Talent.com
Novotech
Senior Medical Monitor | Clinical ResearchNovotech • Melbourne, VIC, AU
Senior Medical Monitor | Clinical Research

Senior Medical Monitor | Clinical Research

Novotech • Melbourne, VIC, AU
30+ days ago
Job description

Job Description

About the Role

\n

The Senior Medical Monitor will be responsible for performing higher complexity medical monitoring tasks, including those as a global/program medical monitor. The SMM may also mentor/line manage a small number of assigned medical monitors. The SMM activities will include coordination and delivery of training, participation in the development and revision of medical monitoring SOPs, contribution to improving the performance of the medical monitoring team and close liaison with Business Development in medical guidance on protocol and project requirements.

\n

This role can be based anywhere in AU.

\n

Responsibilities

\n

    \n
  • Provide medical oversight for Novotech sponsored clinical trials, acting as medical representative to the Novotech project team.
  • \n
  • Prepare a Medical Monitoring Plan for each study according to project scope.
  • \n
  • Provide medical review and commentary on client protocol and/or Investigator Brochure.
  • \n
  • Attend Investigator Meeting; prepare and present safety or medical aspects if required.
  • \n
  • Provide medical review and input to Clinical Monitoring Plan and Safety Management Plan as required.
  • \n
  • Provide medical review, comment and assessment of causality for Serious Adverse Events (SAEs) occurring in Novotech sponsored clinical trials.
  • \n
  • Follow up any medically oriented safety or protocol related questions or queries directly with the Investigator as required.
  • \n
  • Provide ad hoc medically oriented protocol advice to Investigators.
  • \n
  • Lead or participate in Data Safety Monitoring Board (DSMB) activities according to the DSMB charter.
  • \n
  • Review and provide medical input to individual case safety narratives prepared for serious and significant adverse events for CIOMS/MedWatch and clinical study reports.
  • \n
  • Medical review of data listings to highlight and interpret trends.
  • \n

\n

Experience and Qualifications

\n

    \n
  • Medical degree from an accredited and internationally recognized Medical School
  • \n
  • Knowledge of drug safety reporting requirements and practice
  • \n
  • Experience in clinical practice
  • \n
  • Experience in drug development, pharmacovigilance in the pharmaceutical and/or CRO industry.
  • \n
  • Knowledge of drug safety reporting requirements and practice. Prior mentoring/line management experience will be well regarded
  • \n

\n

Benefits

\n

Novotech is proud to offer a great workplace. 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. Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. 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. We look forward to talking to you about working at Novotech.

Create a job alert for this search

Senior Medical Monitor | Clinical Research • Melbourne, VIC, AU

Similar jobs

Quality Coordinator

For Purpose Aged CareWallan, VIC, AU

Make a Difference at Wallan Community Aged Care! .Do you want to work with a passionate and supportive team, that puts people first?.A friendly, focused and driven team, we look to bring on staff w... Show more

Volunteer

For Purpose Aged CareWallan, VIC, AU

Make a Difference at Wallan Community Aged Care! .We understand the significant value of volunteers and the great benefit they bring to our residents.We welcome the application of any person (regar... Show more

Lead / Senior Health Economist

GSKAbbotsford, VIC, AU

Lead / Senior Health Economist.Epidemiology and Health Outcomes.Get future jobs matching this search.Australia - Victoria - Abbotsford.GSK is a global biopharma company with a special purpose – to ... Show more

Clinical Simulation Laboratory Coordinator - Nursing

Acknowledge EducationMelbourne CBD, VIC, AU

Acknowledge Education is entering an exciting new chapter.With a refreshed leadership team and a renewed focus on innovation, growth, and student success, we are building on our 139-year legacy to ... Show more

Sign Up as A Delivery Person - Earn With Uber Eats

Uber eatsKilmore - Broadford, VIC, AU

Start Delivering with Uber Eats.Delivering with Uber Eats is an alternative to a part-time or full-time job and you can get your earnings weekly.Delivering with Uber Eats allows you to earn quick c... Show more

 • Promoted

Senior Grade 3 OT, Pain Management and Research Centre

Alfred HealthCaulfield, VIC, AU

Bayside Health is a public health service delivering high-quality care across every stage of life for close to 1.Melbourne, the Mornington Peninsula, Koo Wee Rup, Bass Coast and Southern Gippsland.... Show more

Casual Residential InReach/ Better@Home Medical Officer

Austin HealthHeidelberg, VIC, AU

Are you a current Austin Health employee?.If yes, please log in to the Austin Health.Employee Login’ using your network login details to search, view and apply for all career opportunities availabl... Show more

Senior Surgery Intern - AEC Moorabbin

Animal Referral HospitalHighett, VIC, AU

Are you looking to advance your surgery skills and be mentored by some of the best in the field?.This 12-month Surgical Internship offers an exceptional opportunity to gain hands-on experience in a... Show more

ECC Vet Director - AEC Frankston

Animal Referral HospitalFrankston, VIC, AU

Animal Emergency Centre (AEC) Frankston is seeking an experienced and values-driven Veterinary Director to lead our emergency hospital into its next chapter.This is a pivotal leadership role respon... Show more

More then your average GP clinic – Elsternwick, VIC

Alecto AustraliaElsternwick, VIC, AU

More then your average GP clinic – Elsternwick, VIC.GP owned practice in prime location.Collegial team of dedicated GPs.Join a collegial team in a GP-owned practice nestled in the leafy streets of ... Show more

Medical Practitioners & Specialists - HealthcareLink Support

HealthcareLink SupportBurwood East, VIC, AU

Paediatric Speech Pathologist - Clinic Based - Eastern Suburbs VIC.Full Time or Part Time, Flexible.Competitive Salary Offer + CPD Allowance + Benefits.Our client is an Allied Health centre located... Show more

General Practitioner | South Yarra| Privately Owned

Healthcare Professionals GroupPrahran, VIC, AU

Large, established patient base.Strong nursing and admin support allowing you to focus on quality patient care.CPD, education sessions, and specialist engagement.Opportunity to develop or expand.Su... Show more

Sonographer

Capital Radiology Pty LtdClayton, VIC, AU

At Capital we’re investing in cutting-edge imaging equipment, building clear career pathways and a workplace culture that empowers and supports our people.We are seeking an experienced Sonographer ... Show more

Senior Medical Science Liaison – Specialty

GSKMelbourne, VIC, AU

Senior Medical Science Liaison – Specialty.Get future jobs matching this search.Australia – Victoria - Melbourne Metro.GSK is a global biopharma company with a special purpose – to unite science, t... Show more

Medical Practitioners & Specialists - Medrecruit

MedrecruitPatterson Lakes, VIC, AU

General Practitioner | Permanent | Bulk Billing | Full Patient Books.Are you looking for a well-established practice with immediate earning potential and a supportive team? We are currently seeking... Show more

2027 Unaccredited Neurology Registrar - Advanced Trainee

Peninsula HealthFrankston, VIC, AU

Bayside Health employees; you must click 'employee login' to apply for this position internally.Lifestyle! A stone throw from the Mornington Peninsula and its surrounds.Work with a supportive healt... Show more