Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.

- Build relationships with investigators and site staff.
- Conduct, drive and manage country specific feasibility and/or site pre-qualification and qualification activities, which may include:

o Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.

o Conduct remote Qualification Visits (QVs).

- Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution.
- Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.
- Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of... country/regulatory/client requirements), and customize and negotiate any amendments.
- Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval.
- Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy.
- Forecast, develop, manage, and revise plans and strategies for:

o IRB/IEC and MoH / RA submission/approval,

o Site activation,

o Patient recruitment & retention.

- Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.
- Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity, study non-compliance, etc.
- Facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all project specific training requirements prior to study start.
- Actively participate in Investigator and other external or internal
- Work in a self-driven capacity, with limited need for oversight.
- Proactively keep manager informed about work progress and any issues.

Qualifications

Skills:

- Strong problem solving skills
- Able to take initiative and work independently, and to proactively seek guidance when necessary.
- Excellent presentation skills.
- Client focused approach to work.
- Ability to interact professionally within a client organization.
- Flexible attitude with respect to work assignments and new learning.
- Ability to prioritize multiple tasks, and achieve project timelines; utilizing strong analytical skills to

make decision autonomously due to the unpredictable nature of the issues that arise.

- Strong ability to make appropriate decisions in ambiguous situations.
- Willingness to work in a matrix environment and to value the importance of teamwork

Strong computer skills including but not limited to the knowledge of a Clinical Trial Management

System (CTMS), Electronic Document Management System (EDMS), and MS-Office products

such as Excel and Word.

- Excellent interpersonal, verbal, and written communication skills.
- Sense of urgency in completing assigned tasks and ability to assist others to meet study/country

deliverables.

- Excellent time management in order to meet study needs, team objectives, and department goals.
- Proven ability to work across cultures.
- Shows commitment to and performs consistently high quality work.
- Ability to successfully work in a (‘virtual’) team environment.
- Consulting Skills.
- Able to accommodate travel time requirements, according to tasks allocation/phase of the study

assigned.

- Act as a mentor and role model for other team members.
- Effectively enlist the support of team members in meeting goals.
- Attention to detail.
- Holds a driver’s license where required

Knowledge and Experience:

- Substantial Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology

Education:

- Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience

#LI-REMOTE
Seoul South Korea

Salary Criteria