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. 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