Study Delivery Lead

Business Introduction

GSK remains committed to achieving bold commercial ambitions for the future. By 2031, we aim to deliver £40 billion in annual sales, leveraging our existing strong performance momentum to significantly increase our positive impact on the health of billions of patients globally. Our Ahead Together strategy is centred on early intervention to prevent and alter the course of disease, thereby protecting people and supporting healthcare systems. Our diverse portfolio consists of vaccines, specialty medicines, and general medicines. Through continuous innovation and a dedicated focus on scientific and technical excellence, we strive to develop and launch new, groundbreaking treatments that address critical health challenges.

Position Summary

This position within Clinical Matrix Team is accountable for end-to-end study delivery from commit to study initiation until study archiving. This role plans and leads the delivery of single country regulatory mandated interventional studies to time, quality, budget, company standards and scientific requirements as outlined in the clinical study proposal.

Responsibilities

Key responsibilities include, but are not limited to: Accountability for the operational delivery of clinical study to time, quality, and budget driving decision-making at pace and leading study team to achieve overall study deliverables.

Accountable for holistic oversight of CROs

Accountable for assessment and selection of CRO and other study vendors under Clinical Matrix Team’s responsibility.

Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs for assigned studies; understand study contribution to program/submission.

Proactively and effectively identify, oversee, and mitigate study risks.

Balance risk/benefit to make decisions based on clear understanding of impact on the study and project.

Ensure appropriate stakeholder communication, including study status, expectations, risks and issues.

Preparation of materials for governance and / or financial review cycles.

Responsible for operational input into protocol and informed consent form development, and other key study documents.

Lead and conduct investigator meetings and other study related meetings; participate in governance meetings as required.

Lead quality efforts to ensure protocol compliance and continual inspection readiness for assigned studies.

Ensure data quality plans and end to end data cleaning is performed instream by the responsible line functions.

Ensure Clinical Study Report is delivered on time and supports GSK’s adherence to local regulatory guidance.

Identify and communicate resource gaps for assigned studies.

Lead / contribute to ways of working and process improvement initiatives.

Create, maintain oversight plans and oversee clinical studies conducted by CRO

Prepare, track and maintain budgets

Present the project updates to senior leadership

Education Requirements (minimum expected)

Bachelor’s or Master’s degree in Pharmacy, Medical, Life sciences or related discipline The role will require a good understanding of complex clinical development and regulatory processes. Also, require strong finance and business acumen and experience working in clinical trial management systems.

Job Related Experience (minimum requirements)

Strong skills and experience in project management and tools in depth knowledge of GCPs and ICH guidelines. Added advantages are: Extensive clinical development experience and proven experience in driving operational study delivery to time, cost, and quality within the pharmaceutical industry or CRO environment.

Proven ability to collaborate with, influence and manage senior stakeholders both within and outside of the organization.

This level of experience is required to provide clinical trials and project management expertise as well as adequate leadership.

Other Job-Related Skills

Ability to work independently in a matrix environment with minimal supervision.

Experience in clinical research: study management, monitoring, data management

Strong skills and experience in project management and tools

Solid experience working in teams with a broad range of cultures, including team leadership

Excellent leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives

Excellent understanding of the clinical study, drug development, sample management and other associated process and quality requirements

Good project management skills (including scope, budget, timeline, and resource planning and management, and use of associated tools and support where available)

Able to lead and work within teams and networks across functional and geographical boundaries; leads by example and promotes collaboration, effective communication and leadership in others

Able to set and manage priorities, performance targets and project initiatives in a global environment.

Applies industry best practices to the design and execution of clinical studies to improve time and cost efficiency

Demonstrates conceptual, analytical and strategic thinking

Effective at problem solving and conflict resolution

Ability to manage change and uncertainty

Excellent leadership skills, influencing and negotiation skills.

Demonstrated experience leading in the matrix environment to deliver projects, develop clinical plans and manage change.

Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting cross- functional matrix teams.

Ability to articulate and champion key decisions and strategy

Proven ability to effectively/confidently communicate with and present to senior teams

Extensive experience working with investigators, regulatory agencies, CROs and/or third-party vendors

Ready to apply? If this role feels like your next step, we encourage you to apply. Tell us how your experience and perspective will help the team deliver better outcomes for patients and customers. We look forward to hearing from you.

Skills Agile Thinking, Business Acumen, Clinical Development, Clinical Research, Clinical Sciences, Clinical Trial Designs, Communication, Creativity, Decision Making, Fostering Collaboration, Good Clinical Practice (GCP), Influencing Without Authority, Pharmaceutical Industry, Project Management, Time Management    

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

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Inclusion at GSK: As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.

Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs.

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.