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Clinical Trial Operations Opportunities at Parexel

Clinical Trial Operations

Clinical Operations Leader

Job ID post-70024407 Shenyang Wobu, Liaoning, China
• Effectively communicate with internal and external customers as well as third party vendors
• Prioritize effectively and respond to urgent requests within team or from sponsor.

Project Initiation & Planning
• Manage study start-up activities, in small size studies
• Provide input to project tools, PL project plan, Central File Maintenance Plan
• Provide input to the format and content for sponsor reports
• Provide input to and oversight of site selection strategy plan
• Develop site selection and monitoring plans for the team
• Review and provide input into patient recruitment plan and retention plan
• Ensure all team members have access to tools and documents
• Establish efficient / effective working relationships with other functional Leaders and
coordinators across geographies and projects within a given program
• Develop study plans, tools and forms.
Project Implementation, Control & Evaluation
• Provide leadership and direction to project team members
• Identify, organize and deliver (where appropriate) study specific training in collaboration with
Project Leader and Project Specialists
• Evaluate and identify resourcing needs and continuously monitor over life cycle of project
• Provide productivity targets to project team members
• Provide performance feedback on team members as appropriate
• Address identified and escalated site issues and drive to closure
• Early recognize areas of potential problems and provide input to contingency plans
• Monitor study timelines, patient recruitment, retention and data cleaning to ensure successful
outcome of the project
• Oversee maintenance and quality check of Central Files
• Maintain and assure quality of work generated and escalate and follow up as appropriate
• Ensure appropriate handover between project team members
• Implement and instigate process improvements within the project
• Provide input to the Revenue Recognition forecast
• Identify changes in scope and liaise with Project Leader
• May be required to conduct site visits as per client or project demands
• Participate in client, investigator and team meetings
• Prepare, participate in and follow up on audits / inspections
• Participate in all required applicable trainings
Project Close-out
• Collaborate with project team (e.g. Project Leader and Data Operations Leader) on database
lock activities
• Together with Project Leader ensure all administrative closeout procedures are completed,
according to Project Close-out Checklist
• Together with Project Leader ensure project is archived and all documentation returned to the
client as specified by the contract
• Participate in end of study meeting and give input to lessons learned information and feedback
relevant information into the relevant functions
Operational
• Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines,
local regulatory requirements and Parexel WSOPs, SOPs, Operational Guidelines, Work
Instructions and study specific procedure
• Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, office and
travel expense claims)

Qualifications

Leadership skills that include:
− ability to lead a virtual team across locations and cultures
− carefully weigh the priority of project tasks and direct team accordingly
− enlist the support of team members in meeting goals
− ability to negotiate and influence with diplomacy in order to achieve results
− ability to make decisions even in ambiguous situations to achieve project timelines and
quality
− ability to proactively identify and solve problems by using a logical, systematic approach
− ability to conduct root cause analysis in business problem solving and process improvement
development
− strong customer focus, ability to interact professionally within a client organization
− ability to manage multiple and varied tasks with enthusiasm, prioritize workload with
attention to detail
− effective time management in order to meet daily metrics or team objectives
• Personal skills that include:
− ability to take initiative and work independently
− ability to successfully work in a team environment
− sense of urgency in completing assigned tasks
− commitment to high quality work and respective consistent performance
− excellent interpersonal, oral and written communication skills
− ability to gain trust and confidence with a client as well as within
− excellent presentation skills
− good consulting skills
− flexibility to change
− ability to travel as required
• Business / operational skills that include
− customer focus
− commitment to delivery and quality
− proactive issue identification and resolution
− provision of win-win solutions to problems
− in-depth understanding and experience in the clinical trial process
− knowledge of SOPs/guidelines, ICH-GCP and other applicable local and international
regulations
− proficient computer and internet skills including knowledge of MS-Office products such as
Excel, Word

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