Miriam Roesner

An accomplished clinical operations professional, excelling amidst industry challenges, drawing from decades of expertise dedicated to advancing pioneering medicines.
Empowering team members to autonomously navigate daily tasks, fostering collaboration toward common goals and customer needs.
Combining extensive experience in people- and product management with excellent interpersonal skills, creativity, and curiosity leads to a unique skill set that allows thriving in diverse professional settings.
With innate problem-solving acumen and seasoned judgment, comfortable adapting to change and finding solutions to unexpected problems.

• Neurology
• Mental Health
• Cardiovascular
• Endocrinology
• Gastroenterology
• Nephrology
• Haematology
• Respiratory
• Women's Health
• Analgesia
• Oncology

• Covance, Sydney, 03/2009, 02/2010, Senior Clinical Research Associate/ Lead CRA, 03/2009, 02/2010, Supported Head of Clinical Operations to prepare, conduct and lead Phase 2 and 3 clinical research studies. Indications: haematology, pancreatic cancer.
• Amgen, Sydney, 08/2006, 03/2009, Senior Associate Clinical Site Management, 08/2006, 03/2009, Site management (selection, initiation, monitoring and closure) for Phase 3 haematology, renal and oncology studies. Coordinated with project managers and the wider study team. Indications: parathyroid disorders, renal failure, anaemia, breast cancer.
• ClinResearch GmbH, Germany, 04/2004, 05/2006, Clinical Research Associate, 04/2004, 05/2006, Contributed to numerous clinical trials within the research group according to protocols, study-specific procedures and regulatory requirements. Indications: prostatitis, hospital-acquired pneumonia, sore throat, tension headaches, asthma, schizophrenia

• Actinogen Medical, Sydney, 09/2018, 01/2024, Project Operations Manager, 04/2023, 01/2024, Clinical Development Manager, 09/2018, 03/2023, Worked with all Actinogen teams, including clinical operations, clinical science, pharmacology, non-clinical, CMC, media & communications, business development and beyond, advancing the company’s product development plans. Managed clinical communications via the company website and social media campaigns and acted as primary contact for public enquiries. Lead project supplies logistics, supports and facilitates non-clinical and clinical study execution through close liaison with investigator sites, identifies and manages third-party vendors used across projects, manages social media campaigns, and leads events planning and attends events that aid in establishing and building relationships with key stakeholders.
• Syneos Health, Sydney, 09/2012, 06/2018, Clinical Team Leader, 01/2015, 06/2018, Senior Clinical Research Associate/ Lead CRA, 09/2012, 12/2014, As a team leader, managed a large team of Clinical Research Associates across Australia, New Zealand and Asia, including in accordance with previously defined performance indicators. Boosted engagement and performance in terms of both quality and quantity by promoting an open culture and inspiring, mentoring and training more junior team members. As Lead CRA, managed and led the planning, execution, and monitoring of clinical trials in accordance with protocols, regulatory requirements, and company standards. In close collaboration with the Project Manager, successfully revitalised a stalled early development project, resulting in enhanced satisfaction among the internal team and the client, which led to the award of a follow-up contract for the next trial phase.
• Aptiv Solutions, Sydney, 03/2010, 08/2012, General Manager/ Project Manager, 03/2010, 08/2012, Launched and led the first-ever APAC office for Aptiv Solutions, formed by merging six biopharmaceutical and medical device services companies into one. Developed relationships and negotiated key contracts with third-party providers to enable the company to expand into markets and deliver regulatory-compliant Phase 3 clinical trials. Wore multiple hats, including General Business Manager, Site Manager, Project Manager, Senior CRA and Event Manager. Left the company prior to the US$143.5 million takeover by ICON.

• Provided pivotal input in the most recent phase 2b trial design by managing a brain receptor occupancy trial from radioactive tracer development over trial design, conduct and results publications in the Journal of Alzheimer's Disease. https://pubmed.ncbi.nlm.nih.gov/38250767/
• Managed and co-represented company at the AAIC (the world's largest forum for dementia research) including booth design, logistics, poster presentation, meetings and events during the conference.
• Swiftly built strong relationships and collaborations with key opinion leaders and world experts to drive the product development of Xanamem.
• Acted as escalation point for internal and external teams by effectively helping with resolution of any site, vendor or communication issues.