Job Description
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:
Is responsible for supporting the setup, documentation and communication of project specific medical monitoring requirements for assigned projects.
Supports medical monitors under medical guidance in the conduct of studies
Reviews medical data including labs, patient profiles, CRF data and eligibility/enrollment reviews
Ensures compliance with and adherence to all internationally recognized standards (e.g. ICH GCP, ICH E2A, ISO14155, etc.), national regulations and SOPs applicable for specific projects.
Participates in the development and review of Medical Monitoring Plans.
Tracks study progress, proactively resolves issues, and makes recommendations to project team/clients.
Works closely with Medical Directors/Investigative Sites/CRAs to document and assist with resolution of clinical issues, e.g. continuing eligibility queries
Collaborates with other departments as needed (e.g. with data management, clinical operations, etc.)
Supports training for new employees and participates in their onboarding
Reviews and QCs documents and work of other associates, as needed
Participates in corporate initiatives and actions that ensure the continued success of the company
What we are searching for
Graduate in medical or science fields (e.g. medicine, nursing, pharmacy, life sciences).
Preferred postgraduate degree (MD, MSc, MPhil or Ph. D, PA) in a clinical, biological, scientific or health-related field.
0-2 years in a relevant pharma or medical related field or role, e.g. CRA, Pharmacy etc.
Knowledge of web-based communication tools for conferences
Fluent verbal and written English as well as the local language(s)
Ability to multi-task and work effectively in a fast-paced environment with changing priorities.
Strong verbal and written communication and negotiation skills.
Excellent organizational and time-management skills, able to prioritize workload to meet deadlines.
Is accountable, dependable and demonstrates strong commitment.
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