Eleni Tsoukala Email & Phone Number

Spata, Gr

Athens, Attiki, Greece

Italy

Italy

Giugliano In Campania, Campania, Italy

Campania, Italy

Act as a core project team member representing clinical delivery with the customer. Current responsibilities include managing the operational aspects of projects to meet contractual requirements in accordance with SOPs, policies and practices; ensuring delivery of study quality and patient recruitment; driving site compliance; and leading, mentoring and training of the clinical operations team.

Athens Greece

Reporting to Regional Clinical Trial Management Manager and Local Head of ClinOps, managing a team of 16 CRAs and 2Regional Trial Assistants from 8 EU countries.Key responsibilities: Implementation and management of clinical trials in a regional setting (within 8 EU countries), ensuring timely delivery of required deliverables on recruitment, quality, timelines and budget specifications. Worked in regional team, acted as a liaison between the team on trial level and the trial team on Regional level.Main projects and indicative achievements:  Developed the Project Management Planwithin a restricted timeframe, on a regional level in order to be able to closely follow up the progress of the assigned clinical trials (based on timelines, KQIs and KRIs), ensuring that timelines and quality are not jeopardized. Closely followed up on recruitment initiatives within the different countries in order to be able to meet the individual countries’ patient commitments. Achieved 90% patient recruitment in assigned trials regionally.  Audit preparation and follow up: Ensured that local teams (CRAs) are prepared for upcoming on site audits and ensured that all follow up actions and CAPAs are closed on time.

Elliniko, Greece

Reporting to Regional Clinical Management Manager, managing a team of 11 Regional Clinical Trial Managers from 6 EU countries. Key responsibilities: Management of trials on a regional and local level, ensuring quality and ethical standards are fully met.  Implemented agreed methods, processes, systems and quality checks, timely resource planning utilizing synergies.  Ensured that clinical trials are allocated to CTMs and conducted within the agreed timelines, quality and budget, and issues are escalated and followed up as needed to Regional CTM manager.Main achievements& responsibilities:  Actively supported on the CTMs development by monitoring their progress on assigned trials, providing support and feedback in a constructive manner. Contributed in the creation of efficient regional teams of CTMs from people around 6 different EU countries with different cultures, way of working and mindset. Closely motivated the regional working instructions development by participating in working groups and ensured deliverables are submittedwithin predefined timelines.

Elliniko, Greece

Reporting to local Head of Clinical Operations, managing a team of 5 local CRAs responsible for their assigned trials.Key responsibilities: Ensured efficient implementation of phase II – III, IV Clinical trials focusing mainly on oncology through the appropriate use of internal and/or external resources, in order to assure that the appropriate processes, procedures, and practices are in place and fully coordinated.Main achievements:  Successfully met the assigned trial commitments as predefined by the global teams with close collaboration with the team of the local CRAs. Target commitment achieved: 90% No major audit findings in all audits performed either in-house audits or on-site audits. Audit compliance: 100% Contributed to build a strong profile of the oncology pipeline of the company in the Greek territory. Actively participate in co-visits with Medical Managers to important KOLs and “rising stars”.

Metamorphosis, Athens Greece

Reporting to local Medical Director and Regional Head of Global Monitoring Operations, managing a team of 5 local CRAs responsible for their assigned trials and 2 Project Assistants. Key responsibilities: Assessed, initiated and managed the implementation of clinical trials in Oncology therapeutic area, ensuring that all activities are conducted on time and budget are compliant with GCP/ICH and Company’s SOP procedures.  Coordinated department training activities, created training plans and perform face to face meetings.  Participated in multidisciplinary teams within the local company and Globally to evaluate and implement process improvement.  Responsible for the evaluation offers for new staff and hiring for the GMO clinical team in Oncology Business Unit in Greece.  Led and evaluated CRAs appraisals in collaboration with the local Medical Director.Main achievements:  Following reconstruction of ClinOps, led the development of ClinOps in Oncology and established the local ClinOps oncology team within Novartis Oncology BU as one unity. Initiate the active collaboration of the ClinOps team with Medical Affairs, Sales and Marketing by participation in the Brand Teams  Supported in the increase of FTEs (both in-house and out-sourced)within the local ClinOps organization, by attracting and initiating Clinical Trials in new or rare indications. Increase in trial number: 2 trials in 2008 and 21 trials in 2011. Supported in the initiation of the 1st multinational clinical trial in the public sector of Cyprus which resulted as a major achievement for both Region and Greece since it was the first time that this was initiated. Enhance the strong network and collaboration with important KOLs and “rising stars” in new or rare indications, supporting also the PAGs (Patient Association Groups) in order to meet their needs and help initiate trials on new or rare disease indications.

Metamorphosis, Athens Greece

As a Sr. CRA in Novartis, I continued working only in oncology trials sharing experience among other CRAs. From Jan 2008, I led a team of CRAs in Oncology BU beside the Sr. CRA responsibilities I had in close collaboration with the Medical Affairs Manager of Oncology. Our team managed to increase the number of trials assigned to the country from 2 two 11 and we got assigned extra headcounts in order to support our activities.

Metamorphosis, Athens Greece

As a CRA in Novartis, I mainly worked on oncology trials performing all monitoring activities based on the monitoring plan as well as IMP Release and shipment to site (from non EU countries).

Athens, Greece

As a CRA, I was responsible for all monitoring activities assigned to me, including feasibility assessments, review of protocols, ICFs etc, monitoring at sites and complilation of MVRs. I collaborated with almost all large Sponsors and got valuable experience in all fields of clinical research such us virology, immunology, COPD, Heart Diseases and Oncology.

Cardiovascular

Master Of Science By Research, Biomedical And Life Sciencies

Activities and Societies: Queen's Margaret Union Senior Member (Alumni), University of GlasgowSpecialized in Molecular Genetics with minor.

Bsc, Biology

Bachelor of Science in Biology awarded by the University of Delaware, U.S.