Manager, Medical Monitoring

• 10 years experience as an MD in the Pharmaceutical industry
• Option to be based anywhere in Australia
• Global CRO with an excellent reputation

Who are we?

We're Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980's. If you already work in this industry you'll know that we are experts in our field.

Why should you join Avance Clinical?

We appreciate that our most important asset is our people. We offer a fun, friendly work environment and a culture that values honesty and respect. We have a strong sense of team. We genuinely appreciate each individual but recognise the collective when achieving success.

We are committed to creating a flexible work environment for our people by supporting them to balance their work commitments and personal needs, both now and into the future.

Broad Purpose

The Manager, Medical Monitoring Services (MMMS) is responsible for providing Medical Monitoring (MM) services for clinical trials being managed by Avance Clinical and for providing oversight and support on the MM service delivery.

Responsibilities include provision of trial specific medical oversight on behalf of the trial sponsor (as per ICH GCP 5.3. Medical Expertise) or acting as an independent/local or global Medical Monitor for assigned clinical trials; providing medical support for services offered by the safety/pharmacovigilance team and act as a general medical opinion resource to internal and external stakeholders.

The Medical Monitor should provide the clinical trial investigator(s) with all medical information on the investigational product known by the trial Sponsor to ensure that the best assessment and treatment decisions may be made.

Core Responsibilities

MM team management:

• Ensure high quality service delivery across projects within agreed timelines.
• Support the DSMMS in resource allocation to ensure timely and compliant service delivery is achieved across projects.
• Monitors the workload of their line reports.
• Support the DSMMS with forecasting of MM workload/backlog and advise of any out-of-scope work to be costed appropriately.
• In liaison with DSMMS, support the preparation or update of applicable SOPS, work instructions and templates.
• Provide oversight and mentoring of their line reports including performance management, and compliance with Avance training requirements.
• Conduct or coordinate training sessions where training opportunities have been identified within their line reports.
• Support the DSMMS with process improvement and reporting of key quality and financial metrics.
• Proactively identify risks and propose mitigation strategies as necessary to address issues and risks to the organization.
• Report regularly to the DSMMS on matter relating to medical monitoring services including general operations, resourcing, system issues, project performance and potential project issues.
• Participate in client meetings, audits/ inspections and business development meetings as required.
• Other duties as directed by the DSMMS.

Medical Monitoring Services:

• Ensure the delivery of high-quality Medical Monitoring services for the assigned studies within agreed timelines.
• Act as the Medical Lead for the study during start up and clinical conduct, including the following tasks:
• Medical Monitor Kick-off Meeting set up.
• Liaising with the Sponsor to define Scope of Work.
• Assists in the medical review of the key study documents such as the protocol and investigator brochure (IB) and provides input on trial design and safety/efficacy assessments as required.
• Review and/or prepare study plans relating to medical monitoring and safety reporting (e.g. Medical Monitoring plans, Safety Reporting Plans, SRC Charter) as required.
• Provides medical oversight (including after-hours medical coverage) for assigned clinical trials offering support to the Investigator and study sponsor in regard to safety or eligibility questions. Serve as a primary medical contact for customers for assigned clinical trials.
• Participates in Safety Review Meetings to provide recommendations on dose escalation or dose modification as required by protocol in studies assigned as a Medical Monitor.
• Ensures that, for each of the assigned trials, the reported safety data is coherent and consistent with current medical knowledge and that it adheres to the currently approved protocol/amendments.
• Provides medical advice in relation to safety issues, and offers recommendations for mitigation strategies, to customers and project team members to minimize risks to clinical trial participant safety and other issues that may impact the benefit: risk ratio of the trial.
• Provides medical input as requested by the wider project team on any study participant safety issues and/or adverse events and advises on appropriate responses to such concerns.
• Provides medical input in support of services delivered by the Drug Safety and Pharmacovigilance team:
• Provide causality and expectedness assessment of Serious Adverse Events on behalf of the trial sponsor when required.
• Provide medical review of adverse events and/or serious adverse events, including review of the narrative, MedDRA and WHODD coding, investigators' assessment on causality, and applicable regulatory reporting, as requested.
• Provide benefit-risk assessment for the study conduct as part of the review of Individual Case Safety Reports (ICSRs)
• Review of safety data to identify and categorise trends that may be indicative of hazards associated with study treatments.
• Review and/or develop Annual Safety Reports (ASR) and Development Safety Update Reports (DSURs) as required.
• Leads and/or participates in therapeutic area training to other Avance team members and outside clients, investigators, and other third-party stakeholders as it pertains to assigned studies.
• Other duties as directed by Line Management or delegate in line with skills, experience and/or qualifications.

Departmental Responsibilities

• Support ongoing quality improvement initiatives within the MM team and the department.
• Facilitate and ensure compliance and timely follow-up /closure of both internal and external QA audits and inspections where MM services are in scope.
• Exercise efficient and cohesive communication between relevant stakeholders at Avance and Avance customers.
• Participates in client meetings and both internal and external audits, as required.
• Provides medical and therapeutic area advice to Study Feasibility efforts. This activity includes, but is not limited to, review of study eligibility criteria and input into site selection and site feasibility evaluations.
• Adheres to all project specific plans and Avance (and client, as required) standard operating procedures and policies.
• Maintains knowledge of relevant drug development regulations and ICH Good Clinical Practice (GCP) guidelines.

Qualifications, Skills and Experience

• Doctor of Medicine (MD) including a minimum of 10 years' experience in the medical or pharmaceutical field required.
• Proven experience in team mentoring, training, and line management.
• Full AHPRA registration in Australia or license in country of registration/practice.
• Relevant work experience in medical monitoring and/or pharmacovigilance and/or drug safety experience in a CRO, pharmaceutical, or clinical environment.
• Proficient with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.
• Adaptable, influential, and motivated individual with a 'hands on' and growth mindset.
• Excellent organisational skills, written and oral communication, and interpersonal skills are required.
• Proficiency in English (written and verbal) required.
• Experience presenting to a wide variety of audiences including internal teams and medical/scientific communities.
• Proactive approach to service execution and issue resolution.
• Display resilience in a fast-paced environment.
• Ability to build and maintain trust and confidence and communicate effectively with internal team members, clients, and external vendors.
• Demonstrated initiative, reliability and ability to work unsupervised.
• Willingness to work in, and be supportive of, a positive and dynamic team culture.

What we offer

• Stimulating work
• Project diversity
• An intellectual challenge
• An agile & flexible workplace
• Opportunity to progress
• Stability
• Sense of community
• A leadership team that are working together on a common goal
• Flexible work options
• Great tools / tech to do your job
• A competitive salary & an extra days holiday for your birthday