Clinical Trial Transparency Job at GSK – Apply Online

Clinical Trial Transparency Job at GSK – Apply Online

Clinical Trial Transparency Job at GSK – Apply Online. GSK is hiring for the Clinical trial manager vacancy at the Bangalore location. Please see the details below and apply now. GSK opening for Clinical Trial Job.

Position – Manager – Clinical Trial Transparency

Job ID – 376986

Location – Bengaluru, India

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.

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
• 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.

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Hello friends, we are attaching the expected interview questions and answers here for the Clinical Trial Biotech Job. Practice the same and attend your interview. All the best!!!

Question 1: Can you provide an example of a challenging project you’ve managed involving clinical trial disclosure and data sharing? How did you navigate the complexities and ensure timely and accurate delivery of required documents? Answer: Certainly. In my previous role, I was tasked with overseeing the end-to-end process of clinical trial data disclosure for a complex oncology study. The challenge was to ensure compliance with multiple regulatory requirements while coordinating with cross-functional teams. To address this, I established a streamlined communication interface and regular check-ins with stakeholders. I also collaborated closely with external service providers to manage the workload efficiently. By implementing a clear project plan, assigning responsibilities, and closely monitoring progress, we successfully delivered all required documents within the specified timelines. This experience taught me the importance of effective project management and collaboration in achieving disclosure objectives.

Question 2: How do you stay updated with the evolving landscape of clinical trial disclosure regulations and transparency requirements? Can you provide an example of how you’ve applied this knowledge to your work? Answer: Staying current with evolving regulations is essential in my role. I actively participate in industry conferences, webinars, and workshops related to clinical trial disclosure and transparency. Additionally, I regularly review updates from regulatory authorities such as the FDA and EMA. An example of applying this knowledge is when a recent regulatory update introduced changes to the reporting requirements for patient-level data sharing. I promptly organized a cross-functional meeting to assess the impact on ongoing studies and collaborated with study teams to revise our disclosure plans accordingly. This proactive approach ensured that our practices remained compliant and aligned with the latest guidelines.

Question 3: Can you share your experience in managing and motivating matrix teams in a clinical research environment? How do you ensure effective collaboration and communication among team members with diverse expertise? Answer: In my previous role, I led a matrix team comprising members from clinical operations, regulatory affairs, and medical writing. To ensure effective collaboration, I established a clear communication framework with regular team meetings and designated points of contact for each functional area. I leveraged my understanding of each team member’s expertise to delegate tasks appropriately and encourage knowledge sharing. I also implemented a reward and recognition program that acknowledged individual contributions within the team. This approach fostered a sense of ownership and camaraderie, resulting in improved collaboration and successful project outcomes.

Question 4: How do you approach implementing change management projects within a regulated environment? Can you provide an example of a change you’ve successfully driven and how you navigated potential resistance? Answer: Implementing change in a regulated environment requires a thoughtful approach. In a previous role, we needed to transition from manual to automated processes for clinical trial disclosure. To address potential resistance, I initiated a change impact assessment, identifying stakeholders who might be affected and their concerns. I then developed a comprehensive communication plan, emphasizing the benefits of the new system in terms of efficiency and accuracy. By involving stakeholders in the decision-making process and addressing their concerns proactively, we gained their buy-in and successfully implemented the change with minimal disruption.

Question 5: Can you describe a situation where you identified transparency risks in clinical trial disclosure processes and implemented strategies to mitigate those risks? Answer: Certainly. In a previous role, during a routine process review, I identified a gap in our documentation process that could potentially lead to incomplete disclosure of a study’s results. To mitigate this risk, I proposed and led the implementation of a standardized checklist for study teams to ensure all necessary documents were prepared and submitted to the relevant registries. I also conducted training sessions to educate the teams about the importance of comprehensive documentation. This approach not only minimized the risk of incomplete disclosure but also enhanced our overall transparency practices by setting a consistent standard for documentation across all studies.

Editor’s Note: Clinical Trial Transparency Job 2023. Clinical Trial Transparency Job at GSK – Apply Online. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook and Instagram.