Site Activation Coordinator

3 hours ago

Shanghai, Shanghai, China Parexel Full time

Aligning our values leads to exceptional achievements.

Primary Responsibilities:

Start-Up Phase (from site identification to pre-initiation):

Serve as Parexel's primary liaison with designated sites, ensuring quality and timely delivery during the start-up phase.

  • Cultivate relationships with investigators and site personnel.
  • Oversee and manage country-specific feasibility and site pre-qualification and qualification tasks, which may include:

- Drafting, negotiating, and facilitating the execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs), and any necessary amendments.
- Conducting remote Qualification Visits (QVs).

Generate visit/contact reports, utilizing judgment to identify site challenges and direct resolution efforts. Formulate strategies to configure, distribute, collect, review, and approve high-quality country-specific and/or site-specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation. Tailor, review, and negotiate country/site-specific Informed Consent Forms (ICF), translations (within the parameters of country/regulatory/client requirements), and negotiate any amendments as necessary. Prepare and submit IRB/IEC and MoH/RA applications (if applicable), resolving conflicts and determining appropriate follow-up until final approval is received. Ensure all relevant documentation is submitted to the trial master file in accordance with project plans and company policies. Forecast, develop, manage, and revise plans and strategies for:

- IRB/IEC and MoH/RA submission/approval,
- Site activation,
- Patient recruitment and retention.

Update and maintain Clinical Trial Management Systems (CTMS) promptly. Identify and address site inquiries and issues, including potential risks related to site activation timelines, patient recruitment strategies, training deficiencies, data quality or integrity, and study compliance. Facilitate and support assigned sites with access to relevant study systems, ensuring compliance with all project-specific training requirements prior to study initiation. Actively engage in Investigator and other external or internal meetings, audits, and regulatory inspections. Work independently with minimal oversight. Keep management informed about work progress and any arising issues.

Maintenance Phase (from initiation to close-out):

Act as Parexel's direct contact with assigned sites, ensuring the overall integrity of study implementation and adherence to study protocols, while resolving site issues.

  • Foster relationships with investigators and site staff.
  • Support sites with access to relevant study systems and ensure compliance with project-specific training requirements.
  • Assess on-site staff assignments and implement corrective actions as necessary.
  • Address and resolve site issues, including the need for additional training and documentation deficiencies.
  • Follow up on unresolved issues from previous visits.
  • Respond to site-related inquiries.
  • Utilize knowledge to identify and evaluate potential data quality and integrity issues, implementing appropriate follow-up actions.
  • Participate in Investigator and other external or internal meetings and audits as required.
  • Collect, review, and approve updated/amended site documentation, including regulatory documents as applicable.
  • Collaborate with site staff to evaluate recruitment plans and provide strategies for improvement.
  • Conduct on-site visits, including Qualification and Initiation visits, applying judgment to independently resolve site issues.
  • Perform remote visits/contacts as needed.
  • Generate visit/contact reports.
  • Assess overall compliance and performance of sites and site staff, providing recommendations for site-specific actions.
  • Manage test article/study supply, including accountability and destruction/return status.
  • Review and follow up on site payment status.
  • Monitor CRF data entry, query status, and SAEs.
  • Conduct on-site study-specific training (if applicable).
  • Perform assessments of site facilities.
  • Recognize the impact of study non-compliance/issues/delays/changes on study timelines and communicate urgent study issues with proposed resolution strategies.

Overall Responsibilities from Site Identification to Close-Out:

Ensure timely and accurate completion of project objectives and updates to applicable trial management systems.

  • Collaborate with team members to achieve project goals, providing strategies for efficient planning and completion, while encouraging team support.
  • Maintain ongoing updates in Clinical Trial Management Systems (CTMS), including regular reviews of site-level data and ensuring timely, high-quality data entry compliance from sites, managing and submitting all relevant documents to the Trial Master File (TMF) with first-time quality, and distributing study documents to sites.
  • Ensure assigned sites are prepared for audits and inspections.
  • Monitor compliance with ICH-GCP and applicable international and local regulations.
  • Delegate administrative tasks to the Administrative Support Team as needed, guiding team members and providing feedback to management regarding performance.
  • Demonstrate commitment to high-quality work.
  • Foster a positive, results-oriented work environment, building collaborative relationships and communicating openly with team members.
  • Maintain knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, and study-specific procedures.
  • Understand project scope, milestones, and budgets, striving for high-quality, timely, and efficient delivery.
  • Provide input for Performance Development Conversations.
  • Keep management informed about work progress and any issues.
  • Develop expertise to become a subject matter expert.
  • Work independently with minimal oversight.
  • Complete additional tasks in a timely manner (e.g., timesheets, expenses, metrics, etc.)

Required Skills:

  • Strong problem-solving abilities.
  • Ability to work independently while seeking guidance when necessary.
  • Effective presentation skills.
  • Client-focused approach.
  • Professional interaction within client organizations.
  • Flexibility regarding work assignments and new learning opportunities.
  • Capacity to manage multiple tasks and evaluate various unpredictable scenarios to meet project timelines.
  • Willingness to work in a matrix environment and value teamwork.
  • Proficient computer skills, including knowledge of Clinical Trial Management Systems (CTMS), Electronic Document Management Systems (EDMS), and MS Office products.
  • Strong interpersonal, verbal, and written communication skills.
  • Sense of urgency in completing tasks and assisting others to meet study deliverables.
  • Developing time management skills to meet study needs and team objectives.
  • Ability to work across cultures.
  • Commitment to consistently high-quality work.
  • Ability to work effectively in a virtual team environment.
  • Willingness to accommodate travel requirements as necessary.
  • Attention to detail.
  • Valid driver's license where required.

Knowledge and Experience:

  • Previous relevant work experience is preferred.

Education:

  • Degree in biological science, pharmacy, or other health-related discipline preferred, or equivalent nursing qualification or other relevant experience.

  • Clinical Trials Activation Specialist

    6 days ago

    Shanghai, Shanghai, China Thermo Fisher Scientific Full time

    Job SummaryWe are seeking a highly organized and detail-oriented Clinical Trials Activation Specialist to join our team at Thermo Fisher Scientific. As a Clinical Trials Activation Specialist, you will be responsible for preparing, reviewing, and coordinating country submissions in line with our global submission strategy.Key ResponsibilitiesPrepare, review,...

  • Booking Activation Coordinator

    4 weeks ago

    Shanghai, Shanghai, China Marriott Vacations Worldwide Full time

    Job Overview The role involves collaborating with the Marketing division to provide a preview package tailored for first-time buyers or members, in alignment with the company's promotional strategies, and facilitating the confirmation of bookings. Candidate Profile Preferred Education and Experience Associate degree or equivalent experience ...

  • Global Study Coordinator

    4 weeks ago

    Shanghai, Shanghai, China Lilly Full time

    Job Summary:Lilly is seeking a highly skilled and experienced Country Study Manager to join our team. As a key member of our clinical operations team, you will be responsible for providing clinical operational expertise to internal and external customers through ownership of country-level study operations.Key Responsibilities:Drive country initiation...

  • Lead Clinical Site Monitor

    4 weeks ago

    Shanghai, Shanghai, China SHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch Full time

    As a prominent global contract research organization (CRO) dedicated to scientific excellence and extensive clinical development expertise, SHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch offers pharmaceutical, biotechnology, and medical device clients a comprehensive array of clinical development, patient access, and...

  • Site Monitoring Specialist

    4 weeks ago

    Shanghai, Shanghai, China Fortrea Full time

    Key Responsibilities 1) The following points are designed to outline the general responsibilities of the role and are not an exhaustive list of all tasks, skills, and duties. 2) Oversee all facets of clinical site monitoring, including routine assessments and closure of study sites, management of study documentation, conducting pre-study and initiation...

  • Imaging Technology Specialist for Clinical Sites

    4 weeks ago

    Shanghai, Shanghai, China PSI CRO Full time

    Position OverviewThis role is focused on providing essential technical support and expertise to clinical sites, specifically in the realm of imaging technologies.Key ResponsibilitiesDeliver comprehensive technical assistance to clinical sites regarding various technologies.Facilitate the creation and execution of study-related documentation, including forms...

  • Clinical Site Management Specialist

    3 hours ago

    Shanghai, Shanghai, China Parexel Full time

    At Parexel, we believe that aligning our values leads to exceptional achievements. Key Responsibilities: Initiation Phase (from site selection to pre-initiation): Serve as Parexel's primary liaison with designated sites, ensuring quality and timely delivery during the initiation phase. Foster strong relationships with investigators and site...

  • Site Management Specialist

    3 hours ago

    Shanghai, Shanghai, China Parexel Full time

    At Parexel, we believe that aligned values lead to extraordinary achievements. Key Responsibilities: Start-up Phase (from site identification to pre-initiation): Serve as Parexel's primary liaison with designated sites, ensuring quality and timely delivery during the start-up phase. Cultivate strong relationships with investigators and site...

  • Supply Chain Coordinator

    1 week ago

    Shanghai, Shanghai, China Dover Corporation Full time

    About the RoleWe are seeking a highly organized and detail-oriented Supply Chain Assistant to join our team at Markem-Imaje in Shanghai. As a key member of our Supply Chain team, you will be responsible for maintaining site supply chain data, planning and organizing SC activities, and managing site office-related facilities.Key ResponsibilitiesCoordinate...

  • Supply Chain Coordinator

    2 weeks ago

    Shanghai, Shanghai, China Dover Corporation Full time

    About the RoleWe are seeking a highly organized and detail-oriented Supply Chain Assistant to join our team at Markem-Imaje in Shanghai. As a key member of our Supply Chain team, you will be responsible for maintaining site supply chain data, planning and organizing SC activities, and managing site office-related facilities.Key ResponsibilitiesCoordinate...

  • Platform Activation Manager

    4 days ago

    Shanghai, Shanghai, China The LEGO Group Full time

    Job Title: Platform Activation ManagerAbout the Role:We are seeking a highly skilled Platform Activation Manager to join our team at The LEGO Group. As a key member of our marketing team, you will be responsible for developing and executing strategies to drive business growth through e-commerce channels.Key Responsibilities:Collaborate with cross-functional...

  • Imaging Technology Specialist for Clinical Sites

    4 weeks ago

    Shanghai, Shanghai, China PSI CRO Full time

    Position OverviewThis role is based in a professional office environment. The official title within PSI CRO will be: Site Technology Specialist.Key ResponsibilitiesDeliver expert technical assistance to clinical sites concerning various technologies.Contribute to the development and execution of study-related documentation, including forms, guidelines, and...

  • Clinical Research Coordinator

    2 weeks ago

    Shanghai, Shanghai, China IQVIA Full time

    Job SummaryWe are seeking a highly skilled Clinical Trial Coordinator to join our team at IQVIA in Shanghai. As a key member of our clinical operations team, you will be responsible for ensuring the smooth execution of clinical trials, from site start-up to close-out.Key ResponsibilitiesManage trial and site administration, including tracking and reporting...

  • Clinical Research Coordinator

    4 weeks ago

    Shanghai, Shanghai, China PSI CRO Full time

    About the RoleWe are seeking a highly organized and detail-oriented Clinical Research Coordinator to join our team at PSI CRO. As a Clinical Research Coordinator, you will play a critical role in the success of our clinical research projects.Key ResponsibilitiesDatabase Management: Maintain accurate and up-to-date databases and tracking systems to ensure...

  • Internship Program Coordinator

    2 weeks ago

    Shanghai, Shanghai, China Infineon Technologies Full time

    {"title": "Job Description", "content": "Job SummaryWe are seeking a highly organized and detail-oriented individual to support our Organizational Excellence (OE) team as an Internship Program Coordinator. In this role, you will assist with administrative tasks, coordinate logistics, and provide support for employee engagement initiatives.Key...

  • Lead Coordinator for Events

    4 weeks ago

    Shanghai, Shanghai, China TÜV Rheinland Full time

    Job Overview • Event Management and Assessment: *Oversee all facets of event management from conceptualization, plan development, coordination with external partners, process oversight, and on-site execution. *Act as the leader of a comprehensive team to guarantee the successful implementation of activities with high-quality outcomes aligned with...

  • Clinical Research Coordinator

    2 days ago

    Shanghai, Shanghai, China PSI CRO Full time

    Job DescriptionWe are seeking a highly organized and detail-oriented Clinical Research Coordinator to join our team at PSI CRO. As a key member of our site management team, you will play a critical role in the success of our clinical research projects.Key Responsibilities:Maintain accurate and up-to-date databases and tracking systems to ensure seamless...

  • Manager of Event Coordination

    4 weeks ago

    Shanghai, Shanghai, China TÜV Rheinland Full time

    Job Overview • Event Management and Assessment: *Oversee all facets of event management from conceptualization, strategic planning, coordination with external partners, process oversight, and on-site execution. *Act as the leader of a comprehensive team to guarantee the successful implementation of initiatives with high-quality outcomes aligned with...

  • CSCM Site Lead

    4 days ago

    Shanghai, Shanghai, China ASML Full time

    Job SummaryASML is seeking a highly skilled CSCM Site Lead to manage demand and supply to ensure material availability progress. The ideal candidate will have a proven track record in service and operations management, with experience in a high-tech or complex business environment.Key ResponsibilitiesManage demand and supply to ensure material availability...

  • Clinical Research Coordinator

    1 day ago

    Shanghai, Shanghai, China PSI CRO Full time

    Company OverviewPSI CRO is a dynamic, global company founded in 1995, bringing together over 2,800 driven, dedicated, and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.Job SummaryWe are seeking a highly organized and detail-oriented Clinical Research Coordinator to join...