Senior Feasibility Specialist

Jobinhalt

Job Title:Senior Feasibility Specialist

Job Location: Taiwan

Job Overview

Collaborate closely with feasibility managers and strategists, project management, clinical management, and biostatistics for the coordination of high-quality feasibility assessments. Independently coordinate feasibility projects and deliverables according to contractual obligations. Actively participate in process development and change initiatives within the group, which may include the development and delivery of training on departmental requirements and other areas that impact feasibility conduct.

Job Duties And Responsibilities

• Assists with assigned pre-award RFP strategic Feasibility and BDM business needs
• Leads the setup, survey programming, and conduct for allocated feasibility studies according to timeline and quality standards, and client expectations.
• Leads internal planning meetings and facilitates training calls.
• Ensures that the development of the initial site list is coordinated among the project team as appropriate.
• Undertakes all required activities to ensure accuracy and quality of survey-driven data and related deliverables.
• Secures global resources for feasibility projects.
• Reviews and analyzes project status to ensure successful completion of milestones, timelines, and deliverables.
• Liaises with the global, cross-functional team, inclusive of numerous departments (i.e., legal, clinical management, etc.).
• Works with team to identify potential risks and out-of-scope activity; discusses contingency plans with leadership.
• Contributes to the development of best practices for feasibility conduct.
• Independently delivers training of feasibility requirements/process/system to project teams.
• Mentors and trains new and junior team members.
• Contributes to the development, testing, and maintenance of the electronic survey tool.
• Ensures compliance with departmental training plans and required SOP’s and supportive documentation
  

Supervisory Responsibilities

No supervisory responsibilities

Job Requirements

• Education
  • Bachelor’s degree preferred or equivalent experience considered, healthcare or life science degree a plus.
  • Enrolled in undergraduate program considered with comparable experience
• Experience
  • 3 years relevant experience in Feasibility as applicable
  • Prior work experience within Pharma or Clinical Research preferred
• Skills/Competencies
• Knowledge of clinical research process related to study start-up and medical terminology
• A basic understanding of Regulatory and Central/Local ethics submission processes for assigned countries
• Strong written and verbal communication skills to express complex ideas to study personnel, internal and sponsor team members
• Excellent organizational and interpersonal skills
• Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities
• Excellent verbal and written communication skills required in local language for assigned countries
• Ability to manage multiple competing priorities within various clinical trials
• Working knowledge of current ICH GCP guidelines and applicable regulations
• Ability to reason independently, assess and recommend specific solutions in clinical settings, and mentor administrative staff
• Ability to work independently, prioritize and work with a matrix team environment is essential
• Flexibility
• Capabilities
  • Working knowledge of Word and Excel is required
    
  Corporate-office location or remote
  
  The company will not accept unsolicited resumes from third party vendors.