Clinical Project Manager - Milano, Italia - Talent Source

Talent Source
Talent Source
Azienda verificata
Milano, Italia

3 settimane fa

Piero Bianchi

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee
Descrizione
:


Location:

Milan, Italy - home based


Schedule:

Permanent OR Freelance - Full Time


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


  • TalentSource Life Sciences (the sponsordedicated division of CROMSOURCE), is searching for a
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Clinical Project Manager to join one of our sponsors in Italy.


Main Job Tasks and Responsibilities:


  • Supports Clinical Development Program Head in scientific initiatives including preparation of publications, meeting presentations, etc.
  • Supports and manages the processes required to support external study review committees (Adjudication Committee, DMC, etc.)
  • Prepares or assists with the preparation of key documents
:

Investigator Brochures, regulatory submission documents, internal or external presentations.

  • Contributes to the preparation and presents draft study synopsis, protocol, informed consent, and clinical documentation associated with IND submissions.
  • Prepares and reviews key documents such as Clinical Study Reports, and NDA/MAA submissions, in coordination with concerned functions (e.g., Medical Writing, Regulatory, Biostatistics)
  • Reviews publications from the scientific and medical literature for important clinical information
  • Contributes to multidisciplinary task forces to support continuous improvement.
  • Development assessments of clinical programs to support life cycle plans and new therapeutic initiatives.
  • Participates in crossfunctional teams for the evaluation of new development ideas, franchise medical
    strategies, and business development assessments.

Education and Experience:


  • Bachelor's degree and 35 years of clinical research and/or clinical development experience within the pharmaceutical industry, CRO healthrelated consulting company, or biomedical/clinical experience within academia (or a combination of aforementioned)
  • Understanding the scientific process, medical and statistical concepts
  • Demonstrated ability to work cooperatively within and outside the organization.
  • Strong judgment and decisionmaking skills with the ability to understand how decisions fit into the broader context of corporate strategies
  • Excellent communication skills verbal, and written in English.
**_
The Application Process_**- Who will you be working for?

**_

About CROMSOURCE _**- CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services.

The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

**_
About TalentSource Life Sciences _**- TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions.

Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth.

For our client-facing positions, you must be confident, be able to drive the role and work autonomously.

CROMSOURCE is an equal opportunities employer.

All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status.

CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.


Keywords:

Clinical Research Scientist, Clinical Scientist, Project Manager, Study Manager, Trial Manager, Clinical Trials, Research, Scientist, Clinical Development, Protocol, Regulatory Submission, GCP, - CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated


Skills:

Clinical Development Manager, Clinical Project Manager, Clinical Study Manager, Clinical Trial Manager, Scientist, Clinical Research Organisation, clinical trials, CRO, GCP, ICH-GCP, Outsourcing

Location:

Italy
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