Clinical Scientist, Global Collaborative Studies, Open to flexible working

Location
Brentford (City/Town), London (Greater)
Salary
£Competitive
Posted
18 Dec 2020
Closes
17 Jan 2021
Ref
273111
Contract Type
Permanent

The primary focus of this role is to handle activities relating to: the provision of safety, risk mitigation and pharmacovigilance (PV) support for the use of ViiV Healthcare (VH) assets in VH supported studies (investigator sponsored studies (ISS), and supported collaborative studies (SCS) conducted with partner organisations); and the fulfilment of VH safety data exchange requirements as part of the legal agreements for these studies.

This is to enable Sponsors to adequately safeguard study participants from the key side effects with VH medications; and enable VH to meet regulatory obligations as product owner and license holder, such as signal detection and management.

In addition, this role will also support more general ISS and SCS activities including specific study accountabilities and management.

Key Responsibilities

  • Run safety, risk mitigation and PV related activities and processes for VH supported studies including: update and maintenance of applicable SOPs/Policies, guidance documents and study proposal, protocol, ICF and legal agreement safety review processes (ViSiONS review forms and workflows); development and implementation of safety training for relevant partners; oversight and support of Study Accountable Persons (SAPs) safety accountabilities during study conduct; input to legal agreement safety data exchange clauses; consulting on impact of PV legislation; implementation and conduct of new quarterly and annual management monitoring and other tracking activities; and overall process improvement.
  • Support Regional ISS and SCS activities and meetings; provide support to Regional ISS Leads and local SAPs to ensure studies are progressed in a timely manner and data are delivered with an appropriate sense of urgency through timely resolution of study issues consistent with relevant policies and procedures.
  • Study Accountable Person (SAP)- driving all aspects of review, implementation and conduct from contracting, Sponsor study team membership, investigator/Sponsor interactions, study milestone / budget and/or drug supply management, study documentation review, through to data disclosure.
  • Cross functional working with key internal partners; understand and maintain relationships and activities to ensure timely, compliant and efficient delivery of ViiV support for ISS and SCS, end-to-end (e.g., GSK and ViiV Safety & PV, Legal, Drug Supplies, Regulatory, Publications, Regions/LOCs)
  • Quarterly contributions of data on the ISS and SCS programme to advise product specific Global Integrated Evidence Plans (IEPs)

Basic Qualifications

  • 3 years or more experience in the pharmaceutical industry in a clinical research /medical role
  • BSc (Hons) in Biology, Clinical or Medical Science or equivalent health care-related specialty
  • Master's degree or PhD would be preferred
  • Pharmacovigilance experience relating to clinical safety reporting/data exchange and risk management
  • Experience of the clinical development process (from Phase 1 to Phase IV), especially related to clinical trial operations
  • Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.
  • Ability to assimilate, interpret and disseminate sophisticated scientific and medical concepts and information
  • Self-motivated, highly organised and have experience co-ordinating multiple projects
  • Ability to work effectively in a team and matrix environment, with proven track record to influence and negotiate with internal partners at all levels in the company
  • Ability to establish and maintain mutually encouraging external/customer facing relationships
  • Excellent technical writing skills, high degree of accuracy with attention to detail.
  • Solution focussed with proven track record to solve sophisticated problems and identify process improvements Computer literate, able to become familiar with new systems and software easily

Why GSK?

At GSK, we're a company with a special purpose, to help people do more feel better and live longer. Realising our purpose starts with us. When we feel at our best, we perform at our best.

When you set out on your adventure at GSK, we make a deal. You commit to living GSK's values and expectations and performing against our Innovation, Performance and Trust priorities. And in return, GSK commits to providing the right environment for you to thrive. Put simply, it's about you being motivated to do your best work, in a place where you can be you, feel good and keep growing.

Together we build an environment where we can all thrive and focus on what matters most to each of us. It is only through the energy, dedication, drive and passion of all of us that we can be the very best for GSK, and importantly, for our patients and consumers.

As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. 

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