Clinical Trial Transparency, Lead

Location

Bangalore | India

Job description

• The purpose of the role of the Manager, Clinical Trial Transparency is to drive the delivery of activities related to data disclosure in GSK RD 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 eg 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 (eg 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 (eg protocol and result summaries, full protocols, reporting and analysis plans and clinical study report synopses) to external registers eg 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 (eg 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

Previous Experience Required

o Broad scientific/ pharmaceutical industry background with more than 6 years of experience in clinical research and/or in pharmaceutical industry.

o Proficiency in GCP/ICH guidelines and regulations governing clinical trial disclosure (FDAAA 801 Final Rule, European Clinical Trial Directive, European Clinical Trial Regulation)

o Knowledge of PhRMA/EFPIA principles of clinical trial disclosure, and related best practices

o Experience with Clinical Trial Disclosure software solution(s)

o Knowledge of GSK clinical/EPI/HE development activities and GCP Guidelines.

o Proven experience of managing and driving complex transversal projects involving senior management

o Previous experience to implement change management projects.

Previous line management and matrix team experience is essential.

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