Clinical Site Manager / CRA

Consistently meet the requirements of a ICSM I with a high degree of proficiency, accuracy, and autonomy:

• Conduct country specific feasibility and/or site pre-qualification

• Review and validate site identification list

• Collect and negotiate Confidentially Agreements (CDA) as required

• Organize translations per country/regulatory/client requirements

• Review and approve country specific and/or site specific documents or essential regulatory documents (SRP)

• Customize, review, configure, and negotiate as required country/site specific Informed Consent Forms (ICF) and their amendments

• Prepare and submit IRB/IEC application and follow up until final approval received (initial submission and amendments)

• Prepare and negotiate as required initial and/or amended CSA at a site level

• Resolve CSA changes requested by the site and approve any change in CSA language with support from Site Contract Leader (SCL) as required

• Collect internal CSA signatures

• Complete routine departmental administrative tasks in an accurate and timely manner (e.g. timesheets, metrics, etc.)

• Proactively keep manager informed about work progress and any issues (including conflicting priorities and free capacity)

• Maintain a good working knowledge of, and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, PAREXELSOPs, other PAREXEL training requirements, and study specific procedures and training

• Ensure good understanding of project scope, milestones, budgets, and time codes and strive for high quality, timely, and efficient delivery

• Update all appropriate Clinical Trial Management systems (CTMS) as indicated per function on an ongoing basis and submit all relevant documents to central files per the Central File Maintenance Plan

• Escalate any site and study issues that require immediate action to the Functional Lead (FL)

• Proactively work with team members to meet project goals

• Show commitment and perform consistent high quality work

In addition;

• Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced, and objective manner

• Manage sites and protocols across multiple therapeutic areas independently

• Support less experienced staff on project assignments as appropriate

• Recognize out of scope activities and communicate to FL

• Recognize impact of issues/delays/changes on study timelines and communicate to FL

• Participate in internal audits/client meetings with support

• Require minimal supervision by ManagerQualificationsSkills

• Good presentationskills

• Client focused approach to work

• Ability to interact professionally with external customers.

• Flexible attitude with respect towork assignments and new learning

• Advanced ability to manage multiple and varied tasks with enthusiasm

• Attention to detail

• Willingness to work in a matrix and virtual team 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

• Strong interpersonal, verbal, and written communication skills

• Advanced problem solving skills

• Sense of urgency in completing assigned tasks

• Effective time management in order to meet daily metrics, team objectives, and department goals

• Ability to work across cultures

• Ability to work independently with little oversight and to proactively seek guidance when necessary

• Strong ability to influence and negotiate resolutions and outcomeswith sites

• Willing and able to travel locally and internationally occasionally as required

Education

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

Language Skills

• Proficient in written and oral English and fluent in relevant local language

Minimum Work Experience

• Previous experience in start-up activities for clinical trials or equivalent experience in clinical research with understanding of clinical trials methodology and terminology