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Job Details

Director of Clinical Oversight - Freelance

Company: Planet Pharma Staffing Limited
Location: Homebased EU
Reference: SC/DIR211
Closing Date: 02 Dec 17
Type: Contract
Salary (£): 80,000 - 100,000
Benefits: NA

Job Summary:

A hugely exciting opportunity has become available with a small US based Biopharma for the position of Director Clinical Oversight. Fully homebased anywhere in EU the successful candidate will have oversight of all clinical activities for a Viral Infection product and be employed on an initial 6month contract.

Requirements:

RESPONSIBILITIES

  • Coordination and project management responsibility for clinical trials
  • Serve as the key contact for the contracted CRO, and ensure accurate and timely information flow within the cross-functional team
  • Collaborate with the clinical research team to provide input into clinical trial protocols and informed consents
  • Conduct site assessment visits to review/ensure site regulatory binder completeness, adherence to the monitoring plan, and compliance with protocol (e.g., tox management, dosing regimen)
  • Serve as primary reviewer for project level study plans and amendments (e.g., project plan, monitoring plan, risk plan) and provide/coordinate input on all other functional group plans (e.g., data management plan, medical monitoring plan, safety management plan) 
  • Ensure compliance with all study plans
  • Serve as a country/region expert in the review of ICFs and consents
  • Review regulatory submission packages (e.g., CTAs) from an operational perspective and provide feedback when appropriate
  • Take part in UAT (user acceptance testing) during the IXRS and clinical database set-up process
  • Ensure quality of clinical trial in cooperation with Clinical Subteams, line management, and Quality Assurance (QA).
  • Review vendor payments/invoices to ensure they are in-line with agreed upon contracts
  • Responsible for trial budget
  • Serve as contact with all trial vendors for work orders and changes in scope
  • Train Clinical Trial Team and CRAs/vendors/investigators on trial requirements, as appropriate
  • Identify any issues that need to be addressed and develop contingency plans together with line management
  • Respond to investigative site questions and Clinical Research Organization (CRO) regarding protocol issues and implementation
  • Work with Regulatory or other appropriate team members on responses to questions occurring during the regulatory approval process of a trial or during the trial (by competent authorities, Independent Ethics Committees (IECs)/Institutional Review Boards (IRBs)
  • Ensure that Clinical Trial Team follows SOPs (Standard Operating Procedures) and regulatory guidelines and GCP guidelines

DURATION

Full-time, 6 Month Contract

COMPENSATION

Attractive hourly rate

LOCATION

Homebased anywhere in EU (Ideally UK) and must be local to an airport as 25% travel

ABOUT PLANET PHARMA

Planet Pharma was founded by a dedicated team of seasoned professionals with extensive experience supporting the pharmaceutical, biotechnology and device industries. We are a unique staffing agency that have dedicated recruiters solely focussing on candidates to support the clients we work with.

Innovative – We constantly explore new ways of working that will help us be more efficient and effective

Entrepreneurial – We look at things differently, immerse ourselves in your world and devise solutions for each and every client

Expert – Everyone on our team is an expert in their field, trained and continually learning to deliver an unrivalled level of experience

Passionate – We are all incredibly proud to be part of Planet Pharma and we genuinely care about the people we work with

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

APPLICATIONS

Please contact Sam Chapple at Planet Pharma on 0203 868 8607 / schapple@planet-pharma.co.uk.

 

Apply for this job: Director of Clinical Oversight - Freelance

Contact Information:

Address:  Head Office
10 Greycoat Place, London,
SW1P 1SB
England
Tel:  +44 203 868 1000
Website:  Visit Our Web Site

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