Maria Myti

• Provided direction and accountability for the operational Study Start Up teams and their delivery at regional and site level.
• Responsible for handling Resourcing, line management, training, functional delivery and input on discussions around quality and operational delivery measurements within the Start Up group
• Conducted regular discussions with Regional Start Up Managers and lead Start Up Management team meetings to keep track of project deliverables during start up phase.
• Assisted with training for Start Up Managers and Associates as required.
• Primary point of Contact between CRO and clients for all project regions in regard to operational questions and escalations.
• Worked closely with Director/Senior Director and/or VP Start Up to communicate all critical issues, business growth opportunities, developing key relationships as well as providing input regarding budgeting discussions to drive productivity and quality within the region.
• Overally responsible for Budget handling , escalations to Senior Management and Financial Risk Management plan
• Driven overall delivery at site and regional level, through your operational team to drive execution of service, client satisfaction, quality and efficiencies.
• Represented Start Up Department at Sponsor and internal audits.
• Accomplished multiple tasks within established timeframes.
• Maintained professional, organized, and safe environment for CRAs, Country Approval and Contract specialists working on Start Up group operational level.
• Enhanced customer satisfaction by resolving disputes promptly, maintaining open lines of communication, and ensuring high-quality service delivery.
• Resolved staff member conflicts, actively listening to concerns and finding appropriate middle ground.

• Lead and managed site start-up portion of assigned project. Directed technical and operational aspects of site start up deliverables across countries. Worked with major functional area leads (project management, clinical management, legal and regulatory) to identify, evaluate, coordinate and oversee fundamental issues pertaining to the successful site start-up of the project. Provided accurate projections, reports, updates and ongoing risk assessments.
• Accountable for achieving the final Start Up deliverable (projected site activations) within the time period specified in the contract with the Customer. Managed all clinical aspects of allocated studies. Served as the primary Start Up contact for the Project Manager and client. (Pharmaceutical /Biotech Company)
• Led employee relations through effective communication, coaching, training, and development.
• Boosted employee satisfaction through regular performance reviews, constructive feedback, and personal development plans.
• Enhanced team productivity by implementing efficient task delegation and time management strategies.
• Developed a high-performing team by recruiting top talent, providing ongoing training, and fostering a positive work environment.
• Managed and motivated employees to be productive and engaged in work.
• Managed budgets effectively, ensuring optimal financial performance while investing in necessary resources for business growth.

• Acted as a Lead on Metastatic Hormone Sensitive Prostate Cancer Study: Supported CTMs in report review for Europe-Middle East and African countries. Oversaw of a team of up to 18 CRAs and reported progress directly to clients (presentation of progress reports within client faced meetings).
• Acted as Monitoring report reviewer and approver for the aforementioned study
• Acted as a reviewer of Protocol Deviations and shared weekly updates with the teams relatively to study systems (Data entry, IVRS, Client Safety reporting system). At the same time performed mentoring/onboarding to new CRAs to the study.

• Selected and approved by the respective country management, with complete Company RegView System training.
• Responsible for the development and timely update of assigned RegView database content and supplemental material for Greece. Ultimate responsibility for management of intelligence content and timely notification of changes in regulations/legislation or alerts of updates.
• Coordinated cross-functional teams to streamline project workflows and enhance communication.

• Represented the company in the global medical research community.
• Developed collaborative relationships with investigators and site personnel to conduct feasibility assessments in accordance with feasibility processes and within deliverable timelines.
• Developed a local knowledge base of sites in the respective market through collaborative working with local Company personnel.
• Utilized local knowledge, company systems, external site lists and sponsor directives to develop and review site lists that are suitable for the strategic needs of the feasibility and to provide local input into the site tiering process.
• Collaborated with cross-functional teams to address site-specific challenges and enhance communication.
• Served as primary point of contact for all site-related matters, streamlining communications for better decisionmaking.
• Implemented robust data analysis practices to guide decision-making in the addition of ''sites of excellence'', enhancing product relevance and customer satisfaction.

• Performed and coordinated all activities required to finalise site contracts (including, contractual terms and conditions, associated investigator grant budget(s) payment schedule terms and conditions and ancillary documents), with investigator sites, pharmacies, laboratories or other relevant contractual parties during the lifecycle of the study.
• Reviewed PPD and/or client site contract templates for compliance with local legislation and practices. Adapted the site contract template to client and investigational site requirements in collaboration with key stakeholders to include the project team and the PPD legal team. Facilitated effective budget negotiation with site personnel in collaboration with stakeholders. Performed and coordinated all amendments to site contracts and financial agreements with investigator sites, pharmacies, laboratories or other relevant contractual parties during the lifecycle of the study. Served as contact with investigative sites for contractual issues and negotiations throughout the lifecycle of a study. Assumed responsibility for any ongoing contract or budget amendments.
• Participated in country process improvement initiatives. Acted as Country subject matter expert for review of Investigator Contract training materials. Liaised with PPD Global Site Contracts, to ensure full compliance with established global processes and corporate directives. Acted as Lead with amendment/novation of client projects and oversaw confidentiality agreement negotiations. Represented PPD in developing collaborative relationships with investigational sites.
• Worked with investigational sites to negotiate budgets for 40 Oncology studies, 3 Circulatory studies, 11 Respiratory studies and 6 Infections/Parasitic Diseases studies.

SCRA: Senior Clinical Research Associate on Phase IIa, IIb and III studies. Performed on site monitoring , Remote and Risk Based Monitoring in Multiple Oncology studies.

• Oversaw clinical trial processes, ensuring compliance with regulatory standards and protocols in various hospitals across the UK
• Led site selection and initiation visits, establishing strong relationships with investigators and site staff.
• Developed and implemented monitoring plans, enhancing data integrity and patient safety throughout trials.
• Mentored junior CRAs, providing training on best practices in clinical research methodologies and compliance.

• SCRA: Senior Clinical Research Associate on a local, phase IV, Diabetes trial. Performed pre-study visits, study start-up activities, initiation visits, managed submissions to Central ECs, organised Investigator Meetings, conducted Investigator pre-study training and collected essential documents. Used eCRFs for data review and mentored Trainee CRAs.
• Clinical Research Associate on :
• A global, phase II (proof of concept) trial for a novel drug tested in Systemic Lupus Erythematosus. Responsible for study medication storage and handling, trained unblinded investigator team, used eCRFs, assured blinding of the study was kept safe, handled emergency unblinding procedures, collected essential documents, performed pre-study, initiation, interim monitoring and close-out visits, source data verification, query resolution, reported AE/SAEs and followed-up to ICH GCP requirements.
• A global, phase IV trial on Serious Gram-Positive Bacterial Infections. Performed pre-study, initiation, interim monitoring visits and study start-up activities, submissions to Central ECs and country CA, collected essential documents, prepared initial contracts and managed Amendments, performed source data verification and timely resolution of data queries. Conducted Investigator Site file reviews for completeness.
• A local phase IV/marketing trial on Rheumatoid Arthritis. Performed pre-study, initiation, interim monitoring and close-out visits, source data verification, timely resolution of data queries and managed AE/SAEs. Performed start-up activities for additional sites selected for this trial.

Clinical Research Associate performing regulatory submissions, obtaining approvals , on site monitoring of the following type of trials:

• A Global, phase III, Heart Failure trial. Performed extensive interim monitoring, source data verification, timely resolution of data queries, final accountability of investigational product, Investigator Site File management and close-out visits. Participated in a Sponsor site audit for a high recruiting site, no major or critical findings.
• A Global, phase II/III, Diabetes study. Performed pre-study, initiation and interim monitoring visits, source data verification, timely resolution of data queries, final accountability of investigational product and Investigator Site File management for several sites.
• A Global, phase II, Exercise Induced Asthma study in children aged 6-14 years old. Performed initiation visits at selected sites and conducted interim monitoring visits, source data verification and site management.
• A Global, phase II/III, Metabolic Syndrome and Hypercholesterolemia study. Performed study start-up activities, initiation and interim monitoring visits, source data verification, timely resolution of data queries, final accountability of investigational product and Investigator Site File management.

Clinical Research Associate performing regulatory submissions, obtaining approvals , on site monitoring of the following type of trials:

• A Global, phase II/III, Hospital Acquired Pneumonia (HAP) due to gram-positive bacteria, including resistant strains such as Methicillin-Resistant Staphylococcus Aureus (MRSA) trial. Responsible for study medication storage and handling, trained un-blinded investigator team, used paper CRFs, assured blinding of the study was kept safe and handled emergency un-blinding procedures. Performed interim monitoring and close-out visits.
• A Global, phase II/III, open-angle Glaucoma trial. Performed pre-study, initiation and interim monitoring visits, source data verification, timely resolution of data queries, final accountability of investigational product and Investigator Site File management.