Associate Director, Clinical Operations Job Description Template
Our company is looking for a Associate Director, Clinical Operations to join our team.
Responsibilities:
- Oversee TMF reviews to ensure completeness and inspection readiness;
- Direct initiatives to identify and implement best practices and continuous improvement plans in clinical development;
- Identify and mitigate against study risks, escalating as necessary;
- Key contributor to IRB/EC and regulatory submissions;
- Has input into estimated study budget and supports RFI/RFP process for studies/programs;
- Escalate potential variances from the timeline/budget real time and proactively to the Director, Clinical Operations to manage changes to scope;
- Participate and respond to Quality Assurance and/or Regulatory authority inspection audits;
- Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews;
- Participate in operational improvement initiatives (e.g. SOP development, training, etc.);
- Provide study-specific mentoring and line management for junior team members, as appropriate;
- Participate in request and review of scope of work, budgets, vendor performance, and issue resolution;
- Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines;
- Manage clinical trial budgets, providing ongoing financial reporting and projections to Ohana’s Finance team;
- Collaborate cross-functionally to ensure clinical program timelines and goals are met;
- Participate in program strategy meetings, ad hoc clinical operations initiatives and programs.
Requirements:
- Highly-organized and detail-oriented with a passion to deliver quality results;
- Intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit;
- 8-10+ years directly managing clinical trials in Sponsor or CRO setting;
- Strong verbal and written communication skills with an ability to build relationships internally and externally;
- Highest levels of professionalism, confidence, personal values and ethical standards;
- Ability to think critically in fast-paced projects with a keen sense of urgency and demonstrated ability to problem solve;
- Good working knowledge of GCP and ICH guidelines;
- Self-motivated and able to work autonomously, as well as a member of a collaborative team;
- In-depth knowledge of clinical trial operations, ICH, GCP Guidelines and other applicable regulatory requirements;
- Experience mentoring and directing members of clinical operations teams;
- Bachelor’s degree in a scientific field required; advanced scientific degree a plus;
- Demonstrated alignment with Axovant values and culture;
- This position requires approximately 20% travel.