Overseeing strategic direction and setting the vision for cutting-edge clinical research.Cultivating strategic partnerships and maintaining relationships with key industry stakeholders.Leading with integrity, ensuring that all operations adhere to the highest ethical standards.Spearheading business development and diversifying services to address emerging industry needs.Ensuring top-notch quality in regulatory and ethics committee submissions.Advocating for industry best practices through active participation in relevant discussions and forums.Emphasizing the importance of Good Clinical Practice and up-to-date regulatory knowledge across the organization.Facilitating groundbreaking clinical trials by ensuring effective project implementation.

Oversee and deliver successful clinical operations across Romania, Bulgaria, and Greece, ensuring seamless collaboration with Clintec staff and clients.Managed project timelines and monitored milestones to maintain adherence to project schedules.Directed teams to remain aligned with project objectives, satisfying Project Manager expectations.Conducted and contributed to feasibility studies for prospective clinical trials.Handled all regulatory authority (RA) and ethics committee (EC) submissions, ensuring quality and timely submission of initial study applications and substantial amendments.Supported project team members, assisting in ensuring the achievement of project deliverables.Executed co-monitoring visits, reinforcing adherence to SOPs and monitoring guidelines.Led the execution and implementation of assigned clinical research projects, ensuring objectives are met efficiently.Human Resources and TrainingOversaw performance management, fostering professional development and ensuring compliance with training requirements.Identified and addressed training needs within the team, enhancing skill sets and performance.Mentored staff, assisting with career development and day-to-day operational challenges.Participated in talent acquisition processes, from interviewing to providing hiring recommendations.Collaborated with HR to resolve disciplinary and grievance issues effectively.Ensured comprehensive onboarding for new hires and maintained meticulous training records.Quality AssuranceGuaranteed the integrity of clinical trials by facilitating audits and maintaining GCP compliance.Facilitated client-conducted audits, ensuring high standards of quality and compliance.Audited suppliers and vendors for Clintec International to uphold service quality.Communicated all GCP compliance concerns to Quality Assurance and Line Management.Maintained strict version control of SOPs, ensuring all staff followed updated and current procedures.

Key Responsibilities:Strategic Oversight: Spearheaded clinical operations in Romania, ensuring alignment with project objectives and close collaboration with Project Managers and Clinical Research Associates (CRAs).Project Management: Vigilantly monitored and tracked project milestones to guarantee timely execution within the stipulated timelines.Team Leadership: Focused the team on their project deliverables, consistently meeting the expectations of assigned Project Managers.Feasibility Studies: Actively participated in feasibility assessments to support the strategic planning of clinical studies.Regulatory Affairs: Directed RA/EC submissions at the national level, ensuring quality, compliance, and timeliness in initial study submissions, substantial amendments, and other regulatory activities.Quality Assurance: Conducted co-monitoring visits to uphold high standards in monitoring techniques and adherence to SOPs and monitoring guides.Project Execution: Took ownership for effectively implementing all assigned projects, ensuring excellence in execution.Human Resources & Training:Talent Management: Oversaw performance management within the country’s operations, identifying developmental needs and fostering career progression.Mentorship: Served as a mentor, guiding staff in their daily work and long-term career ambitions.Talent Acquisition: I played an instrumental role in talent scouting, interviewing, and making recommendations to management to bolster team capabilities.HR Coordination: Worked alongside the HR department to resolve disciplinary and grievance matters, ensuring a harmonious work environment.Onboarding: Managed induction processes for new hires, ensuring comprehensive orientation and proper maintenance of training records.Staff Development: Ensured all team members possessed up-to-date training records, aligning with company standards and regulatory requirements.

Clinical Trial Oversight: Rigorously monitored clinical trials to ensure strict compliance with ICH-GCP standards, the Declaration of Helsinki, and Federal Regulatory Requirements, upholding the highest levels of Good Clinical Practice.Site Management Expertise: Diligently managed site operations, ensuring protocol adherence, meticulous source data verification, and accurate CRF entries.Document Development and Review: Authored, reviewed, and refined key clinical trial documents, including Case Report Forms and Informed Consent Forms, ensuring precise, clear, and comprehensive study material creation.Protocol Contribution: Contributed to study protocol design and refinement, offering critical insights during development and review processes.Regulatory and Ethics Submissions: Efficiently compiled and submitted necessary research documentation for regulatory and ethics committee approvals.Monitoring and Site Visits: We executed comprehensive pre-study, interim, and close-out visits to affirm the integrity of the trial and ensure adherence to established guidelines.Drug Administration Oversight: Conducted and documented drug formulation administration, ensuring accurate execution of procedures and record-keeping.Collaborative Relationships: I foster strong relationships with medical monitors, principal investigators, clinical staff, and sponsors, ensuring seamless communication and coordination.Meeting Organization and Support: Organized and participated in investigator meetings, adding value through meticulous planning and execution.Project Management Assistance: Provided comprehensive support to Project Managers/Country Managers, handling various tasks with agility and attention to detail.

Team Leadership: Managed a dedicated team comprising 2 Clinical Trial Assistants (CTAs) and 2 Clinical Site Monitors, fostering a collaborative environment emphasizing quality and protocol adherence.Clinical Trial Oversight: Spearheaded early country planning and feasibility assessments and efficiently coordinated the start-up phase of all in-house clinical trials, ensuring timely and effective trial initiation.Budget Management: Developed study budgets reflective of country-specific requirements, demonstrating a keen ability to align financial resources with project objectives.CRO Partenes Management: I maintained strong partnerships with contract research organizations (CROs) for outsourced clinical trials, upholding stringent quality standards and ensuring trial integrity.Regulatory Submissions: Prepared and managed submission files for Ethics Committees (EC), ensuring regulatory compliance and facilitating productive ongoing interactions.Site Coordination: Selected, initiated, and conducted monitoring of clinical studies by BMS Standard Operating Procedures (SOPs) and protocols, guaranteeing the accuracy and reliability of study data.Financial Negotiations: Successfully negotiated financial agreements with institutions, investigators, and third-party vendors, balancing cost-effectiveness and organizational needs.

Feasibility Studies: Spearheading comprehensive feasibility studies to establish the groundwork for future clinical trials, ensuring viable, efficient, and ethical research pathways.Document Management: Diligently collecting and managing essential documents from various sites for submission to Competent Authorities (CA) and National Ethics Committees (NEC), maintaining compliance and ensuring a seamless start to clinical trials.Site Selection & Monitoring: Playing a crucial role in the selection and initiation of clinical study sites, adhering strictly to protocol requirements. My vigilance in monitoring ensures that each trial's integrity is maintained and objectives are met without compromise.Financial Negotiation & Team Coordination: Expertly negotiating financial agreements with principal investigators to align trial goals with fiscal efficiency. My leadership in motivating the investigators' team has been instrumental in achieving enrollment targets and driving success. Furthermore, I adeptly coordinate on-site medical teams and the activities of project assistants to ensure cohesiveness and productivity throughout the trial process.