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

Work arrangement
Yes