Medical Monitor Oncology experience

Medical guidance to site personnel and the project team regarding Protocol and other studyspecific medical aspects

24 / 7 medical consultancy support to investigators and project team

Monitoring of patients safety and wellbeing :

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 studyrelated documents (including the preparation of the MM plan)

Participation in Kickoff Meetings Investigator Meetings and other studyrelated 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 recoding 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
• Selfmotivated able to work independently as well as in multidisciplinary teams and with the intellectual flexibility to continually develop and learn new skills
• Indepth knowledge of medical terminology and of GCP ICH guidelines relevant to global drug safety and drug development process and regulations
• Good decisionmaking 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 humancentric 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.

Remote Work : Employment Type :

Fulltime

Key Skills

Hospital Experience,Acute Care,Basic Life Support,ICU Experience,Infusion Experience,Triage,TFS,Conflict Management,Nursing,Critical Care Experience,Epic,Medication Administration

Experience : years

Vacancy : 1