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Summary

peter bubak, dds (leg. tandläkare)

 

 

runiusgatan 3

112 55 stockholm

sweden

 

mobile: +46 708 32 32 48

 

e mail: bubakp@hotmail.com

 

 

Education

 

 

 

Doctor of dental Surgery, 1991

karolinska institute, stockholm, sweden

 

 

 

professional experience

 

ppd, stockholm, sweden                                                                                                                                pctm                                            2008 - 2016

                                                                                                                                                                                                    sctm             2006 - 2008

ctm                                     2004 - 2006

                                                                                                                                                                                                    rcr                                     2004 - 2011

scra i                                 2003 - 2004

 

pctm: as principal clinical team manager and Project Manager managing a Phase II global clinical study in ulcerative colitis.responsible for overall activities globally, including financial regional responsibility in apac and emea.

 

 

pctm: as principal clinical team manager and Project Manager managing a the european part of a Phase II nhl study . responsible for the overall activities in the emea region, including clinical, Pharmacovigilance and financial part of the study. performed co monitoring visits.

 

pctm: as principal clinical team manager and Project Manager managing a the european part of a Phase III clostridium difficile diarrhea study . responsible for the overall activities in the emea region, including clinical, Pharmacovigilance and financial part of the study.

 

pctm: as principal clinical team manager, managing a global Phase III multiple sclerosis trial. responsible for the clinical deliveries. responsibility for the management of a team of CTMS (4) and cras (50) in 30 countries (emea, north america, south america and asia) through clinical start-up, initiation, monitoring, close out and database locks. performed co monitoring visits.

 

sctm: as senior clinical team manager, managed, trained and mentored a team in mumbai, india on a global Phase III Diabetes type 2 study. tasks included study recovery, preparation for dbl, Training of CRA team and mentoring of newly recruited ctm´s. performed co monitoring visits.

 

sctm: as senior clinical team manager, managing a global Phase III multiple sclerosis trial. responsible for the clinical deliveries. responsibility for the management of a team of CTMS (3) and cras (32) in 22 countries (eu, russia, australia, canada and republic of south africa) through clinical start-up, initiation, monitoring, close-out and database locks. performed co monitoring visits.

 

ctm: as clinical team manager, managed a global Phase III multiple sclerosis trial. responsible for the clinical deliveries. managed a team of cras (24) in 18 countries (eu, australia and new zeeland) through monitoring, close-out and database lock. performed co monitoring visits.

 

ctm tasks: accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study science)" >Protocol) within the time period specified in the contract with the customer. manages all Clinical operations aspects of allocated studies. serves as the primary Clinical operations contact for the Project Manager.

 

responsible for the co-ordination and management of all Clinical operations project team members on an international basis (particularly CRA’s), within designated projects. implements and manages the necessary Training, tracking and Quality Systems within the clinical portion of the project. involved in regular and proactive liaison with the Project Manager, Clinical operations managers and other functional groups as appropriate.

 

co-ordinates standardised start up and Clinical monitoring guidelines (in conjunction with query guidelines). ensures essential document quality. reviews monitoring visit reports. performs co-monitoring visits where necessary. identifies and performs any required Troubleshooting activities. manages query resolution process.

 

rcr: performing a final and independent Quality Control of essential documents required for start of a Clinical Trial in europe/africa/australia.

 

scra i: senior Clinical Research Associate on a global Phase III non-hodgkin lymphoma trial. performed monitoring visits.

 

scra i: senior Clinical Research Associate on a global Phase III multiple sclerosis trial. performed monitoring visits.

 

omnicare clinical research ab, stockholm, sweden                                    ctm                                     2002-2003

                                                                                                                                                                              scra                                                                   2001-2003

                                                                                                                                                                              Country Manager 2002-2003                                                          

scra: senior Clinical Research Associate on a european Phase III torticollis trial. performed pre-study, initiation, Interim monitoring and close-out visits. during this trial participated in 1 clean data transfer.

 

scra/ctm: senior Clinical Research Associate on a european Phase IV onychomycosis trial. performed pre-study, initiation, Interim monitoring visits. acted as Clinical Trial manager. assisted in CRA-Training, performed accompanied visits in sites around europe with the CRA´s in the study. planned a CRA meeting during this trial. participated in 1 clean data transfer.

 

Country Manager: managed the office of omnicare clinical research ab in stockholm, Member of the board of omnicare clinical research ab.

 

covance, stockholm, sweden                                                                                                                           scra    1998-2001

 

scra: Clinical Research Associate on a global Phase III heart failure trial. performed pre-study, initiation and Interim monitoring visits. during this trial acted as lead CRA and mentored a team with one CRA and one pa.

 

scra: Clinical Research Associate on a european Phase III panic anxiety trial. performed pre-study, initiation and Interim monitoring and close-out visits. participated in 1 clean data transfer.

 

scra: Clinical Research Associate on a european Phase III depression trial. performed pre-study, initiation and Interim monitoring visits.

 

scra: Clinical Research Associate on a european Phase III malignant melanoma trial. performed initiation and Interim monitoring.

 

boehringer mannheim, stockholm, sweden                                                                          CRA              1996-1998

 

CRA: Clinical Research Associate on a european Phase III breast Cancer trial. performed pre-study, initiation and Interim monitoring visits.

 

CRA: Clinical Research Associate on a local Phase III diabetic (type i) trial. wrote the science)" >Protocol and designed the crfs. planned and managed an Investigator meeting. performed pre-study, initiation and Interim monitoring visits.

 

CRA: Clinical Research Associate on a local Phase III post partum anemia trial. wrote the science)" >Protocol and designed the crfs. planned and managed an Investigator meeting. performed pre-study and Interim monitoring visits.

 

CRA: Clinical Research Associate on a global Phase III ischemic stroke trial. performed Interim monitoring visits.

 

merck sharpe & dohme sweden ab, stockholm, sweden                                  CRA  1995-1996          

 

CRA: Clinical Research Associate on a global Phase III migraine trial. performed pre-study, initiation and Interim monitoring visits. performed Data entry and managed queries.

 

 

eli lilly sweden ab, stockholm, sweden                                                         Sales representative. 1994-1995

 

worked as a Sales representative in a large district in middle sweden, responsible for informing about a h2-blocker, a painkiller and an antibiotic.

 

faculty of oral prosthetics, karolinska institute, stockholm, sweden assistant Dentist 1992

 

worked as a Teacher in the faculty of oral prosthetics managing the students practical work on patients. handled complicated cases in oral prosthetics.

 

 

private practitioner, stockholm, sweden                                                                                        assistant Dentist 1992-1994

worked as a Dentist in a private practice.

 

paternity leave                                                                                                                                                                                                        1992-1993

 

internship at nhs clinic, halstahammar, sweden                                                                                                           1991-1992

 

 

 

licenses & certifications

 

  • professional certificate in Dentistry, january 1992.

 

 

professional development

 

 

 

 

professional affiliations

 

  • Member of the swedish dental society since 1992.

 

computer experience

 

Windows, ms word, ms Excel, ms PowerPoint, siebel

 

 

languages

 

mother tongue-swedish, fluent- English, good comprehension- norwegian, polish-basic knowledge

 

 

 

Clinical Trial experience

 

 

therapeutic experience

 

 

 

infections/parasitic diseases: onychomycosis, cl difficile diarrhea.

oncology: malignant melanoma, breast Cancer, non hodgkin’s lymphoma

endocrine/metabolic: Diabetes type i

haematology: post partum anemia

mental disorders: depression, panic anxiety

nervous system: multiple sclerosis, migraine, torticollis

circulatory: ischemic stroke, heart failure

gastrology: ulcerative colitis

 

 

Experiences

Past Experience

  • CRA/CTM Sweden

    January 1995 --- April 2016

Personality

Self Assessment :
Self-disciplineResponsibilityResiliencyProblem solvingProactivityOrganizationFlexibilityEfficiencyCuriosityCollaborationCommunicativeAdaptability

Knowledge

Self Assessment :
Diabetes R&D21 CFR Part 11Budget ManagementBudget ProcessCancer ResearchCardiovascular diseasesClinical DevelopmentClinical monitoringClinical operationsClinical trial budgetingClinical trial managementClinical Trial Management System (CTMS)Clinical trialsCoachingContract negotiationCROElectronic Data Capture (EDC) EnglishForecastingGood Clinical Practice (GCP)ICH guidelinesInfectious diseasesMicrosoft OfficeNeonatologyNeurologyoncologyPatient recruitmentPharmaceutical IndustryPhase IIPhase IIIPhase IVSupervising CRAsTeam Management

Skills and Expertise

Self Assessment :
Design case record forms Develop protocols Interact with nurses Interact with physiciansApprove monitoring reportsApprove patient informationApprove queriesApprove suitability of patient information and consent documentsApprove consent documentsArchive trial documentation and correspondence.Assess site feasibilityAssess subject safetyassess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Attend investigator meetingClinical data collectionCoach clinical staffCollaborate with principal investigatorCollaborate with project teamCollect patient forms and questionnairesCommunicate with investigatorCommunicate with sponsorComplete case report form (CRF)Complete study proceduresConduct close-out visitsConduct maintenance visitsConduct site initiationConduct studiesConduct the trialConfirm protocol complianceControl protocol versionsCreate clinical project documents according to the protocolCreate study documentsData verificationDesign subject consent formDocument employees training requirementsEnsure data consistencyEnsure data integrityEnsure good clinical practice (GCP)Ethics committee submissionsGastrointestinal diseasesGeneral office managementGuide staffInformed consent processInteract with CROsInteract with ethics committeeInteract with KOLInteract with nursesInteract with pharmacistsInteract with physiciansLead teamsManage contractors Manage projects resourcesManage multiple projectsManage study budgetMonitoring subject complianceReport Key Performance Indicators (KPI's)Resolves queriesRespond to audit findingsReview informed consent processSchedule trial visitsSelect investigatorsSelect sitesSite managementSupervise clinical monitorsTrain StaffWork cross-functionally

Education

  • DDS in Doctor of Dental Surgery from Karolinska Institute in 1991

Languages

BrightOwl Assessment:
Self Assessment:
Swedish
Native
English
Full Proficiency
Polish
Elementary Proficiency
Serbian
Elementary Proficiency

Area / Region

Stockholm, Sweden

Others

Driving License
  • Yes

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