Associate Director, Clinical Operations

The Company

My client is a leading late-stage biotech company who specialise in advancing targeted therapies to address autoimmune diseases. They are seeking an Associate Director, Clinical Operations to join their team!

The Role
The position is accountable for the successful global or regional execution of outsourced clinical trials assigned by their manager, across multiple therapeutic areas. Ensuring that all activities will be conducted within agreed timelines and budget, and in alignment with all the applicable SOPs and regulatory requirements. This position will interface with all other applicable teams both internal and external.

Responsibilities

Considered the study owner with a focus on trial management supervision of primarily outsourced clinical trials. As part of the End-to-End Process includes trial set-up, execution, analysis and reporting (includes trial closure) and post-study activities. Measures study progress against agreed upon timelines to milestones.

• Ensure accurate budget management for assigned trials. This includes ensuring vendors and affiliate budgets are tracking according to plan. Updates are made to account for scope changes.
• Ensure enrollment commitments meet the projected enrollment across the regions at the clinical trial level, monitors patient recruitment at the global level, and ensure timely and accurate documentation and communication of study progress and issue escalation.
• Ensures that study monitoring is performed as per sponsor or 3rd party SOPs, tracks monitoring progress through reliable metrics and escalates any concerns appropriately.
• Ensure compliance with global health authority regulations and guidelines and internal operating procedures and processes. Participate in preparation for, and conduct of, Health Authority inspections and internal QA audits. Ensure that clinical trials operate in a constant state of inspection-readiness.
• Data Management Oversight; accountable for delivery of data for planned deliverables i.e., Data Monitoring Committee (DMC) review, Interim Analysis (IA), Database Locks (DBL), etc.
• Ensure appropriate trial-specific training and in the set-up and coordination of Investigator Meetings, if applicable.

• Ensure deliverables are carried out according to the trial plan. Provides updates to all appropriate people or teams on the deliverable status. Ensure required reports are generated and available for real time tracking of trial status according to trial plan.

• Strong interaction with other functional teams as it relates to assigned projects.

• Any other duties as assigned by the Functional Manager.
  
  Qualifications

• BS degree or equivalent in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).

• Minimum of 10 years clinical trial experience in the pharmaceutical industry, or equivalent.

• Requires clinical research operational knowledge, including study design and data management.

• Project planning/management and communication skills.

• Should be flexible and able to manage global or regional teams in a virtual environment.

• Excellent decision-making and strong financial management skills are essential to this position.

• Effective leadership skills and proven ability to foster team productivity and cohesiveness.

• Computer literacy, including experience in CTMS, EDCs and the MS Office Suite of programs with a strong working knowledge of Excel.