Job Description
Summarized Purpose:
Completes site activation or amendment deliverables within the assigned projects and ensures all project deliverables meet customer expectations, as well as, contracted deliverables by providing accurate projections, report updates, and ongoing risk assessments.
Essential Functions and Other Job Information:
Essential Functions
• Collaborates with multiple team members in a matrix environment for the effective delivery of site activation or amendments within assigned projects.
• Assists with coordination of the flow of information between internal teams, clients, or functional departments involved in site activation or amendments.
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• Participates in developing plans/guidelines for project implementation.
• Monitors and analyzes project status to ensure successful progress and completion of all assigned projects and provides metrics and status updates to senior team members and/or upper management.
• Performs risk identification and contingency planning.
• Collaborates with team members to manage financial and contractual aspects of the studies related to site activation or amendments.
• Participates in establishing appropriate controls to ensure that project resources and expenses are aligned with budgets.
Qualifications:
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years). CAS and CRA experience is prefered.
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
• Able to work well and efficiently with cross-functional teams
• Organizational and communication skills
• Attention to detail relevant to driving colleagues to achieve broader study deliverables
• Ability to identify risks related to contractual deliverables and review potential solutions
• Demonstrates basic understanding of cross-cultural awareness and is able to adapt appropriately
• Basic understanding and appreciation of clinical research/ development, including medical and therapeutic areas, phases and medical terminology
• Ability to lead, liaise and coordinate activities as part of a cross-functional project team
• Firm knowledge/understanding of clinical development guidelines and directives