Ładowanie opisu…

Study Start Up Lead w Warząchewka Polska, Polska - Jobeax

Study Start Up Lead w Warząchewka Polska, Polska is listed on Jobeax. Browse 110,000+ vacancies available.

Join us in redefining what it means to work for a CRO.

When you work at Rho, it’s more than just a job—you become part of the Rho Factor. We’re a proud bunch of science nerds who love tackling big challenges together. We’re not your typical CRO, and we’re not trying to be. Here, curiosity is encouraged, fresh approaches are welcome, and collaboration is at the heart of everything we do.

Whether you’re a data wizard, analytical genius, project mastermind, or any other role, you’ll fit right into the equation of the Rho Factor. Expect plenty of geeky jokes, eccentric personalities, spontaneous brainstorms, and a supportive community where people genuinely care about their work—and each other.

You’ll have the opportunity to experience a thriving company with real stability - financial, workforce, and corporate, which has created a safe environment to innovate and develop over a long and rewarding career.

This is your opportunity to join Rho as a Study Start Up Lead - we are open to this role being located in Italy, Spain, Poland, Latvia, Lithuania or Bulgaria. This is a remote opportunity.

Responsibilities

Manage the study start up process through site activation, working with Project Manager and Clinical Trial Lead to ensure timely site activations
Participate in Sponsor meetings with respect to study start up, including endorsement of the SSU Operational Targets & mitigation of delivery risks, establishing client expectations for delivery, communication, reporting, and metrics
Partner closely with both Functional Leads and SSU Team Members to proactively identify study start up related issues
Ensure that relevant systems are maintained and up to date to analyze study start-up progress metrics against targets/timelines (at a project/country/site level)
Provide operational oversight to SSU Associates on assigned projects
Responsible for all submissions and obtaining approval from IRB/ECs (incl CTIS Part 2 package);
May be responsible for submissions to Regulatory Authorities in non-EU countries (ex. UK, Georgia, South Africa etc)
Coordinate feasibility efforts and work together with Clinical Team Leads on site identification
Identify the Site Essential Document (SED) packet elements required, agree with relevant internal staff, track the completion and upload of documents, and communicate with all parties (e.g., Sponsor, Site Staff, Internal Staff) the status of documents; participate as the SED Reviewer as necessary
Coordinate and develop the Start Up approach for IRB/EC approval at specified regional levels, including country level approval, and provide oversight of specific activities from SSU Team Members
Partner with Clinical Team Leads and the client to identify requirements for the Site Initiation Visit (SIV) and Site Activation
Coordinate the informed consent form (ICF) development, including the review, negotiation and approval with relevant internal and external parties
Support business development with proposal preparation and review and bid defense efforts
Coordinate site budget development, including the review, negotiation and approval with relevant internal and external parties.
Coordinate site contract negotiation process
Develop country/site-specific startup timelines and strategies and oversee startup activities in the country
Facilitate cooperation between cross-functional teams regarding startup activities

Qualifications

At least 4 years of industry experience, including 2+ years of study start up leading experience or equivalent
Demonstrated ability in the leadership of a team of individuals in study start-up
Knowledge of applicable international regulatory requirements and guidelines (i.e., ICH-GCP, and/ or EU-Directives)
Strong knowledge of Regulatory and Central/Local ethic submission processes for assigned countries
Strategic and creative risk management and contingency planning
Strong written and verbal communication skills to express complex ideas to study personnel, internal and sponsor team members
Excellent organizational and interpersonal skills
Strategic and tactical thinking skills
Client-focused action-oriented approach to work
Ability to work independently, prioritize and work with a matrix team environment is essential
Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities
Strong presentation skills
Global start up experience is preferred
Proficient computer and internet skills, including working knowledge of MS-office applications, such as MS Outlook, Word and Excel
Expected required travel 10% on average

Please submit your resume / CV in English. We are excited to hear from you!

Aplikuj na ofertę

Podobne oferty

Więcej podobnych stanowisk

Global Study Start-Up Lead - Remote

21 dni temu

Zdalnie

A leading CRO is seeking a Study Start Up Lead to manage the study start-up process through site activation and ensure timely activations. This role demands strong leadership skills, a solid understanding of regulatory requirements, and excellent communication abilities. The position is remote, available for candidates ...

Poland, Warząchewka Polska

Digital Forms

Technology Lead / Engineering Lead

Dzisiaj

Zdalnie
Hybrydowo
Pełny etat
Część etatu
Kontrakt

180 zł PLN

... government-adjacent) What we offer - Up to 180 PLN/h net (B2B, VAT invoice) - Remote/hybrid from Poland, full-time, permanent - Work with AI/LLM features already live in production (LLM-based document classification, RAG for decision support) - Growth path toward a senior/VP-level engineering leadership position within 12–24 months

Poland, Warszawa

Tech Lead / Team Lead (.NET / DevOps / Architecture)

3 dni temu

Zdalnie

Szukamy doświadczonej osoby na stanowisko Tech Lead / Team Lead, która stanie na czele naszego zespołu inżynierskiego. Osoby, która łączy w sobie głęboką wiedzę technologiczną z umiejętnościami przywódczymi, ma kluczowy, realny wpływ na architekturę całego systemu i potrafi wyznaczać kierunki rozwoju technologicznego. Jeśli ...

Poland, Kraków

HSBC Service Delivery

Practice Lead

13 dni temu

Zdalnie

24466 zł

... fulfil your potential. Whether you want a career that could take you to the top, or simply take you in an exciting new direction, HSBC offers opportunities, support and rewards that will take you further. Your career opportunity Practice Lead in Applied Capability Engineering (ACE) drives organization-wide capability initiatives ...

Poland, Kraków

Doradca - Doradczyni Klienta Premium / Premium Consumer Advisor - w kanale HoReCa - pop-up store - Lotnisko Chopina

1 dzień temu

Pełny etat
Część etatu
Kontrakt

Umowa o pracę lub zlecenie – Ty wybierasz, co pasuje do Twojego stylu życia. Pracę na pełen lub część etatu w dni handlowe w godzinach 5:00 - 22:00 w trybie zmianowym podczas funkcjonowania punktu (poniedziałek - niedziela).

Poland, Wrocław

Veeva Systems

Associate Consultant - Entry-Level Technology Consulting (Remote)

Dzisiaj

Zdalnie

120000 zł / rocznie

... a technical consultant who thrives in an environment where we work hard for our customers and each other. * Now hiring for our April 2027 and September 2027 start dates. The Program As part of the Consultant Development Program, you will: - Ramp up quickly. Your journey begins with an intensive, team-based onboarding program ...

Poland, Warszawa

POWSZECHNY ZAKŁAD UBEZPIECZEŃ SPÓŁKA AKCYJNA

Agent/Agentka Ubezpieczeń PZU SA - Program „Bezpieczny Start”

Dzisiaj

Masz doświadczenie w prowadzeniu biznesu lub sprzedaży? Połącz karierę agenta ubezpieczeniowego z rozwijaniem własnej działalności - dołącz do PZU! Twoje obowiązki - Aktywne pozyskiwanie klientów i sprzedaż ubezpieczeń majątkowych, komunikacyjnych oraz na życie.

Poland, Myszków

Serwis urządzeń mobilnych | Szybki start - również dla studentów

Dzisiaj

10k

... urządzeń mobilnych. Wymagania: - znajomość pakietu Office oraz Excel, - mile widziane doświadczenie na podobnym stanowisku. Oferujemy: - stawkę godzinową, - szybki start, - atrakcyjne godziny (8:30-16:30), - bonusy (nawet do 1000 zł brutto co miesiąc), - umowę zlecenie z możliwością przystąpienia do dobrowolnego ubezpieczenia ...

Poland, Warszawa

POWSZECHNY ZAKŁAD UBEZPIECZEŃ SPÓŁKA AKCYJNA

Agent/Agentka Ubezpieczeń PZU SA - Program „Bezpieczny Start”

Dzisiaj

Poland, Mysłowice

POWSZECHNY ZAKŁAD UBEZPIECZEŃ SPÓŁKA AKCYJNA

Agent/Agentka Ubezpieczeń PZU SA - Program „Bezpieczny Start”

1 dzień temu

Poland, Pabianice

POWSZECHNY ZAKŁAD UBEZPIECZEŃ SPÓŁKA AKCYJNA

Agent/Agentka Ubezpieczeń PZU SA - Program „Bezpieczny Start”

1 dzień temu

Poland, Częstochowa

POWSZECHNY ZAKŁAD UBEZPIECZEŃ SPÓŁKA AKCYJNA

Agent/Agentka Ubezpieczeń PZU SA - Program „Bezpieczny Start”

1 dzień temu

Poland, Myszków

Clinical Trial Analytics Consultant

1 dzień temu

... decision-making. Key Responsibilities Conduct exploratory analysis of historical clinical trial performance data. Develop recruitment forecasts and predictive models to support study planning. Perform scenario simulations and sensitivity analyses to evaluate planning assumptions and potential outcomes. Provide analytical support for ...

Poland, Warszawa

NetSuite Team Lead

Dzisiaj

... Proven experience as NetSuite Solution Architect / Lead Consultant. Experience with NetSuite migration projects. Strong knowledge of NetSuite OneWorld. Experience leading ERP discovery and gap analysis. Strong understanding of business processes: Finance; Supply Chain; Manufacturing; Procurement. Experience evaluating OOTB vs ...

Poland, Kraków

SpaceCat

Influencer Strategy Lead

Dzisiaj

Zdalnie

13000 - 15000 zł

... i dowożą. Takich, na których można polegać i którzy chcą rosnąć razem z rynkiem, a nie tylko za nim nadążać. Szukamy osoby na stanowisko Influencer Strategy Lead , która będzie odpowiadać za strategię selekcji i współpracy z twórcami internetowymi oraz kierunek rozwoju tego obszaru w całej organizacji - realnie wpływając ...

Poland, Gdańsk

Connectis_

Java Lead Developer

Dzisiaj

Zdalnie
Kontrakt

24000 - 26500 zł

... znajomość języka polskiego. Wspólnie z naszym Partnerem z branży technologicznej poszukujemy doświadczonego/ej specjalisty/ki do świadczenia usług jako Java Lead Developer . Projekt obejmuje migrację rozbudowanego systemu do zarządzania majątkiem dla biura maklerskiego z architektury desktopowej (około 1700 plików C++, ...

Poland, Opole

Agile Delivery Lead

Dzisiaj

Hybrydowo

RITS Group to firma informatyczna, która oferuje najwyższej jakości usługi programistyczne zarówno dla rynku polskiego, jak i międzynarodowego. Jesteśmy dumni, że należymy do grona najszybciej rozwijających się spółek technologicznych. Naszym priorytetem jest jakość oraz innowacyjność dostarczanych rozwiązań, a nasza kultura ...

Poland, Warszawa

Nike

Lead Retail Associate

Dzisiaj

... company looks for people who can grow, think, dream and create. Its culture thrives by embracing diversity and rewarding imagination. The brand seeks achievers, leaders and visionaries. At NIKE, Inc. it’s about each person bringing skills and passion to a challenging and constantly evolving game. Otwieramy nowy sklep NIKE ...

Poland, Gliwice

Lead Platform Engineer

Dzisiaj

Kontrakt

$2k USD

... platform modernizationSupportive team and agile, startup-like cultureHybrid by design mode and opportunity to work remotely within PolandChance to work abroad for up to 60 days annuallyBusiness-driven relocation opportunitiesWe provide growth opportunities:Career development programsThought leadership, mentoring, soft skills ...

Poland, Katowice