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Associate Director, TMF Operations

Arena Pharmaceuticals, Inc. • San Diego, CA
a month ago

Arena Pharmaceuticals is driven to deliver novel, transformational medicines with optimized pharmacology and pharmacokinetics to patients globally. Arena’s proprietary pipeline includes multiple potentially first or best-in-class assets with broad clinical utility.

The Opportunity:

In conjunction with the VP, Clinical Operations, the Associate Director, Head of TMF Operations will develop the overall strategy, define the processes and organizational structure for TMF Management at Arena, and provide daily oversight of TMF activities and TMF staff to ensure regulatory inspection-readiness and compliance with applicable regulations. The Associate Director will establish a high performing team and partner with cross functional teams to ensure timely and quality delivery of the TMFs. The Associate Director will act as the TMF process owner and provide expertise in document content, technologies, and processes. The Associate Director will provide oversight ensuring standardization, training, quality, and timely clinical trial documentation across all programs.

What you will dive into:

  • Plan, implement, lead, and oversee end-to-end TMF activities for all products, projects, vendors, or services
  • Establish and manage the quality oversight of TMF including quality checks, TMF metrics, and KPIs
  • Develop, review, and implement policies, SOPs, and associated documents for TMF management
  • Hire, manage, and effectively allocate TMF resources to meet project needs
  • Oversee TMF staff and liaise with cross-functional document owners to ensure that TMF content is controlled and accurately filed
  • Collaborate with Service Providers and CROs on TMF management including reviewing process, ensuring TMF completeness and managing the transfer of TMF records as needed
  • Serve as the Point of Contact in audits and inspections for TMF related requests and questions
  • Optimize eTMF capabilities to support TMF processes, provide users training as needed, and ensure consistent use and application of technology and standards
  • Develop and train TMF staff and stakeholders on TMF processes, requirements, and expectations
  • Lead, provide oversight and/or implement change initiatives to develop and improve the execution and effectiveness of TMF processes
  • Identify and leverage external knowledge of industry best practices and processes
  • Develop and manage vendors and budgets

What we expect:

  • BS/BA and 12+ years of related experience; or equivalent combination of education and experience
  • 12+ years’ experience working in clinical research
  • 8 years’ experience working in Records Management, including 5+ years’ experience using eTMFs, managing active, inactive, and archived records, analyzing business processes, and developing and implementing Records Management policy and procedures
  • 6 years of people management experience with demonstrated experience in motivating teams, setting up goals, providing leadership and guidance as needed
  • Experience in TMF requirements, end-to-end TMF processes, and the TMF Reference Model
  • Strong understanding of the clinical development lifecycle, study and site management, and overall trial planning and execution
  • Strong knowledge with electronic document management systems (eTMF)
  • Excellent attention to detail, strong critical thinking, and logical problem solving
  • Ability to proactively identify potential issues and formulate potential course(s) of action
  • Excellent organizational, time management, and project management skills
  • Experience and comfort in working both independently and as part of a multifunctional team
  • Understanding of resource management and organizational capacity
  • Proven organizational skills and strong ability to prioritize workload
  • Commitment and ability to handle high workloads, demanding situations, and deadlines
  • Ability to interact and communicate effectively, both verbally and written, with colleagues and management, both within and outside clinical operations, including upper management, vendor personnel, and clinical investigators and site personnel
  • Able to carry out responsibilities with minimal to no supervision

What We Offer:

  • To be part of a growing company and fantastic team passionate about developing novel drug therapies to improve people’s lives
  • Opportunities to learn and contribute to creative solutions
  • Competitive compensation package including long-term incentives
  • Comprehensive health insurance (highly subsidized cost sharing on all medical plans)
  • Generous matching 401k retirement plan
  • Flexible time off policy and holidays including two company-wide shut-down periods each year
  • Multi-cultural work environment
  • Company celebrations

Arena celebrates and supports our differences and is proud to be an Equal Employment Opportunity and workplace. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Arena is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance due to a disability, you may contact us at jobs@arenapharm.com.

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