Associate Clinical Operations Leader

Key Accountabilities:

Sponsor 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

• Support overseeing and / or managing study start-up activities, as applicable
• Provide input with LM consultation/support to:
• project tools and study plans
• the format and content for sponsor reports / templates if applicable
• Provide input to and oversight of site selection strategy plan with LM consultation/support and under guidance of Clinical Operations Leader.
• Support development of site selection and monitoring plans with LM consultation/support
• Review and provide input into patient recruitment plan and retention plan
• Assist with ensuring all team members have access to study systems, tools and documents
• Establish efficient / effective working relationships with other Functional Leaders  
• Support development of study plans, tools, forms, templates pertaining to Clinical Operations
• Work with Clinical Operations Leader to provide input on relevant vendor plans, clinical supply strategy and management.  Support vendor access and assist with troubleshooting vendor issues.

Project Execution

• Provide leadership and direction to project team members
• Provide input to identifying, organizing and delivering (where appropriate) study specific training in collaboration with Clinical Operations Leader, Project Leader and Project Specialists
• Support evaluating and identifying resourcing needs and continuously monitor the use of resources over project life cycle
• Provide study productivity targets to project team members
• Provide performance feedback on team members and work with line management, as appropriate
• 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
• Assist the Clinical Operations Leader in liaising with vendors to support clinical activities
• Support overseeing maintenance and quality check of TMF
• 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 proactively initiating process improvements
• Provide input to the Revenue Recognition forecast
• Identify changes in scope and liaise with Clinical Operations Leader and/or Project Leader
• May be required to conduct site visits as per sponsor or project demands
• Participate in sponsor, investigator and team meetings as appropriate
• Prepare, participate in and follow up on audits / inspections
• Participate and deliver all required applicable trainings as appropriate.

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
• Together with the Clinical Operations Leader and Project Leader ensure project is archived and all documentation returned to the sponsor 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 procedures
• Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, office and travel expense claims)
• Responsible for reviewing site qualification, initiation, monitoring, and close-out visit reports to ensure they meet quality standards, Standard Operating Procedures (SOPs), ICH-GCP guidelines, and protocol specifications. This includes reviewing documentation of findings and follow-up actions, identifying potential data quality or compliance issues, assessing their impact on study timelines, and escalating critical concerns with recommended solutions.

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
• Ability to conduct root cause analysis in business problem solving and develop process improvements 
• Strong customer focus, ability to interact professionally within a sponsor 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 first-time quality and 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, MS Teams and other collaboration platforms

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 in-house CRA 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 cross-functional activities

Education:

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