Clinical Scientist - Remote

Medical Management United States


Description

Position at Premier Research

We’re looking for an exceptional Clinical Scientist to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.

At Premier Research, we are science-minded and heart-centered. Join us.

Responsible for providing scientific support to Premier Research in and specifically work together with the Medical Directors to provide scientific input for bid defenses and RFPs. Works under medical supervision to support study related medical monitoring activities that are led by the medical directors in accordance with regulations and SOPs.

The Clinical Scientist:

  • Is responsible for setting up, documenting and communicating project specific medical monitoring requirements as the lead Clinical Scientist for assigned projects.
  • Supports medical monitors under medical guidance in the conduct of studies
    • Develops and reviews medical monitoring and other study related plans
    • Trains project team and sites in the protocol
    • Reviews site and project team queries
    • Reviews medical data including labs, patient profiles, CRF data and eligibility/enrollment reviews
    • Initiates medical monitoring activities during the start-up of clinical trials including development of process documents aligned with the study protocol, budget, standard operating procedures, and ethical requirements.
    • Writes and reviews Medical Monitoring Plans.
    • Reviews budget and scope of medical team’s responsibilities addressing inadequacies or concerns with the Medical Director and/or project management team.
    • Tracks study progress, proactively resolves issues, and proposes corrective action to project team/clients.
    • Processes and addresses protocol non-compliances at Investigative sites and ensures adherence to ethical guidelines
    • Collaborates with Medical Directors on the medical-operational aspects of complex clinical studies
    • Conducts medical data review and generates data queries
    • Attends Investigator Meetings and interacts with Investigative site staff and client representatives
    • Is a point of contact and knowledge resource for Medical Directors to consult with on study-specific drug/device medical activities
    • Works closely with Medical Directors/Investigative Sites/CRAs to document and assist with resolution of clinical issues, e.g. continuing eligibility queries
    • Reviews study documentation (e.g. budget, protocol, CRF, DSMB charter, etc.)
    • Supports implementation and use of new technology tools
    • Prepares for audits and inspections by sponsors or regulatory agencies
    • Participates in internal and external project team and client meetings
  • Assists Medical Monitors in business development
    • Performs scientific research for and provides input into the RFP
    • Provides a background scientific package for bid defense team members
    • Attends bid defenses in support of the medical team
    • Produces budgets

You'll Need

  • 2-4 years in a relevant pharma or medical related field or role, e.g. CRA, Pharmacy etc.
  • 1 – 2 years’ experience of working in a medical or safety department
  • Demonstrable knowledge of medical terminology and experience of handling medical data review and query resolution.
  • Graduate in medical or science fields (e.g. medicine, nursing, pharmacy, life sciences).
  • Preferred postgraduate degree (MSc, MPhil or Ph. D) in a clinical, biological, scientific or health-related field.
  • The above education requirements may be waived if existing exact-match work experience is present and deemed to be sufficient.
  • Knowledge of ICH / GCP regulations
  • Working knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures
  • Knowledge of web-based communication tools for conferences
  • Fluent verbal and written English
  • Excellent team player, collaborative and able to build an effective team.
  • Ability to multi-task and work effectively in a fast-paced environment with changing priorities.
  • Strong verbal and written communication and negotiation skills.