Sr. Clinical Trials Administrator

About us

Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals 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 research, develops and markets innovative drugs in its three therapeutic areas: AIR (products and services that promote respiration, from new-born to adult populations), RARE (treatment for patients with rare and ultra-rare diseases) and CARE (products and services that support special care and consumer-facing self-care).
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 transparent ethical behavior at all levels. 
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 USA

Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty and rare disease markets. We are a B Corp™ and Benefit company awarded Top Employer status for six consecutive years and certified as a Great Place to Work. 
At Chiesi, we share an entrepreneurial spirit and act as a force for good, pursuing high social and environmental standards, to ensure the wellbeing of our people, patients, and communities. We offer a work environment where professionals have the opportunity to build a purposeful career focused on helping others while achieving a fulfilling work-life balance, meeting exciting challenges, and engaging in important and rewarding work.

What we offer

Chiesi offers competitive benefits, services, and programs that enrich the personal and professional lives of our employees.   Our shared values of passion, innovation, trust and integrity bring out the individual talents and diverse perspectives of each of our colleagues.  Our environment encourages each individual to reach his or her full potential and drive outstanding results. We celebrate that “Every one of us is different. Every one of us is Chiesi."

 

Purpose

To manage the administrative aspects of clinical trials at  every  stage  of  the  process  (study  documents, implementing  and  maintaining  databases,  coordinating  payments  and  supplies  to  research  units.)
 

Main Responsibilities

• Awarding process: -Participates  in  the  completion  and  review  of  the RFPs in collaboration with the CPMs. -Manages the payment process related to Awarding Letter and SoW, which are filed in the electronic study files as reference documents for the study budget management during the whole study duration. -CTA  follows  study  purchase  process  according  to  Chiesi  policy    and  may  prepare  study Purchase Request in SAP.

• Study documentation: -Prepares/assembles study  documentation, including but not limited to,   submission  package to Regulatory  Authorities and  Ethics  Committees, study documents prepared through HERMES,  reviews English texts and translations, checks the formatting of documents such as protocols, CSRs and appendices, follows the  publications’ process.

• Monthly and periodic costs review-CTA verifies completeness, accuracy and content of the TTP  in  cooperation  with  the  CPM,  manages  the  correspondence  with  CRO  PM  in  case  of  comments on TTP content. Follows the payment process, entering SES’  in SAP system (this task may be delegated to the Cost & Resource Administrator / Specialist if SAP system is not available to the CTA directly). -Attends monthly justification meetings. -Provides  input  for  budget  development  and  checks   monthly   costs   invoiced   to   Chiesi   based on planned study activities vs actual.

• TMF-Handles  and  maintains  paper/electronic  TMF  according  to  ICH/GCP  guidelines  and  local  Health    Authorities    standards.    Has access and manages the electronic internal repository where study documents are maintained -Responsible  for  electronic  TMF  set-up  and  maintenance  during  the  study,    oversight  of filing  documentation  completeness,  through  ongoing quality checks and metrics, oversight of CRO filing activities in the electronic TMF in collaboration with the eTMF Vendor. -Responsible   for   paper   TMF   reconciliation   after study completion. -Studies performed in US: filing of relevant IND submission documentation, as per Chiesi WI.

• CPM support and CRO oversight-Supports  CPM  in  study  management  and  CRO oversight. CTA is involved in day-to-da