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Freelance Country Approval Specialist - Denmark/ Sweden

Employer
i-Pharm Consulting
Location
Denmark / Sweden
Salary
Negotiable
Start date
16 Sep 2019
Closing date
30 Sep 2019

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Discipline
Clinical Research, Clinical Operations
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Job Details

i-Pharm Consulting are seeking on behalf of a leading Global CRO a Freelance Country Approval Specialist. This is a home-based contract ideal for someone based in Denmark or Sweden who has extensive experience preparing local Danish EC/RA submissions.

This is a 6-month contract up to 1.0 FTE to join their Site Start Up team. In this role you will perform assigned activities within Denmark that lead to start-up of investigative sites in all phases of clinical trials.

Experience in initial submissions is vital.

THE ROLE

  • Prepare, review and coordinate initial Ethics Committee and Regulatory Affairs in Denmark (Translators will be on hand to assist Swedish natives)
  • Keep updated on local laws and regulations in Denmark
  • Act as main contact with Regulatory Authorities (RA) and Central/Regional Ethics Committees (ECs)
  • Support the development of local ICFs
  • Ensure local activities are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards
  • Ensure an efficient start-up process on assigned studies

LOCATION

Home based - Denmark or Sweden

RATE

Competitive hourly rate

DURATION

6 months

0.7 - 1.0 FTE

REQUIRED

  • Life science degree
  • Strong experience within CROs
  • Strong experience prioritising high workloads
  • Significant experience within Study Start Up
  • 3+ years in independently preparing initial EC/RA submissions in Denmark
  • Ability to work independently
  • Recent EC/CA submissions in Denmark are essential

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 / Clinical Operations Coordinator / 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 / SSU / Study Start Up Specialist / Country Approval Specialist / Clinical and Regulatory Affairs Specialist / EC / RA / Denmark / Sweden / Regulatory Affairs / Ethics Committee / Copenhagen / Aarhus / Odense / Aalborg / Esbjerg / Randers / Kolding / Horsens / Vejle / Roskilde / Stockholm / Gothenburg / Malmo / Uppsala / Vasteras / Orebro

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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