Associate Director, Clinical Operations - FSP (Sydney or Melbourne)

Home, AUS
20 Jan 2021
19 Feb 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)
JOB SUMMARY Provides leadership, direction and management to Clinical Operations staff in the assigned area. Provides training, consultation and oversees quality related for operating activities of assigned staff to ensure project deliverables are met. Acts as primary point of contact for resourcing escalations, assuring utilization, performance and development of Clinical Operations staff. May liaise with other departments or business units to optimize resources as well as to establish harmonize clinical operations practices, processes and tools. Contributes to operational initiatives.


• Line Management of Clinical Operations staff, responsibilities including administrative oversight, professional development, performance appraisals, and mentoring/counselling of staff, including the management and development of other Clinical Operations line managers. Manages staff by establishing goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level.

• Liaise with Resourcing management on active awarded and proposal project assignments. Review workload for all staff in reporting chain. Manage the resource availability for the assigned staff/region, ensuring projects are suitably resourced and staffing needs are identified in a timely fashion, resolving potential resourcing conflicts to facilitate mutually beneficial resolutions.

• Provide expert operational oversight and guidance to support prioritization of activities, review and monitor the work performed, metrics compliance, and development of contingency plans, among others. Analyze performance and quality metrics to assure TBU achievement of regional productivity and compliance metrics. Address improvement initiatives as identified.

• Support the assessment of overall regional Clinical Operations staff growth and actively participate in the selection and hiring process. Proactively works to ensure staff retention and turnover rates remain within expected levels.

• Ensures quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WI) and compliance with federal and local guidelines and ICH GCP. Ensures all staff follows required training and completes the required documentation. Provides regular compliance updates to management accordingly.

• Oversees progress of teams supporting clinical projects. Ensures individual and team tasks are completed according to country/region specific and government regulations and per Sponsor/Customer expectations and contract. Support the management of customer relationships, and escalate more serious issues as required.

• Work closely within appropriate business unit/region to ensure staff performance on studies and correct deficiencies as identified by staff, clients, and auditors. Ability to develop and oversee, and provide direction to more junior managers in their reporting line, in the development of training plans and formal performance management plans for individuals to address performance deficiencies, when necessary.

• Identify needs and may make recommendations for process improvement and efficiencies. Participate in committees and work groups to support the development and implementation of new initiatives and strategic direction of the TBU and cross-TBU Clinical Operations.

• May provide support to Business Development to facilitate new project awards during the Bid Defense process, providing expert Clinical Operations guidance where required. May participate in marketing activities, client presentations and proposal development.


• Bachelor's degree in life sciences, nursing degree, or equivalent related experience, plus extensive clinical research experience in a contract research organization, pharmaceutical or Biotechnology Company, including some time in a leadership capacity or equivalent combination of education, training and experience is required.

• Extensive knowledge of and experience with GCP/ICH guidelines and other applicable regulations.

• Demonstrate strong leadership, tactical and strategic thinking skills. Demonstrate understanding of the workflow process, roles and responsibilities of multiple functional areas. Knowledge of financial concepts as related to forecasting, budgeting, and proposal generation.

• Ability to understand, explain and communicate project concepts and put into detailed plans. Ability to anticipate and address critical issues; and develop contingency plans in a proactive manner.

• Must demonstrate proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail. Ability to gain working knowledge in other applicable business tools and systems

• Requires above average attention to detail, accuracy, and organizational, interpersonal, and team-oriented skills. This includes excellent communication and presentation skills, both written and spoken, with an ability to inform, influence, convince, and persuade.

• Ability to travel as necessary (approximately 20%)


Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

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