Job Description

: Site Name: Bengaluru Luxor North Tower Posted Date: Sep 16 2022 Ready to help shape the future of healthcare? GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of diseas

: Site Name: Bengaluru Luxor North Tower Posted Date: Sep 16 2022 Ready to help shape the future of healthcare 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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. Job Purpose:- The purpose of the role of the Manager, Clinical Trial Transparency is to drive the delivery of activities related to data disclosure in GSK R&D in the respective therapy area (Oncology, Specialty, Vaccines). The role is accountable to ensure consistent, timely and complete delivery of clinical documents and data related to GSK Sponsored human subject research e.g. protocol and results summaries, full protocols, reporting and analysis plans and clinical study reports, and patient level data, ensuring ethical and transparent disclosure of data in compliance with GSK Policy on Disclosure as well as external regulations in collaboration with a multidisciplinary team of experts across projects. The role will support the implementation of new processes to meet regulatory requirements related to transparency of clinical studies and other data disclosure deliverables and drive the operational delivery of current and future transparency commitments (e.g. plain language summaries). The role holder will need to make judgment calls to apply policy and practice recommendations to complex situations involving multiple internal stakeholders. The role is responsible to maintain the standards to highest level for data accuracy through the scrupulous respect of an established, auditable process, and communication of process to all involved players. The role holder will have to combine project management and governance aspects in a matrix environment. Key Responsibilities:- Drive end to end process delivery and improvements in the area of regulated and policy driven clinical disclosures and data sharing. Serve as a single-point of contact for project teams and functional matrix teams for questions related to Data Disclosure. Assess studies for disclosure and patient level data sharing requirements and guide study teams through the achievement of complete, consistent and timely disclosure and listing of studies in scope for public disclosure registries such as GSK/ViiV Study Registers, Clinicaltrials.gov, EU Clinical Trials Register, EU PAS register and Data sharing websites (such as Clinical Study Data Request (CSDR)). Ensure timely, consistent and accurate delivery of data disclosure artefacts (e.g. protocol and result summaries, full protocols, reporting and analysis plans and clinical study report synopses) to external registers e.g. ClinicalTrials.gov, EU Clinical Trials Register and GSK/ViiV Study Register, and to other national registers, as required. Collaborate with a team of recognized subject matter experts to ensure quality of output. Work with outsourced resources (platforms, consultants) to ensure resources to address workload beyond FTE capabilities. Supervise and monitor delivery of the documents amongst the different Service providers involved. Coordinate workload distribution and establish/ maintain a robust communication interface across all people involved in the delivery of the documents. Act as primary point of contact for service provider(s). Monitor CRO performance. Supervise quality of output delivered by individual members of the team Maintain awareness of changes in the disclosure, transparency and data sharing landscape, including new legal, regulatory requirements and industry trends and translates into GSK's Clinical Trial Disclosure and Transparency strategy. Promote consistent process for trial disclosure activities throughout the therapy area. Contribute to the development of procedural documentation including guidance documents and / or instructional documents. Support maintenance and improvement of processes for disclosure function according to evolving requirements. Proactively identify business transparency risks and propose and implement strategies to manage the implications of these risks on the business. Support risk management framework implementation, including risk identification, assessment and prioritisation and the definition of mitigation plans. Drive compliance to organizational key performance indicators and monitor for continuous improvement in clinical data transparency and data sharing (e.g. Transparency Dashboard). Contribute to the development of training material for the business, clinical support services and service provider(s). Develop and maintain knowledge and expertise in Data Disclosure environment (Publications and Data Disclosure). Partner with key internal stakeholders to strengthen ensure that GSK practices for Policy requirements are in line with relevant internal and external requirements. Knowledge/Education Required:- Minimum Level of Education Required - University Scientific Degree Master or equivalent professional experience Preferred Level of Education - Phd Area of Specialization - Pharmacy, Chemistry, Bio Engineer, Biology, Medical Doctor, Bio Medical Sciences, Medical Governance qualification is an asset Minimum Level of Job-Related Experience Required:- Broad scientific/ pharmaceutical industry background with more than 6 years of experience in clinical research and/or in pharmaceutical industry. Proficiency in GCP/ICH guidelines and regulations governing clinical trial disclosure (FDAAA 801 Final Rule, European Clinical Trial Directive, European Clinical Trial Regulation) Knowledge of PhRMA/EFPIA principles of clinical trial disclosure, and related best practices Experience with Clinical Trial Disclosure software solution(s) Knowledge of GSK clinical/EPI/HE development activities and GCP Guidelines. Proven experience of managing and driving complex transversal projects involving senior management Previous experience to implement change management projects. Previous line management and matrix team experience is essential. Job-Related Experience sections above that are required for the job:- Significant knowledge and understanding of R&D environment, policies and procedures and applicable regulated disclosure requirements. Strong understanding of GSK Organization strategy. Able to make links within GSK organization. Ability to incorporate strategy & organizational considerations and to operationalize them. Proven sense of urgency. Possesses excellent English language written and verbal communication skills in addition to proven negotiation skills. Promotes motivation and empowerment of others in order to accomplish individual, team and organizational objectives. Ability to resolve problems with use of knowledge, information and networks in a flexible way and to be successful in a matrix environment. Self-motivated with the ability to work independently, to develop credibility with colleagues within iGSK. Act as a role model in line with GSK core values and behaviours. Comfortable to evolve in changing and challenging environment. At GSK we value diversity (Gender, LGBTQ +, PwD etc.) and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution. .LI-GSK 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. 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. 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