Smaranda Doucet

• As a Clinical Monitoring Oversight Assessor at Beaufort, I engage on a project basis to deliver sponsor oversight across European clinical trial sites.

I perform independent sponsor-level oversight across clinical trial sites in Europe, focusing on quality, risk identification, and inspection readiness. I operate with a holistic oversight lens, assessing not only compliance but also underlying patterns that may impact patient safety and data integrity.

Key Responsibilities:

-Conduct independent oversight of clinical sites to evaluate adherence to protocol, ICH-GCP, and regulatory requirements
-Assess CRA performance during on-site visits, focusing on critical thinking, risk identification, and decision-making—not just task execution
-Evaluate site processes and documentation practices to identify systemic risks beyond isolated findings
-Identify emerging quality and compliance issues, propose pragmatic corrective actions, and guide teams on proportional response strategies
-Produce high-quality oversight reports highlighting risk signals, root causes, and actionable recommendations
-Contribute to inspection readiness by ensuring alignment between site practices, sponsor expectations, and regulatory standards

• Clinical Operations with a Sponsor Oversight Lens
  
  -Support biotech and clinical-stage companies in strengthening clinical operations through a sponsor oversight approach
  -Design and apply pragmatic, risk-based oversight aligned with ICH E6(R3) and Quality-by-Design principles
  -Identify systemic risks impacting patient safety, data integrity, and overall study delivery
  -Conduct targeted oversight activities (on-site and remote) focused on patterns, not just isolated findings
  -Enhance inspection readiness by aligning operational practices with regulatory expectations
  -Advise on vendor oversight, study management, and cross-functional execution
  -Translate oversight insights into clear, actionable improvements for study teams

• George Medicines (London) – Clinical Operations & Oversight Manager (US)-Freelancer
  
  -Led clinical operations for US-based trials, with full responsibility for study execution, recruitment, and CRO coordination
  -Defined and drove recruitment strategy, including digital and site-level initiatives, to ensure timely patient enrollment
  -Managed day-to-day study operations while applying a sponsor oversight lens to identify systemic risks and ensure quality across sites and vendors
  -Acted as primary interface between sponsor and CRO, aligning strategy, timelines, and operational delivery
  -Monitored study performance, proactively addressing operational and quality risks to keep trials on track
  -Introduced and applied structured oversight practices to strengthen visibility on trial execution and support sponsor-level decision-making

• Responsibilities on this role:
  
  -Executing feasibility assessments in oncology on behalf of the sponsor while also building and maintaining a national network comprising more than 20 specialized oncology centers.
  -Performing site evaluations and qualification assessments to identify optimal locations for clinical trials.
  -Coordinating and overseeing the initiation activities to ensure sites are well-prepared and compliant for study start-up.
  -Taking charge of site preparedness through comprehensive start-up activities, ensuring all locations are compliant and equipped for successful trial execution.
  -Managing the sponsor's electronic Trial Master File (e-TMF), while also ensuring data integrity and regulatory adherence.

• Mediscience Network is a Contract Research Organization (CRO)-Site Management Organization (SMO) in clinical trials business, with offices in Romania and Poland , providing services as CRO or SMO to pharmaceutical companies .
  
  Associate Director, CRO/SMO
  
  -Built and scaled clinical operations across Romania and Poland, establishing a high-performing CRO/SMO delivery model
  -Designed operational frameworks for study execution, including monitoring strategies, recruitment approaches, and risk management practices
  -Led and mentored cross-functional teams (Project Managers, CRAs, Coordinators), driving performance, consistency, and quality across studies
  -Evaluated protocols and study plans from an operational perspective, shaping execution strategies and feasibility
  -Developed and implemented patient recruitment strategies, contributing to successful enrollment across multiple studies
  -Oversaw resource planning, budgeting, and financial forecasting to ensure project profitability and sustainable growth
  -Negotiated and executed contracts with sponsors, CROs, and investigators across multiple therapeutic areas
  -Built and managed a national network of 60+ clinical trial sites, enabling scalable study delivery
  -Played a key role in sponsor and regulatory audits, ensuring inspection readiness and quality standards
  -Contributed to business development by securing new clients and expanding service offerings
  
  Key Achievements:
  
  -Supported the development and execution of 25+ Phase II–IV clinical trials in respiratory (asthma, COPD) and vaccines (adult & pediatric)
  -Established long-term collaborations with a broad network of investigators (pulmonologists, allergists, pediatricians, GPs, ENT specialists)

• Project Management (SMO Activities)

-Directed operational delivery across a network of clinical trial sites, ensuring alignment with sponsor expectations and study timelines

-Coordinated site activities, including visits, communications, and logistics with investigators, coordinators, and sponsors

-Planned and managed end-to-end study execution, covering timelines, budgets, site management, clinical supplies, and data flow -Drove both strategic planning and day-to-day execution to ensure studies progressed efficiently and predictably

-Acted as central point of coordination between sponsor, sites, and internal teams to ensure clear, consistent communication

-Led regular project meetings to track progress, resolve issues, and align on priorities and decisions -Ensured timely communication of study updates, protocol changes, and sponsor requirements across all stakeholders -Identified and resolved study and site-level issues, supporting teams with practical, solution-oriented approaches

-Monitored study budgets and billing, ensuring alignment with financial forecasts and contractual agreements

• Monitored activities for a top 5 pharmaceutical company, conducting on-site and off-site visits according to monitoring plan and sponsor requirements.
• Reporting any inadequacies identified at sites to Sponsor and ensuring proper follow-up until they are solved.
• Ensuring accurate study drug accountability and reconciliation.
• Maintaining trial master file up to date, making sure all required documents are filed appropriately.
• Supporting sites with adverse events reporting and ensuring proper follow-up.
• Facilitated communication between sites and local/central study team, ensuring alignment and timely information sharing.
• Supported sponsor audit processes, ensuring compliance and readiness of sites for review.

• Managed site operations for various studies, contacted sponsors, expanded network of sites and investigators, submitted files to regulatory authorities, and organized investigator meetings.
• Maintained regular communication with the Sponsor to track study progress and ensure effective collaboration between sites and the Sponsor.
• Co-ordinate study conduct in the sites, according to GCP and the protocol; ensure good data quality and co-operation of the sites.
• Training and supporting site staff to fulfil all Sponsor requirements.
• Support the clinical site to obtain all required templates of documents, laboratory kits, requisition forms and all other necessary materials.
• Created strategies to recruit subjects for clinical studies.
• Assisted clinical sites in building referral networks to enhance participant recruitment.
• Maintain contact with other parties involved in the study (suppliers, data management staff, central and local labs, central and local diagnostic/imaging partners).
• Facilitated audits and inspections at centers to ensure compliance with protocols and regulatory standards.

• Fostered relationships with key opinion leaders while orchestrating a nationwide educational program to improve knowledge of allergy treatments.
• Played a key role in establishing the framework for a country-wide educational series aimed at general practitioners in the field of allergy diseases.
• Marketed anti-allergic medications to healthcare professionals, including specialized hospital doctors, pharmacists, and general practitioners, enhancing product awareness and adoption.
• Coordinated and attended industry events and medical conventions, emphasizing product education and networking in Bucharest and Prahova regions.
• Managed and supported trainers, who were esteemed experts in this therapeutic domain.

• Successfully launched Diflazon, a generic fluconazole medication, in Romania and led the sales to become the highest in the country for two consecutive quarters within my designated region.
• Promoted generic and over-the-counter products to healthcare professionals, enhancing brand awareness across Galati, Constanta, Braila, Tulcea, Bucharest, and Prahova.
• Coordinated over 20 successful round-table discussions, presentations, and symposia, driving engagement with healthcare professionals.

• Advised patients on medication usage, including dosage, potential interactions, and possible side effects.
• Delivered prescribed medications to patients, ensuring accuracy and adherence to safety protocols.
• Collaborating with pharmacists and other healthcare professionals to ensure optimal patient care and smooth pharmacy operations.
• Implemented and oversaw storage protocols and record-keeping systems for secure handling of medications, enhancing compliance and safety.
• Adhering to departmental guidelines, ongoing quality improvement objectives, and established safety and infection control standards.
• Provided front-end customer service by greeting patients, processing sales transactions, and resolving inquiries or complaints effectively.