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Global SSU Lead - 6 Month Contract - Remote (EU Candidates)

Employer
i-Pharm Consulting
Location
Homeworking
Salary
Negotiable
Start date
10 Nov 2020
Closing date
24 Nov 2020

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Job Details

i-Pharm is urgently seeking on behalf of a Top Global CRO, a Freelance Senior Study Start-Up Project Delivery Manager. Our client is seeking a qualified professional with at least 6 years of industry experience, who is also able to take on management of Site Start-Up (SSU) deliverables within a region or globally. Accountable for the delivery of activation-ready study sites on time, on budget, and in compliance with all applicable regulations

THE ROLE

  • Responsible for the management of site activation deliverables within a region or globally, within assigned projects.
  • Collaborates with major functional area leads (SSU Country Managers, Project Management, and Clinical Management) to identify and evaluate fundamental issues pertaining to Site Start-Up, project regulatory pathway, successful patient enrolment, interpret data on complex issues, make good business decisions, and ensure solutions are implemented
  • Ensures all project deliverables meet the internal and customers' expectations as per contracted deliverables, providing accurate projections, reports and updates, and ongoing risk assessments.
  • Start-up regulatory activities (submissions, oversight of communication to competent authorities/ethics committees, import/export licenses, study maintenance submissions)
  • Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
  • Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).

LOCATION

Europe - Remote

RATE

Competitive Hourly Rate

DURATION

6-months

1.0 FTE

REQUIRED

  • Bachelor's degree in a scientific discipline or equivalent
  • Minimum 6 years of industry experience
  • Minimum 5 years' experience working in SSU
  • Experience with at least one of the following trial types: paediatric, medical devices, bioequivalence, advanced therapy products, or vaccines.
  • Experience with leading at least 10 studies from award and into maintenance; at least 3 of those studies must have included more than 15 countries across multiple regions
  • Excellent understanding of clinical trial process across Phases II-IV and ICH GCP

ABOUT i-PHARM CONSULTING

i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the UK and Europe. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology, and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance, and Bioinformatics.

www.i-pharmconsulting.com

TO APPLY

If you would like to discuss this vacancy further, please call Robert Zevallos on +44 (0)203 189 0486, or email rzevallos@i-pharmconsulting.com. If this role is not suitable, Robert is also available to discuss other possible positions or answer any general questions regarding your career and the current market.

KEYWORDS

CRA / Contract / Freelance / Clinical Research Associate / CRO / Contract Research Organisation / Respiratory / Asthma / Cystic Fibrosis / Oncology / Breast / Pancreatic / Lung / Renal / Solid Tumour / Skin / Lymphoma and Non Hodgkin / Cervical / Melanoma / Friedreich's Ataxia / Multiple Sclerosis / Epilepsy / Migraine / Sleep Disorders / Neuropathic Pain / Malignant Pain / Fibromyalgia / London/ Phase II / Phase III / Monitoring / London i-Pharm / Home Based / Country / SCRA / Senior CRA / CTMS / EDMS / GCP / SOP / SSU / SIA / Site Activation / Study Start Up / Team Lead /

Company

i-Pharm Consulting provides Talent Solutions for the global Life Sciences sector.

We are an award-winning international life sciences recruitment company with offices in London, Munich, Frankfurt, Sydney, New York, Charlotte, and Los Angeles. In a highly competitive marketplace, we connect top talent with the very best opportunities.

Since 2008, i-Pharm’s independent, expert, and ethical approach to procuring talent has helped power the pioneering progress made by Pharmaceutical, Biotech and MedTech companies around the world. 

With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.

For candidates, we become “career partners”. We know them as people, not CVs, learning about their aims, motivations and personal situation. We build open dialogue, provide honest advice and offer ongoing support, whether or not we’re currently working with them. ​

As a result, we have supported many specialists in this focused field throughout their careers, helping them plan their path through life sciences by identifying the right roles for them, not just any roles to suit us.

We change the lives and trajectory of our candidates' careers by offering incredible opportunities with the best clients in the sector.

 

Company info
Website
Telephone
+44 (0) 20 3189 2299
Location
52 Bedford Row
London
England
WC1R 4LR
United Kingdom

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