Life Sciences

Clinical Operations Analyst

Contract

Medasource

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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:

  • 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.

 

 

Qualifications:

  • 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.

Clinical Operations Analyst Cambridge, MA

For over 16 years, Eight Eleven has established and maintained relationships that are designed to meet your IT staffing needs. Whether it’s contract, contract-to-hire, or permanent placement work, we customise our search based upon your company’s unique initiatives, culture and technologies. With our national team of recruiters placed at 21 major hubs around the nation Eight Eleven finds the people best-suited for your business. When you work with us, we work with you. That’s the Eight Eleven promise.

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.

Benefits & Perks:

Eight Eleven Group is an equal opportunity employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

Pay Disclaimer:

The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.

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