Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality.
We have positioned ourselves right in the middle of the action, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.
Working at Premier Research means being an individual - you will be recognised for what you do and you will truly have an impact.
You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority.
Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
We’re looking for a Medical Monitor to join our team. This is a permanent role to be based in our office in Warsaw, Poland.
Neurology, Oncology, Pediatric, Rare Disease, Psychiatry or Dermatology experience is preferred.
These are excellent opportunities for medics to enter the clinical research industry and apply their medical knowledge directly.
Training and mentoring will be provided on the job
Candidates should be able to offer fluency in written and spoken English, possess an excellent eye for detail and be confident and accountable for making independent decisions.
Imagine. Inspire. Innovate. Impact. With Us.
You'll be accountable for :
Setting up, documenting and communicating project specific medical monitoring requirements for assigned projects.
Supporting medical monitors under medical guidance in the conduct of studies
Developing and reviewing medical monitoring and other study related plans
Training project team and sites in the protocols
Reviewing site and project team queries
Reviewing medical data including labs, patient profiles, CRF data and eligibility / enrollment reviews
Assisting Medical Monitors in business development
Performs scientific research for and provides input into the RFP
Conducting medical data review and generates data queries
Ensuring compliance with and adherence to all internationally recognized standards
Initiating 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
Reviewing budget and scope of medical team’s responsibilities addressing inadequacies or concerns with the Medical Director and / or project management team
Tracking study progress, proactively resolves issues, and proposing corrective action to project team / clients
Processing and addressing protocol non-compliances at Investigative sites and ensuring adherence to ethical guidelines
Collaborating with Medical Directors on the medical-operational aspects of complex clinical studies
Attending Investigator Meetings and interacting 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
Preparing for audits and inspections by sponsors or regulatory agencies
Reviewing and QCing documents and work of other associates, as needed
Mentoring other more junior members of the team
Supporting PV activities as needed
You'll need this to be considered :
Graduate in medicine
Ideally, previous clinical practice experience in oncology, dermatology, pediatrics, or neuro-psychiatry is preferred (Board certification or equivalent not required).
CRO experience in an alternative function is preferred (e.g. CRA, data management)
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
Fluent verbal and written English as well as the local language(s)
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.
Excellent organizational and time-management skills, able to prioritize workload to meet deadlines
Is customer service focused in approach to work both internally and externally
Maintains a positive, results orientated work environment