Study Manager

Business Introduction
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
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Our approach to R&D

Position Summary

This position within GCSD works cross- functionally within internal (e.g. LOC) and external partners (e.g. vendors) to deliver delegated operational tasks from CSI (Commit to Study Initiation) until study archiving to time, quality, budget, company standards and scientific requirements as outlined in the clinical study protocol.

The SM is accountable for delivery of delegated operational tasks to time, quality, budget, company standards and scientific requirements, supporting decision making at pace and supporting study teams to achieve overall study deliverables in consultation with the Global Study Lead (GSL) and Global Study Manager (GSM).

The SM as Scrum Master is responsible for effective implementation of STOM ways of working and facilitation of key STOM ceremonies. The SM collaborates closely with Study Leadership Team (SLT) and Working Group (WG) Leads to proactively identify and address obstacles that may impede the study team's progress. Additionally, the SM ensures transparency and alignment across stakeholders by guiding the team in the effective use of collaborative tools (e.g., Jira or other platforms) to track progress, manage workflows, and foster communication.

Responsibilities

- SM works in close partnership with the GSL and GSM on end-to-end operational study delivery activities, from study setup to study archival, with the focus on overseeing SDS activities and ensuring completeness of internal systems/databases/tracing tools and project plans (CSAP).

- SM works cross functionally, with internal and external team members, in accordance with STOM framework, current clinical study regulations and GSK procedures, policies, best practices and standards, and plays a key role in successful study delivery,providing subject matter expertise across key processes and systems throughout the life cycle of the study.
- Clinical study management activities in scope of the SM may include any of the following, agreed in partnership with the GSM and GSL:

- Monitoring study conduct and progress, identifying, resolving and escalating risks/issues which may impact delivery of the study to the necessary quality, timeline and budget objectives and maintaining systems.
- Reviewing and leading development of key clinical documents and manuals, including the Protocol and Informed Consent Forms, and leading development of study plans (e.g. Monitoring Plan, Vendor Management Plan, Protocol Deviation Management Plan, Risk Management Plan, Communication Plan, Pharmacy Manual etc.) for external and internal use in assigned studies.
- Facilitating and maintaining interactions and meetings with internal (including but not limited to regulatory, LOC, quality assurance, Monitors meeting/Investigators’ Meeting, STOM Ceremonies) and external partners (including CROs and third-party vendors) to ensure the successful delivery of assigned studies.
- Support GSM in CRO oversight, overseeing study-specific deliverables, ensuring continued monitoring and timely delivery of activities delegated to third parties
- Vendor management-could serve as a primary point of contact overseeing study-specific deliverables, ensuring continued monitoring and timely delivery of activities delegated to third parties
- Country oversight, acting as a primary point of contact, tracking of recruitment progress, data completeness and compliance, overseeing protocol deviations, risks, regulatory approvals and import license status with support of SDS where appropriate.
- Coordinating study-related activities and overseeing study team's communication – meetings, info-spaces, newsletters, action logs, communication plans, team lists with the support of SDS.
- Overseeing delivery of clinical supplies, investigational products and all study materials provided by GSK or external service providers and communicating issues/risks to continuity of supplies and proposing solutions as appropriate.

- Data oversight to ensure the study is inspection ready at all times, including oversight of eTMF completeness and SDS deliverables (eTMF setup, periodic reviews, following up on missing documents, Safety Reports Dissemination-), and assure that SDS keeps all eTMF documents complete and verified for quality.
- Overseeing of budget tracking done by SDS – managing Task/Change Orders, expenses, tracking updates, checking consistency between systems and agreements and escalating issues to the GSL. Internal SM can act as a PO owner
- Actively contributes to the Study Leadership Team, Central Study Team and (if necessary) in working groups (Scrum Master role) and acts as a mediator by breaking down barriers, strengthening team dynamics, building business agility and embracing change.
- Ambassadors in increasing utilisation of AIML tools, driving automation of manual processes, finding efficiencies and more effective ways of working
- SM is a proactive problem solver, able to act independently with minimal input
- SM acts as a mentor for less experienced colleagues.
- SM can play a role of a Subject Matter Expert (SME) in selected systems and processes
- FSP staff oversight (SDS, other as applicable)
- Investigator/Monitors’ meeting preparation, coordination and acting as a presenter, where required
- Could serve as a primary point of contact for SSU, Feasibility, Regulatory, DM & CM teams

Basic Qualification

- University degree or equivalent, preferably in medical or biological science or discipline associated with clinical studies
- At least 8 years of relevant work experience in a pharmaceutical/scientific environment.
- Knowledge of clinical trials, drug development process.
- Strong knowledge of ICH-GCP, clinical study delivery process, including regulations, operational best practices, industry standards. Well familiar with key systems used in clinical trial delivery. Experience in using Trial Master File industry accepted standard.
- Project management skills (preferably with analytical/financial skills) and good leadership skills.
- Excellent verbal and written communication in English.
- Strong communication and relationship building skills, including external service provider management skills.

Preferred Qualification

Strong knowledge of, and skills in applying, applicable clinical trial regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.

- Ability to manage multiple competing priorities with leadership guidance across various clinical studies with good planning, time management and prioritization skills.
- Logical/analytical thinking and an inclination to spot patterns and outliers. Quality mindset, critical sense, attention to details, effective training and mentoring skills.
- Good understanding of the principles of project planning and management.
- Knowledge of project finance and accounting principles in order to understand budget, invoices, cross-charges and expense reports.
- Excellent comprehension of Microsoft Office tools (Excel, PowerPoint, Word, Outlook, etc.). Knowledge of advanced Excel, timelines/budget tracking systems and clinical trial management systems.
- Good stakeholder management and communication skills (oral and written), strong interpersonal skills.
- Good networking capabilities and ability to influence and manage stakeholders, ability to facilitate and lead cross-functional meetings, challenge status quo and inefficient ways of working.
- Results driven and efficient. Motivated and dynamic personality. Able to evolve in a changing and challenging environment, coach the study team members to focus on value, building business agility and embracing change.
- Ability to adjust to work in cross-functional squads in the agile model.
- Role model in line with GSK core values and expectations. Team spirit and ability to work across cultures and geographies with a high awareness and understanding of cultural differences.

Inclusion at GSK

We welcome people from different backgrounds and life experiences. We support an inclusive workplace where everyone can contribute and grow. If you need adjustments during the recruitment process, tell our recruitment team how we can support you.

Ready to apply

If this role matches your skills and goals, we encourage you to apply. We look forward to hearing how you can help progress evidence generation and make a meaningful difference for patients.

Skills

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 [email protected] to discuss your needs.

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