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HomeCompaniesParexelSenior Site Start Up Specialist

Senior Site Start Up Specialist

Parexel · China-Chengdu · Active · Workday Recruiting

Job facts

FieldValue
CompanyParexel
TitleSenior Site Start Up Specialist
Normalized title-
Department / team-
LocationChina
Work model-
Employment typeFull Time
Salary-
Statusactive
ATS providerWorkday Recruiting
Posted / first seen2026-06-02 / 2026-05-30
Changed / last seen2026-06-04 / 2026-06-04

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Linked records

CompanyParexel
Sourcea38f5933-8d87-4b90-bb56-84b4c1881427
ATS providerWorkday Recruiting

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 : SSU Coordination and Execution Coordinates, guides, and assists with all start up activities prior to site activation, including but not limited to: Site Informed Consent Form (“ICF”) localization and guidance in line with regulatory/health authority requirements. Ethics Committee (“EC”) information, meeting dates & costs. Ethics applications & associated online systems. Ethics & Governance submission processes. Clinical Trial Health Authority application and regulatory submission process. Contracts & Indemnity request process. For global studies, localize global ICF with country requirements. Local sample application and permit submission processes   Maintains up to date knowledge, ensuring adherence and compliance with local regulatory requirements and associated documentation   Reviews, analyzes, and collates metrics to ensure processes are in place that drive efficiency and reduction of timelines across start up and contracts negotiation   Ensures all start up information & requirements are kept up to date in a central repository for both global and local study teams   Assists with label preparation and approval (local label representative) for studies in collaboration with local regulatory department   Tracks metrics and SSU timelines to identify trends and opportunities for improvement Relationship management Liaises and collaborates with relevant authorities/bodies to further enhance clinical trial processes, government policies/laws, via innovative approaches   Maintains current, and awareness of changes in, startup processes across government, hospital & industry & liaises with stakeholders to resolve any SSU issues   Proactively responds to information survey requests by government/ industry bodies   Provides continuous and proactive communication with ECs/hospital administration/industry bodies to obtain accurate and up to date information on clinical trial status and activities   Maintains communication with local legal/regulatory/clinical operation to ensure input is sought and all internal/external requirements are met   Provides guidance to Country Study Managers (CSMs) and Country Study Specialist (CSS) on regulatory/ethics, tracks & drives site activations by regular review and monitoring status of submissions/ activations   Collaborates with vendor management and procurement to provide input as required into vendor identification, selection, and Request for Information (RFI)/ Request for Proposal (RFP) process   Liaises and shares best practices with other SSU within the region/organization New Site Identification Assists with identification and tracking of new sites in collaboration with CSMs   Performs/coordinates site level feasibility activities including evaluation of patient population and final site selection Contracts/ Budget Negotiates contracts and study budgets with sites during the SSU phase to ensure finalization   Provides local fee structures and budgetary advice as required and ensure compliance to Fair Market Value (FMV) in the country   Collaborates with CSMs to maintain data to ensure FMV   Liaises with management/CSMs to implement budget cost containment and implement contingencies as required Compliance with Parexel standards Complies with required training curriculum    Completes timesheets accurately as required    Submits expense reports as required    Updates CV as required    Maintains a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements Skills: Demonstrated competence in analysis, planning and problem solving.   Excellent communications including the ability to state opinions clearly, ask questions, seek clarification, communicate facts objectively, challenge when appropriate, and pursue issues to resolution.   Ability to present clear messages from complex information/data to all levels in the organization in both written and spoken English.   Ability to make effective decisions.   Proven project management and organizational skills and the ability to prioritize and manage multiple tasks with flexibility.   Demonstrated teamwork and ability to make an active contribution to team performance.   Demonstrated computer literacy, to usage of MS Office software, web-based systems, and databases.    A flexible attitude with respect to work assignments and new learning.    Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.   Willingness to work in a matrix environment and to value the importance of teamwork. Knowledge and Experience : >1.5 years of proved SSU experience in clinical trials, experience in global company is preferred.    Demonstrated knowledge and understanding of ICH-GCP, the regulatory, ethics and contractual requirements for starting clinical trials in China.    Achieved a satisfactory level of technical, functional, and/or professional skill/knowledge in position – related areas; keeps up with current developments and trends in areas of expertise; leverages expert knowledge to accomplish results. Education: University Degree or equivalent preferably in a medical/science-related field.

Full job record

Job ID0eaf3df71e9eee373a522eb2b5bec9f011146d53
Org ID0c6955f0-4e0e-43b2-98b7-c020651fe1bc
Source IDa38f5933-8d87-4b90-bb56-84b4c1881427
Board IDa38f5933-8d87-4b90-bb56-84b4c1881427
Providerworkday
Provider Job Key/job/China-Chengdu/Study-Start-Up-Specialist-II-Sr-Chengdu_R0000042030
TitleSenior Site Start Up Specialist
Normalized Title
Statusactive
Activeyes
Location TextChina-Chengdu
Department
Team
Employment Typefull_time
Workplace Type
Remote Policy
CountryChina
Region
City
Salary Raw
Salary Min
Salary Max
Salary Currency
Salary Period
Source URLhttps://wd1.myworkdaysite.com/recruiting/parexel/Parexel_External_Careers/job/China-Chengdu/Study-Start-Up-Specialist-II-Sr-Chengdu_R0000042030
Apply URLhttps://wd1.myworkdaysite.com/recruiting/parexel/Parexel_External_Careers/job/China-Chengdu/Study-Start-Up-Specialist-II-Sr-Chengdu_R0000042030
First Seen At2026-05-30 06:03:30Z
Last Seen At2026-06-04 10:12:20Z
Last Checked At2026-06-04 10:12:20Z
Last Changed At2026-06-04 10:12:20Z
Inactive At
Source Posted At2026-06-02 00:00:00Z
Source Updated At
Raw Payload Uris3://bluework-jobs-prod-raw-590183727216/raw/provider=workday/board=wd1.myworkdaysite.com|parexel|Parexel_External_Careers/date=2026-06-04/2026-06-04T10-11-33-526Z-e695244596e4a98bf99d23615b3a3bbe6d4d72790661bc4e4c026b63361fb42f.json
Event Fields
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Parsed Structured
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Extensions
{}
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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><span><b><u>Key Accountabilities</u></b><u>:</u>  </span></p><p><span><b>SSU Coordination and Execution</b>  </span></p><ul><li><span>Coordinates, guides, and assists with all start up activities prior to site activation, including but not limited to: Site Informed Consent Form (“ICF”) localization and guidance in line with regulatory/health authority requirements. Ethics Committee (“EC”) information, meeting dates &amp; costs. Ethics applications &amp; associated online systems. Ethics &amp; Governance submission processes. Clinical Trial Health Authority application and regulatory submission process. Contracts &amp; Indemnity request process. For global studies, localize global ICF with country requirements. Local sample application and permit submission processes  </span></li></ul><ul><li><span>Maintains up to date knowledge, ensuring adherence and compliance with local regulatory requirements and associated documentation  </span></li></ul><ul><li><span>Reviews, analyzes, and collates metrics to ensure processes are in place that drive efficiency and reduction of timelines across start up and contracts negotiation  </span></li></ul><ul><li><span>Ensures all start up information &amp; requirements are kept up to date in a central repository for both global and local study teams  </span></li></ul><ul><li><span>Assists with label preparation and approval (local label representative) for studies in collaboration with local regulatory department  </span></li></ul><ul><li><span>Tracks metrics and SSU timelines to identify trends and opportunities for improvement  </span></li></ul><p><span> </span></p><p><span><b>Relationship management</b>  </span></p><ul><li><span>Liaises and collaborates with relevant authorities/bodies to further enhance clinical trial processes, government policies/laws, via innovative approaches  </span></li></ul><ul><li><span>Maintains current, and awareness of changes in, startup processes across government, hospital &amp; industry &amp; liaises with stakeholders to resolve any SSU issues  </span></li></ul><ul><li><span>Proactively responds to information survey requests by government/ industry bodies  </span></li></ul><ul><li><span>Provides continuous and proactive communication with ECs/hospital administration/industry bodies to obtain accurate and up to date information on clinical trial status and activities  </span></li></ul><ul><li><span>Maintains communication with local legal/regulatory/clinical operation to ensure input is sought and all internal/external requirements are met  </span></li></ul><ul><li><span>Provides guidance to Country Study Managers (CSMs) and Country Study Specialist (CSS) on regulatory/ethics, tracks &amp; drives site activations by regular review and monitoring status of submissions/ activations  </span></li></ul><ul><li><span>Collaborates with vendor management and procurement to provide input as required into vendor identification, selection, and Request for Information (RFI)/ Request for Proposal (RFP) process  </span></li></ul><ul><li><span>Liaises and shares best practices with other SSU within the region/organization  </span></li></ul><p><span> </span></p><p><span><b>New Site Identification</b>  </span></p><ul><li><span>Assists with identification and tracking of new sites in collaboration with CSMs  </span></li></ul><ul><li><span>Performs/coordinates site level feasibility activities including evaluation of patient population and final site selection  </span></li></ul><p><span> </span></p><p><span><b>Contracts/ Budget</b>  </span></p><ul><li><span>Negotiates contracts and study budgets with sites during the SSU phase to ensure finalization  </span></li></ul><ul><li><span>Provides local fee structures and budgetary advice as required and ensure compliance to Fair Market Value (FMV) in the country  </span></li></ul><ul><li><span>Collaborates with CSMs to maintain data to ensure FMV  </span></li></ul><ul><li><span>Liaises with management/CSMs to implement budget cost containment and implement contingencies as required  </span></li></ul><p><span> </span></p><p><span><b>Compliance with Parexel standards</b>  </span></p><ul><li><span>Complies with required training curriculum   </span></li></ul><ul><li><span>Completes timesheets accurately as required   </span></li></ul><ul><li><span>Submits expense reports as required   </span></li></ul><ul><li><span>Updates CV as required   </span></li></ul><ul><li><span>Maintains a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements  </span></li></ul><p><span> </span></p><p><span><b><u>Skills:</u></b>  </span></p><ul><li><span>Demonstrated competence in analysis, planning and problem solving.  </span></li></ul><ul><li><span>Excellent communications including the ability to state opinions clearly, ask questions, seek clarification, communicate facts objectively, challenge when appropriate, and pursue issues to resolution.  </span></li></ul><ul><li><span>Ability to present clear messages from complex information/data to all levels in the organization in both written and spoken English.  </span></li></ul><ul><li><span>Ability to make effective decisions.  </span></li></ul><ul><li><span>Proven project management and organizational skills and the ability to prioritize and manage multiple tasks with flexibility.  </span></li></ul><ul><li><span>Demonstrated teamwork and ability to make an active contribution to team performance.  </span></li></ul><ul><li><span>Demonstrated computer literacy, to usage of MS Office software, web-based systems, and databases.   </span></li></ul><ul><li><span>A flexible attitude with respect to work assignments and new learning.   </span></li></ul><ul><li><span>Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.  </span></li></ul><ul><li><span>Willingness to work in a matrix environment and to value the importance of teamwork.  </span></li></ul><p><span>  </span></p><p><span><b><u>Knowledge and Experience</u></b>:   </span></p><ul><li><span>&gt;1.5 years of proved SSU experience in clinical trials, experience in global company is preferred.   </span></li></ul><ul><li><span>Demonstrated knowledge and understanding of ICH-GCP, the regulatory, ethics and contractual requirements for starting clinical trials in China.   </span></li></ul><ul><li><span>Achieved a satisfactory level of technical, functional, and/or professional skill/knowledge in position – related areas; 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