Study Delivery Lead

2 weeks ago

Stevenage, Hertfordshire, United Kingdom GSK Full time

Site Name:
UK - Hertfordshire - Stevenage

Posted Date:
Mar

Study Delivery Lead - Value, Evidence and Outcomes (VEO), Vaccines
Are you a clinical operations professional looking for an exciting and varied role in a dynamic, high performing department? Are you currently in a scientific role but looking for a new challenge? This could be the job for you

This role within VEO Study Delivery and Quality Operations involves the end-to-end design, execution, and reporting of clinical studies.

The types of studies run by VEO include:

  • Interventional studies
  • Noninterventional studies using primary data collection, including prospective studies enrolling patients and or/HCPs, de novo registries, discrete choice experiments, creation of new datasets with secondary data (e.g., with EMRs/chart abstraction), patient reported outcomes development and validation
  • Noninterventional comparative and descriptive studies using secondary data sources, including retrospective studies, burden of illness and drug utilisation studies, prevalence/incidence studies of exposure, risk factors and outcomes
  • Studies utilizing a mixture of existing medical data and the collection of new data via sites or directly via patients
  • Economic modelling studies and supplemental analyses of clinical trials/metaanalyses

In this role you will

  • Take responsibility and/or accountability for the setup, coordination, execution, and delivery of the VEO portfolio in partnership with the Science Lead, with responsibilities including but not limited to:
  • Planning and leading the delivery of VEO studies to timelines, quality, budget, company standards and scientific requirements; from concept protocol to final study report
  • Oversight, coordination and delivery of a fully feasible Study Protocol, Informed Consent Forms, operationally robust study documents and Clinical Study Reports
  • Accountability for the study delivery strategy (e.g. country selection, diversity, patient identification and engagement strategy, recruitment plan, digital platforms/tools etc)
  • With the majority of VEO studies fully outsourced this role includes responsibility and/or accountability to drive assessment, selection, engagement, and management of appropriate vendors
  • Ensuring compliance with ICH/GCP & ENCePP guidelines and/or applicable guidelines for VEO studies such as Good Pharmacovigilance Practices (GVP), Good Epidemiological Practices (GEP) and CIOMS, all applicable laws and regulations, and GSK SOPs, for all products and services delivered for their designated studies
  • Making decisions which balance risk/benefit with clear understanding of impact on the study and project; acts to mitigate risk where appropriate
  • Working with matrix partners, Study Delivery Therapy Area Lead and/or manager to develop and manage study level budget within project budget allocation
  • Active partnership building for their portfolios and collaboration with therapy aligned staff in other functions. Interact effectively across boundaries with other global functions using influencing and relationshipbuilding skills

_ Closing Date for Applications:
April 12th, 2023 (COB)_
Please take a copy of the Job Description, as this will not be available post closure of the advert.#LI-GSK

_ Why you?_

Qualifications & Skills:

We are looking for professionals with these required skills to achieve our goals:

  • Bachelor's degree in life sciences or related discipline
  • Broad understanding of the pharmaceutical industry and the clinical development process
  • Ability to establish and build internal and external relationships at all levels in a highly dynamic matrix environment
  • Highly developed communication skills appropriate to the target audience, promoting effective decisionmaking where necessary
  • Ability to work independently and proactively and to take on leadership roles on crossfunctional study teams
  • Excellent leadership skills
  • Excellent influencing and negotiation skills

Preferred Qualifications & Skills:

If you have the following characteristics, it would be a plus:

  • In depth knowledge of study management and knowledge of essential regulatory guidelines worldwide
  • Proven expertise in the proactive identification of issues which may impact clinical programmes coupled with the ability to contribute to solutions affecting crossfunctional matrix teams
  • Advanced degree (e.g. MS, PhD, PharmD) or equivalent experience
  • Demonstrated experience leading in a matrix environment to deliver projects, develop clinical plans, and manage change
  • Experience in managing relationships with vendors to ensure successful delivery of projects

_ Why GSK?_
Uniting science, technology and talent to get ahead of disease together

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver s

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