Medical Monitor (Slovakia)
- Clinical Research, Clinical Administrator, Clinical Project Manager, Clinical Research Associate, Clinical Research Nurse, Clinical Services, Clinical Supplies, Clinical Trials Manager / Administrator, Drug Safety, Feasibility, Pharmacoeconomics, Pharmacovigilance, Study Site Coordinator, Study Start Up, Data Management / Statistics, Clinical Data Management, Informatics, Statistics, Medical Affairs, Medical Advisor, Project Management, R & D Project Management, Regulatory Project Management, Quality, QA / QC, Quality Validation Engineer, R & D , Biochemistry, Biology, Biotechnology, Chemistry, Pharmacology, Pre - clinical, Scientific, Regulatory Affairs, CMC, Compliance, Labelling, Regulatory Writing
Role: Medical Monitor
Location: Bratislava, Slovakia - office based
Contract Type: Permanent
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 Bratislava, Slovakia. Neurology, oncology, pediatric, 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.
You must be eligible to live and work in Slovakia in order to apply for this role.
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