Senior Study Delivery Lead

Job purpose :

• The Senior Study Delivery Lead (sSDL) is the Project Manager of a study. As such, the sSDL is accountable to ensure that the study team is planning and executing the study according to time, budget and quality and as defined in the Development Plans (Clinical, Epidemiology, Global and Local studies), in the study management plan, in the study protocol, and in adherence with ICH-GCP guidelines, GSK Vaccines control documents and within regulatory requirements. The sSDL has the accountability for 1 or several complex studies, and perform the full set of activities of the Study Delivery Lead (see Job description of SDL) and has the ability and the seniority to manage the delivery of any types of studies (different areas, complex/unusual early setting, new/unusual indication, pivotal / Phase III and efficacy studies, clinical as well as epidemiology and local studies, complex countries/regional environment). The sSDL is able to develop and follow the most efficient operating model for supported/collaborative studies, to manage appropriately the risks linked to supported/collaborative studies and has experience and skills to manage all associated requirements – Same for the management and oversight of outsourced studies (including RFP/Bid defense and contract management). The sSDL is able to manage large & multidisciplinary study team (up to 30 team members) and manages studies with a budget that can be >10 M€ with more than 15000 human subjects for studies. The sSDL may have the responsibility for a clinical development sub-program and therefore can be contributor to the program strategy development and program delivery oversight. The sSDL is the reference and role model within study delivery lead team

In this role you,

• are ensuring the translation of scientific objectives in the Study Management Plan. By using integrated processes, tools and measures you ensures the study oversight, delivery of the study on time, according budget and with quality, using a risk based approach methodology

• lead a multifunctional team to ensure study Oversight, study delivery and takes operational decisions at study level (will refer to Project Delivery Lead as needed).

• Participate in country and site selection, with reference to pre-selection decisions made at Development Plans level

• develop and ensure on-time execution of supportive documents, plans and manuals including the monitoring plan, study procedures manuals, core operational packages for submission and for countries

• are responsible for vendor management activities including selection and contract development when outsourced activities are owned by the Study Delivery Lead

• develop and follow the most efficient operating model for collaborative studies, to manage appropriately the risks linked to supported/collaborative studies and has experience and skills to manage all associated requirements – Same for the management and oversight of outsourced studies (including RFP/Bid defense and contract management)

• provide input to the clinical study report / module appendix

• As part of his/her development, you may contribute to a small clinical development sub-program operational strategy and takes the oversight of its delivery

• are typically responsible for >4 trials of average to very high design and protocol complexity

• maintain expertise in GCP and in clinical study management methodology and support process improvement initiatives and shares best practices within the Study Delivery Lead team and beyond.

Basic Qualifications:

We are looking for professionals with the following required skills to achieve our goals (must-have):

• >8 years of significant experience in managing complex clinical research studies, clinical operations or equivalent. Has a very good understanding of the clinical research and clinical trial management, associated regulatory, processes and quality requirements.

• 2 years of experience in regional clinical study leadership desirable (field experience)

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

• Demonstrates an excellent understanding of the clinical study, drug development , sample management and other associated process and quality requirements, including ICH/GCP guidelines and SOPs

• Strong 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

Preferred Qualifications:

The following characteristics are assets (nice-to-have):

• Experience in the healthcare or pharma industry

• Possesses excellent English language written and verbal communication skills in addition to proven negotiation skills.

• Knowledge of French is an asset

Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork in a culture of Innovation, Performance and Trust.

Our Vaccines business has a broad portfolio and innovative pipeline of vaccines to protect people of all ages. We deliver over two million vaccine doses per day to people living in over 160 countries.

For further information, please visit www.gsk.com.

Our department:

Research and Development (R&D)

Patient-focused Research and Development (R&D) is the heart of our business. Our R&D department seeks to discover and develop new vaccines, to protect against diseases where vaccines are not yet available and to improve on those vaccines that already exist. Part of our R&D programme targets diseases particularly prevalent in the developing world, including the World Health Organisation’s three priority diseases - HIV/AIDS, tuberculosis and malaria. Research into candidate vaccines for other diseases of the developing world, such as dengue are at an earlier stage of development.

When it comes to developing the vaccines of the future, we’re looking for real experts in their respective fields who are interested in working in the stimulating environment of an international healthcare company.

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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