Clinical Operations Leader (PM)

Job description

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