Clinical Trial Transparency

**Department**:Global Clinical Development**Team**:R&D, Pharmacovigilance & Regulatory Affairs**Job Type**:Direct Employee**Contract Type**:Permanent**Location**:Paris, FR**_About us_**
- Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas:

- **Discover more here**
- We are proud to be the largest global pharmaceutical group to be awarded
- **B Corp Certification**, a recognition of
- **high social and environmental standards**. We are a
- **reliable** company that adopts and promotes a
- **transparent and ethical behavior** at all levels.- We believe that the success of
- **Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors**. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.- In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.**_Chiesi Research & Development_**
- Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, chemical manufacturing and controls, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden) and Toronto (Canada).**_Who we are looking for_**

**Purpose**
- To contribute to the implementation and maintenance of the Clinical Trial Disclosure requirements within Chiesi Global Clinical Development.
- To act as EDMS Subject Matter Expert and Key User for the GCD Department, supporting the management activities for clinical studies documentation, throughout documents life-cycle and system maintenance;

**Main Responsibilities**

**Clinical Trial Disclosure/Transparency Process**:

- Coordinates the registration of clinical trials on ClinicalTrials.gov website, acting as Chiesi CT.gov Administrator, and local registries when needed;
- Works cross-functionally and collaboratively to plan as well as coordinate the global transparency activities (posting of summary results in EU/US registries, Lay Summaries results for Patients and general public, Clinical Data Sharing, and other transparency-related activities in the EU, US and third countries) and to ensure/support compliance with procedures and to manage external communication;
- Maintains regularly updated the content of the Chiesi Clinical Trial Transparency and Data sharing page on the Chiesi Group web-site;
- Coordinates interaction/collaboration with specialised providers to plan and execute the activities,
- Initiates and follows up all actions required for assigned budget planning and management
- Escalates alerts when needed

**Contribution to Clinical Trial Disclosure/Transparency Process improvement**:

- Develops job aids, working instructions, training materials and procedures, as needed;
- Helps to raise and maintain awareness across the organisation of changes in the Transparency landscape, including both regulatory requirements and industry trends

**Electronic document management system (EDMS)**
- Defines system requirements and operational workflows according to the needs of the represented functions;
- Contributes and actively participates in IT projects to enhance technical functionalities of the system and in the execution of some technical validation tests to verify the correct implementation of system functionalities in compliance with regulatory requirements;
- Performs training to end users on the document management system, as needed;
- Prepares, reviews and updates training material on the system;
- Manages requests for GCD users account activation/deactivation and system roles/permissions assignment/modification;
- Provides backroom support during regulatory agency inspections and audits.

**Experience Required**
At least 2/3 years in similar functions in a R&D environment or a position in Clinical Study management

**Education**
Master's Degree in Life Sciences o University Degree in Life Sciences

**Languages**
Fluent English

**Technical Skills**
Regulatory mind-set, Clinical Trials knowledge; IT skills

**Soft Skills**
- Quality orientation
- Attention to details
- Planning and organiz