Associate Director/Director, Clinical Operations

Job Description

The Associate Director, Clinical Operations responsibilities will include leadership oversight for clinical study conduct including cross-functional sub-teams (internal and CRO), study planning, budgeting, and financial oversight, monitoring study and program timelines, and ensuring compliance with GCP. The focus is the tactical and daily operations of the assigned clinical program(s). The role is expected to provide senior level support and guidance to the clinical operations study team, management of the team and act as the interface with the cross-functional project team. This position reports to the CMO.

  • Anticipate project requirements and institute appropriate actions to ensure timelines and project goals are met
  • Oversight of designated activities outsourced to CROs, central and special labs and other vendors
  • Participates in developing and drafting protocols, amendments, CRF, informed consent forms, Investigator Brochures, annual progress reports, clinical study reports and other documents as needed or requested
  • Review required clinical documents.
  • Responsible for the study oversight and partners with Clinical and Project Management to ensure clinical study milestones are adhered to
  • Develop study specific monitoring plans and ensure appropriate quality and timely monitoring of clinical sites
  • In conjunction with the CRO clinical manager, review trip reports and other aspects of site monitoring including, performance metrics and quality. Identify, troubleshoot and resolve issues pertaining to site monitoring for in-house and CRO monitored studies
  • Conduct pre-study, initiation, routine monitoring and closeout visits of study sites, when necessary
  • Oversee study specific tasks such as Investigator identification, recruitment, collection of Investigator regulatory documents and site activation for domestic and international clinical studies
  • Ensures that clinical studies are properly resourced, managed, and executed following the study plan and in accordance with established timelines and quality standards
  • Provides high level oversight of clinical study data, i.e., flow from the sites (CRF completion) to data entry including listings/tables/figures
  • Ensures that clinical studies follow guidelines and necessary processes and procedures, as applicable (e.g., Code of Federal Regulations, ICH Guidelines and Good Clinical Practices, FDA, EMA, PMDA) and appropriate industry standards
  • Develops and/or utilizes appropriate metrics to assess performance, compliance, and cost effectiveness
  • Selects and oversees, effectively manages, and collaborates with CROs/vendors/partners Ensures adherence to vendor/partner scopes of work, including timelines and budgets, while providing insight and guidance around potential study changes to ensure efficiency and mitigate against fluctuating study costs or study delays
  • May be responsible for direct supervision or line management

Job Requirements

  • Master’s Degree or Doctorate in Biological Science or equivalent in allied healthcare
  •  Pharmaceutical, biotechnology, or clinical research experience for a minimum of 12 years, among which, more than 8 years are in Pharmaceutical and Biotechnology industry including demonstrated skills and competency in monitoring and clinical operations management tasks. Oncology experience (including study start up through closure) is preferred
  • Prior experience leading clinical development planning (phase 1-3) and interactions with Key Opinion Leaders, scientific advisors
  • Thorough knowledge of ICH Guidelines, GCP and the clinical trial process
  • Understanding of data management, statistical programming and regulatory affairs sufficient to perform project management responsibilities
  • International clinical trial management experience is a plus
  • Insight of study budget process including vendor and Investigator agreements and contracts, CRO budgets, invoicing and payments, site budgets and payment administration
  • Builds connections by developing positive, collaborative partnerships that drive sustainable business results
  • Experience with clinical protocol design, clinical trial operations, clinical trial bio-specimen logistics, analytical and clinical validation of biomarker assays, and vendor interactions
  • Demonstrated ability to think strategically and creatively
  • Thrives in a highly collaborative, multi-disciplinary team setting
  • Highly effective verbal and written communication skills
  • Excellent computer skills
  • Ability to manage clinical projects with minimum supervision
  • This role requires up to 20% travel in support of clinical study activities

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