1. Name: Marta
Walewska
Senior Manager Clinical Operations
+48 692 412 324
Summary
Medical Doctor with 13 years’ experience in clinical research in CRO and pharma company, 6 years of CRA experience,
Thorough knowledge of ICH GCP and applicable local regulations, experience in Quality Management, experience of working
directly with Sponsors and clinical sites and Investigators.
Employment History
Senior Manager Clinical Operations
Covance Clinical Development Services
Jul 2009 – Sep 2013
Warsaw,Poland
Early Clinical Development 01 September 2013 – Present
Global Quality Manager for ECD Clinical Operations from May 2015
• Develop and maintain effective relationships with ECD management team, country leads and Project Managers to
manage effectively Clinical Operations staff in CEE( Poland, Czech Rep, Slovakia, Bulgaria, Russia) and Israel
;supporting 50% increase in operations in ECD since 2013
• Developing contacts with new Investigational sites (3-4 per year) ,performing site assessment visits to recruit potential
investigators for future studies (major focus – oncology);
• Communicate with KOLs and Investigators to discuss possibility to run specific studies (based on the feasibility
information) in Poland;
• Develop a database of sites :past performance, recruitment and quality for Poland;
• promoting CEE region for early clinical studies : cooperating with Investigators? Relations and Project Managers to
promote CEE region for early phases studies
• build company network of preferred sites
• develop the database with past site performance, recruitment and quality
• Oversee assessment visits planning and execution (globally), ensure the adequate number of visits is planned and
executed each quarter;
• Prepare & perform trainings , monthly meetings to share experience and best practices
• Measure performance indicators for assigned staff within Clinical Operations;
• Review training compliance reports and trip report compliance reports (globally),
• Perform Monitoring Assessment Visits and Clinical Quality Control visits
• Review internal audit reports and provide ECD response for Corrective and Preventative Actions ,act as a CAPA
Council Lead
• Contribute to the departmental training matrix, involve in SOP review and process improvements (CRA
optimization,internship program,CRA dashboard)
• Accountable for overseeing country -level study start-up, conduct, and close-out activities ,directly responsible for
small ,1 site studies( as a PM)
Senior Clinical Operations Manager
(Clinical Operations and Flexible Solutions)
Jan 2011 – Aug 2013
• Overall management of supervised staff in Poland, Czech Republic, Latvia, Lithuania Estonia

2. • maintaining and building relationships with four different clients,
• ensuring client and employee satisfaction
• performing assessment and accompanied field visits ;
• setting objectives for team members with ongoing reviews and conducting formal annual appraisals;
• Selecting and providing resources for; ensuring appropriate operation margin on project and managing all the costs
related to those;
CoSource Manager
Jul 2009 – Dec 2010
• Client management in Poland and Baltic states, maintaining and building relationships with the clients, preparing
proposals and contracts negotiations.
• Delivering and executing on ongoing projects; selecting and providing resources for Clients in cooperation with
recruitment and HR department; ensuring appropriate operation margin on project and managing all the costs related
to those;
• Working as a part of CoSource Management team to drive and improve internal processes as Conducting recruitment
for various positions in clinical research in Romania, Egypt, Czech Rep Lithuania, Latvia ,Estonia and Bulgaria,
directly communicating with clients;
PharmaNet sp z oo ,Warsaw,Poland
Position:Senior Clinical Research Associate
May 2005 – Jun 2009
• Acting as Lead CRA for the multinational project under direction of a Project
• Review progress of projects and initiate appropriate actions to achieve target objectives.
• Organize and make presentations at Investigator Meetings;
• Participate reviewing monitoring visit reports,provide feedback and mentoring for CRA;
• Interact with internal work groups to evaluate needs, resources and
• Act as contact for clinical trial supplies and other suppliers (vendors:local labs, CT scans and radiology dpt );
• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites,
maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned;
• Responsible for preparation for internal, external and agency audits (FDA and Polish Regulatory Inspection in June
2007);
• Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities,
translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as
assigned;
• Negotiate study budgets with l investigators and assist the Covance legal department with statements of agreements as
assigned;
Position: Clinical Research Associate II
Sanofi /Sanofi-Aventis Warsaw, Poland
Apr 2004 – Apr 2005
• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites,
maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties
(multinational trial, multicenter trial, Cardiovascular mega trial :responsibility for 9 Polish sites (300 pts), and EC
submissions) .
• General On-Site Monitoring Responsibilities
• Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities,
translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor.
Clinical Research Associate –outsourced to the Client
Kiecana Clinical Research Warsaw, Poland
Mar 2003 – Apr 2004
• Key responsibilities –as above
John Wayne Cancer Institute, Santa Monica ,California, USA
Feb 2000 – Sep 2002

3. • Act as contact for project team and study sites.
• Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter
patients into the study.
• Cooperate with the Patient Associations to promote clinical trial among this group (X-linked hypophosphatemia)
• Assist the local project team members with other administrative activities as required (e.g. LEC approval for ICF ,
correspondence with patients, preparation of status reports, and organization of investigators? meetings).
• Co-ordinate meetings with project team, including taking minutes.
• Set up and maintain clinical investigator files and documentation.
• Prepare study-related documents and other materials for delivery to archives
fluent in speaking and writing, passed TOEFL exam
• Russian ,German passive knowledge
• Polish native
Experience in Medicine
• 1994-1998
Pediatrician
• Regional Pediatric Outpatient Clinic, Warsaw, Poland .
• 1994-1997 Regional Pediatric Hospital, Warsaw, Poland Pediatrician
• 2000-2002 John Wayne Cancer Institute, Santa Monica ,California ,Administrative Assistant in medical research ( X-
linked hypophosphatemia patients),working on PhD dissertation (bone metabolism in juvenile patients with X-linked
hypophosphatemia)
Education
• July 2016 MBA Management , Center for Post Graduate Studies, Lazarski University, Warsaw, Poland
• 2010-2011 Post Graduated Study in Human Resources Management in Organization, Warsaw School of Economics,
• November1997 Post Graduated Medical Studies, Specialization: Pediatrician ,Warsaw, Poland
• June 1993 Medical Academy Warsaw, Poland , MD Diploma
JOB-SPECIFIC COMPETENCIES & SKILLS
solid networking and relationship building (among departments,countries and sites)
good negotiation skills
Good problem solving skills
self-motivated & proactive
Conflict resolution
I can spend more time on travel due to my family situation