Clinical Operations Leader (PM)

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