Lead and advise clinical study monitors to ensure necessary and relevant clinical data is collected to meet project deadlines in accordance with clinical protocols.
- Support the Clinical Project Manager with input into the writing of clinical study reports and papers
- Preparation of clinical documents and participation in audits
- Perform literature searches and prepare responses in answer to technical questions posed by external stakeholders across both Eurosilicone and Nagor
- Update and maintain relevant scientific intelligence and communicate internally as appropriate for both Eurosilicone and Nagor
- To act as PRRC for Eurosilicone
- To undertake any other reasonable duties

**Qualifications/Experience**
- At least 2 years of medical device industry experience especially with MDR and Class III medical devices
- Degree in a relevant field (life sciences/ medical sciences)
- Good team player
- Proficient in word/ excel
- Fluency in French and English both written and spoken
- Knowledge of the one or more of the following:

- Information management (e.g. experience with relevant scientific databases)
- Regulatory requirements
- Medical Device Regulations (MDR)
- Medical writing (e.g. Training and/or experience in medical writing and clinical data appraisal).
- Excellent communication skills (both written and oral) and the ability to build effective relationships with customers and colleagues
- An eye for detail