Project Specialist (Contract)

Premier Research Group; United States; A distancia; USD 34.000 - 55.000; A tiempo parcial

Descripción de la vacante

Premier Research is seeking a Project Specialist (Contract) to join our team. You will coordinate project activities, deliverables, and milestones to ensure successful execution alongside cross-functional groups.

The role involves data entry, analysis, document collection, and inspection readiness support. You will draft and maintain project documentation, aid in development of KPIs, and manage site shipments and TMF documentation under supervision.

Formación

• Bachelor’s degree or international equivalent in a clinical, biological, scientific, or health-related field or equivalent combination of education, training and experience.
• 3 to 5 years of practical experience with clinical trial administration or proven experience in all primary job functions.
• Excellent English verbal and written communication skills.

Responsabilidades

• Coordinate project activities, deliverables, and milestones to support project execution and delivery.
• Perform project support activities including data entry, analysis, document tracking, reporting, and inspection readiness support.
• Identify and support resolution of project risks and issues with cross-functional teams.

Conocimientos

English proficiency

Communication skills

Educación

Bachelor’s degree or international equivalent

Descripción del empleo

Premier Research is looking for a Project Specialist (Contract) to join our Functional Services Provider (FSP) team.

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
• Your ideas influence the way we work, and your voice matters here.
• As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Join us and build your future here.

What You’ll Be Doing:

• Coordinate project activities, deliverables, and milestones to support successful project execution and delivery.
• Perform project support activities, including data entry and analysis, document collection and tracking, reporting, and inspection readiness support.
• Identify, elevate, and support the resolution of project risks and issues in collaboration with cross-functional teams.
• Draft, maintain, and distribute project documentation, including procedures, proposals, progress reports, newsletters, and presentations.
• Under direct supervision, collect and analyse data from operational study leads to assist in the development and maintenance of Key Performance tools.
• Oversee overall study team tracking, project system access for team members, creation and maintenance of team members and site contact information within specified system(s), overall management of site shipments (site and patient materials) in accordance with study milestones, and study documentation (TMF), as appropriate.

What We Are Searching For:

• Bachelor’s degree, or international equivalent from an accredited institution, preferably in a clinical, biological, scientific, or health-related field or equivalent combination of education, training and experience
• 3 to 5 years of practical experience with clinical trial administration (e.g. – Inhouse CRA, CTA, site administration, clinical monitoring). Alternately, must have proven experience in all primary job functions.
• Demonstrates excellent English verbal and written communication skills
• Proven ability to drive successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership
• Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities
• Knowledge of International Conference on Harmonization (ICH)/Good Clinical Practices (GCP) and/or ISO14155 requirements as well as knowledge of the relevant country specific regulatory requirements for conducting clinical trials

Please note this is a 1099 contractor opportunity

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status