Senior Clinical Project Manager

4 giorni fa

Italia ClinChoice Inc. A tempo pieno

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds....

ClinChoice is searching for an experienced Senior Project Manager to work with one of our pharmaceutical partners. This can be a home-based position, with occasional visits to the office. It will initially be a Fixed Term Contract until the end of December 2025.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counterparts.

Main Job Tasks and Responsibilities:

  • Supervising the assigned clinical research projects.
  • Coordinating and maintaining the planning of the activities for the assigned projects.
  • Management of the CRO by acting as primary contact, managing day-to-day relationships, raising issues as soon as they are identified.
  • Management of study budget, scope changes and financial reconciliation.
  • Preparation and coordination of scientific meetings including KOLs meeting, Investigators’ meeting, and blinded review meeting.
  • Preparation, review and approval of Clinical Study Report (CSR) in cooperation with the Medical Writer and other required key team stakeholders.
  • Reporting to Company's senior management.
  • Operational management coordination of assigned projects.
  • Clinical Development Plan (CDP) definition in relation to studies’ operational aspects.
  • Interactions with all functions supporting the Clinical Development Plan.
  • Line Management of Clinical Project Managers (CPMs).
  • Supervises Clinical Research Associates (CRAs) activities, ensuring compliance with ICH/GCP guidelines and applicable laws and regulations.
  • Supervises the CTAs in archiving activities.
  • Collaborates in complying and enforcing Company procedures.

Education, Experience and Skills:

  • University Degree in scientific, pharmacy or other health related discipline, or equivalent.
  • Proven experience as Clinical Project Manager.
  • Strong knowledge of clinical study design, clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements.
  • Knowledge of planning tools and planning principles.
  • Knowledge of clinical research process from Phase I/II through final regulatory submission.
  • Prior experience in electronic data capture preferred.
  • Fluent in English and Italian.
  • Proficiency in Microsoft Office (e.g., Word, Excel, Outlook).
  • Willingness to travel.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Senior Clinical Project Manager, CPM, Project Management, Clinical Trials, EDC, TMF, ICH-GCP, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated

#LI-CM1 #LI-FULLTIME #TEMPORARY

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