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Summary

1. clinical Project Manager (cpm) responsible to manage, control and co-ordinate along with project team(s)/Member(s) performing of Clinical Trial project life-cycle (initiate, plan, conduct, close). experience in different Clinical Trial phases (i-iv) and therapeutic indications.

2. 10+ years experience in Pharmaceutical Industry (primary Clinical research and development).

3. postgraduate academic specialization degree in pharmaceutical management & Marketing.

4. valid work permit to work in eu/swiss. dual citizenship (eu)

Experiences

Current Experience

  • Clinical Project Manager (CPM) / Clinical Project Lead (CPL)


    Since January 2015
    • manage, control and co-ordinate along with other project teams/members performing of Clinical Trial project lifecycle (initiate, plan, conduct, close).
    • serve as primary project contact with sponsor to ensure Communication is maintained and reporting schedules are adhered to.
    • prepare and perform study-specific staff trainings; prepare study tools, review/update sops, customize applicable documents used in the study (different Project Management plans, study manuals, guidelines);
    • control of submission/ approval process and further correspondence with (c)ecs / ra by also providing inputs in pertinent documents finalization (science)" rel="nofollow">Protocol, icf, other patient related, ils/els as applicable).
    • strict control over the Compliance of all study milestones as per contract obligations followed via different kpis and other metrics e.g. start-up submission timeliness, patients' enrolment (fpi/lplv), Data Management Compliance etc.
    • manage project Budgets/costs/accruals;
    • manage contract process execution (cda, saa, msa, sows/wos, cos).
    • manage vendor selection (rfp, bidding, oversight of outsourced activity).
    • set up etmf requirements and control the central filing process; set up ixrs (irt), edc, central Lab / imaging systems including uat process.
    • participate and facilitate audits and inspections; escalate findings and action plans to appropriate parties. lead Problem Solving and resolution efforts (capa plan implementation).
    • organize and chair s study team meetings/teleconferences (kick-off, periodical).
    • prepare and conduct Investigator meetings Presentations, as requested.
    • Manage, control and co-ordinate along with other project teams/members performing of clinical trial project lifecycle (initiate, plan, conduct, close).
    • Serve as primary project contact with Sponsor to ensure communication is maintained and reporting schedules are adhered to.
    • Prepare and perform study-specific staff trainings; prepare study tools, review/update SOPs, customize applicable documents used in the study (different project management plans, study manuals, guidelines);
    • Control of submission/ approval process and further correspondence with (C)ECs / RA by also providing inputs in pertinent documents finalization (Protocol, ICF, other patient related, ILs/ELs as applicable).
    • Strict control over the compliance of all study milestones as per contract obligations followed via different KPIs and other metrics e.g. start-up submission timeliness, patients' enrolment (FPI/LPLV), data management compliance etc.
    • Manage project budgets/costs/accruals;
    • Manage contract process execution (CDA, SAA, MSA, SOWs/WOs, COs).
    • Manage vendor selection (RFP, bidding, oversight of outsourced activity).
    • Set up eTMF requirements and control the Central Filing process; Set up IxRS (IRT), EDC, Central LAB / IMAGING systems including UAT process.
    • Participate and facilitate audits and inspections; Escalate findings and action plans to appropriate parties. Lead problem solving and resolution efforts (CAPA plan implementation).
    • Organize and chair s study team meetings/teleconferences (kick-off, periodical).
    • Prepare and conduct Investigator Meetings presentations, as requested.

Past Experience

  • Regional Manager

    December 2013 --- December 2015
    ce countries

  • Site Manager/CTM

    March 2013 --- February 2014

  • Site Manager/Clinical Research Associate

    April 2010 --- March 2013

  • Clinical Research Associate (CRA)

    January 2009 --- January 2010

  • MSc Pharm ( central marketing sector and production sector )

    January 2006 --- January 2009
    Marketing sector, central - participating in Planning the Strategy for focus products; Coordinator for company continuing Pharmaceutical/medical licence educations(cpe/cme ); key user for crm ( Customer Relations management ) Software implementation production sector, liquid and solid forms - supervising and assisting in production Operations for solid and injection forms (including lyophilized injections in dual chamber vials “act-o-vial”, which are state-of-the-art production lines consistent with highest us regulations ) ensuring • FDAGMP • glp Compliance regulatred by company sops and required by law.

  • Pharmacist

    April 2006 --- January 2006
    serving patients by providing information and advice on Health, providing medications and associated services ( internship period )

Knowledge

Self Assessment :
Phases of clinical development (phase I to IV)Project ManagementPharmaceuticalsClinical trials
LinkedIn Assessment :
GCPCROGMPPharmacovigilanceClinical DevelopmentClinical trialsEDCClinical monitoringICH-GCPRegulatory submissionsSOPCTMSRegulatory affairsoncologyPharmaceuticsMedical writingGLPTherapeutic AreasClinical operations

Skills and Expertise

Self Assessment :
Communication Analytical skillsleadershiporganizationalProblem solving Create SOPs Interact with physiciansproject managementIdentify risksImplement Key Performance Indicators (KPI's)

Education

  • Postgraduate academic study in Pharmaceutical Marketing and Management from Faculty of Pharmacy - University of Belgrade in 2009
  • Master degree in Pharmacy from Faculty of Pharmacy - University of Belgrade in 2006
  • Master in Pharmacy from University of Belgrade in 2005

Languages

BrightOwl Assessment:
Self Assessment:
Serbian
Native
Croatian
Native
Bosnian
Native
English
Full Proficiency
German
Elementary Proficiency
Hungarian
Elementary Proficiency

Area / Region

Hungary / Serbia

Others

Driving License
  • Yes

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