Clinical Project Manager
CHIESI Farmaceutici
- Cary, NC
- Permanent
- Full-time
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 USAChiesi 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 offerChiesi 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."PurposeAccountable for coordination of the operational management of assigned projects in order to develop compounds in line with Chiesi goals and medical/scientific standards.
- Accountable for communication to all stakeholders on the progress of the study
- Accountable to maintain and respect budget according to study signed contractMain Responsibilities
- Making appropriate operational decisions to ensure that clinical trials are initiated and completed on time, on budget and to the required quality standards, securing compliance with ICH and Chiesi SOPs.
- Providing clinical operations input to Clinical Program Leader and study team members during study design, Protocol Review Committee and critical steps of the study conduct,
- Study documents:
- Managing e-doc process for relevant study documents
- Collaborates with relevant contributors and accountable team members to ensure timely production and review of study-related documentation
- Give his/her professional support to the planning and organization of investigator meeting and/or scientific/safety board meetings, Data Safety Reviews, Blind reviews and any other study-relevant meeting.
- Clinical Trial Supplies: Liaising with GTD coordinator to assess needs for drug supply, completion of the CTS request form, place orders with relevant departments in due time, and agree with CTS primary & secondary packaging, use of IVRS, shipment to depot or to investigational site(s), management of study drugs labels / study drug leaflets. If applicable he/she might delegate to CTA.
- Obtaining, evaluating and coordinating required input from all internal departments/specialists to ensure clinical trials comply with SOPs and all necessary standards, as detailed below. Giving input in the Chiesi system to track study audits.
- At least 5 years of experience in a similar position in a pharmaceutical company or CRO.
- Track record of achievements in successful planning and execution of at least 5 clinical studies.
- Added value will be given for direct experience in implementation of centralized systems set up and large clinical trial experience in respiratory therapeutic area
- Degree in Life Sciences or equivalent.