Olga Bednarz Email & Phone Number

Poland

Warsaw Metropolitan Area

- Responsible for monitoring of clinical sites, maintenance of study files, conduct of pre-study initiation visits, regular visits and close out visits, assists on audit/inspection visits and assists in site and vendor contracting process, liaison with vendors and other duties- Responsible for recruitment of potential investigators, involvement in CA and EC submissions and notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other… Show more - Responsible for monitoring of clinical sites, maintenance of study files, conduct of pre-study initiation visits, regular visits and close out visits, assists on audit/inspection visits and assists in site and vendor contracting process, liaison with vendors and other duties- Responsible for recruitment of potential investigators, involvement in CA and EC submissions and notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor- Functions as the primary contact for sites regarding regulatory compliance and protocol questions and communicates with clinical sites on an ongoing basis to address and resolve issues;- Assists in Business Development activities Show less

Vancouver, British Columbia, Canada

- Supervises daily management of clinical sites to ensure smooth operations that conform to GCP and regulatory requirements.- Point of contact between Sonic Incytes and clinical sites for all clinical trial related activities.- Responsible for maintaining and managing of the TMF- Supports the site initiation process including preparation and review of IRB documents, contracts, consent documents and protocols.- Participates in study design and execution, providing input into… Show more - Supervises daily management of clinical sites to ensure smooth operations that conform to GCP and regulatory requirements.- Point of contact between Sonic Incytes and clinical sites for all clinical trial related activities.- Responsible for maintaining and managing of the TMF- Supports the site initiation process including preparation and review of IRB documents, contracts, consent documents and protocols.- Participates in study design and execution, providing input into study protocols, CRF design, and assisting with study or site feasibility.- Conducts site initiation visits and coordinates the timely training of Velacur users at the clinical site.- Participates in routine site monitoring process, performs site close-out activities.- Tracks patient enrollment and monitors the collection of patient data. Escalates any issues or delays with patient enrollment.- Identifies and tracks site and protocol related deliverables including the creation and communication of timelines.- Reviews and contributes to clinical study reports. Show less

Warsaw Metropolitan Area

- preparing and being responsible for Trial Master File setup, conduct and close-out- performing high-level review of assigned TMF parts and informing Document Owners about deficiencies and required corrective and preventive actions- permanent close cooperation with CRAs to ensure site level documents completeness- executing compliance check for expected documents- performing Quality Check (QC) review- "rescue study" management, executing and supervising migration of paper… Show more - preparing and being responsible for Trial Master File setup, conduct and close-out- performing high-level review of assigned TMF parts and informing Document Owners about deficiencies and required corrective and preventive actions- permanent close cooperation with CRAs to ensure site level documents completeness- executing compliance check for expected documents- performing Quality Check (QC) review- "rescue study" management, executing and supervising migration of paper TMF into eTMF- liaising with KCR project team members and document owners in the scope of assigned activities and projects for TMF related needs- managing and enforcing creation of Investigator Site File (ISF) binders- supervising and keeping up with current clinical study schedule, milestones, and deadlines- generating the QC Plan for QC execution and evaluates QC results compared to threshold- supporting less experienced staff with knowledge and experience, acting as a Peer Buddy Mentor- participating and coordinating preparation of the completed studies for archiving Show less

Warszawa, Woj. Mazowieckie, Polska

- Coordinating marketing campaigns for clients and other external stakeholders- Copywriting, medical writing, visual content creation- Assessing the results or marketing campaigns with monitoring and reports- Coordinating the company presence during external events- Responsible for designing and coordinating marketing materials production (White Papers, Company One Pagers, etc.)- Supporting Business Development department, helping with bid defense presentation content… Show more - Coordinating marketing campaigns for clients and other external stakeholders- Copywriting, medical writing, visual content creation- Assessing the results or marketing campaigns with monitoring and reports- Coordinating the company presence during external events- Responsible for designing and coordinating marketing materials production (White Papers, Company One Pagers, etc.)- Supporting Business Development department, helping with bid defense presentation content preparation- Monitoring trends in clinical research, R&D, CRO market- Responsible for maintaining media contacts and updating media database- Responsible for contacting media, applying proactive approach- Responsible for researching and gaining marketing and PR intelligence on competitors Show less

Warszawa, Woj. Mazowieckie, Polska

- management of the Clients' social media profiles- managing advertising campaigns in Social Media- independent creation and implementation of brand communication strategies in Social Media- cooperation with influencers and celebrities- supporting day-to-day activities of the PR team- assessing the results or marketing campaigns with monitoring and reports

Warszawa, Woj. Mazowieckie, Polska

- management of the Clients' social media profiles- managing advertising campaigns in Social Media- independent creation and implementation of brand communication strategies in Social Media

Warsaw, Masovian District, Poland

- organization and supervision of the maintenance of firefighting equipment- ordering personal protection equipment for the Clients- preparation of reports on commercial activities

Kijów

translation of documentation (in French) and libretto editing (in English)

Kijów

- creating TV reports- content creation and editing for TV presenters- creating dubbing and voiceovers- newsreading

Postgraduate Degree, Clinical Research

Healthcare Management Department: Organization and Management of Clinical Trials

Master'S Degree, Eastern European Studies

Master'S Degree, History