Site Start Up Specialist

Vor 4 Tagen

Wien, Österreich Thermo Fisher Scientific Vollzeit

PPD, now Thermo Fisher’s clinical research business, is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.

At PPD, we are passionate, deliberate, and driven by our purpose
- to improve health
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

Our goal-driven teams combine and deliver start up activities for the clinical trials, collaborating to improve processes, cycle and flexibility. We partner with our sites, businesses and colleagues around the world to decrease startup timelines and exceed expectations.

PPD is currently looking for a **Site Start Up Specialist (Country Approval Specialist) who will be home based a in Austria**.

**In this role, you will**:

- Provide local regulatory strategy advice (MoH &/or EC) to internal clients
- Provide project specific local SIA services and coordination of these projects
- May have contact with investigators for submission related activities
- Key-contact at country level for either Ethical or Regulatory submission-related activities
- Coordinate, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation
- May develop country specific Patient Information Sheet/Informed Consent form documents
- May assist with grant budgets(s) and payment schedules negotiations with sites.
- Support the coordination of feasibility activities, as required, in accordance with agreed timelines
- Enter and maintain trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner
- Ensure the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs
- Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided

**Required Skills, Qualification and Experience**:

- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Related experience or equivalent combination of education, training, & experience
- Effective oral and written communication skills
- Excellent English and German language skills (at least C1 level)
- Excellent interpersonal skills
- Strong attention to detail and quality of documentation
- Good negotiation, organizational and planning skills
- Good computer skills and the ability to learn appropriate software
- Basic medical/therapeutic area and medical terminology knowledge
- Ability to work in a team environment or independently, under direction, as required
- Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulation

As well as being rewarded a competitive salary, we offer a benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly values a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together.

**Our 4i Values**:
**Integrity - Innovation - Intensity - Involvement**

LI-Remote #LI-BN1

  • Site Start Up Specialist

    vor 2 Wochen

    Wien, Österreich Thermo Fisher Scientific Vollzeit

    Our team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global...

  • Reg & Start-up Specialist 1

    Vor 4 Tagen

    Wien, Österreich IQVIA Vollzeit

    Job Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Essential Functions - Under general supervision, serve as...

  • Regulatory & Study Start-up Specialist (M/w/d)

    Vor 3 Tagen

    Wien, Österreich IQVIA Vollzeit

    We currently offer an exciting opportunity as **Regulatory & Start-Up Specialist (m/w/d)** to work in both fields of _ethics and submissions_ and _contracting and budget negotiations_ in our Country Site Activation Department. You can work in our Vienna office, alternatively you can work home-based as well. **While projects vary, your typical...

  • Regulatory & Study Start-up Specialist (M/w/d)

    vor 15 Stunden

    Wien, Österreich IQVIA Vollzeit

    We currently offer an exciting opportunity as **Regulatory & Start-Up Specialist (m/w/d)** to work in both fields of _ethics and submissions_ and _contracting and budget negotiations_ in our Country Site Activation Department. You can work in our Vienna office, alternatively you can work home-based as well. A specialization in contracting and budgets would...

  • Site Contract Specialist

    vor 3 Wochen

    Wien, Österreich Thermo Fisher Scientific Vollzeit

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

  • Site Contract Specialist

    Vor 2 Tagen

    Wien, Österreich Thermo Fisher Scientific Vollzeit

    Our team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global...

  • Site Contract Specialist

    vor 2 Wochen

    Wien, Österreich Thermo Fisher Scientific Vollzeit

    Our team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global...

  • Site Contract Specialist

    Vor 4 Tagen

    Wien, Österreich Thermo Fisher Scientific Vollzeit

    PPD, now Thermo Fisher’s clinical research business, is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. At PPD, we are passionate, deliberate, and driven by our purpose - to improve health! At PPD we hire the best, develop ourselves and each other, and...

  • Study Start-up Associate

    vor 2 Wochen

    Wien, Österreich Labcorp Vollzeit

    Labcorp Drug Development has supported the pharmaceutical industry in developing more medicines worldwide than any other company, including the top 50 best-selling drugs on the market today. Join us and see why more than 90% of the top 20 global pharmaceutical companies are repeat customers! If you are looking to take on responsibility and leverage your...

  • Site Contract Specialist

    vor 2 Wochen

    Wien, Österreich Thermo Fisher Scientific Vollzeit

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

  • Job Posting Title Regulatory and Start Up

    vor 3 Wochen

    Wien, Österreich Novasyte Vollzeit

    Regulatory and Start Up Specialist IQVIA RSU Work from any location Must speak German and English Join us on our exciting journey! IQVIA Clinical Functional Services Partnerships (FSP) business is unique. Our teams are dedicated to a single sponsor partner, where the common goal is quality delivery for our customers. We set ourselves apart with...

  • Feasibility Site Liaison Specialist

    Vor 3 Tagen

    Wien, Österreich PPD Vollzeit

    **JOB DESCRIPTION**: We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of...

  • (Junior- / Senior-) Regulatory & Start-up

    vor 15 Stunden

    Wien, Österreich IQVIA Vollzeit

    Job Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Essential Functions - Under general supervision, serve as...

  • 18078-reg & Start Up Spec 1

    vor 3 Wochen

    Wien, Österreich IQVIA Vollzeit

    Job Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Essential Functions - Under general supervision, serve as...

  • Start-Up Portfoliomanagerin

    vor 2 Wochen

    Wien, Wien, Österreich Wiener Stadtwerke GmbH Vollzeit

    Start-Up Portfoliomanager*in & Venture ClientingDie Wiener Stadtwerke sind mit fast 18.000 Mitarbeiter*innen der bedeutendste Infrastrukturdienstleister für den Großraum Wien. Mit Innovationskraft und Erfahrung halten wir die Stadt am Laufen und machen sie klimafit für die Zukunft.Das erwartet dichStart-Up Portfoliomanagement:- Verantwortung für die...

  • Finanzstratege mit Start-up-Erfahrung

    Vor 5 Tagen

    Wien, Wien, Österreich Adhara GmbH Vollzeit

    Unser AuftraggeberAdhara GmbH, ein Unternehmen im Gesundheitsbereich, hat sich in kurzer Zeit etabliert und ist bereits Marktführer in seinen Kern-Segmenten. Durch innovative Produkte und eine gesundheitsfördernde Ausrichtung zählt das Unternehmen zu den aufstrebenden Unternehmens des Landes.Mit seiner Skalierbarkeit und internationalen Ausrichtung bietet...

  • Site Technology Specialist

    vor 2 Wochen

    Wien, Österreich PSI CRO Vollzeit

    **Company Description** PSI is a leading Contract Research Organization with more than 28 years in the industry offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. As a Site Technology Specialist, you will work with...

  • Study Start-up Manager

    vor 2 Wochen

    Wien, Österreich AstraZeneca Vollzeit

    **Study Start-up Manager (M/F/d) - Schwerpunkt Studienverträge** **Standort: Wien/Remote** AstraZeneca ist eines der weltweit führenden biopharmazeutischen Unternehmen, welches sich auf die Entdeckung, Entwicklung undVermarktung verschreibungspflichtiger Arzneimittelkonzentriert. Weltweit profitieren Millionen Patient:innen von unseren innovativen...

  • On Site Support Specialist

    vor 3 Wochen

    Wien, Österreich Linear International LTD Vollzeit

    **Overview**:The On Site Support Specialist, a crucial member of our support team, plays a vital role in resolving incidents and requests related to On Site support. This role involves working closely with the customer's Service Desk, local representatives, and End Client's teams to ensure efficient support and maintenance of hardware and software. The On...

  • Site Manager- ASAP START

    vor 4 Wochen

    Wien, Wien, Österreich at Vollzeit

    Corplex is a growing and dynamic construction company experienced in all types of building construction specializing in industrial markets. Due to continued growth, our business requires the services of an experienced Site Manager. In this role, you will be responsible for assisting the Project Manager in the delivery of the assigned project by supervising...