Aktuelle Jobs im Zusammenhang mit Senior Study Start-up Specialist - Berlin - Precision for Medicine
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(Senior) Study Start-up Specialist
Vor 5 Tagen
Berlin, Deutschland Precision Medicine Group VollzeitPrecision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific...
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Global Study Start Up Lead
vor 1 Woche
Berlin, Deutschland Parexel VollzeitWhen our values align, there's no limit to what we can achieve. Parexel is beginning to search for an experienced global Start Up Lead/Manager to join one of our key sponsors in the EMEA.In this role you are accountable and responsible for defining, developing and delivering the global study start up project strategy by partnering with roles across the...
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Berlin, Berlin, Deutschland Stealth Start-up (Mobility, Berlin) Vollzeit 48.000 € - 60.000 € pro JahrWe're a stealth, Tier-1 VC-backed mobility start-up that's rewriting how vehicle inspection centers are built and operated. With a proven expansion blueprint and a clear M&A strategy, we'll triple revenue next year. Our founders - serial entrepreneurs who've raised >USD 80m from top-tier US investors and just closed another strong Seed round - are pushing...
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Founder's Associate @Mobility Stealth Start-up
vor 1 Woche
Berlin, Berlin, Deutschland Stealth Start-up (Mobility, Berlin) Vollzeit 80.000 € - 120.000 € pro JahrWe're a stealth, Tier-1 VC-backed mobility start-up that's rewriting how vehicle inspection centers are built and operated. With a proven expansion blueprint and a clear M&A strategy, we'll triple revenue next year. Our founders - serial entrepreneurs who've raised >USD 80m from top-tier US investors and just closed another strong Seed round - are pushing...
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Founder's Associate @Mobility Stealth Start-up
vor 2 Wochen
Berlin, Berlin, Deutschland Stealth Start-up (Mobility, Berlin) Vollzeit 90.000 € - 120.000 € pro JahrWe're a stealth, Tier-1 VC-backed mobility start-up that's rewriting how vehicle inspection centers are built and operated. With a proven expansion blueprint and a clear M&A strategy, we'll triple revenue next year. Our founders - serial entrepreneurs who've raised >USD 80m from top-tier US investors and just closed another strong Seed round - are pushing...
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Expansion Manager @Mobility Stealth Start-up
vor 2 Wochen
Berlin, Berlin, Deutschland Stealth Start-up (Mobility, Berlin) Vollzeit 60.000 € - 120.000 € pro JahrWe're a stealth, Tier-1 VC-backed mobility start-up that's rewriting how vehicle inspection centers are built and operated. With a proven expansion blueprint and a clear M&A strategy, we'll triple revenue next year. Our founders - serial entrepreneurs who've raised >USD 80m from top-tier US investors and just closed another strong Seed round - are pushing...
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Berlin, Deutschland Stealth Start-up (Mobility, Berlin) VollzeitWe’re a stealth, Tier-1 VC-backed mobility start-up that’s rewriting how vehicle inspection centers are built and operated. With a proven expansion blueprint and a clear M&A strategy, we’ll triple revenue next year. Our founders - serial entrepreneurs who’ve raised >USD 80m from top-tier US investors and just closed another strong Seed round - are...
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Berlin, Deutschland Stealth Start-up (Mobility, Berlin) VollzeitWe’re a stealth, Tier-1 VC-backed mobility start-up that’s rewriting how vehicle inspection centers are built and operated. With a proven expansion blueprint and a clear M&A strategy, we’ll triple revenue next year. Our founders - serial entrepreneurs who’ve raised >USD 80m from top-tier US investors and just closed another strong Seed round - are...
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Berlin, Deutschland Stealth Start-up (Mobility, Berlin) VollzeitWe’re a stealth, Tier-1 VC-backed mobility start-up that’s rewriting how vehicle inspection centers are built and operated. With a proven expansion blueprint and a clear M&A strategy, we’ll triple revenue next year. Our founders - serial entrepreneurs who’ve raised >USD 80m from top-tier US investors and just closed another strong Seed round - are...
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(Junior) Expansion Manager
vor 3 Wochen
Berlin, Deutschland Stealth Start-up (Mobility, Berlin) VollzeitWe’re a stealth, Tier-1 VC-backed mobility start-up that’s rewriting how vehicle inspection centers are built and operated. With a proven expansion blueprint and a clear M&A strategy, we’ll triple revenue next year. Our founders - serial entrepreneurs who’ve raised >USD 80m from top-tier US investors and just closed another strong Seed round - are...
Senior Study Start-up Specialist
vor 2 Wochen
**Precision for Medicine is not your typical CRO.**
Becoming a member of our growing team, means you will be embarking on an opportunity to work with leading Oncology experts with a niche precision medicine company. We stand out from the crowd with an unusual value proposition; focusing exclusively on Oncology clinical trials that incorporate the use of biomarkers essential to targeting patients more precisely and effectively. We are not a behemoth sized CRO, which affords you the opportunity to have a voice that is heard and the ability to truly make an impact on drug development. Enough about us, let's talk about you.
The Senior Study Start Up (SSU) Specialist is a seasoned, experienced professional in country site start-up activities.
Responsibilities will be dependent upon the location of the SSU according to the applicable regulations and processes governing study and site start-up and activation. Typically, these include activities such as Informed Consent Form review and adaptation, Regulatory Document collection and quality review, Support to Regulatory and sites on IRB/EC/CA submissions and support to Site Contracts group in budget and contract negotiation.
The Sr. SSU acts as Subject Matter Experts for questions by other in-country members (CRAs, CSSs or others) supporting site start-up activities, trainer for non-experienced staff on site start-up activities as well as owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities.
**Essential functions of the job include but are not limited to**:
- Responsible for delivery, in terms of timeliness and quality, of site activation within the assigned country/sites and foreseeing and mitigating any risks.
- Preparation/Support of EC/IRB submissions, collection and review of regulatory documents, notifications to IRB, EC and regulatory authorities, as appropriate.
- Preparation/Support the development of start-up plans and essential document checklists.
- Partner with the assigned site CRA to ensure alignment in communication and secure site collaboration.
- Review and manage collection of essential documents required for site activation/IMP release.
- Customize country/site specific Patient Information Sheet and Informed Consent Forms.
Responsible/facilitate the translation and co-ordination of translations for documents required for submission.
- Maintain communication with other key functions participating to country start up i.e.,
- Clinical Operations, Project Management, Regulatory and Site Contracts management group on project specific status and deliverables.
- Act as SME for collection and maintenance of local IRB/Ethics Committee (EC), other related organizations, site contracts and budget negotiations and any other start up requirements for assigned country.
- Participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.
- If required, support Regulatory group on research of local requirements for documentation of CA submissions, approvals, and subsequent follow-up documentation.
- Participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.
- Development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.
- Development of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.
- Mentor staff on local study start-up regulations, submissions, and internal procedures.
- Interacts with client, participates in proposal activities, including development and client presentations as required.
- Performs other duties as assigned by management.
**Minimum Required**:
- Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.
- 5 years or more as a SSU specialist in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
**Other Required**:
- Excellent communication and organizational skills are essential.
- Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
- Fluency in English and for non-English speaking countries the local language of country where position based.
**Preferred**:
- Relevant site start-up (feasibility, contract negotiations, submissions) experience for the particular country.
- Experience using Study Start-up tracking tools/systems
- Ability to prioritize workload to meet deadlines.
- Can assist junior SSU activate specialists in problem resolution.
**Competencies**
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
- Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of
