Manager, Medical Monitoring

Manager, Medical Monitoring About Avance Clinical Avance Clinical is a Contract Research Organisation offering specialised services that support drug development for the pharmaceutical and biotechnology industries. With a rich history dating back to the, we pride ourselves on deep expertise in this field. Why Join Avance Clinical? We value our people above all. Our work environment is fun, friendly, and built on honesty and respect. We foster a strong sense of teamwork, recognising both individual contributions and collective success. We are committed to a flexible, future‑ready workplace that supports work‑life balance. Broad Purpose The Manager, Medical Monitoring Services (MMMS) is responsible for providing Medical Monitoring (MM) services for clinical trials managed by Avance Clinical and for overseeing and supporting MM service delivery. Core Responsibilities Ensure high‑quality service delivery across projects within agreed timelines. Support the DSMMS in resource allocation to ensure timely and compliant service delivery. Monitor the workload of line reports and forecast MM workload / backlog. Assist in preparation or update of applicable SOPs, work instructions, and templates. Provide oversight and mentoring of line reports, including performance management and compliance with training requirements.> Conduct or coordinate training sessions for line reports. Support process improvement and reporting of key quality and financial metrics. Identify risks and propose mitigation strategies. Report regularly to the DSMMS on medical monitoring services, including operations, resourcing, system issues, and project performance. Participate in client meetings, audits / inspections, and business development meetings as required. Other duties as directed by the DSMMS. Medical Monitoring Services Responsibilities Ensure the delivery of high‑quality MM services within agreed timelines. Act as the Medical Lead for the study during startup and conduct: Medical Monitor Kick‑off Meeting set‑up. Scope of Work definition with Sponsor. Medical review of key study documents (protocol, IB) and input on trial design. Preparation of study plans relating to medical monitoring and safety reporting. Provide medical oversight (including after‑hours) and serve as primary medical contact. Participate in Safety Review Meetings and provide recommendations on dose escalation / modification. Ensure reported safety data is coherent and consistent with current medical knowledge and protocol. Provide medical advice on safety issues and mitigation strategies. Provide medical input on study participant safety issues and adverse events. Provide medical input in support of services delivered by the Drug Safety and Pharmacovigilance team: Assess causality and expectedness of serious adverse events for the sponsor. Review narratives, MedDRA and WHODD coding, and regulatory reporting of adverse events. Conduct benefit‑risk assessments for study conduct. Identify safety data trends and hazards. Develop Annual Safety Reports (ASR) and Development Safety Update Reports (DSURs). Lead or participate in therapeutic area training for Avance team members and external stakeholders. Other duties as directed by line management. Departmental Responsibilities Support ongoing quality improvement initiatives within the MM team. Facilitate and ensure compliance with internal and external QA audits and inspections. Communicate efficiently with all relevant stakeholders. Participate in client meetings and audits as required. Provide medical and therapeutic area advice to study feasibility work. Adhere to project‑specific plans, SOPs, and policies. Maintain knowledge of drug development regulations and ICH GCP guidelines. Qualifications, Skills and Experience Doctor of Medicine (MD) with a minimum of 10 years' experience in the medical or pharmaceutical field. 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, pharmacovigilance, or drug safety within a CRO, pharmaceutical, or clinical environment. Proficiency with ICH GCP guidelines and other regulatory rules, plus medical terminology and clinical research principles. Adaptable, influential, and motivated with a hands‑on mindset. Excellent organisational, written, and verbal communication skills. Proficiency in English (written and verbal) required. Experience presenting to diverse audiences (internal teams, medical / scientific communities). Proactive approach to service execution and issue resolution. Resilience in a fastpaced environment. Ability to build and maintain trust and confidence with internal team members, clients, and vendors. Demonstrated initiative, reliability, and ability to work unsupervised. Willingness to contribute to a positive and dynamic team culture. What We Offer Stimulating work Project diversity Intellectual challenge Agile & flexible workplace Opportunity to progress Stability Sense of community Collaborative leadership team Flexible work options Modern tools / tech for your job Competitive salary & extra holiday days for your birthday Seniority level: Mid‑Senior level Employment type: Full‑time Job function: Research Referrals increase your chances of interviewing at Avance Clinical by 2x #J- #J-18808-Ljbffr