Senior Director of Clinical Operations

The Sr. Director of Clinical Operations will lead all Clinical Development Operations to achieve program objectives and ensure successful completion of assigned clinical trials and related clinical trial milestones within established timelines and budgets.

The Sr. Director will oversee the development of study protocols, clinical study execution, ethics and regulatory submissions, subject recruitment, clinical study monitoring, clinical compliance, SOP development and training, safety evaluations, preparation of study data reports, and data and vendor management. In addition, the Sr. Director will play a leadership role internally and with external stakeholders.


Job: Sr. Director of Clinical Operations

Position Location: Orlando, FL

Position type: Full-time 

Required languages: English required, Spanish or other languages a plus 

Compensation: Based on qualifications and experience

Qualifications:

  • Bachelor’s degree in a health-related discipline with applied training/experience relevant to the clinical trials or health research environment (e.g., SOCRA and its equivalent)
  • 10 years of relevant work experience in pharma and/or a CRO
  • Proven experience in contributing to the overall strategic direction of a company or business unit
  • Expertise in the areas of clinical operations, clinical development and strategic planning of early to late stage clinical trials
  • Excellent knowledge of FDA and ICH/GCP regulations and guidelines
  • Experience managing global clinical trials within a  global organization
  • Excellent organization skills and ability to multi-task in an extremely fast paced environment with changing priorities
  • Ability and a willingness to be both strategic and tactical
  • Excellent written and verbal communication skills
  • Technical skills understanding and experience in EDC and mobile platforms (a plus)
  • Master’s Degree or PhD preferred
  • PMP certification a plus

Responsibilities:

  • Provide stragetic resourcing, planning, oversight and execution of clinical trials to achieve program objectives and high-quality deliverables within established timelines and budgets
  • Lead and/or participate in the development and review of department policies, SOP’s and other controlled documents
  • Process implementation
  • Assist with the build of a Clinical Development Operations infrastructure  capable of successfully planning and conducting multiple early to late stage clinical trials to achieve corporate objectives
  • Develop and implement resource management and trial metric tracking tools and establish performance goals by role
  • Develop and maintain systems for effectively managing service provider relationships
  • Ensure operational excellence in our clinical stage programs by applying high industry standards, policies, systems, and processes across all trials
  • Lead the budget negotiation process and finalize contracts with key clinical vendors (This role will be accountable to Senior Management for ensuring studies stay within their approved clinical project budgets)
  • Evaluate and monitor resources and develop resource allocation plans across projects
  • Stay abreast of the latest developments in the fields of project management and clinical monitoring in drug development
  • Maintain and improve professional knowledge of technological advancements in clinical and project management

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