Clinical Project Manager

Date:  Nov 10, 2022
Department:  Global Clinical Development
Job Type:  Direct Employee
Team:  R&D, Pharmacovigilance & Regulatory Affairs
Contract Type:  Permanent
Location: 

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

This position will provide coordination of the operational management of assigned projects in line with Company goals and medical/scientific standards, maintenance and respect of budget according to study signed contract and communication to all stakeholders on the progress of the study. 

Main Responsibilities

Manage Clinical Trials:  Manages directly up to 2 Clinical Trials depending on size and complexity of the trial.  Makes appropriate operational decisions to ensure that projects are initiated and completed on time, on budget and to the required quality standards, secures compliance with ICH, GCP and Chiesi Farmaceutici Standard Operating Procedures (SOPs).  Develops full synopsis and protocol involving all relevant study team members. Accountable for communication to all stakeholders on the progress of the study.

Management of CRO: Responsible for management of CRO and any third party vendors contracted directly by Chiesi Farmaceutici. Will as primary contact, managing day-to-day relationships, raising issues as soon as they are identified. Ensures adherence to scope of work within timelines and budget. Reviews and provides input for study related documents prepared by CRO (project plan, monitoring plan, risk management plan).  Prepares and coordinates/collaborates scientific meetings: investigators’ meeting, blind reviews, etc.

Prepares the Clinical Study Report (CSR): Prepares the Clinical Study Report (CSR) in cooperation with the Medical Writer, reviews the CSR, coordinates its review/approval by required members.

Provides clinical operations input during study design, Protocol review Committee, extended Clinical Team Meetings and reports to different stakeholders and Top management at critical steps of the study conduct.

Additional Project Management Duties:

  • Develops full synopsis and protocol and related documents based on the Study Outline contained in the Clinical Development Plan (CDP) involving all relevant contributors (Clinical Research Physician, Statistician/Data Manager, Clinical Pharmacologist, Drug Safety Scientist, CTS coordinator, Ad Hoc Members).
  • Collaborates with relevant contributors and accountable team members to ensure timely production and review of other important study-related documentation (IMPD, Insurance certificate, EUDRACT form, CRF, Statistical Analysis Plan, Data Management Plan, etc.).  Manages e-doc processes for relevant study documents.
  • CRO and/or Providers selection:  Contributing to their selection as responsible of the implementation of the request For Proposal (RFP) (supported by other study team members) and reviews the proposals/contracts and/or prepares contract appendices when applicable as per the Chiesi guideline/SOP in place.  Acknowledges the contract reading.
  • Responsible for management of the CRO.  Acting as primary contact for external (CRO) but also internal customers, representing the Study Team, for operational part of the clinical trials allocated to her/him.  Managing day-to-day relationships, raising issues as soon as they are identified.  Ensures adherence to scope of work within timelines and budget.  Reviews and provides input for study related documents prepared by CRO (project plan, monitoring plan, risk management plan, etc.)
  • Prepares and coordinates/collaborates to scientific meetings: investigators’ meeting, scientific/safety board meetings, Blind reviews and any other study-relevant meetings.
  • Registers the study in public registries (e.g.: clinicaltrial.gov, EUDRA registry)
  • Clinical Trial Supplies:  Liaises with Clinical Trial Supply (CTS) coordinator to ensure appropriate provision and distribution of CTS to the sites/depots.
  • Ensures follow-up during the study conduct.  Ensures that the trial complies to SOPs and all necessary quality standards.  Responsible for corrective and preventive actions and follow-ups (e.g. in case audits).  Reviews SOPs and writes working instructions.
     

Experience Required

  • At least 4 years in a similar job in pharmaceuticals or CRO
  • Track record of achievements in successful planning, execution and close of at least 5 clinical studies
  • Knowledge of principles of clinical study design.
  • Knowledge of planning tools and planning principles.
  • Knowledge of ICH/GCP and company SOPs.
  • Ability to successfully manage multiple tasks and multifunctional resources concurrently while maintaining high attention to detail while responding to rapidly changing priorities and aggressive deadlines.
  • Proficient in MS Office (Word, Excel, Project), Adobe and ISI Toolbox.
     

Education

 

  • BS/BA in Life Sciences or similar discipline

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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