- 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 Analyst - Cambridge, United States - Medasource
Description
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<<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:
Qualifications:
Medasource provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.
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