ALONA PALM

• Accountable for the planning, implementation and execution of clinical trials, including resourcing, preparation and conduct of BID meetings, onboarding selected vendors, development of study deliverables plan, milestones and data quality
• Oversee third party vendors to operationalized study specifications
• Directs the operational execution of clinical study activities in accordance with the company's SOPs, ICH Guidelines, and Good Clinical Practices (GCP) to ensure overall data quality, integrity, and patient protection
• Accountable for planning, tracking and forecasting the Global Clinical Operations budget and timelines for the studies against the agreed goals
• Develops and maintains budgets for studies that include short and long-range clinical forecasting and monthly accruals based on clinical activity to support Clinical Development financial goals
• Manages CRO relationship to ensure the appropriate scope of work, oversight and training of clinical investigators and achievement of study milestones within agreed upon timelines and budget
• Leads and directs the Cross-Functional Clinical Sub-Teams to define study specifications, achieve study milestones through operational feasibility and budget and timeline estimates and operational accountability and management of study deliverables and is the primary point of contact interfacing between functional groups, investigator sites and vendors
• Provides oversight and quality control of due maintenance of TMF including required study and regulatory documentation, e.g., reports for Competent Authority submissions, master patient informed consent, Monitoring Plan, Pharmacy Manual, Investigator Agreements and budgets
• Key contributor to the development, review and approval of study documents including but not limited to protocol, ICF, statistical analysis plan, and clinical study report
• Conducts lessons learned exercises to provide continuous process improvement and sharing of best practices
• Participate in and lead departmental initiatives

• Provide clinical operations expertise by implement processes and systems that are critical to the success of the clinical programs
• Provide oversight and expertise in the management of CROs, consultants, vendors, and clinical sites
• Oversee the start-up and monitor the management of clinical studies ensuring they are conducted in compliance with the agreed study plans and all applicable regulations and requirements
• Management of cross-functional teams to ensure proper initiation, execution, and conduct of clinical trials and generation of high-quality clinical data
• Monitor progress of clinical activity and manage several millions budget, timelines, and clinical data collection
• Create, review and approve study-related plans generated by CROs and vendors, and ensures the documentation is in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies
• Initiate and coordinate the authoring, review and finalization of clinical study-related documents such as protocols, protocol amendments, ICFs, clinical study reports (CSRs), regulatory submissions and other publications as required
• Interact with investigational sites, clinical consultants, and other vendors
• Prepare and deliver program/study updates at the Upper level
• Request and critically evaluate proposals and change orders from CROs, vendors and investigator sites
• Contribute to overall clinical operations team knowledge by sharing best practices and participating in improvement initiatives
• Demonstrated exceptional adaptability in navigating complex situations or rapidly changing environments with ease.

• Management of cross multifunctional study execution team to ensure goals and timelines are met, studies are conducted following the top-level quality standards and according to the ICH GCP, FDA, EMA, Canadian & other local regulations and the company's standard operating procedures (SOPs)
• Facilitate Clinical Service Agreements and other study contracts through Legal and Financial review
• Manage and oversee CROs and other vendors to ensure compliance with the processes and regulatory guidelines and within the contracted timelines, terms and conditions
• Trial budgeting, financial review, negotiation and planning of the expenses and spending by working closely with the appropriate partners, vendors and company's financial department
• Anticipate potential study issues, analyze the risks and implement mitigation measurements to minimize and eliminate potential impact
• Contribute to Global clinical / regulatory submissions, including IND and NDA (FDA, EMA, Canadian and other countries), by constant monitoring and control in-house and on-site inspection readiness planning/training processes
• Drives traceability procedures for investigational products and coordinates clinical supply planning with cross functional team members
• Provides Clinical Operations coordination and control of all important study activities, including but not limited to: site identification and selection; enrolment models and patients retention strategy; clinical supply planning and drug supply; planning, organization and conducting of investigator & vendors meetings (bid-defense, kick-off, etc.); development of informed consents forms; structure and management of Trial Master File; development of monitoring, communication, management and other study plans; development of study systems; development of EDC / Case Report Forms; review of data during the study; data cleaning and database lock; writing the Clinical Study Report; etc

• ICH GCP & FDA compliance and QA review of study on-site delivery
• Readiness for FDA inspections: verification of study documentation, coaching of investigators and study staff

• Led global early development phase clinical trials by planning and defining scope, budget, and resources, including cross management of internal team departments and contracted vendors as well as the direct collaboration with the Sponsor's R&D
• Key Contributions:
• Implementation of applicable Essential Documents and systems according to the clients' requirements and expectations and within the contracted terms and budget
• Identifying opportunities for improvement to recognize and mitigate risks at the earliest stage of the project

• Global management of early phase clinical trials in cancer and autoimmune diseases (multiple myeloma) by planning, budgeting, resourcing, database building, Essential Documents implementation, overseeing the work of contracted research organizations and vendors, collaboration with project stakeholders, cooperation with scientific committees to align clinical trial processes and objectives with industry requirements
• Key Contributions:
• Verification of trial validity and safety by control of all clinical data collection and reporting in line with ICH GCP, EMA and FDA regulations, local regulatory requirements, company's SOPs and industry standards

• All aspects of Clinical Operations management: resourcing the current projects, appraisal evaluation, training, and support & control the CRAs and other clinical staff (experienced and newcomers)
• Key Contributions:
• Readiness for health authorities' inspections: coaching, training, drilling the CRAs and investigators
• People management and resourcing supervising

• Global management of multiple international clinical trials as the central supervisor and point of contact for all stakeholders and regulatory bodies by building productive, compliant teams of clinical, scientific, research, and legal professionals focused on meeting project targets
• Assurance of compliance with a wide range of regulations and standards as from research ethics to site safety, maintenance of reliability and safety of clinical research
• Regular monitoring of projects progress in order of keeping high level of critical KPIs and on-time completion of clinical trials, facilitating the transition from research to approval and commercial availability

Key Contributions:

• Quality Control of the projects at each level: QA visits – 150 visits during 6 years; QC review of TMF; QA audits – 60 audits during 6 years, FDA and national authorities inspections – 4 FDA inspections

• Clinical team management and guiding of clinical research studies by applying protocol criteria to the selection and regular monitoring of clinical sites and staff, CRF review, and the verification of source data
• Supervising of all clinical trial operations, including liaising with regulatory authorities to ensure compliance with national regulations and companies' SOPs

• Proper delivery of clinical trials in accordance with ICH GCP, FDA regulations, country legislation, protocol requirements and company's SOPs