GSK BSc Life Science Job – Apply For Clinical Ops Analyst Opening
GSK BSc Life Science Job – Apply For Clinical Ops Analyst Opening. GSk BSc Clinical Operations Job details are provided below. If you are interested go through the details and apply now for BSc Clinical Operations Job.
Position – Senior Clinical Operations Planning & Feasibility Analyst
Req ID – 376764
Site Name: Bengaluru Luxor North Tower
Job description –
As R&D efforts follow science without constraint, we need to take full advantage of our internal data and expertise, as well as leverage external services and technology, to inform, optimize and validate our clinical trial protocols, feasibility planning and study delivery plans. This includes leading & managing a robust site feasibility process.
As such we are seeking to
appoint a Senior Clinical Operations Planning & Feasibility Analyst to create data driven, high quality insights and modelling to support clinical operations project and study team members. This role will directly support clinical operations planning & feasibility activities.Key Responsibilities include, but are not limited to:
- Supports the implementation of the global Country Selection and Site Identification feasibility process for each study, including a data-driven recommendation for countries to pre-select to participate in feasibility activities and final country selection.
- Work cross-functionally with internal groups including but not limited to the Study Delivery team (SDL, SDM, SDS), Clinical Operations Asset Lead, Protocol Design Lab, Clinical Supplies/TRD, Lab Manager, Global Regulatory, Global Medical, Epidemiology, Global Marketing/Commercial, and Local GMASE Medical/Clinical Teams as needed to obtain stakeholder feedback on key study requirements for feasibility and build relationships with relevant stakeholders throughout the feasibility process.
- Activities to support data gathering and data analysis for feasibility. Potential data sources include literature searches, investigator databases, epidemiology databases, and use of other internal tools to support feasibility data gathering.
- Supporting the development of feasibility documentation to support the study including Country Pre-Selection Proposals, Feasibility KOM slides, and Feasibility Questionnaires.
- Demonstrate ownership and accountability through effective problem solving throughout the feasibility process.
- Enable self-service analytics by building and maintaining interactive dashboards and reports incorporating key stakeholder feedback (i.e. Feasibility and SSU team, Global Clinical Operations)
- Use internal and industry data sources, along with data analytics, to generate insights used for the planning of clinical trials
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor’s degree in life sciences
- 5-9 years of relevant industry experience
- Previous experience in a clinical development operations or study feasibility role at a CRO, pharmaceutical company or other relevant environment
- Tack record in problem solving.
- Results orientated with a drive to set and reach challenging goals with high standards for performance
- Excellent written and verbal communication skills
- Ability to work in a matrix environment
- Learning Agility
- Understanding of the drug development process
- Understanding of all relevant industry guidelines (ie; FDA, GCP and ICH guidelines)
Preferred skills:
- Master’s or PhD degree in relevant field
- Experience utilizing clinical trial recruitment modelling tools
- High level of proficiency with Microsoft Office
Greetings, dear friends. We have compiled a set of interview questions and corresponding answers that you may anticipate encountering during your interview for the PhD Clinical Operations Job. We encourage you to prepare thoroughly so that you can excel in your upcoming interview.
Question 1: Can you explain your experience in implementing the global Country Selection and Site Identification feasibility process for clinical trials? Answer: In my previous role, I was responsible for overseeing the implementation of the global Country Selection and Site Identification feasibility process for clinical trials. This involved analyzing various data sources, such as literature searches, investigator databases, and epidemiology databases, to recommend countries for pre-selection. I collaborated extensively with cross-functional teams, including Study Delivery, Clinical Operations, Regulatory, and Medical teams, to gather stakeholder feedback and ensure that key study requirements were met. This experience has equipped me with the ability to effectively manage the feasibility process and build relationships with relevant stakeholders.
Question 2: How do you ensure the quality and accuracy of feasibility documentation? Can you provide an example? Answer: Ensuring the quality and accuracy of feasibility documentation is crucial for successful study planning. In my previous role, I led the development of Country Pre-Selection Proposals, Feasibility KOM slides, and Feasibility Questionnaires. One example that demonstrates my approach is when I collaborated with the Protocol Design Lab to create a Feasibility Questionnaire. I incorporated their input regarding protocol complexity and specific requirements into the questionnaire, ensuring that the feasibility process was aligned with the study’s goals. This attention to detail and collaboration helped enhance the accuracy and effectiveness of the feasibility documentation.
Question 3: Describe a challenging problem you encountered during the feasibility process and how you resolved it. Answer: While working on a complex clinical trial feasibility assessment, I encountered challenges related to identifying suitable countries with the required patient population. To address this, I utilized clinical trial recruitment modeling tools to analyze historical data and predict patient enrollment potential in different regions. By doing so, I was able to provide valuable insights to the study team, helping them make informed decisions about country selection. This experience showcased my problem-solving skills and the importance of leveraging technology to overcome feasibility challenges.
Question 4: How do you handle working in a matrix environment and collaborating with various internal teams? Answer: Collaborating in a matrix environment requires effective communication and adaptability. In my previous roles, I consistently engaged with cross-functional teams, such as Study Delivery, Clinical Supplies, Regulatory, and Medical teams. I actively participated in meetings, ensuring that all stakeholders were informed and aligned with study requirements. To foster collaboration, I proactively sought feedback from team members, incorporated their perspectives, and established strong working relationships. This approach enabled me to navigate the matrix environment successfully and deliver on project goals.
Question 5: Could you elaborate on your experience in using data analytics to generate insights for clinical trial planning? Answer: Data analytics plays a pivotal role in optimizing clinical trial planning. In my previous roles, I used a combination of internal and industry data sources to extract meaningful insights. For instance, I employed data analytics to assess patient demographics, disease prevalence, and site performance metrics, which informed the selection of suitable countries for trials. By applying advanced data analysis techniques, I was able to provide evidence-based recommendations that contributed to the planning of successful clinical trials.
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