Manager/lead - Clinical Trial Transparency
1 day ago
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 Find out more 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 ClinicalTrials gov 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 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 so that we can confirm to you if the job is genuine
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