Clinical Project Director

4 giorni fa

Lazio, 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/Director to work with one of our pharmaceutical partners to oversee Clinical Project Leaders who are in charge of clinical studies.
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: Oversight and operational management of clinical trials from study design until study close-out, ensuring on-time and on-budget completion, with adherence to the required quality standards and compliance with ICH, GCP, and Company's Standard Operating Procedures (SOPs).
Design and development of full synopsis and protocol by leading cross-functional team members.
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 incl.
KOLs meeting, Investigators' meeting, 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).
Oversight of CPMs involved in different trials of assigned programs.
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 GLP for bioanalytical assays.
Knowledge of Trial Master File.
Fluent in English and local language(s).
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 acknowledgment 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 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.
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