Are you looking for an opportunity to support process improvement initiatives and shares best practices related to Clinical studies and projects?  If so, this is the role for you.

• To assist local study teams in coordinating the planning, start-up and maintenance of operational activities involved in clinical studies within agreed budget, timescales and in accordance with GSK written standards and ICH GCP.
• Maintain up to date participating site information (including contact details, contracts and reports).
• Assist with preparation, collation, review and tracking of all documentation required for approvals processes (e.g. regulatory, ethics, green light process etc).
• Responsible for preparing the Investigator and Sponsor files with essential documents for the initiation of sites participating in clinical studies. Assist with maintaining the sponsor files during the life of the study. Responsible for archiving at the end of study in accordance with relevant GSK SOPs, policies and local regulatory requirements.
• Responsible to manage all logistical aspects of clinical studies according to GSK operating standards and good clinical practice and to ensure that studies receive the support needed to meet timelines and budget.
• Assist with study and site related processes (e.g. handling of data queries)
• Accountable for local activities required in the monitoring of study milestones at each stage of the study; Input and oversee clinical study tracking systems including but not limited to: CTMS, OPAL, list of submissions to RA &ECs, list of shipments to centers, safety database, and metrics database; amend inaccurate milestones and ensure that all issues are communicated and escalated appropriately.
• Responsible for accuracy of study systems. Proactively identifies issues and raises them to take necessary corrective action to ensure smooth and rapid progress of studies.
• Based on local requirements, may be responsible to manage the financial operational aspects including, benchmarking, assisting with study budget build, regular study budget forecasting, setting up purchase orders, reconciling invoices, issuing and tracking payments in accordance with vendor agreements, providing monthly accruals to finance and query resolution.
• Based on local requirements, may be responsible to oversee the clinical and ancillary supplies vendor(s), preparing and reviewing importation documentation, and logistics.
• As an active participant of clinical study teams, engage in local study meetings during the life of the study to obtain general knowledge about the study and be responsible for given tasks. Assist with study related activities such as organizing study meetings and scheduling travel, producing minutes for study-related meetings, assembling training and study materials, updating contact details, maintaining study documentation, assisting in the preparation of documents and other tasks as required.
• Accountable for acquiring/maintaining an optimal level of knowledge of GSK tools and systems to effectively manage them. Is the single point of contact for local study teams for study support questions.
• Maintain effective communication and working relationships with Investigators, other site staff, above country colleagues and other GSK staff.
• Adhere to GSK written standards, processes and ICH GCP guidelines. Keep up to date with all the changes / required knowledge on ICH GCP, GSK written standards and attending appropriate training sessions. Participate continuously in relevant training courses to improve personal/professional skills.
• Share best practices within the LOC and with colleagues in other LOCs.
• May be supporting multiple studies simultaneously and must prioritize appropriately to meet business needs to ensure delivery of results.
• Assist with the planning, logistics and preparation of local Investigator meetings (travel arrangements, preparation and distribution of study related presentation material etc).
• Assist in setting up new employees on relevant systems and completing documentation.
• Assist in completion and tracking of ABAC related activities.

Why you?

Basic Qualifications:

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

• Bachelor’s degree in General Sciences or Life/Health related Science Degree

• Experience working in a pharmaceutical or scientific environment

• Project Management experience

Preferred Qualifications:

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

• Scientific background and knowledge of clinical trails

• Detail-oriented and organized

• Systematical approach to problem solving

• Good time management skills with the ability to clearly identify priorities and manage multiple tasks

• Knowledge of basic finance and accounting principles to understand budget, invoices, cross-charges and expense reports

• Knowledge of Microsoft office tools with advanced Excel, MS project, eTrack, Documentum and SAP

• Excellent communication skills

Why GSK?

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. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.

• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.

• Continuously looking for opportunities to learn, build skills and share learning.

• Sustaining energy and well-being

• Building strong relationships and collaboration, honest and open conversations.

• Budgeting and cost-consciousness

DEI

GSK is an Equal Opportunity Employer and we want GSK to be a workplace where everyone can feel a sense of belonging and thrive. All qualified applicants will receive equal consideration for employment without regard to disability, race/ethnicity, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, or age.

Disability

GSK is committed to being inclusive for people with disabilities. With support from our Global Disability Council and our employee resource group, the Disability Confidence Network, we are working hard to create an inclusive workplace where all our people can thrive. Since 2020, GSK has been an active member of the Valuable 500 pledge, a collection of 500 global companies all committed to placing disability inclusion on the leadership agenda. We are delivering on its objectives through our disability confidence plan.

*Li-GSK  

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.

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