Ewa Byrtek

*Key Duties & Responsibilities:

• Lead and coordinate activities that ensure quality, consistency, and integration of study data and progress operational deliverables to time, cost and quality objectives from Study Specification (SS) through to study close-out activities and Clinical Study Report (CSR)
• Work with and lead cross-functionality, with internal and external partners, on global studies across different phases of drug development as well as therapy areas
• Contribute to steering committees, submission assembly teams, regulatory defence teams, and Advisory Boards as necessary
• Contribute to the planning and conduct of internal and external meetings (e.g. Investigators’/Monitors’ meeting)
• Monitor study conduct and progress, proactively identifying and resolving issues which may impact the delivery of the study and/or quality, timeline as well as budget objectives
• Lead the preparation of study documents (e.g. Informed Consent Form, Clinical Study Agreement, Patient Participation Card, Global Monitoring Plan, tSDV plan, eCRF Instructions, etc.)
• Provide input and review data management deliverables (e.g. Unique eCRF specification, Data Validation Specification, Data Management Plan, etc.)
• Contribute to protocol development and the development of other Operations documents, as appropriate, as well as any updates/amendments to those documents
• Establish and maintain interactions with key stakeholders including the facilitation of communications with MCs, Strategic Partners, Academic clinics and investigational study sites, as appropriate, and external service providers (Third Party Vendors) to identify and resolve operational feasibility issues as well as facilitate study start-up activities.

*Clinical Trials: In-depth Experience in the following therapeutic areas:

Rheumatoid Arthritis IIb 9
Hypertension III 21

*Clinical Trials: In-depth Experience in the following therapeutic areas:

Osteoarthritis IIb/III 184
Polyneuropathy II/III 122
Rheumatoid Arthritis III 11
Rheumatoid Arthritis II/III 6
Rheumatoid Arthritis II 5
Diabetes Type 2 II 4
Ankylosing Spondylitis II Screening period at present

*Duties & Responsibilities:
• Protocol Reading, Manage study Startup Activities (e.g. Site Feasibility), Meet study Enrollment and study Goals- Screening & Randomization, Coordinate and Supervise site Visits, Accurate and Punctual data entry (eCRF and InForm), Ensure that Queries are resolved in an Accurate and Timely manner, Coordinate Study Labs and Procedures, Study Drug Compliance, Conduct Drug Accountability (Register Drug, IVRS System, Dispense Drug, Collect Drug, Count Drug, Keep Site Drug logs updated), Adverse Events & Serious Adverse Events Reports (SAE) submission and reporting, Extensive Knowledge in ICH/GCP Guidelines, Co-Monitoring experience, Assist with Audit Preparation, Study Closeout, Maintain Confidentiality when performing all duties and responsibilities

*Administrative:
• Maintain effective working relationships with Study Team and Monitors for well-timed and successful issue resolution
• Multitask- Answering emails, data entry (online), answering calls, resolving problems
• Work as a team member in a team oriented environment and independently
• Responsible for Oversight of All studies with the Study Team and the Assignment of studies to Research Staff as well as Supervision of Study Team

*Laboratory In-Depth Experience with:
• Covance Central Laboratory
• Quintiles
• Quest Diagnostics

*Online Research Training Certificates for:
• Phase Forward- Inform Training (version 4.6)
• Pfizer- OC-RDC OneSite Data Entry (16/06/2009)
• Pfizer- Impala e-Training Guide (16/06/2009)