Clinical Project Manager
Cary, NC, US
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
Accountable 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 contract
Main 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:
- Developing full protocol from the Study Outline contained in the CDP, involving all relevant contributors/accountable persons
- 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.
Experience Required
- 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
Education
- Degree in Life Sciences or equivalent.
Chiesi USA is an equal opportunity employer committed to hiring a diverse work force at all levels of our business. All qualified applicants receive consideration for employment without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, veteran status, gender identity or expression or any other basis protected by local, state or federal law. This policy applies with regard to all aspects of one’s employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.
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