Clinical Site Management Specialist

5 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 personnel. Conduct and oversee country-specific feasibility assessments and site pre-qualification activities, which may involve:

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

Create visit/contact reports, utilizing judgment to identify site challenges and directing resolution efforts. Formulate strategies to configure, distribute, collect, and review 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 customize and negotiate any amendments. Prepare and submit IRB/IEC and MoH/RA (if applicable) applications, resolving conflicts and determining appropriate follow-up until final approval is received. Ensure all relevant documentation is submitted to the trial master file according to project plans and company policies. 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 promptly, including potential risks with site activation timelines, patient recruitment strategies, training deficiencies, data quality, study compliance, etc. Assist allocated sites with access to relevant study systems and ensure 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 challenges.

Maintenance Phase (from initiation to closeout):

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

Cultivate 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. Resolve site issues, including the need for additional training and documentation deficiencies. Follow up on any outstanding issues from previous visits. Respond to site-related inquiries. Utilize knowledge to identify and evaluate potential data quality and integrity issues, determining 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 continuously and provide strategies for improvement. Conduct on-site visits, including Qualification and Initiation visits, applying judgment to resolve site issues independently. Perform remote visits/contacts as needed. Generate visit/contact reports. Assess site compliance and performance, providing recommendations for site-specific actions. Manage test article/study supply, including accountability and return status. Review and follow up on site payment status. Monitor CRF data entry, query status, and SAEs. Conduct site-specific training as applicable. Perform assessments of site facilities. Recognize the impact of study non-compliance/issues/delays on timelines and communicate issues requiring immediate action, along with proposed resolution strategies.

Overall Responsibilities from Site Identification to Closeout:

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. Continuously update Clinical Trial Management Systems (CTMS), performing regular reviews of site-level data and ensuring high-quality data entry compliance from sites, managing and submitting all relevant documents to the Trial Master File (TMF), ensuring first-time quality, and distributing study documents to sites. Ensure assigned sites are audit and inspection ready. 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 challenges. 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.)

Skills Required:

Strong problem-solving abilities. Ability to work independently while seeking guidance when necessary. Effective presentation skills. Client-focused approach. Professional interaction within client organizations. Adaptability to work assignments and willingness to learn. Capacity to manage multiple tasks and evaluate unpredictable scenarios to meet project timelines. Teamwork-oriented mindset. Proficient computer skills, including knowledge of CTMS, EDMS, and MS-Office products. Strong interpersonal, verbal, and written communication skills. Sense of urgency in completing tasks and assisting others. Developing time management skills to meet study needs and team objectives. Ability to work across cultures. Commitment to high-quality work. Ability to work effectively in a virtual team environment. Willingness to accommodate travel requirements as needed. 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 relevant experience.

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