Clinical Operations Planning And Feasibility Associate Director

Year    Mumbai, Maharashtra, India

Job Description


Site Name: India - Maharashtra - Worli Mumbai Posted Date: Feb 28 2023 Key Responsibilities . Use internal and industry data sources, along with data analytics, to generate insights used for the planning of clinical trials . Utilisation of current and emerging data sources to identify risks and challenges to optimise clinical trial protocol design . Lead the site feasibility process in close partnership with the network of local offices . Provide timely, high-quality deliverables (e.g. recruitment plans, feasibility report) to clinical trial teams to support the clinical trial planning . Actively participate in team meetings to obtain relevant information and present the result of their work . Comprehensive tracking of assumptions used to generate deliverables . Line management of a team of analysts: recruitment, objective setting, performance review, development, and resources tracking & management . Contribute to the tracking and reporting of KPIs and OKRs . Drive continuous improvement in Feasibility and Clinical Operations Planning processes . Identify and share trial informatics best practice and exemplars within Clinical Operations. . May support the assessment, piloting and embedding of new data analytics and data sources to ensure GSK continues to access best in class solutions. . May act as Subject Matter Expert or System Business Owner for tools and systems . Maintain information on impact and successes. . Provide mentoring and coaching to more junior members of staff Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: . Bachelor\'s degree in relevant field . 7+ years relevant industry experience . Demonstrated leadership in a clinical development operations or study feasibility role at a CRO, pharmaceutical company or other relevant environment . Proven track record in problem solving . Excellent project management skills gained in a complex matrix organization . Results orientated with a drive to set and reach challenging goals with high standards for performance . Excellent influencing and negotiation skills . Excellent written and verbal communication skills . Ability to build strong relationships . Ability to analyse data from divergent sources and translate it into meaningful recommendations . Good 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 . Line management experience . Knowledge of Agile methodology . Experience utilizing clinical trial recruitment modelling tools . Experience utilizing industry clinical trial related data sources (i.e., CiteLine, DQS, TriNetX, etc) . Experience across therapeutic areas would be advantageous . Experience with data manipulation, visualization, or advanced analytics . High level of proficiency with Microsoft Office 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. 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Job Detail

  • Job Id
    JD3026040
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Mumbai, Maharashtra, India
  • Education
    Not mentioned
  • Experience
    Year