Medical Services Manager

The Medical Services Manager is a role which may be allocated to either a permanent employee or contractor. The Medical Services Manager is responsible for management of medical aspects of assigned clinical trials, in accordance with the project scope and Medical Management Plan. The aim of the role is to ensure patient safety aspects of Novotech sponsored clinical trials are appropriately managed.

Responsibilities

Medical Services Manager responsibilities on an individual project will be defined in the project agreement and further detailed in the Medical Management Plan. They include, but are not limited to:

• 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.
• 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 Data Safety Monitoring Board (DSMB) activities according to the DSMB charter.
• Review and provide medical input to individual case safety narratives prepared for serious and significant adverse events for CIOMS/MedWatch and clinical study reports.
• Medical review of data listings to highlight and interpret trends.
• Review and provide medical input to clinical study report and interpretation of study results.
• Medical review of coding of Con Meds and AEs including resolution of coding failures discrepancies and questions.
• Other responsibilities as defined in the Medical Management Plan.

Qualifications

• Medically qualified with experience in clinical practice.
• Experience in drug development, pharmacovigilance in the pharmaceutical and/or CRO industry.
• Knowledge of drug safety reporting requirements and practice.

We are committed to a transparent recruitment process. Where a salary range is not included in this job advertisement, shortlisted candidates will receive the applicable salary range before their first interview, in accordance with applicable local legislation

About Novotech

Novotech is proud to offer a great workplace. We are committed to being an employer of choice 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 that work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave, flexible leave entitlements, wellness programs, and ongoing development opportunities.

We are looking for people who are passionate about clinical research and biotechnology and who want to contribute to the development of new medicines and therapies.

We are committed to creating an inclusive workplace where everyone can bring their authentic selves to work. We welcome applications from people from diverse backgrounds and experiences.

We look forward to hearing from you.