Start-up Specialist (Level II or Sr.) (Taipei)

This role is for upcoming future opportunities that may arise at Fortrea.

Fortrea is excited to connect with talented individuals for future opportunities. If you meet the job requirements, we&aposll invite you for an interview. If you&aposre pre-selected, our recruiter will keep in touch and let you know when the role officially opens, so we can reconfirm your interest before moving forward with an offer.

Job Overview

Oversees tasks related to the conduct of clinical trials in the start-up phase and at times, maintenance phase. This may be inclusive of international clinical trials, but focus will be primarily US and UK. Responsible for provision of client deliverables on-time, within budget and scope and with required quality for assigned projects or program. Drives documentation for the project, ensuring the accuracy and quality of regulatory data. Supervise and assess the performance of the core team members and motivate, train, and develop the team’s expertise to ensure efficient and effective day-to-day operations, while maintaining good relationships with sponsors.

Summary Of Responsibilities

• Provide training, utilization, development, and performance review of assigned staff.
• Lead development of start-up processes.
• Serve as lead for site related start-up activities, as applicable, during study start-up phase.
• May present at external and/or internal meetings including, but not limited to BID Defense, Client Kick Off Meetings.
• Understand client expectations and project specifications to forecast timelines of study startup (up to certain point). Communication of timelines with project managers for projects conducted in the US and UK.
• Coordinate with GCD start-up, when contracted in support of CPS studies where required (i.e., understand project requirements, secure resources, monitor progress of GCD project team members).
• Ensure that all start-up staff allocated to assigned project(s) adhere to professional standards and SOPs.
• Participate in identifying SOPs for training matrix for start-up staff. Schedule/conduct training as applicable.
• Interpret billing guidelines for functional area and train start up team accordingly.
• Ensure direct reports are trained in the study budgeting process and assist PM in communicating with sites as appropriate. Assist PM and PC with Investigator Grants Estimate (IGE) to ensure estimate reflects the scope of the project.
• Review and provide input to relative functions areas, for the development of core study documents; oversee Investigator Package compilation.
• Adheres to parameters to Start-up plans.
• Oversee IRB/EC/HRA/CA submissions (including amendments as applicable) and approval status (except for Fortrea US CRU studies). Coordinate addressing queries ensuring required timelines are met.
• Oversee/negotiate NIHR/NHS costing tool templates as applicable. Coordinate queries/updates ensuring required timelines are met.
• Coordinate PIC site activities as required.
• Support inspections, internal and client audits. Support resolution of inspection/audit findings for start-up functions.
• Collate and distribute essential study related documents to regional start-up staff inclusive of all Investigator Package Plan documents, patient facing materials, and any additional documents as required for a project.
• Oversee/set up and distribute regulatory binders as applicable for the study.
• Oversee Green Light approval regionally and globally. Alert PM of any risks.
• Establish working relationships with client project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business.
• Responsible for appropriate issue escalation per Fortrea quality SOPs.
• Manage and report on client project metrics for start-up expectations and deliverables.
• Work with clinical monitoring project team members to ensure accuracy and completion of all study documents.
• Timely and accurate document reviews prior to finalization.
• Direct contact with variety sites, investigator sites, commercial CROs and academic.
• Contributes updates on investigator sites for internal metrics.
• All other duties as needed or assigned.
  
  

Qualifications (Minimum Required)

• University/college degree (life science preferred) or certification in a related allied health profession (i.e., nursing, medical or laboratory technology) from an appropriately accredited institution.
• In lieu of the above requirements, candidates with greater than six (6) years supervisory experience in a health care setting and four (4) years clinical research experience in the pharmaceutical or CRO industries will be considered.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Working knowledge of time and cost estimate development.
• Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
• Broad knowledge of drug development process and client needs.
  
  

Experience (Minimum Required)

• Minimum 2 years working experience as SSUS in global pharma/CRO. If local pharma/CRO experience will have 0.5 adjustment of the working experience.
• Experience in managing projects in a virtual environment.
• Demonstrated ability to handle multiple competing priorities and to utilize resources effectively.
• Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system.
• Demonstrated ability to lead by example and to encourage team members to seek solutions independently.
• Excellent communication, planning and organizational skills.
• Ability to review/analyze and report relevant data and interpret protocols and regulatory documents.
• Ability to work independently.
• Ability to negotiate and liaise with clients in a professional manner.
• Ability to present to staff at all levels.
• Strong computer skills with an ability to understand, access and leverage technology alternatives.
• A working knowledge of ICH GCP, US FDA and MHRA regulations, regulations applicable to local office, guidelines, and practices regarding Good Clinical Practices.
  
  

Preferred Qualifications Include

• Master&aposs or other advanced degree.
• Working knowledge of Fortrea and the overall structure of the organization.
• Basic knowledge of Fortrea sales and business development strategies and procedures.
• Working knowledge of Fortrea SOPs.
  
  

Physical Demands/Work Environment

• Must be able to sit at a computer for long periods of time.
• Must be able to use hands to finger, handle or touch objects, tools, or controls, including a computer keyboard, for up to 8 hours per day.
• Standard office and/or home working environment.
• Risk of eye strain.
• Will involve out-of-normal office hours as required by the role.
  
  

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