Clinical Research Scientist Chase

7 giorni fa

Italia Barrington James A tempo pieno

**Job Description: CNS Clinical Project Manager**

**Position**: Clinical Project Manager - CNS
**Location**: Milan, Italy
**Employment Type**: Full-Time
**Industry**: Biotechnology
**Company Overview**:
Join a well-established and fully funded biotech company at the forefront of central nervous system (CNS) therapeutics. With an innovative pipeline targeting unmet medical needs in neurology and psychiatry, we are expanding our clinical operations team and are seeking a dedicated **Clinical Project Manager (CPM)** to oversee and drive our CNS clinical trials to success.
**Key Responsibilities**:

- **Clinical Trial Oversight**:

- Plan, execute, and manage all phases of CNS clinical trials, ensuring they are delivered on time, within scope, and budget.
- Oversee multiple trials simultaneously across international sites, ensuring alignment with company objectives.
- **Team Leadership**:

- Collaborate with cross-functional teams including regulatory, data management, medical affairs, and external vendors.
- Act as the primary point of contact between sponsors, investigators, and site staff to ensure effective communication.
- **Regulatory & Compliance**:

- Ensure all trials adhere to ICH-GCP guidelines, company SOPs, and relevant regulatory requirements.
- Prepare and review essential regulatory documents and submissions to ethics committees and authorities.
- **Budget & Resource Management**:

- Develop, track, and manage clinical trial budgets, contracts, and resources.
- Optimize resources to meet trial objectives efficiently.
- **Vendor and CRO Management**:

- Select, contract, and oversee third-party vendors, including CROs, ensuring quality deliverables and adherence to timelines.
- Conduct regular performance reviews and risk assessments to maintain vendor accountability.
- **Site Management**:

- Lead site identification, initiation, and monitoring to ensure high-quality trial conduct.
- Address site challenges proactively and implement corrective actions as needed.
- **Data Integrity and Reporting**:

- Ensure robust data collection, monitoring, and quality control processes.
- Collaborate with biostatistics and data management teams for timely data analysis and reporting.

**Required Qualifications**:

- **Education**: Bachelor's or advanced degree in life sciences, pharmacy, or a related field.
- **Experience**:

- 5+ years in clinical trial/project management, with a strong focus on CNS therapeutic areas.
- Proven track record of managing international multi-site trials.
- Hands-on experience with all phases of clinical trials, especially Phase I-III.
- **Skills**:

- Deep understanding of CNS disorders and their clinical development challenges.
- Strong organizational, leadership, and decision-making abilities.
- Proficiency in project management tools and systems.
- Fluent in English and Italian (both written and verbal).

**Preferred Qualifications**:

- Prior experience in biotech or pharmaceutical CNS drug development.
- Knowledge of emerging CNS therapies, biomarkers, or advanced trial designs.
- Familiarity with Milan's clinical research ecosystem and key opinion leaders.

**What We Offer**:

- An opportunity to work with a highly skilled and passionate team in a cutting-edge biotech environment.
- Competitive salary, benefits, and performance-based incentives.
- A collaborative culture fostering innovation and personal growth.
- The chance to contribute to life-changing therapies for CNS disorders

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italy

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