Basic Requirements:
• Bachelor’s degree in life sciences or related discipline.
• 6 to 8 years of experience in clinical operations or related research.
• In-depth knowledge of study management, essential regulatory guidelines worldwide, and the clinical development process.
• Advanced degree (e.g. MS, PhD, PharmD) or equivalent experience.
• Knowledge and experience of Non-Interventional Studies (NIS).
• Proven expertise in the proactive identification of issues which may impact clinical- programmers coupled with the ability to contribute to solutions affecting cross-functional matrix teams.
• Demonstrated experience leading in a matrix environment to deliver studies, develop clinical plans, and manage change.
• Proven experience in managing relationships with vendors to ensure successful delivery of studies.
Key Responsibilities:
• Planning and leading the delivery of assigned studies to timelines, quality, budget, company standards and scientific requirements; from concept to a handover point applicable to the study type, which may be up to final study report and archiving.
• Supporting the coordination and delivery of a fully feasible Study Protocol and any other relevant study documentation.
• Supporting the Scientific Lead in the assessment and selection of appropriate vendors and leads on the engagement and management of selected vendors.
• Working with matrix partners, manager and/or NIS P&D TA Study Delivery Head to develop and manage study level budget within project budget allocation.
• Ensuring prompt escalation of study and project level issues and risks to manager or NIS P&D TA Study Delivery Head, as appropriate.
• Working effectively in partnership with the Scientific Lead (and extended team, if required) to deliver assigned studies. Interacts effectively across boundaries with other global functions using influencing and relationship-building skills.
• Ensuring compliance with ICH/GCP & ENCePP guidelines and/or applicable guidelines for NIS 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.
• May lead or contribute to initiatives to improve processes and/or ways of working.
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 stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way.
GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable.
If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in “gsk.com”, you should disregard the same and inform us by emailing askus@gsk.com, so that we can confirm to you if the job is genuine.