Study Start Up and Regulatory Affairs Specialist

2 settimane fa

Roma, Italia Ergomed A tempo pieno

Company Description

Ergomed PLC is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.

Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia

Our company allows for employee visibility (you have a voice) creative contribution and realistic career development.

We have nourished a true international culture here at Ergomed.

We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.

Come and join us in this exciting journey to make a positive impact in patient’s lives.

**Job Description**:
**We are looking for someone who can speak French and/or German**

Provides Study Start-Up Specialist activities in support of assigned projects including **regulatory submissions, informed consent review, site contract/budget negotiation, essential document collection and review in preparation of site initiation and activation.**

Provides leadership to junior department and project team members.

**DUTIES AND RESPONSIBILITIES**:
Work closely with project teams to ensure efficient start-up processes for assigned projects in accordance with ICH-GCP, relevant Standard Operating Procedures (SOPs) and/or Sponsor-specific requirements.

May act as Study Start-Up Specialist Lead at project level; may directly interact with customers and sponsors as required. May serve as main point of contact for all project-specific Study Start-Up Specialist activities.
- Support the Regulatory Lead to project site-specific submission/approval timelines and ensure they are met; if forecasted timelines are not reached, provide clear rationale for delays and contingency plans to mitigate impact. Anticipate and identify site issues during start-up process and resolve minor to moderate issues independently.
- Provide support to Site Contract Lead to agree on country/site
- template contract and budget. Provides support in negotiating budget and contract with site until resolution of issues and contract execution.
- Collect, review for completeness and compliance, and track essential documents to facilitate efficient site initiation and activation. Investigate incomplete, inaccurate or missing documents to ensure accuracy and completeness of information. Prepare study team reports or updates regarding status of essential document collection, review and approval.
- Actively correspond with selected sites for updates regarding essential document completion, Informed Consent Form (ICF) development and regulatory/EC submissions/approvals.
- Participate in ICF development, review, negotiation and approval processes.
- Coordinate with study teams, sponsors, clinical monitoring, clinical contracts and/or other functional areas on the priority and processing of documents leading to investigational product release, site activation and site initiation.
- Attend project team meetings and training sessions according to project and/or Sponsor requirements.
- Arrange for and/or review translation of essential documents as required.
- Assist with feasibility and site identification activities as needed.
- Ensure all relevant essential documents are submitted to Trial Master File (TMF) in a timely manner as defined by SOPs and study-specific requirements.
- Assist with mentoring and training of department staff and new-hire

**Qualifications**:
French and/or German language skills.

Bachelor’s degree (BA/BS) in a science-related field preferred or equivalent combination of education, training and experience.
Experience working the pharmaceutical, biotechnology or CRO industry and knowledge of clinical trials process required.
Previous experience in Study Start-Up and site contract negotiation.

Excellent oral and written communication skills.
Excellent interpersonal and organizational skills with strong attention to detail.
Good customer/client relationship management and proactive problem-solving skills.
Knowledge of the principles, methods, and procedures of clinical research.
Good computer skills including MS Word, Excel, PowerPoint, Outlook.
Experience with ICH/GCP documentation and process preferred.
Ability to assess, coordinate, and organize/reorganize workload of multiple projects in accordance with project priorities/assignments and timelines with focus on execution.

Additional Information

We offer excellent chances to progress and develop. We work on a global basis on interesting projects within rare diseases, oncology, and neurology. This is an ideal position to continue developing a career in clinical drug development.

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, gen

  • Study Start Up Specialist

    2 settimane fa

    Roma, Italia TFS HealthScience A tempo pieno

    TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions. **Join Our Team as a Study Start Up Specialist** **About...

  • Clinical & Regulatory Affairs Specialist

    2 settimane fa

    Roma, Italia Meditrial Europe Ltd. A tempo pieno

    Meditrial is a full-service clinical research organization (CRO) dedicated to clinical trial conduct, medical education, regulatory affairs and market access. Our offices are located in Germany, Italy, Switzerland, UK, United States and our teams rely on digital tools to work collaboratively to achieve shared goals. Since 2008, Meditrial delivers...

  • Regulatory Affairs Specialist

    2 settimane fa

    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._ -...

  • Regulatory and Site Readiness Specialist Ii

    3 settimane fa

    Roma, Italia Labcorp A tempo pieno

    We are seeking a Study Start Up Specialist to be responsible for country study start up (SSU) activities and performing quality review of essential documents. The SSU Specialist is responsible for overseeing and leading SSU activities in collaboration with country team members (CLM and CRA) with the objective to improve site activation and maximize patient...

  • Regulatory and Site Readiness Specialist Ii

    1 settimana fa

    Roma, Lazio, Italia Labcorp A tempo pieno

    We are seeking a Study Start Up Specialist to be responsible for country study start up (SSU) activities and performing quality review of essential documents. The SSU Specialist is responsible for overseeing and leading SSU activities in collaboration with country team members (CLM and CRA) with the objective to improve site activation and maximize patient...

  • Junior Regulatory Affairs Specialist

    2 settimane fa

    Roma, Italia Adecco Italia A tempo pieno

    Adecco italia Spa is looking for an important client in the pharmaceutical sector a JUNIOR REGULATORY AFFAIRS SPECIALIST Basic Functions & Responsibility (may not be limited to) - Carry out linguistic checks, high quality review of translations and QRD checks on Summary of Product Characteristics and Patient Information Leaflets. - Timely preparation and...

  • Regulatory Affairs Specialist

    3 settimane fa

    Roma, Italia Manpower srl A tempo pieno

    **Il nostro Cliente**: AZIENDA MULTINAZIONALE OPERANTE NEL SETTORE CHIMICO-FARMACEUTICO **Ci ha incaricati di ricercare**: UN/UNA REGULATORY AFFAIRS SPECIALIST **La sede**: ROMA **Il lavoro**: - Uno _**specialista in affari regolatori**_ _si assicura che la sua azienda segua rigorosamente le _**norme **_e i _**regolamenti governativi**_ _relativi agli...

  • Regulatory Affairs Specialist

    3 settimane fa

    Roma, Italia ManpowerGroup A tempo pieno

    Azienda: AZIENDA MULTINAZIONALE OPERANTE NEL SETTORE CHIMICO-FARMACEUTICO Descrizione: **Il nostro Cliente**: AZIENDA MULTINAZIONALE OPERANTE NEL SETTORE CHIMICO-FARMACEUTICO **Ci ha incaricati di ricercare**: UN/UNA REGULATORY AFFAIRS SPECIALIST **La sede**: ROMA **Il lavoro**: - Uno _**_specialista in affari regolatori_**_ si assicura che la sua...

  • Regulatory Affairs Specialist

    1 settimana fa

    Roma, Lazio, Italia Jr Italy A tempo pieno

    col-wideJob Description:IstruzioneLaurea specialistica / Vecchio ordinamentoAdecco Italia Spa – Branch Roma Ovest, for a prestigious multinational of pharmaceutical chemical sector, is looking for aRegulatory Affairs SpecialistThe chosen candidate, under general supervision responsible for the local coordination and the preparation of documents/packages...

  • Regulatory Affairs Specialist

    1 settimana fa

    Roma, Lazio, Italia Manpower srl A tempo pieno

    **Il nostro Cliente**:AZIENDA MULTINAZIONALE OPERANTE NEL SETTORE CHIMICO-FARMACEUTICO**Ci ha incaricati di ricercare**:UN/UNA REGULATORY AFFAIRS SPECIALIST**La sede**:ROMA**Il lavoro**:- Uno _**specialista in affari regolatori**_ _si assicura che la sua azienda segua rigorosamente le _**norme **_e i _**regolamenti governativi**_ _relativi agli obiettivi e...

  • Regulatory Affairs Manager

    2 settimane fa

    Roma, Italia Ergomed A tempo pieno

    Company Description Ergomed PLC is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease. Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia Our company allows for employee visibility (you...

  • Regulatory Affairs Executive

    3 settimane fa

    Roma, Lazio, Italia Philip Morris International A tempo pieno

    Regulatory Affairs Executive - RomaBe part of a revolutionary changeAt Philip Morris International (PMI), we've chosen to do something incredible. We're totally transforming our business and building our future on smoke-free products.With huge change, comes huge opportunity. So, wherever you join us, you'll enjoy the freedom to dream up and deliver better,...

  • Regulatory Affairs Executive

    1 mese fa

    Roma, Lazio, Italia Philip Morris International A tempo pieno

    Regulatory Affairs Executive - RomaBe part of a revolutionary changeAt Philip Morris International (PMI), we've chosen to do something incredible. We're totally transforming our business and building our future on smoke-free products.With huge change, comes huge opportunity. So, wherever you join us, you'll enjoy the freedom to dream up and deliver better,...

  • Regulatory Affairs Specialist

    2 settimane fa

    Roma, Italia PrimeVigilance A tempo pieno

    Company Description We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs...

  • Clinical Start-up Specialist

    1 settimana fa

    Roma, Lazio, Italia Novo Nordisk A tempo pieno

    Are you an experienced clinical research professional interested in the start-up and regulatory aspects? Do you need to have things in order, and attention to detail is one of your qualities? If you are ready to make a difference in our clinical department, you might be our new Clinical Start-Up Specialist. Apply today and drive the change with us at Novo...

  • Regulatory Specialist, Italy

    3 settimane fa

    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...

  • Regulatory Specialist, Italy

    1 settimana fa

    Roma, Lazio, 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 be a key...

  • Government Affairs Manager

    2 mesi fa

    Roma, Italia AstraZeneca A tempo pieno

    **Government Affairs Manager** At AstraZeneca, we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve, no matter where you start with us. As **Government Affairs Manager** you will be accountable for managing the...

  • Regulatory Affairs Support

    1 settimana fa

    Roma, Lazio, Italia Viatris Inc. A tempo pieno

    Regulatory Affairs Support - Internship page is loaded Regulatory Affairs Support - Internship Solicitar locations Rome, Lazio, Italy time type Tiempo parcial posted on Publicado ayer job requisition id R VIATRIS ITALIA S.R.L.En VIATRIS, vemos la atención médica no como es, sino como debe ser. Actuamos con valentía y estamos en una posición única para...

  • Regulatory Affairs

    1 settimana fa

    Roma, Lazio, Italia Confidenziale A tempo pieno

    Importante realtà nel settore farmaceutico ricerca una risorsa da inserire in qualità di:Regulatory Affairs La risorsa si occuperà di:- Essere a conoscenza di eventuali condizioni - obblighi adottati nell'ambito delle autorizzazioni 'immissione in commercio e di altri impegni relativi alla sicurezza - 'uso sicuro dei prodotti; -Assicurare la conduzione...