Medical Monitor, General Medicine
Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.
We’re looking for an exceptional Medical Monitor, General Medicine 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.
You’ll be doing:
Responsible for providing scientific support to Premier Research in business. Supports study related medical monitoring activities that are led by the medical directors in accordance with regulations and SOPs, in particular focusing on medical data review.
The Medical Monitor:
- Is responsible for setting up, documenting and communicating project specific medical monitoring requirements for assigned projects.
- Supports medical directors 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
- Assists Medical Directors in business development
- Performs scientific research for and provides input into the RF
- For High Quality Medical Support:
- Conducts medical data review and generates data queries
- 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.
- Provides support to Medical Directors with their Medical Monitoring activities.
- 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
- 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
- Represents the department and interfaces with other departments, as needed (e.g. with data management, clinical operations, etc.)
- Creates training plans for new employees
- Supervises and trains new employees
- For Commercial Success:
- Ensures activities are carried out to a high standard and as efficiently as possible with proactivity and customer focused delivery
- Reviews and QCs documents and work of other associates, as needed
- Mentors other more junior members of the team
- Participates in corporate initiatives and actions that ensure the continued success of the company
- Supports PV activities as needed
- Other activities as designated
- Graduate in medicine
- Extensive 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
- Knowledge of web-based communication tools for conferences
- 2 years in a relevant pharma or medical related field or role, e.g. CRA, Pharmacy etc.
- Same as Level 1.
- 2 or more 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.
- Same accountabilities as Level 1 & 2.
- 5 or more years’ experience of working in a medical or safety department
- Demonstrable expert knowledge of medical terminology and detailed knowledge of medical monitoring processes and regulations and expert experience with medical data review