Clinical Operations Analyst

3 weeks ago

Boston, United States Medasource Full time

Clinical Operations Analyst

Boston, Massachusetts (Hybrid)

1 year contract with likelihood of extension

Project Goal & Overview:

Our client is seeking a highly experienced Senior Clinical Analyst to lead and execute enterprise initiatives for clinical operations teams. A Senior Clinical Analyst will be responsible for providing strategic direction and leadership in the areas of Veeva Vault, change management, and adoption strategies. This high-level individual will drive transformative change and innovation within the organization.

Deliverables/Milestones:

  • Develop and execute strategic plans and initiatives to optimize the use of Veeva Vault and other clinical technologies, aligning with initiatives and industry best practices.
  • Provide leadership and guidance to junior analysts and cross-functional teams, fostering a culture of collaboration, innovation, and continuous improvement.
  • Lead the development and implementation of comprehensive change management strategies to drive the successful adoption of Veeva Vault and other clinical technologies across the organization.
  • Champion the importance of user engagement and acceptance, advocating for user-centric design principles and fostering a culture of innovation and continuous improvement.
  • Serve as the subject matter expert on Veeva Vault and related clinical trial management systems (CTMS), electronic trial master file (eTMF), and regulatory document management systems.
  • Expert on industry trends, emerging technologies, and best practices, identifying opportunities for innovation and optimization to enhance clinical operations and drive efficiency.
  • Collaborate with key stakeholders across the organization, including clinical operations, regulatory affairs, data management, and IT, to assess user needs, gather requirements, and develop tailored solutions to address business challenges.
  • Oversee quality assurance activities to ensure the integrity, accuracy, and compliance of clinical trial data within Veeva Vault applications, in accordance with regulatory requirements (e.g., FDA guidelines, GCP standards).
  • Lead efforts to prepare for audits and inspections, providing documentation and support as needed to demonstrate compliance and adherence to regulatory standards.

Qualifications:

  • Bachelor's degree in Life Sciences, Computer Science, Information Technology, or related field. Advanced degree (e.g., Master's, MBA) preferred.
  • Significant experience working in a clinical business environment, with a proven track record of success in leading complex projects and initiatives.
  • Expertise in Veeva Vault or similar clinical trial management systems (CTMS), electronic trial master file (eTMF), or regulatory document management systems.
  • Strong leadership and management skills, with the ability to inspire and motivate cross-functional teams and drive results in a dynamic and fast-paced environment.
  • Excellent communication and interpersonal skills, with the ability to effectively engage and influence stakeholders at all levels of the organization.
  • Strategic thinker with a customer-focused mindset, adept at developing innovative solutions to address business challenges and drive operational excellence.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively across departments and levels of the organization.

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