Site Activation (SSU) Team Manager

2 days left

Location
Homeworking
Salary
Negotiable
Posted
07 Jan 2021
Closes
21 Jan 2021
Ref
2608ZL10
Contact
Zara Linehan
Hours
Full Time
Contract Type
Contract
Experience Level
Management

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.

LOCATION

Europe - Home Based

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 Zara Linehan on +44 (0)203 189 0470, or email zlinehan@i-pharmconsulting.com. If this role is not suitable, Zara 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 /

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