Manager/Lead - Clinical Trial Transparency

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
At GSK, we are committed to ensuring transparency in clinical trials to build trust and advance science. In this role, you will lead efforts to ensure compliance with global clinical trial transparency regulations and policies. You will collaborate with cross-functional teams, manage processes, and drive improvements to ensure timely and accurate disclosure of clinical trial information. This is an opportunity to make a meaningful impact on public health while growing your career in a supportive and inclusive environment.

Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Lead the end to end process delivery of clinical trial transparency activities, ensuring compliance with global regulations and GSK policies.

- Evaluate studies to identify disclosure and patient-level data sharing requirements, while ensuring high-quality, complete, consistent, and timely disclosures. Guide study teams in listing studies in public disclosure registries such as GSK/ViiV Study Registers, , EU Clinical Trials Register, EU PAS Register/RWD Catalogue, and relevant data-sharing platforms.

- Collaborate with cross-functional teams to ensure timely and accurate disclosure of clinical trial information to public registers.
- Develop and implement processes to improve transparency and disclosure activities across the organization.
- Monitor changes in global transparency regulations and translate them into actionable strategies for GSK.
- Identify and manage business risks related to clinical trial transparency, implementing effective mitigation strategies.
- Provide training and guidance to internal teams and external partners to ensure consistent and high-quality transparency practices.

Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
- Master's degree in Life Sciences or a related field.
- Minimum of 6 years of experience in clinical research or the pharmaceutical industry.
- Strong knowledge of global clinical trial transparency regulations, including FDAAA Final Rule, EU Clinical Trial Regulation, and other relevant guidelines.
- Experience in managing complex projects and working with cross-functional teams.
- Proven ability to deliver high-quality outputs within deadlines.
- Excellent communication and stakeholder management skills.

Preferred Qualification
If you have the following characteristics, it would be a plus:
- Advanced degree in Life Sciences or a related field.
- Experience with clinical trial disclosure software solutions.
- Knowledge of anonymization techniques and data sharing practices.
- Familiarity with PhRMA/EFPIA principles and best practices for clinical trial disclosure.
- Experience in implementing process improvements and change management initiatives.
- Previous experience in a leadership or team management role.

This role is based in India (Bangalore) and offers a hybrid working model, combining remote work (based out of Bangalore location) with on-site collaboration.

We encourage you to apply if you are passionate about making a difference in clinical trial transparency and want to contribute to GSK's mission of getting ahead of disease together.

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- to discuss your needs.

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