Clinical Research Scientist / SCRA / CPM - Italy

Clinical Research Scientist / SCRA / CPM - Italy

Contributes to project clinical strategies. Has a key role in the authorship of clinical documents. Supports budget management and operational tracking and control. Supports process improvement.

The main responsibilities:

- Contributes to the project strategy and to Clinical Development Plans (CDP)

- Writes both scientific and operational parts of Clinical Trials Protocols (CTP) and related documents

- Writes andor supervises write-up of Clinical Trial Reports

- Contributes to clinical parts of regulatory dossiers

- Interacts with representatives ethics committees and opinion leaders and participates to meetings as appropriate

- Contributes to publication strategy and write-up of abstracts, posters and papers

- Gives scientific presentations at internal and external meetings

- Supports Unit Head or senior clinical research scientist in budget tracking and management, Key Performance Indicators (KPI) tracking and improvement

- Supports process improvement

Reporting lines of the job:

Unit Head, or Senior CRS, or Unit Physician in solid line

* reports to (position) - mention both line/hierarchical and functional reporting lines if applicable:

Line: Head of Unit or Unit Physician or Senior Clinical Research Scientist

Functional: N/A

* direct reports (positions) - mention both line/hierarchical and functional reports if applicable, and indicate number of incumbents: JCSC/CSC/SCSC

Functional: N/A

Specific professional/technical expertise and experience required for the job:

(Knowledge and skills can be gained through formal education and/or work experience; mention formal degree only when must for the job; otherwise focus on knowledge & skills; express experience required in particular position or within specific field in number of years)

- Degree in a science or health related discipline.

- 5-7 years hands-on experience in clinical research in industry or academia

- In depth knowledge of GCPs and ICH Guidelines.

- Solid Understanding of clinical trial design, trial execution and operations

- Understand and applies medical & business knowledge to clinical trials execution

- English proficiency

- Computer literacy

- Communication skills, planning, organization, and business knowledge

- Project Management skills and basic understanding of project management tools

- Positive attitude and calm

- Ability to manage multiple projects at the same time

- Work independently within a matrix organization.

- Capable of autonomous decision making

- Demonstrated solid experience in working on teams with a broad range of cultures

- Problem solving.

- Strategic thinking.

- Proactive nature.    

Desirable:

- Post Graduate degree in pharmaceutical medicine

- Previous experience in the field of vaccinology

Tagwords: "clinical research scientist" "clinical research" "scra" "senior clinical research associate" "Clinical project manager" "cpm" "italy" "tuscany" "ich gcp" "pharmaceutical" "cro" "clinical research organisation" "biotech" "clinical" "respiratory" "cardiovascular" "vaccines" "oncology" "clinical scientist"