At a Glance
- Tasks: Oversee safety in clinical trials and ensure integrity of trial subjects.
- Company: Accelagen, a leader in innovative clinical research.
- Benefits: Flexible working arrangements, professional growth, and impactful work.
- Other info: Dynamic environment with opportunities across diverse therapeutic areas.
- Why this job: Join a collaborative team making a real difference in patient outcomes.
- Qualifications: Life Sciences or medical qualifications with clinical trial experience.
The predicted salary is between 61650 - 75350 $ per year.
Accelagen is expanding its Medical Affairs team and looking for an experienced Medical Monitor who will be responsible for overseeing the safety aspects of clinical trials and to ensure the safety and integrity of the trial subjects throughout the trial, from the initial design of the study to the final close-out.
The Medical Monitor will act as the point of reference for Accelagen study team members and investigative sites and determine how to evaluate safety events within a clinical trial.
About You
As an experienced Medical Monitor you are an organised and detail-oriented professional who enjoys working in a collaborative environment and takes ownership of delivering high quality outcomes and clinical trial safety.
Key Responsibilities
- Provide medical oversight for sponsored clinical trials, acting as medical representative to the project team.
- Prepare a Medical Monitoring Plan for each study according to project scope and provide medical review and commentary on client protocol and/or Investigator Brochure development.
Provide medical review and input to Safety Management Plan as required and provide medical review, comments, and assessment of expectedness for Serious Adverse Events (SAEs) occurring in sponsored clinical trials.
- Follow up any medically oriented safety or protocol related questions or queries directly with the Investigator as required.
- Provide ad hoc medically oriented protocol advice to Investigators.
- Lead or participate in Safety Review Monitoring meetings (SRC) or Data Safety Monitoring Board (DSMB) meetings as required.
- Review and provide medical input to individual case safety narratives prepared for serious and significant adverse events for CIOMS/Med Watch and clinical study reports (CSR).
- Medical review of data listings to highlight and interpret trends.
- Review and provide medical input to Clinical Study Report (CSR) and interpretation of study results.
- Review of Protocol Deviations and assessment of the impact on patients' safety or study data accuracy
Qualifications & Experience
- Life Sciences, Pharmacy, RN qualified or other technical qualification.
- Medically qualified with recent experience in clinical practice in Australia
- A minimum of 3 years' clinical trial experience in pharmaceutical or biotechnology companies or experience as a clinician
- Familiarity with the clinical trial operation processes and in-depth knowledge of industry guidelines and regulations
- Expertise in complex study designs, across a wide range of therapeutic indications and ability to assess scientific data.
- Must be able to work well in a team environment to ensure safety and compliance on clinical trials
Why Join Accelagen?
At Accelagen, you'll be part of a collaborative and high-performing team supporting innovative clinical research across a diverse range of therapeutic areas.
We offer opportunities for professional growth, flexible working arrangements, and the chance to make a meaningful impact on clinical trials that improve patient outcomes.
Medical Monitor in Sydney employer: Accelagen Pty Ltd
Accelagen is an exceptional employer that fosters a collaborative and high-performing work culture, where you can contribute to innovative clinical research while enjoying flexible working arrangements. With a strong focus on professional growth and development, employees are empowered to make a meaningful impact on clinical trials that enhance patient outcomes, making it a rewarding place to advance your career in the life sciences sector.
