Clinical Study Manager / Operations and Science Lead - HIV

Job Ref: J27417
Sector: Clinical
Sub-sector: Pharmaceuticals
Job Type: Temporary
Date Added: 01 August 2018
  • Middlesex, England, UK
  • £375.11 per Hour
    HOUR
  • Arnaud Heroult
  • 0203 096 4712

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Clinical Study Manager / Operations and Science Lead - HIV - 12 months - global Pharma - West London, UK

12 months contract

Competitive daily rate

Exciting Brand portfolio

One of my main pharmaceutical strategic partner is now seeking a Clinical Operational Manager to add to their growing team.

This role will be working on Phase 3 HIV pivotal registration studies. Studies involve 13-15 countries: US, Mexico, Australia, Korea, Italy, UK, France and more. No extensive travel required (2 trips to the US).

The successful candidate will be a team player with a focus on excellence and proven operational delivery of global Phase 3 pivotal registration studies. FDA/EMA/RoW central team submission experience from an operational perspective would be a benefit. Some flexibility is required to work with the wider global team in different time zones.The ability to work within a complex matrix environment is essential.

Responsibilities:

  • In house studies, multi-country late phase study management
  • Accountable to ensure all relevant studies follow SOPs and GCP
  • With direction from Senior Clinical Staff, collaborate with Clinical Operations functional groups (Regional Monitoring, Data Management, stats, clinical supplies and Operations Management) to ensure on time delivery of studies
  • Manage sites/countries transitioning from study to commercial supplies.
  • Manage study budgets
  • Escalate issues as needed to the Clinical Investigational Lead/medical monitor
  • Provide input into identifying implications of study progress upon overall timeline goals conduct plans
  • With oversight manage study start-up, conduct and close-out
  • Assist in the management of CRO's or other outsourcing partners as appropriate
  • Provide input into content and execution of investigator meetings / may present selected topicsProvide input into development of CRF
  • Provide input into site selection with coordinated input
  • Aptitude for clinical systems, can do attitude, ability to work across projects/studies

Requirements:

  • Bachelor's or Master's degree in science or a biology-related field with an advanced degree and/or certification preferred
  • A thorough understanding of the entire process of conducting a clinical study
  • A process-driven mentality and are you able to influence without authority in a matrix organisation
  • The skills to manage conflicting priorities with evolving and often challenging timelines
  • A keen attention to detail and are you service-orientedExperience in managing communications with external vendors
  • In depth and up to date knowledge of Good Clinical Practice and other regulatory standards (e.g. ISO 14155)
  • Excellent time management skills & project management experience
  • Eligibility to work and live in the UK

About SRG:

SRG is the market leading supplier of Clinical and Drug development recruitment services to the Life Sciences industries. By putting people at the heart of what we do we are the catalyst that connects the best talent with organisations in the pursuit of 'Creating Tomorrow's World'& helping patients world-wide.

HOW TO APPLY?

For an immediate consideration please press 'apply' now, alternatively contact Arnaud Heroult on +44 (0)203 096 4712 and get more information about the role.

Our team at SRG Clinical also cover roles in Biometrics, Medical Affairs, Clinical Operations, Medical Information, Pharmacovigilance and Regulatory affairs so do not hesitate to call me at +44 (0)203 096 4712.

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https://www.srg.co.uk/en/job-seekers/referral

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.

SRG
31/08/2018 14:09:04
GBP 375.11 375.11.