Associate Director Study Management

The Associate Director Study Management (AD Clinical Operations) is responsible for leading a team of Global Trial Leaders and Trial Managers within the Study Management Organization.  The position is responsible for staff development and study oversight, and will work closely with the Director for input on project assignments, workload distribution, resourcing, and prioritization.  The Associate Director directly influences trial objectives and ensures common operational issues/challenges are identified within and potentially across trials and programs and are addressed through operational risk mitigation, including proposals for alternative solutions.  The Associate Director is accountable for the operational execution and delivery of assigned trials within a program, ensuring alignment across study teams and functions.

This is a hybrid role based in Maidenhead. However, for exceptional candidates, remote working arrangements may also be considered.

Summary of Key Responsibilities

Accountable for the delivery of the operational strategy in alignment with the Clinical Development Plan, ensuring alignment with the business goals and trial delivery objectives (including resourcing, budget, and change control) by partnering with CTWG and CDST on timeline creation. May Chair and/or support the Trial Leader in leading the CTWGfor the successful execution of assigned trial/s.

• Develop and execute trial operational strategies for assigned studies and contribute to broader program-level planning in partnership with the Director and cross-functional stakeholders.
• Lead operational scenario planning and mitigate trial level risks that may impact timelines / budget.
• Ensure appropriate timely and quality oversight, and appropriately escalate issues to the Director, Quality and functional leadership.
• Ability to effectively communicate the operational strategy, and defend the operational plan and costs associated to CTWG, CDST, Director, leadership and at governance meetings as appropriate.
• Lead and ensure inspection readiness for the trial/s
• Build knowledgeable and skilled team with competencies and capabilities to successfully set up and deliver clinical trials
• Promote strong collaboration across cross-functional teams
• Setting goals in alignment with company, program, and departmental goals
• Ensure staff training on procedures and systems associated with their roles
• Develop a team that consistently achieves strong results through nurturing individual growth, effectively managing performance, and providing guidance
• For early development programs, AD may represent Clinical Operations at CDST
• Interface with internal key stakeholders including, but not limited to; Finance, Program Management, Vendor Management, Safety, Accounting, Supply, Quality Assurance, Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio Analytical, Medical Affairs; which may include acting as a liaison between groups.
• Lead or participate in process improvement activities at a trial and department level as needed
• Participate in preparation for, and conduct of, Health Authority Inspections and internal QA audits
• Ability to travel (expected annual average of 10% but flexibility to go over or below this as required).

Qualifications

• BS/ BA degree is required.
• Minimum 8+ years of clinical research experience gained with a CRO, Biotech or Pharmaceutical Company working on Phase 1-4 global clinical trials, at least 3 of which leading end to end global clinical trials with experience in conducting Phase 3 registrational trials.
• Minimum 2-5 years of direct people leadership experience, including coaching, performance management, and development of clinical operations professionals.
• Experience in and knowledge of the pharmaceutical development process
• Excellent decision-making, analytical and strong financial management skills are essential to this position
• Ability to manage all aspects of execution of a clinical trial
• Must possess excellent leadership skills, proven ability to foster team productivity and cohesiveness and the ability to operate and execute with limited supervision
• Experience in leading without authority and in multifunctional matrixed and global environments
• Strong project planning/ management, communication (written and verbal) and presentation skills
• Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability.
• Apply project management best practices to programs. Experience in novel clinical drug development.
• Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project.

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