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
Originally posted on