Lead Clinical Research Associate
UK/France, IT
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
- Lead and coordinate the clinical monitoring of assigned clinical studies according to ICH GCP, Chiesi procedures and regulatory standards and Manage the clinical monitoring of clinical studies as assigned by the Clinical Project Manager.
- Ensure global or country site level study protocol compliance of the assigned clinical studies in progress, working closely with the CPM and other key stakeholders
- Responsible for the validity of data generated in assigned clinical studies
Main Responsibilities
- Coordinates and oversees all clinical site management and monitoring aspects of assigned clinical studies, providing clinical support to the study team and overseeing study specific CRAs
- Prepare and provide site and CRA trainings and lead CRA team meetings
- Review essential documents for completeness prior to site activation, monitor trip report review and approval, review investigator site file
- Conducts co-monitoring site visits or other monitoring visits (site qualification visit, site initiation visit, interim monitoring visit, or close-out visit) as required by study needs
- Responsible for regulatory and monitoring activities for at least 1 country involved in the assigned clinical study. Plan and conduct monitoring site visits (site qualification visit, site initiation visit, interim monitoring visit, or close-out visit) and regulatory submissions to ECs/RA.
- Support the CPM in the development and review of clinical study documents, trackers and plans (Consent forms, Case Report Forms, Clinical Study Plans and Reports, other study trackers as required)
- Support the CPM in the TMF document upload and quality check file reviews
- Work with the CPM on developing and updating of Chiesi procedures and reports as assigned
- Act as the Sponsor primary point of contact for clinical operations activities for investigative sites, managing day-to-day contacts, as assigned
Experience Required
Experience in rare disease or similar, 5 years of clinical study monitoring experience + 1-2 years with LCRA experience or track record of successful achievements in a similar role in the frame of industry or CRO.
Education
Master Degree
Languages
Fluent in english, knowledge of french will be considered as a plus
Technical Skills
Proficient in EDC, eTMF, IRT and CTMS systems
Soft Skills
- Communication skills
- Goal orientation
- Leadership and social influence
- Planning and organizational skills
- Team working
What we offer
You would join a dynamic, fast-growing, challenging and friendly environment.
In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.
We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.
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