About this role
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.
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