Associate Clinical Operations Leader

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Client Liaison

• 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
• Provide input to project tools, PM 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
• Support development of site selection and monitoring plans for the team
• Review and provide input into patient recruitment plan and retention plan
• Assist with ensuring all team members have access to tools and documents
• Establish efficient / effective working relationships with other functional Leaders and coordinators
• Support develop study plans, tools and forms.

Project Implementation, Control & Evaluation

• Provide leadership and direction to project team members
• Provide input to Identifying, organizing and delivering (where appropriate) study specific training in collaboration with Project Leader and Project Specialists
• Support evaluating and identifying resourcing needs and continuously monitor the use of resources over project life cycle
• 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
• Support early recognition of 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
• Support overseeing 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 with support from Clinical Operations Managers
• Support implementing and instigating process improvements
• Provide input to the Revenue Recognition forecast
• Identify changes in scope and liaise with Clinical Operation Leader and/or Project Leader
• May be required to conduct site visits as per client or project demands
• Participate in client, investigator and team meetings as appropriate
• 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 Clinical Operations Leader and Project Leader ensure all administrative closeout procedures are completed according to Project Close-out Checklist
• Together Clinical Operations Leader and with Project Leader ensure project is archived and all documentation returned to the client as specified by the contract
• May 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)

Skills:

• 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 Parexel
• Good learning ability
• Action oriented
• Good presentation skills
• Good consulting skills
• A flexible attitude with respect to assignments and new learning
• Ability to travel as required

Business / operational skills that include

• Customer focus
• Commitment to quality work and respective consistent performance
• Proactive issue identification and resolution
• In-depth understanding and experience in the clinical trial process and understanding of all aspects of project life cycle
• Knowledge of SOPs/guidelines, ICH-GCP and other applicable local and international regulations
• Ability to become proficient with Parexel systems
• Proficient computer and internet skills including knowledge of MS-Office products such as Excel, Word, Power Point, Outlook, WebEx

Knowledge and Experience:

• Strong command of written and spoken English language, local language proficiency as required
• Relevant work experience - CRA experience or minimum substantial relevant experience (preferably on site monitoring experience)
• “Coordinating experience”: Preferably obtained while working in a Sr CRA or Sr CMA position
• Substantial experience in clinical research in Clinical functions. Individuals should have potential to understand cross functional activities related to data processing, cleaning and site management
• Individuals should have a strong understanding of the cross functional activities

Education:

• Degree in a life science, nursing qualification or relevant clinical and or clinical management experience