Inspiring the Leaders at Forge of Leaders, the Leadership Development Centre.

End-to-end project management

http://www.gcppl.org.pl/

(via DOCS International)Therapeutic Areas:• Oncology – Prostate cancer• Oncology – Multiple melanoma, CAR-T• Oncology – Lymphoma (NK/T-Cell Lymphoma; NKTCL)

Therapeutic Areas:• Neurology: Alzheimer disease; Multiple sclerosis;• Pulmonology: Asthma; IPF; ILD;• Immunology/Rheumatology/Ophthalmology: Sjogren's syndrome;• Ophthalmology: AMD.Main duties:- Management and general oversight of projects (at C&EE region level = 11 countries),- CROs oversight;- Set-up of study timelines, budget and forecasts, resources, risk and quality plans;- Development of study timelines at C&EE region level and study milestones oversight;- Set-up of patient recruitment & retention strategies for the regional & study level;- Providing leadership to multi-functional matrix study teams through all stages of clinical trials;- Managing and coaching of project teams (CTAs, CRAs, Local PMs);- Providing input from a country/region perspective into development and implementation of drug management, contracts, budgeting, resourcing, source document verification, data flow, case report forms, and safety monitoring;- Building and maintaining a professional relationship between company and investigators within a region;- Acting as a RWE/RWD Lead in Poland (subject matter expert and cross-departments strategy coordinator).

Lead CRA acting as regional PM for phase III studies and global PM for phase I & II studies.Therapeutic areas:• Oncology: Prostate cancer, phase I/II;• Oncology: Solid cancer, phase I;• Oncology: NSCLC, phase II and III;• Infectious Diseases: UTI, phase III;• Nephrology: CKD, phase III.Main duties:• Acting as Lead CRA (co-PM/regional PM) for ph III studies & global Project Manager for Ph I and II studies,• Set-up of study-specific plans, guidelines, procedures, logs and other study documents,• Vendors management,• Country/Regional budget set-up,• Patients recruitment process - supervision and region level support,• Study progress reporting,• Supervision and support of local (country/site level) contractual process,• Management of project teams (consisting of PAs-CTAs/CRAs/SrCRAs) and providing teams with project-specific trainings,• Co-monitoring and field trainings - acting as a trainer and mentor for less experienced staff,• Providing trainings to Clinical Operations department,• Cooperation with key opinion leaders in Europe.

Therapeutic areas:• Oncology: NSCLC, phase II• Cardiology: CHF, phase II• Nephrology: CKD, phase III

Therapeutic areas:• Infectious Diseases: AIDS & HIV - phase III• Pulmonology: COPD, phase IV• Nephrology: CKD, phase II• Oncology: NSCLC, phase II