Ssu Regulatory Coordinator/contracts Management

7 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



  • Roma, Italia Bespoke Recruitment A tempo pieno

    Job location**:CORK, IRELAND (funded relocation package and agency support) **_ Our client, a **global pharmaceutical company, **islooking for a Clinical Trial Associate - **_Budgets and Contracts_**, with fluency in **Italian language.** **Their main responsibilities are as follows**: - Contract **Negotiations - **communicating and negotiating contracts...


  • Roma, Lazio, Italia Syneos Health, Inc. A tempo pieno

    **About Us**Syneos Health, Inc., a leading integrated biopharmaceutical solutions organization, empowers customers to succeed in the modern market.We combine unique clinical, medical affairs, and commercial insights into outcomes that address contemporary realities.Our Clinical Development model puts the customer and patient at its core.We continuously...

  • Office Coordinator

    22 ore fa


    Roma, Italia Demolytic A tempo pieno

    **Roma** **Italia** We are looking for a skilled Office Coordinator to undertake a variety of day-to-day office and clerical tasks. You will be an integral part in ensuring that our office operations run smoothly and are successful in supporting other business activities. An excellent office coordinator is, above all, an organized and competent professional...


  • Roma, Italia STERIS Canada Corporation A tempo pieno

    Job Title: Regulatory Affairs Specialist Job Category: Regulatory Affairs Description: At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. Position Summary We are looking for a Regulatory Affairs Specialist to join our Regulatory Team...


  • Roma, Italia Amazon EU SARL (Italy Branch) A tempo pieno

    Demonstrable contracts management or other comparable experience with Italian government procurement contracting laws, rules and regulations, including European Union Public Procurement laws and policy - Experience supporting RFx requests and knowledge of RFx compliance requirements - Ability to demonstrate sound judgement even in ambiguous situations -...


  • Roma, Lazio, Italia Meditrial Europe Ltd. A tempo pieno

    Job Title: Regulatory Affairs SpecialistMeditrial Europe Ltd. is seeking an experienced Regulatory Affairs Specialist to oversee the regulation process for products requiring governmental approval in the lifescience industry, specifically pharma and medtech.Job SummaryThe successful candidate will be responsible for ensuring compliance with regulatory...


  • Roma, Italia Demolytic A tempo pieno

    **Roma** **Italia** We are looking for an Account Coordinator to provide day-to-day administrative support to our Account Executives and Account Representatives to ensure smooth sales procedures. To succeed in this role, you should be highly organized and able to perform multiple tasks for different teams/clients at the same time. If you have experience with...


  • Roma, Lazio, Italia EUSA Pharma A tempo pieno

    Job Overview:We are seeking a seasoned Regulatory Affairs CMC Specialist to join our team at EUSA Pharma.About the Role:The ideal candidate will possess consolidated experience in Chemistry, Manufacturing and Control (CMC) aspects to manage the preparation of dossiers for submission to regulatory authorities worldwide.Key Responsibilities:Technical Section...


  • Roma, Italia Angelini Pharma A tempo pieno

    Requisition ID: 6227- Location: Roma, IT- Company: ANGELINI PHARMA SPA- Professional area: Medical, R&D- Job Description: - _We have an opportunity for a _**_Regulatory Affairs Specialist._** **_Main activities:_** - _ Definition and development of regulatory strategies, supporting the Regulatory Affairs Director and in line with the Company’s needs._ -...


  • Roma, Italia LEO Pharma A tempo pieno

    **Company Description** At LEO Pharma, we are at a pivotal point in our transformation journey to advancing medical dermatology by developing new biologics, in a mostly unexplored therapeutic area in the world today. Every day, we seek inspiration from people living with skin diseases. We are passionate about identifying and addressing their greatest...


  • Roma, Italia JSB SOLUTIONS S.R.L A tempo pieno

    **JSB Solutions**, società di servizi nel settore Life Science che offre consulenza, gestione di studi clinici e sviluppo software, con 3 sedi in Italia (Firenze, Parma e Milano) è alla ricerca di un **Regulatory Affairs Consultant**: - (JSB.PPL.24.007)_ da inserire all'interno della nostra divisione degli **affari regolatori**. **Regulatory Affairs di...


  • Roma, Lazio, Italia Best Hotel Service A tempo pieno

    Descrizione del lavoroNell'ambito della nostra squadra di Best Hotel Service, stiamo cercando un professionista qualificato per ricoprire il ruolo di Coordinatore Gestione Alberghiera. Questa posizione richiede una combinazione di competenze tecniche e capacità di leadership per supportare l'eccellenza nella gestione degli alloggi.Scheda LavoroTipo di...


  • Roma, Italia Leo Pharma A tempo pieno

    Company Description At LEO Pharma, we are at a pivotal point in our transformation journey to advancing medical dermatology by developing new biologics, in a mostly unexplored therapeutic area in the world today. Every day, we seek inspiration from people living with skin diseases. We are passionate about identifying and addressing their greatest health...


  • Roma, Italia EastHORN Clinical Services A tempo pieno

    **Job summary**: As a **Regulatory Specialist **you will be expected to actively participate in all start up activities and perform CA and EC submissions. You will be responsible for communication with Regulatory Authorities and Ethics Committees and function as an expert for Regulatory issues in Italy. Reporting to **Clinical Operations Manager**, you will...


  • Roma, Italia Thales A tempo pieno

    Location: Roma, Italy In fast changing markets, customers worldwide rely on Thales. Thales is a business where brilliant people from all over the world come together to share ideas and inspire each other. In aerospace, transportation, defence, security and space, our architects design innovative solutions that make our tomorrow's possible. Roma hosts the...


  • Roma, Italia Demolytic A tempo pieno

    **Roma** **Italia** We are looking for a responsible Project Coordinator to administer and organize all types of projects, from simple activities to more complex plans. Project Coordinator responsibilities include working closely with our Project Manager to prepare comprehensive action plans, including resources, timeframes and budgets for projects. You will...


  • Roma, Lazio, Italia Page Personnel A tempo pieno

    About the RoleWe are seeking a skilled Technical Project Coordinator to join our team in Rome, Italy.Key ResponsibilitiesLead and manage IT projects from initiation through to completion, ensuring alignment with business objectives.Collaborate with cross-functional teams to define project scope, goals, deliverables, and timelines.Apply Agile methodologies to...


  • Roma, Italia Worldline A tempo pieno

    **This is Worldline** We are the innovators at the heart of the payments technology industry, shaping how the world pays and gets paid. The solutions our people build today power the growth of millions of businesses tomorrow. From your local coffee shop to unicorns and international banks. From San Francisco to Auckland. We are in every corner of the world,...


  • Roma, Lazio, Italia Zespri A tempo pieno

    About ZespriZespri is a leading marketer of kiwifruit, with a mission to help people, communities and the environment thrive through the goodness of kiwifruit. We work with growers and post-harvest companies to source high-quality kiwifruit, which we supply to wholesale and retail customers worldwide.Job DescriptionWe are seeking a highly organized Support...


  • Roma, Italia British American Tobacco A tempo pieno

    . **BAT is evolving at pace - truly like no other organisation.** **To achieve the ambition, we have set for ourselves, we are looking for colleagues who are ready to live our ethos every day. Come be a part of this journey!** **Purpose Statement** To act as a stakeholder manager for MPs, political institutions and regulatory authorities, NGOs and civil...