Who we are looking forThis is what you will do- 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
You'll be responsible for:- Typically manages 1-3 clinical trials, depending on size, complexity, phase of development and therapeutic area
- Responsible for management of the Clinical CRO/Providers
- Acting as primary contact for Clinical (CRO) but also internal customers; representing the Study Team for operational part of the clinical trials allocated to them.
- Ensures adherence to scope of work within timelines and budget.
- Reviews study related documents prepared by CRO (project plan, monitoring plan, risk management plan, site contracts when required,...).
- Performs co-monitoring when needed, as specified in SOP.
- Collaborates in the set-up and maintenance of the Study Risk Register. Responsible clinical risk review involving all relevant study team functions and for the follow-up on actions with vendors (CRO, direct and third-party vendors).
- Responsible for the management of the study eTMF (related to clinical operations) with the Clinical Trial Administrator (CTA).
- Prepares and coordinates/collaborates to scientific meetings: investigators' meeting, scientific/safety board meetings, Data reviews and any other relevant meeting(s).
- Manages the preparation of experts/KOLs contract if any (when expert is dedicated to the study).
- Study results and related deliverables:
- Prepares & reviews he Clinical Study Report (CSR) in cooperation with the Medical Writer, and its approval.
- Supports and/or coordinates the presentation of clinical study results internally and externally
- Clinical Trial Supplies: liaises with Clinical Trial Supply (CTS) coordinator to define the CTS strategy/plan
- Manages the CTS once delivered to sites 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 of audits).
- Provides clinical operations input during study design, Clinical Protocol Approval Committee (CPAC), Extended Clinical Team Meetings
- Budget Management
- Prepares and presents budget in collaboration with Clin Ops Lead
- Accountable for budget management for the ongoing studies
You will need to have- At least 3 years of experience in a similar position in a pharmaceutical company.
- Fluent in English
- Track record of achievements in successful planning and execution of at least 5 clinical studies.
- Degree in Life Sciences (biological science, pharmacy or other health related discipline) or equivalent.
- Knowledge of principles of clinical study design
- Knowledge of principles of Clinical Research Statistics
- Knowledge of planning tools and planning principles Knowledge of ICH/GCP and company SOPs
- Knowledge of GLP for bio analytical assays (for Clinical pharmacology studies) Familiar and up to date with relevant literature
LocationHybrid role based in Cary, NC. #LI-Hybrid
What we offerNo matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way.
We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive.
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