Marco Moggia

As Clinical Operations Manager, I lead and manage a team of clinical research professionals, ensuring the successful execution of clinical trials while maintaining strict adherence to Good Clinical Practice (GCP), ICH guidelines, and global regulatory requirements. My key responsibilities include:

Strategic Resource Allocation: Assigning staff to clinical studies based on experience, training, and workload capacity, optimising operational efficiency.
Training and Development: Overseeing the onboarding, training, and continuous professional development of staff, ensuring they have the necessary materials, systems access, and SOP knowledge to fulfil their roles effectively.
Performance Management: Conduct regular performance assessments, identify gaps, implement tailored professional growth plans and provide coaching and mentorship to enhance competency and retention.
Quality Oversight and Risk Management: Managing CAPA (Corrective and Preventive Actions) following safety audits and issue investigations, identifying quality risks, and executing mitigation strategies.
Process Optimization & Compliance: Developing Standard Operating Procedures (SOPs), implementing CTMS (Clinical Trial Management Systems), and ensuring adherence to IQVIA's corporate quality and process improvement initiatives.
Stakeholder Collaboration: Engaging with internal and external stakeholders, including investigators, sponsors, and regulatory bodies, to address trial challenges and maintain compliance with project milestones.
Budget and Resource Management: Managing trial budgets, reviewing financial reports, and ensuring optimal resource allocation to support ongoing and future research initiatives.
This role has refined my leadership, problem-solving, and clinical research oversight skills, preparing me to excel as a Clinical Operations Manager.

As a Disability Assessor, I was responsible for conducting clinical assessments and evaluations for disability claimants, requiring a strong foundation in medical decision-making, case management, and regulatory compliance. My responsibilities included:

Assessment & Analysis: Conducting comprehensive medical evaluations to determine the impact of disabilities on daily life, reviewing supporting evidence from multiple healthcare professionals.
Data Integrity & Documentation: Maintaining detailed and accurate medical records and reports, ensuring compliance with national health and insurance regulations.
Stakeholder Communication: Liaising with healthcare professionals, claimants, and regulatory agencies, providing evidence-based recommendations while maintaining ethical and professional standards.
Process Improvement & Training: Collaborating with internal teams to enhance assessment methodologies and participating in ongoing training to stay updated on best practices and evolving regulatory requirements.
This experience strengthened my analytical, risk assessment, and regulatory compliance expertise, which is critical for overseeing clinical trial quality and regulatory adherence.

In my role as a Medical Writer, I was responsible for developing high-quality clinical research documentation that adhered to ICH-GCP and regulatory submission requirements. Key responsibilities included:

Regulatory and Scientific Writing: Authored Clinical Study Reports (CSRs), safety narratives, and regulatory documentation, ensuring clarity, accuracy, and adherence to international regulatory guidelines.
Data Review & Analysis: Conducted literature reviews and clinical data interpretation, synthesising complex medical information into accessible reports for sponsors, stakeholders, and regulatory authorities.
Process Standardization: Assisted in developing and refining SOPs and best practices for clinical research documentation.
Cross-functional Collaboration: Worked closely with clinical operations, regulatory affairs, and data management teams to ensure timely and high-quality deliverables.
This role refined my ability to interpret, analyse, and communicate clinical trial data, essential for overseeing clinical operations and quality management.

As a Clinical Research Nurse, I played a vital role in executing Phase I and II clinical trials, ensuring compliance with Good Clinical Practice (GCP) and ICH regulations. Responsibilities included:

Patient Enrollment & Study Execution: Screening, recruiting, and enrolling clinical trial participants while ensuring informed consent and ethical compliance.
Safety Monitoring & Data Collection: Conducting ECG monitoring, vital sign assessments, and investigational product administration, ensuring adherence to study protocols.
Stakeholder Coordination: Working alongside Principal Investigators, sponsors, and multidisciplinary teams to maintain study integrity.
Training & Compliance Oversight: Developing training materials for staff and contributing to SOP implementation and regulatory audits.
This role solidified my expertise in clinical research operations, regulatory compliance, and data integrity management, preparing me to lead clinical operations teams.

As a Staff Nurse, I was responsible for delivering high-quality patient care, emergency interventions, and mentorship. Key responsibilities included:

Clinical Supervision: Coordinating patient care plans and mentoring junior nurses to maintain clinical excellence.
Regulatory Compliance: Ensuring adherence to hospital policies, medication safety protocols, and national healthcare regulations.
Process Improvement: Implementing initiatives to enhance patient outcomes, operational efficiency, and team collaboration.

As a Staff Nurse in a high-acuity setting, I was responsible for comprehensive patient care, emergency response, and adherence to clinical protocols. Managing an average of 15 to 20 patients in a 30-bed ward, I ensured accurate monitoring, documentation, and timely intervention to maintain patient safety and optimise health outcomes.

Key responsibilities included:

Clinical Oversight & Patient Monitoring: Continuously assessing vital signs, tracking patient progress, and escalating concerns to physicians for timely intervention.
Medication & Treatment Administration: Safely administering IV medications, blood transfusions, and treatments, ensuring adherence to strict protocols and best practices.
Infection Control & Surgical Care: Implementing infection control protocols, performing wound care management, and maintaining a sterile environment to prevent complications.
Emergency & Critical Care: Delivering life-saving interventions, CPR, and first aid, remaining calm and composed during medical emergencies.
Interdisciplinary Collaboration & Communication: Assisting physicians during surgeries, treatments, and diagnostic tests, while ensuring seamless handovers through accurate, concise reporting.
This role strengthened my ability to manage patient care in high-pressure environments, uphold regulatory and clinical standards, and collaborate effectively with multidisciplinary teams—critical skills for overseeing clinical operations in research and healthcare settings.

In this role, I combined clinical expertise, market analysis, and patient education to enhance healthcare service delivery and community health awareness. By collaborating with pharmacy managers, sales staff, and healthcare professionals, I contributed to comprehensive patient care solutions while leveraging market research and strategic outreach to improve customer experience and business performance.

Key achievements and responsibilities:

Health Education & Patient Engagement: Designed and implemented an interactive health education program that engaged 15+ participants daily, focusing on disease prevention, medication adherence, and lifestyle management. Provided one-on-one health coaching to improve patient outcomes.
Market Research & Customer Insights: Conducted market research to assess patient and customer needs, using insights to develop targeted awareness campaigns on key health issues like diabetes and hypertension.
Business Development & Sales Strategy: Implemented marketing campaigns, built long-term client relationships and contributed to achieving monthly sales and performance KPIs through expert product knowledge and tailored customer guidance.
Inventory & Process Optimization: Managed stock levels, streamlined processes, and improved efficiency to ensure the availability of essential healthcare products and services.
This experience strengthened my ability to bridge clinical expertise with strategic business and patient engagement initiatives, ensuring effective healthcare delivery, stakeholder collaboration, and operational efficiency—all key skills applicable to clinical operations and research management.