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About the Role
The Senior Medical Services Manager will perform complex medical monitoring tasks, potentially acting as a global/program medical monitor. This role may involve mentoring junior medical monitors, coordinating training, contributing to SOP development, improving team performance, and liaising with Business Development for medical guidance.
Responsibilities
- Provide medical oversight for Novotech sponsored clinical trials, acting as medical representative to the Novotech project team.
- Prepare a Medical Monitoring Plan for each study according to project scope.
- Provide medical review and commentary on client protocol and/or Investigator Brochure.
- Attend Investigator Meeting; prepare and present safety or medical aspects if required.
- Provide medical review and input to Clinical Monitoring Plan and Safety Management Plan as required.
- Provide medical review, comment and assessment of causality for Serious Adverse Events (SAEs) occurring in Novotech sponsored clinical trials.
Requirements
- Must be qualified as a medical Doctor with experience in clinical practice.
- Experience in drug development in the pharmaceutical and/or CRO industry.
- Knowledge of drug safety reporting requirements and practice.
- Unrestricted working rights in Australia.
Skills
- Medical monitoring
- Clinical trial oversight
- Protocol review
- Investigator Brochure review
- Serious Adverse Event (SAE) assessment
- Drug development
- Drug safety reporting
Location
- Australia
Work Type
- Full-time
Experience Level
- Senior
- Medical Doctor with experience in clinical practice
- Experience in drug development in the pharmaceutical and/or CRO industry
Education Level
- Medical Doctor
Benefits
- Flexible working options
- Paid parental leave for both parents
- Flexible leave entitlements
- Wellness programs
- Ongoing development programs
- Mentorship opportunities
- Professional development programs
- Flexible benefits framework (NovoLife)
About the Company
- Novotech is a global full-service clinical Contract Research Organization (CRO).
- We are committed to fostering an environment that reflects the life-changing work we do.
- Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE).
- Expanded global footprint with 30+ offices across Asia-Pacific, the United States, and Europe.
- We have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model.
- We offer a collaborative culture, where every voice is heard and valued.
Equal Opportunity
- We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.
- We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
- We are a Circle Back Initiative Employer and commit to respond to every application.