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:** * Oversee and / or manage study start-up activities as applicable * Provide inputs to project tools and study plans * Provide inputs to the format and content for sponsor reports/templates, if applicable * Provide input to and oversight of site selection strategy plan * Develop site selection and monitoring plans   * Review and provide input into patient recruitment plan and retention plan * Ensure all team members have access to study systems, tools and documents * Establish efficient / effective working relationships with other Functional Leaders across geographies and within a given program * Develop study plans, tools, forms and templates pertaining to Clinical Operations * 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 * Identify, organize and deliver (where appropriate) study specific training in collaboration with Project Leader and Project Specialists * Evaluate and identify 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 * To effectively recognize potential problem areas early and develop robust contingency and risk management plans, * Monitor study timelines, patient recruitment, retention and data cleaning to ensure successful outcome of the project * Liaise with vendors to support clinical activities * Oversee 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 * Implement and proactively initiate process improvements within the project, as and when needed * Manage the clinical portion (e.g., COL, SSUL, CRA, iCRA) of the project according to the contracted scope and proactively monitors for changes in scope.  * Monitor cost drivers and actively seeks ways to optimize resources, ensuring efficiency and cost-effectiveness in clinical operations team * In exceptional circumstances, may be required to conduct site visits as per sponsor or project demands * Participate in sponsor, investigator and team meetings * 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 Management Lead) and relevant vendors on database lock activities * Liaise with vendors to ensure process for return of clinical supplies from sites * Together with Project Leader ensure all administrative closeout procedures are completed according to the close-out process * Together with Project Leader ensure project is archived and all documentation returned to the sponsor as specified by the contract * 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 procedure * 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 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 * Excellent 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 delivery and quality * Proactive issue identification and resolution * Provision of win-win solutions to problems * 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 * Proven clinical experience or management experience in healthcare, clinical research, or contract research organization * Substantial experience in clinical research including relevant experience as a team Leader in Clinical functions or proven experience in coordinating clinical trials. Relevant Work experience in clinical research * Experience in Coordination of Clinical Trials – Preferably relevant working experience as an Associate Clinical Operations Leader or proven experience in a similar role * Individuals should have a strong understanding of the cross functional activities **Education:** * Degree in a life science, nursing qualification or relevant clinical and or clinical management experience