Clinical Project Director Lazio

Clinical Project Director
Roma
Lazio, Lazio

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 of Clinical Project Leaders Participate in the selection activities of the clinical centers/CROs that will perform the studies.

Act as point of contact for relations with CROs in charge of clinical studies and supervise the delegated activities.

Manage the preparatory activities for the conduct of clinical studies.

Participate in the development of clinical protocols as well as of the various study-related documents and coordinate their review by the study teams.

In collaboration with the CRO, coordinate the preparation of the documentation necessary to request authorization for the execution of clinical studies.

Manage the study start-up and study closure procedures.

Participate in co-monitoring visits to clinical centers/CROs.

Responsible for the certification of the cost of the studies.

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.

Close management and training are the core instruments 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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