- 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.
- 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.
- 3-5 years working in a clinical business environment, with a proven track record of success in leading complex projects and initiatives.
- Bachelor's degree in Life Sciences, Computer Science, Information Technology, or related field. Advanced degree (e.g., Master's, MBA) preferred.
- 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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Clinical Operations Specialist - Boston, United States - Medasource
Description
Clinical Operations Analyst
Client: Pharmaceutical Client of Medasource
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:
Qualifications:
