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Sr. Clinical Trial Manager

3 settimane fa

Milano, Italia Syneos - Clinical and Corporate - Prod A tempo pieno

**Description**

Sr. Clinical Trial Manager (Clinical Research Medical Advisor) - FSP - Homebased - Italy

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:
**WORK HERE MATTERS EVERYWHERE**

Why Syneos Health
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.

**Responsibilities**:
The Sr. Clinical Trial Manager (Clinical Research Medical Advisor) is responsible for providing medical and scientific leadership to ensure the high-quality execution of clinical trials and studies in the assigned country or cluster. This role bridges Clinical Development and cross-functional teams, ensuring local medical input and compliance with regulatory standards.

**Key Responsibilities**
- Lead local clinical/medical aspects of trial implementation, including protocol review, site selection support, feasibility assessments, and recruitment **strategy**planning.
- Act as the medical representative to support study design, regulatory interactions, and site training to ensure protocol adherence and patient safety.
- **Identify pro actively recruitment challenges or operational challenges and develop migration plans.**:

- **Provides protocol/compound and indication trainings to internal and external partners**:

- Provide medical input for Informed Consent Forms (ICFs) and safety reporting.
- Partner with clinical operations, regulatory, medical affairs, and external experts to optimize trial execution.
- Support safety oversight: review serious adverse events (SAEs), provide pharmacovigilance support, and ensure clinical data quality.
- Contribute to early trial start-up by validating study feasibility and supporting site engagement and training.
- Ensure adherence to Good Clinical Practice (GCP), ICH guidelines, and country regulations.
- Contribute to internal and external scientific discussions, including advisory boards and investigator meetings.
- Provide clinical/medical expertise for regulatory inspections, audits, and trial documentation.
- **May work cross country**

**Qualifications**

**Education**:

- **Medical Doctor Degree is essential**:

- PharmaD or PhD could be relevant in case of solid experience as Medical Science Liason/Advisor

**Language**:
**Local Language fluency required**
- **Fluent in English (speaking and writing)**

**Experience**:

- Minimum 3 years in clinical development or clinical practice in the pharmaceutical or healthcare sector.
- Strong understanding of clinical trial design, implementation, and ICH/GCP principles.

**Skills**:

- Proven ability to analyze complex clinical/scientific issues and provide practical solutions.
- Strong communication and leadership skills to work cross-functionally.
- Problem-solving mindset and agility across therapeutic areas.
- Excellent presentation skills in English **and** local language.

**Technical Competence**:

- Strong protocol review and feasibility assessment skills.
- Understanding of safety and regulatory requirements in clinical trials.
- Experience supporting regulatory submissions, **Audits**and inspections.

**Travel Requirement**
- Up to 50% travel

**Get to know Syneos Health**

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

**Additional Information**

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