Clinical Trial Administrator - Maternity leave
Flexible, IT
About us
Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with 90 years’ experience, operating in 31 countries with more than 7,000 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 have been awarded with 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.
We are committed to embrace diversity, inclusion and equal opportunities. 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 Global Rare Diseases
Chiesi Global Rare Diseases is a Chiesi Group’s business unit established in February 2020 and focused on research, development and commercialization of treatments and patient support services for rare and ultra-rare disorders, many of whom have limited or no treatments available.
This unit is based in Boston, Massachusetts, with a strong synergy with the headquarters in Parma.
Rare unit has a focus on research and product development for lysosomal storage diseases, rare hematology, ophthalmology disorders and rare immunodeficiencies. The unit is also a dedicated partner with global leaders in scientific research, patient advocacy and care. Discover more here.
What we are looking for
Purpose
To manage the administrative and documentation aspects of clinical trials at every stage of the process (study documentation, maintaining databases, creating/ updating trackers and support with supplies management)
Main Responsibilities
- Support the CPM in preparation of study TMF Plan and Map, and other Clinical Study Plans as required
- Maintains paper/ electronic TMF and electronic internal repositories according to applicable guidelines, regulations and procedures
- Perform TMF periodic quality checks and reconciliation after study completion
- Support the CPM in the activities to maintain the TMF Inspection Ready
- Participate in the TMF specific training as required
- Participate in the completion of the RFPs in collaboration with the CPMs
- Prepare/assemble study documentation (e.g. study documents managed through EDMS) and supports the CPM in ensuring the compliance of the clinical trial with internal SOPs and applicable regulations
- Prepare and maintain all trackers required for the study conduct
- Prepare and ship the ISFs to the investigational sites as required
- Support the study team during internal audit and inspections
- Support the CPM in managing the EDMS processes
- Support the CPM in managing the insurance request for a Clinical Trial
- Interact with external providers during study conduct as required
- Participate in study specific meetings, e.g., KOM, IM, update meetings with the CROs/ CSPs, and other meetings as required
- Collaborate with CPM, CS Unit and QA in order to manage activities related to clinical trial supplies, for example prepares the CTS Request Form for validation by the CPM
- Manage the study Inbox Email
- Assist the eCTD team in the formatting of all documentation related to a clinical study, as required
- Support with invoices verification and all the administrative trackers received from the CROs/ CSPs
- Support in management of study related payment procedures including the reconciliation
Experience Required
- Minimum 2 years of experience in similar position in Pharmaceutical or CRO industry and in R&D environment
- Previous experience managing electronic TMF including set-up, maintenance, QC/ QR and query management. Familiar with TMF reference model
- Sound knowledge of ICH/GCP and applicable regulations
- Ability to successfully manage multiple tasks and multifunctional resources concurrently.
Education
BS/BA in Life Sciences or similar discipline
Languages
Fluent in English
Soft Skills
- Analytical skills
- Communication skills
- Goal orientation
- 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 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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