Senior Study Manager- FSP

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    "title": "Senior Study Manager- FSP",
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    "location": "China-Shanghai Shinmay",
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    "timeType": "Full time",
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    "startDate": "2026-05-06",
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    "jobDescription": "<p><b>When our values align, there&#39;s no limit to what we can achieve.</b><br /> <br />At Parexel, we all share the same goal - to improve the world&#39;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.</p><p>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&#39;re committed to making a difference.</p><p></p><p></p><p><u><b>Key Accountabilities:</b></u></p><p></p><p><b>Sponsor Liaison:</b></p><ul><li>Effectively communicate with internal and external customers as well as third party vendors;</li><li>Prioritize effectively and respond to urgent requests within team or from sponsor.</li></ul><p></p><p><b>Project Initiation:</b></p><ul><li>Oversee and / or manage study start-up activities as applicable</li><li>Provide inputs to project tools and study plans</li><li>Provide inputs to the format and content for sponsor reports/templates, if applicable</li><li>Provide input to and oversight of site selection strategy plan</li><li>Develop site selection and monitoring plans  </li><li>Review and provide input into patient recruitment plan and retention plan</li><li>Ensure all team members have access to study systems, tools and documents</li><li>Establish efficient / effective working relationships with other Functional Leaders across geographies and within a given program</li><li>Develop study plans, tools, forms and templates pertaining to Clinical Operations</li><li>Provide input on relevant vendor plans, clinical supply strategy and management. Support vendor access and assist with troubleshooting vendor issues.</li></ul><p></p><p><b>Project Execution:</b></p><p></p><ul><li>Provide leadership and direction to project team members</li><li>Identify, organize and deliver (where appropriate) study specific training in collaboration with Project Leader and Project Specialists</li><li>Evaluate and identify resourcing needs and continuously monitor the use of resources over project life cycle. </li><li>Provide study productivity targets to project team members</li><li>Provide performance feedback on team members and work with line management, as appropriate</li><li>To effectively recognize potential problem areas early and develop robust contingency and risk management plans,</li><li>Monitor study timelines, patient recruitment, retention and data cleaning to ensure successful outcome of the project</li><li>Liaise with vendors to support clinical activities</li><li>Oversee maintenance and quality check of TMF</li><li>Maintain and assure quality of work generated and escalate and follow up as appropriate</li><li>Ensure appropriate handover between project team members with support from Clinical Operations Managers</li><li>Implement and proactively initiate process improvements within the project, as and when needed</li><li>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. </li><li>Monitor cost drivers and actively seeks ways to optimize resources, ensuring efficiency and cost-effectiveness in clinical operations team</li><li>In exceptional circumstances, may be required to conduct site visits as per sponsor or project demands</li><li>Participate in sponsor, investigator and team meetings</li><li>Prepare, participate in and follow up on audits / inspections</li><li>Participate and deliver all required applicable trainings, as appropriate</li></ul><p></p><p><b>Project Close-out:</b></p><ul><li>Collaborate with project team (e.g. Project Leader and Data Management Lead) and relevant vendors on database lock activities</li><li>Liaise with vendors to ensure process for return of clinical supplies from sites</li><li>Together with Project Leader ensure all administrative closeout procedures are completed according to the close-out process</li><li>Together with Project Leader ensure project is archived and all documentation returned to the sponsor as specified by the contract</li><li>Participate in end of study meeting and give input to lessons learned information and feedback relevant information into the relevant functions</li></ul><p></p><p><b>Operational:</b></p><p></p><ul><li>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</li><li>Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, office and travel expense claims)</li><li>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.</li></ul><p></p><p><u><b>Skills:</b></u><br /><b>Leadership skills that include:</b></p><ul><li>Ability to lead a virtual team across locations and cultures</li><li>Carefully weigh the priority of project tasks and direct team accordingly</li><li>Enlist the support of team members in meeting goals</li><li>Ability to negotiate and influence with diplomacy in order to achieve results</li><li>Ability to make decisions even in ambiguous situations to achieve project timelines and quality</li><li>Ability to proactively identify and solve problems by using a logical, systematic approach</li><li>Ability to conduct root cause analysis in business problem solving and process improvement development</li><li>Strong customer focus, ability to interact professionally within a sponsor organization</li><li>Ability to manage multiple and varied tasks with enthusiasm, prioritize workload with attention to detail</li><li>Effective time management in order to meet daily metrics or team objectives</li></ul><p></p><p><b>Personal skills that include:</b></p><ul><li>Ability to take initiative and work independently</li><li>Ability to successfully work in a team environment</li><li>Sense of urgency in completing assigned tasks</li><li>Commitment to high quality work and respective consistent performance</li><li>Excellent interpersonal, oral and written communication skills</li><li>Ability to gain trust and confidence with a client as well as within Parexel</li><li>Good learning ability</li><li>Action oriented</li><li>Excellent presentation skills</li><li>Good consulting skills</li><li>A flexible attitude with respect to assignments and new learning</li><li>Ability to travel as required</li></ul><p></p><p><b>Business / operational skills that include:</b></p><ul><li>Customer focus</li><li>Commitment to delivery and quality</li><li>Proactive issue identification and resolution</li><li>Provision of win-win solutions to problems</li><li>In-depth understanding and experience in the clinical trial process and understanding of all aspects of project life cycle</li><li>Knowledge of SOPs/guidelines, ICH-GCP and other applicable local and international regulations</li><li>Ability to become proficient with Parexel systems</li><li>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</li></ul><p><br /><u><b>Knowledge and Experience:</b></u></p><ul><li>Strong command of written and spoken English language, local language proficiency as required</li><li>Proven clinical experience or management experience in healthcare, clinical research, or contract research organization</li><li>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</li><li>Experience in Coordination of Clinical Trials – Preferably relevant working experience as an Associate Clinical Operations Leader or proven experience in a similar role</li><li>Individuals should have a strong understanding of the cross functional activities</li></ul><p><br /><u><b>Education:</b></u></p><ul><li>Degree in a life science, nursing qualification or relevant clinical and or clinical management experience</li></ul>",
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