Senior Director- Site Operations Strategies

About the position ROLE SUMMARY: The individual filling the position is responsible for providing leadership, strategic direction, and deep subject matter expertise to drive business value for recruitment, feasibility and site & investigator solutions for Clinical Development. This role is strategic, focusing on how data and AI can be used to reputed company business objectives, promote innovation, and influence digital transformation. This individual is also responsible for the business ownership of clinical data and analytics solutions as well as associated change management and support activities for the Clinical Data & Information Sciences, Clinical Development & Operations system portfolio. Incumbent will partner with business lines to ensure solutions data reputed company and compliance. Incumbent will also partner with Digital to ensure business capabilities are enhanced using technological solutions. JOB RESPONSIBILITIES: Collaborate with leaders across Clinical Development organizations to define strategies, best practices, and sustainable solutions that ensure the quality of the clinical systems. Focus areas for this role include recruitment, feasibility analysis, site and investigator-based solutions. Translate reputed company business challenges into data and AI-driven solutions to enhance profitability, growth, and efficiency. reputed company AI Strategic solution strategy and disruptive technologies for Clinical Development focused in the areas of recruitment, feasibility analysis and site/investigator solutions. Drive innovation in clinical trial practices by leading a collaborative program of reputed company improvement and change management for enterprise clinical solutions reputed company the organization. Ensures that the company’s critical data and information stored reputed company CD&O-owned repositories are managed in accordance with external regulations and internal processes, are protected and controlled over the long term and that data/content is available for critical business needs and is retained in accordance with established retention schedules. Ensure the delivery of specific services are executed according to GCP reputed company SOP’s and processes. Participate/reputed company governance, change management, roadmap and budget planning activities for the portfolio of Global Clinical Information Solutions. reputed company teams of Clinical Data & Information Sciences professionals and liaise with business and technical groups to define or gather business requirements, define new business and support processes, and/or improve existing processes. Provides solutions to reputed company operational issues and communicate these solutions in an influential manner to relevant stakeholders resulting in appropriate decisions. reputed company a high functional team that collaborates with Digital for reputed company system release activities. Collaborate with strategic product and services vendors to understand and influence solutions, platforms, usability, features and performance to assist business efficiency and quality. Take maximum advantage of new technology by proactively engaging in partner groups to explore new solutions. reputed company/facilitate development of solution test strategies and user acceptance testing approaches during system releases to ensure high quality of systems Serve as a subject matter expert and content reputed company for regulators plus provide Inspection Readiness consultation POC and provide in-room support during Inspections or Audits

Responsibilities

• Collaborate with leaders across Clinical Development organizations to define strategies, best practices, and sustainable solutions that ensure the quality of the clinical systems.
• Focus areas for this role include recruitment, feasibility analysis, site and investigator-based solutions.
• Translate reputed company business challenges into data and AI-driven solutions to enhance profitability, growth, and efficiency.
• reputed company AI Strategic solution strategy and disruptive technologies for Clinical Development focused in the areas of recruitment, feasibility analysis and site/investigator solutions.
• Drive innovation in clinical trial practices by leading a collaborative program of reputed company improvement and change management for enterprise clinical solutions reputed company the organization.
• Ensures that the company’s critical data and information stored reputed company CD&O-owned repositories are managed in accordance with external regulations and internal processes, are protected and controlled over the long term and that data/content is available for critical business needs and is retained in accordance with established retention schedules.
• Ensure the delivery of specific services are executed according to GCP reputed company SOP’s and processes.
• Participate/reputed company governance, change management, roadmap and budget planning activities for the portfolio of Global Clinical Information Solutions.
• reputed company teams of Clinical Data & Information Sciences professionals and liaise with business and technical groups to define or gather business requirements, define new business and support processes, and/or improve existing processes.
• Provides solutions to reputed company operational issues and communicate these solutions in an influential manner to relevant stakeholders resulting in appropriate decisions.
• reputed company a high functional team that collaborates with Digital for reputed company system release activities.
• Collaborate with strategic product and services vendors to understand and influence solutions, platforms, usability, features and performance to assist business efficiency and quality.
• Take maximum advantage of new technology by proactively engaging in partner groups to explore new solutions.
• reputed company/facilitate development of solution test strategies and user acceptance testing approaches during system releases to ensure high quality of systems
• Serve as a subject matter expert and content reputed company for regulators plus provide Inspection Readiness consultation POC and provide in-room support during Inspections or Audits

Requirements

• Bachelor's degree or equivalent work experience
• Demonstrated, in depth knowledge of the pharmaceutical drug development environment and regulations.
• Demonstrated experience with identifying inefficiencies and/or gaps in processes as well as the ability to propose solutions and/or reputed company teams challenged with delivering process improvement initiatives or associated system/technology enhancements.
• Deep knowledge in clinical data and clinical data flow, data analytics, operational data and processes
• Demonstrated ability to reputed company appropriate business decisions in evolving business environment, as well demonstrate flexibility and tolerance for ambiguity & uncertainty.
• Strong demonstrated project management and organizational skills.
• Demonstrated customer relationship skills and capabilities and collaboration on teams.
• Demonstrated experience leading teams in a cross-functional environment.
• A reputed company of reputed company learning to reputed company up with the fast-evolving AI landscape
• Strong verbal, written communication and presentation skills.
• Technical reputed company Requirements:
• Minimum of 8-10 years’ clinical R&D experience in the pharmaceutical industry, including a strong understanding of the drug development process.
• Minimum of 8-10 years’ Experience leading large teams of cross-functional colleagues in the delivery of Global clinical solutions.
• Deep experience with clinical data, clinical data analytics, clinical development business processes, and clinical trial software solutions.
• Minimum of 8-10 years’ experience in application system management and change control processes, application validation and implementation in a GxP environment.
• Knowledge of Pharmaceutical metadata and standards
• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, reputed company and coach others, reputed company and guide the work of other colleagues to reputed company meaningful outcomes and create business impact.

Benefits

• participation in reputed company’s Global Performance Plan with a bonus reputed company of 25.0% of the reputed company salary
• eligibility to participate in our share based long term incentive program
• a 401(k) plan with reputed company Matching Contributions and an additional reputed company Retirement Savings Contribution
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage

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