Job Description

· Medical guidance to site personnel and the project team regarding Protocol and other study-specific medical aspects

· 24/7 medical consultancy support to investigators and project team

· Monitoring of patient’s safety and well-being:

o Detection of trends and outliers

o Signal detection

o Eligibility check

o Review of selected laboratory parameters

o Protocol deviations review with proposed grading from medical/safety perspective

o Review of subject discontinuation list

o Monitoring of specific safety parameters (risks due to IMP or AxMP safety profile as well

as an indication)

· Medical review/creation of case/narratives and participating in the SAE reconciliation as support to the Safety Department

· Regular presentations of MM reports to the study team

· Medical Review of patient data

· Medical input to the study-related documents (including the preparation of the MM plan)

· Participation in Kick-off Meetings, Investigator Meetings, and other study-related meetings,

including participation at the safety committee meetings (DSMB, IDMC, and SRC meetings) andpresentation of the safety data

· Training of the project team and investigators on the indication, IMP, AxMP, and other medical aspects of the study

· Reviews or assists in the review of medical coding to assure congruency with the terms reported in the case report form (CRF) and provides re-coding of events if appropriate · Overview of SP activities and review of the SP visit reports

· Bid Defence meetings and interactions with the sponsor.

Qualifications

• Medical Doctor degree.
• Experience in clinical research in medical monitoring within oncology
• Experience from a CRO
• Proven, efficient medical communication
• Highly organized, with strong interpersonal, presentational, and documentation skills
• Proven efficiency in timely delivery
• Self-motivated, able to work independently, as well as in multi-disciplinary teams, and with the intellectual flexibility to continually develop and learn new skills
• In-depth knowledge of medical terminology and of GCP, ICH guidelines relevant to global drug safety and drug development process and regulations
• Good decision-making and problem resolution based on all relevant information.
• Strategic thinking, recognizing key issues and providing practical solutions
• Ability to work effectively in an environment characterized by tight timelines and changing priorities.

Additional Information

Why Ergomed

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.

We offer:

• Training and career development opportunities internally

• Strong emphasis on personal and professional growth

• Friendly, supportive working environment

• Opportunity to work with colleagues based all over the world, with English as the company language

Our core values are key to how we operate, and if you feel they resonate with you then Ergomed is a great company to join!

Quality

Integrity & Trust

Drive & Passion

Agility & Responsiveness

Belonging

Collaborative Partnerships

We look forward to welcoming your application.