Ssu Regulatory Coordinator/contracts Management

3 mesi fa

Roma, Italia Syneos Health Clinical A tempo pieno

**Description**

**Site Start-Up Regulatory Coordinator**

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

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.

**Job responsibilities**
- Provide support with site selection lead and Project Manager (PM)/SSU Leadership (SSUL) to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial.
- Assists in administration of contract management and essential document processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project, country and site level.
- Assists with quality control processes and translation processes related to submissions, contracts and essential documents.
- Under supervision may assist in negotiations of budget and contracts with site and via Site Contracts Service Center and SSUL with Sponsor until resolution of issues.
- Assists in the reviews of contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented.
- Assists SSU staff with the active project management of ongoing contract issues; performs follow-up on all outstanding contract issues.
- May serve as communication liaison between site contracts staff and internal and external customers. Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues. Prepares correspondence as necessary.
- Assists in providing and generating (amended) contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; initiates and introduces creative ideas and solutions.
- Arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.
- May assist in ensuring compliance within the forecasted country/site timelines, helping to ensure compliance with milestone progress in agreed upon SSU tracking system in real time.
- Facilitates the execution of contracts by company signatories.
- Supports the maintenance of contract and essential document templates and site-specific files and databases.
- Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
- Reviews and complies with SOPs and Work Instructions (WIs) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.

**Qualifications**

**What we’re looking for**
- Associate’s Degree or equivalent combination of education and training preferred.
- Good understanding of clinical trial process across Phases II-IV and ICH GCP.
- Ability to interact effectively and appropriately with investigative site personnel and internal stakeholders.
- Good organizational skills and good attention to detail, with proven ability to handle multiple tasks effectively.
- Ability to take direction from multiple individuals and set priorities accordingly.
- Ability to effectively communicate across multiple function groups (Clinical team, PM, Director).
- Demonstrated ability to work independently, as well as part of a team.
- Utilize problem-solving techniques effectively.
- Quality-driven in all managed activities.
- Flexibility and

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