Anna Wójcik

Data entry into CRFs and QC of medical data. DM introduction training and oncology
therapeutic training. EDC System: Clincase
Therapeutic experience: Oncology Phase II

- Simplification of regulatory documentation (close cooperation with global Regulatory Directors),
- Process improvement,
- Submission and Financial Disclosure team: support during the preparation of FDA 1572 Forms, CVs, verification of completeness of the data based on reports from IMPACT, ANGEL, FD Team and training for study team about submission and FD process.
- Enablement Lead (Phase I and II Oncology) – Crossfunctional Lead management on global
level.

- Review clinical trial data in accordance with [Global] Data Management Plans and applicable standardized data management, processes (SOPs, Work Instructions, etc.) to identify erroneous, missing, incomplete, or implausible data,
- Run ancillary programs (e.g., diagnostics, special listings, reconciliation discrepancy listings) used to support the review of clinical trial data,
- Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification / correction to the database (Medidata RAVE),
- Apply quality control procedures and checks to ensure data quality standards (client and Covance) are achieved,
- Interact with the dictionary coding and maintenance group to ensure appropriate process set-up and application,
- Assist with the reconciliation of central laboratory and/or third party vendor data (eCRF, eDiary, specialty laboratory, etc.),
- Assist with the aggregate review of clinical data by patient, site, and/or project to identify data trends (patient safety, compliance, etc.), and/or data inconsistencies that require further investigation,
- Assist in the development and testing of data management system edit / data validation checks (diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities,
- Support the training of project staff on project-specific, global, standardized data management processes.
EDC System: Medidata RAVE
Therapeutic experience: Diabetes (phase II), Acute Coronary Syndrome (phase III)

- Supporting project managers and directors in key projects deliveries and milestones (global and local level) with applicable local regulatory requirements and ICH-GCP guidelines,
- Project administration on global and local level (Training Coordinator, Subject Matter Expert eTMF and CTMS, study status reports, Global Investigator Meeting),
- Remote and local Assistants Team group Leader,
- Participates in teleconferences and meetings with Sponsor or/and study staff,
- Communications with Polish sites, backup for CRAs, CPMs,
- Cooperation in site selection,
- Set up and maintain paper and eTMF, management of CTMS (global and local level),
- Preparing clinical trial documents such as local informed consent forms (ICFs), global and
local Newsletters, Study File/Investigator binders, drug destruction form, Note to File,
updating local/global manuals/documents (e.g. patient diaries, instructions).
- Responsible for clinical supply (e.g. drugs for sites) and non-clinical supply management for local (polish sites) and global sites,
- Management of clinical data for Drug Safety (SUSARs, safety reports for EC and sites),
- Submission and notifications to Ethics Committees and Regulatory Authorities,
- Liaise with vendors, partners, subcontractors,
- Budgeting: collaboration with finance/budgeting representative for contract development,
approval and maintenance, payments (investigators, vendors, grants,), budget updating in CTMS,
Therapeutic experience: Anemia (Phase II), pediatric and adult Asthma (Phase II), Multiple sclerosis (Phase IV)

- Communications with Polish sites,
- Managing of study supplies and organize shipments to the Polish sites,
- Management of clinical data for Drug Safety (SUSARs) and financial department
(payments for investigators and hospitals),
- Submission and notifications to Ethics Committees and Regulatory Authorities.

PhD project (PhD Studies) about “Potential mechanisms for regulation of neurogenesis in the neonatal rat model of Cerebral Hypoxia-Ischemia”.
-Planning and carrying out research project on pre-clinical stage (hypoxic-ischemic encephalopathy),
-Management of scientific data to improve the laboratory method, prepare posters, publications and oral presentations in the international conferences,
-Working with animals (conducting rats brain surgery, preparation samples for neurological and biochemical research),
-Working on CorelDraw, Excel, PowerPoint, statistical analysis programs.

Internship in the Institute of General Genetics & Cytology
(The International Association for the Exchange of Students for Technical Experience Program).
Planning and carrying out research project on pre-clinical stage, preparing research results (documents)

I took part in Research Project supervised by
Associate Professor Grzegorz Wilczyński MD, PhD
Planning and carrying out research project on pre-clinical stage (anti-epileptic treatment), preparing research results (documents)

I took part in Research Project Grants about “Comparison of the role of pathway signalling RhoA/ROCK in normal and transformed cells of the nervous system”, Supervised by Associate Professor Wanda Kłopocka, PhD.
Planning and carrying out research project on pre-clinical stage (glioblastoma multiforme), preparing research results (documents, posters, publications, oral presentations), customer service (helping with confocal microscopy)

I took part in Research Project Grants about “Additive effect of sodium butyrate to the preparation of substitute milk and/or starter feed on the development of the gastrointestinal tract in calves”, Supervised by Professor Romuald Zabielski, PhD
Planning and carrying out research project on pre-clinical stage (effect of drug on intestine of calves), preparing research results (documents, oral presentations).

planning and carrying out research project on pre-clinical stage (muscular dystrophy), preparing research results (documents, oral presentations)