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Job Details

CPM II / Senior Project Manager - Ophthalmology- Europe

Company: RBW Consulting
Location:
Reference: SI-CPM-OPT
Closing Date: 30 Dec 16
Type: Permanent
Salary (£): 80,000 - 100,000
Benefits:

Top Job

Job Summary:

I am currently working on a new fantastic opportunity for my client who is looking for a Senior Clinical Project Manager. If you are looking to work for a Global CRO who values your work and quality over quantity then make yourself known and get in touch!

Requirements:

I am looking to speak with SCPM's who are interested in being in a unique therapeutically aligned business unit to Ophthalmology.

Our dedicated Ophthalmology group and clinical operations team have years of experience working on ophthalmology clinical trials. With our extensive ophthalmology clinical experience across the broad spectrum of indications and our regulatory experience across all geographic areas, you can be confident we’ll have given your product the best chance of seeing success.

I am seeking Project Manager II or Senior Project Manager for my clients Ophthalmology Department within CNS to be based in Europe in either the office or regionally from home in any of the following locations - UK, Germany, Poland, Netherlands, Spain, Italy, Hungary, Czech Republic, Serbia, Bulgaria

DUTIES AND RESPONSIBILITIES:

  • To discuss and liaise with clients in conjunction with others regarding study design, feasibility, protocols, Case Report Forms, costs and timeframes.
  • To prepare and review protocols and other study related documents such as informed consent and Investigators Brochure (IB).
  • To prepare submission documents for the Research Ethics Committee and regulatory authorities such as MHRS, ARSAC and R & D.
  • To attend the Research Ethics Committee meetings in order to present the project.
  • To set up, maintain and archive Investigator Site Files (ISF) and Trial Master Files (TMF’s).
  • To manage projects according to current Standard Operating Procedures (SOPs).
  • To report projects according to client specific procedures or to Simbec Research SOPs.
  • To prepare /QC check pharmacokinetic reports
  • To assist when necessary in Investigational Medicinal Product (IMP) assembly/preparation and accountability.
  • To supervise, mentor and train staff as required.
  • To maintain an awareness of current advances in clinical pharmacology and pharmaceutical research, with specific reference to current/future application.
  • To keep senior managers informed of project progress.
  • To negotiate with clients either alone or with others of the project contacts which will include financial as well as scientific, medical or administrative issues.
  • To represent the Project Management department at client meetings and deputise for Director of Project Management as required.
  • To be familiar with and work to all relevant SOPs in force.
  • To conduct all studies to the standards of Good Clinical Practice (GCP)

This idea candidate must have:

  • BSc degree in life sciences or MSc of PhD in a related field
  • 3 or more years Project Management experience in clinical research - CRO or Pharma
  • Current knowledge of ICH GCP and UK Statutory Instrument No. 1031
  • Awareness of regulatory and ethics submission requirements
  • Excellent communication skills, written, aural and oral
  • Excellent negotiation skills
  • Excellent organisation and time management skills
  • Excellent computer skills
  • Coaching and mentoring experience
  • Knowledge of Phase I and principles of pharmacokinetics

This is one of several positions I am currently recruiting for so do please get in touch for a confidential discussion around your current situation and what your ideal next move would be. Please contact Sayful Islam on +44 (O)1293 584 300 or email a CV to sayful.islam@rbwconsulting .com

Clinical research associate | CRA | CRA II | SCRA | senior clinical research associate | monitoring | clinical trials | clinical research | Oncology | Respiratory | Cardiovascular | regional travel | pharma | pharmaceutical | trials | clinical research | single sponsor | South England | South East | South West | 

Apply for this job: CPM II / Senior Project Manager - Ophthalmology- Europe

Contact Information:

Address:  Brighton
Southdown House, 130a Western Road, Brighton BN1 2LA
BN1 2LA
England
Tel:  01293 584 300

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