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Project Specialist
Premier Research. Partner with the Project Manager to ensure overall project delivery through coordination and oversight of the cross-functional project team .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical research project management, including budget tracking, vendor management, and compliance with ICH/GCP regulations. Proficient in facilitating team communications and maintaining project documentation to ensure audit readiness.
Highest-signal resume keywords
Clinical Research ExperienceBudget ManagementICH/GCP Regulations KnowledgeProject Management TerminologyMS Office Suite Proficiency
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical ResearchBudget TrackingVendor ManagementProject ManagementClinical Monitoring Procedures
Soft Skills
Team CommunicationOrganizational SkillsMeeting Facilitation
Industry Keywords
FDA Guidance DocumentsEU DirectivesISO14155 RegulationsLife SciencesHealthcare
About the role
Key responsibilities & impact- Partner with the Project Manager to ensure overall project delivery through coordination and oversight of the cross-functional project team
- Facilitate team communications and maintain internal and external project documentation
- Maintain internal and external project team contact lists
- Schedule internal and external team meetings, develop agendas, capture minutes, and manage action/decision logs
- Create and distribute study newsletters as required
- Manage and track budgets related to vendor projects, including supplies and invoices
- Track out-of-scope services and assist in preparing Change Orders
- Track supplies, invoices, and budgets relating to vendor management
- Ensure projects are audit ready
- Create and manage required project systems, SOP indices, and study team lists
- Manage study team/contact lists, system access requests, and email distribution lists
Requirements
What you’ll need- Associate’s degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field and a minimum of 2 years of clinical research experience
- OR a Bachelor’s degree, or international equivalent, preferably in a clinical, biological, scientific, business, or health-related field, and a minimum of 1 year of professional work experience in clinical research, healthcare, business, finance, and/or project management preferred
- Basic knowledge of ICH/GCP regulations
- Working knowledge of FDA guidance documents/EU directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures
- Basic knowledge of project management terminology and guidelines
- Strong computer skills in MS office suite required
- Immediately available or only a short notice period to be considered
- This role is offered as a 1 year Fixed Term Contract on Premier Research payroll
Benefits
Comp & perks- Health insurance
- Life insurance
- Retirement plan
- Paid time off
- Employee Assistance Program
- Flexibility and balance to support your life requirements