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- Initiation Clinical Site Manager I
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Initiation Clinical Site Manager I
Parexel International Corporation
China - Shanghai - Home Based
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 prequalification
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 meetings, audits & regulatory inspections.
• Work in a self-driven capacity, with limited need for oversight.
• Proactively keep manager informed about work progress and any
issues.Qualifications• Problem solving skills.
Able to work independently, seeking/taking guidance when necessary.
• Sound presentation skills.
• Client focused approach to work.
• Ability to interact professionally within a client organization with the support of manager or CSMⅡ
/Ⅲ
• Flexible attitude with respect to work assignments and new learning.
• Ability to manage multiple tasks, to evaluate a variety of unpredictable scenarios, and achieve
project timelines; apply understanding of study protocol(s).
• 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.
• Sound interpersonal, verbal, and written communication skills.
• Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country
deliverables.
• Developing ability for effective time management in order to meet study needs, team objectives,
and department goals.
• Developing ability to work across cultures.
• Shows commitment to and performs consistently high quality work.
• Ability to successfully work in a (‘virtual’) team environment.
• Able to accommodate travel time requirements, according to tasks allocation/phase of the study
assigned.
• Attention to detail.
• Holds a driver’s license where required
Job posted: 2021-07-11