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Experiences

Current Experience

  • Site Management Associate

    Mannheim, Germany
    Since September 2015

    • recruits and evaluates potential sites for participation in late phases studies.

    o utilizes assessment tools, questionnaires, and study site materials in evaluation of study sites performs essential document collection, review, maintenance and close out activities.

    o ensures sponsor and Investigator obligations are met in Compliance with applicable guidelines and local regulatory requirements.

    o supports investigators with submissions according to applicable local, regulatory, and irb/iec requirements performs study tracking to ensure that the study files are current, accurate, and complete.

    o tracks Clinical study management information in CTMS o documents site and client contact and study interactions in a timely and professional manner.

    • liaises with internal and external customers to meet project specific goals.

    o participates in sponsor and project-related meetings and appropriately interacts with client and team.

    o acts as a liaison with Clinical supply/service vendors and other functional area team members to meet project team goals. 

    o manages study sites to ensure adherence to the late phase study design.

    o acts as primary point of contact for assigned study sites o tracks patient enrollment, study supplies, and Data entry efforts for assigned study sites.

    o escalates unresolved issues to the appropriate project team Member(s).

    o possesssion of study coordinating center responsibility on a rotational basis as assigned by manager, or designee.

    • performs data review and query resolution tasks for assigned sites.

    o reviews the Clinical data for enrolled patients and data discrepancies within Clinical Databases.

    o creates queries related to the crf/eCRF data (dcf - data clarification forms).

    o communicates with study sites to achieve resolution to outstanding data queries follows database closure procedures for freezing, locking, and unlocking Clinical Databases resolves internal and external Clinical issues for client Research projects.

    o assists in maintaining Clinical project documents, including site and/or Data Management plans, monitoring guidelines, data review guidelines, site Operations manuals and monitoring visit letter templates under guidance of operational team lead/lead sma.

    o interacts with client(s), vendors and pra functional areas as secondary project contact for Clinical issues.

    o provides Clinical status information to team members and Project Management under guidance of operational team lead/lead sma.

    • implements and monitors post-Marketing studies to ensure sponsor and Investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH guidelines.

    o coordinates and conducts telephone pssv, siv, and cov visits in order to assess the Qualification of potential study sites, to initiate and instruct site personnel on the proper conduct of studies, to review data and ensure accuracy of data collected, and to terminate studies.

    o provides regular Clinical status information to team members and Project Management o ensures serious adverse event (sae) reporting according to project specifications.

    • Recruits and evaluates potential sites for participation in Late Phases studies.

    o Utilizes assessment tools, questionnaires, and study site materials in evaluation of study sites Performs Essential Document Collection, Review, Maintenance and Close Out activities.

    o Ensures sponsor and investigator obligations are met in compliance with applicable guidelines and local regulatory requirements.

    o Supports investigators with submissions according to applicable local, regulatory, and IRB/IEC requirements Performs Study Tracking to ensure that the study files are current, accurate, and complete.

    o Tracks clinical study management information in CTMS o Documents site and client contact and study interactions in a timely and professional manner.

    • Liaises With Internal and External Customers to meet project specific goals.

    o Participates in sponsor and project-related meetings and appropriately interacts with client and team.

    o Acts as a liaison with clinical supply/service vendors and other functional area team members to meet project team goals. 

    o Manages study sites to ensure adherence to the late phase study design.

    o Acts as primary point of contact for assigned study sites o Tracks patient enrollment, study supplies, and data entry efforts for assigned study sites.

    o Escalates unresolved issues to the appropriate project team member(s).

    o Possesssion of study coordinating center responsibility on a rotational basis as assigned by Manager, or designee.

    • Performs data review and query resolution tasks for assigned sites.

    o Reviews the clinical data for enrolled patients and data discrepancies within clinical databases.

    o Creates queries related to the CRF/eCRF data (DCF - Data Clarification Forms).

    o Communicates with study sites to achieve resolution to outstanding data queries Follows database closure procedures for freezing, locking, and unlocking clinical databases Resolves internal and external clinical issues for client research projects.

    o Assists in maintaining clinical project documents, including Site and/or Data Management Plans, Monitoring Guidelines, Data Review Guidelines, Site Operations Manuals and Monitoring Visit Letter Templates under guidance of Operational Team Lead/Lead SMA.

    o Interacts with client(s), vendors and PRA functional areas as secondary project contact for clinical issues.

    o Provides clinical status information to team members and project management under guidance of Operational Team Lead/Lead SMA.

    • Implements and monitors post-marketing studies to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH guidelines.

    o Coordinates and conducts telephone PSSV, SIV, and COV visits in order to assess the qualification of potential study sites, to initiate and instruct site personnel on the proper conduct of studies, to review data and ensure accuracy of data collected, and to terminate studies.

    o Provides regular clinical status information to team members and project management o Ensures Serious Adverse Event (SAE) reporting according to project specifications.

Past Experience

  • Drug Distributor Cologne, Germany

    April 2015 --- August 2015

    • participating in ward rounds, taking patient drug histories and involvement in decision-making on appropriate treatments;

    • liaising with other medical staff on problems patients may experience when taking their medicines;

    • discussing treatments with patients' relatives, community Pharmacists and gps;

    • ensuring medicines are stored appropriately and securely;

    • supervising the work of less experienced and less qualified staff;

     • answering questions about medicines from within the Hospital, other Hospitals and the general public; •keeping up to date with, and contributing to, Research and development;

    • providing information on expenditure on drugs;

    • preparing and quality-checking sterile medications, for example, intravenous medications;

    • controlling maximmum of Pharmaceutical forms in patient orders.

    • accountability for Clinical Trial medication.

  • Pharmacist Burscheid, Germany

    August 2013 --- March 2015

    • checking prescriptions to ensure that there are no errors and that they are appropriate and safe for the individual patient;

    • providing advice on the dosage of medicines and the most appropriate form of medication, for example, tablet, injection, ointment or inhaler;

    • participating in ward rounds, taking patient drug histories and involvement in decision-making on appropriate treatments;

    • liaising with other medical staff on problems patients may experience when taking their medicines;

    • discussing treatments with patients' relatives, community Pharmacists and gps;

    • ensuring medicines are stored appropriately and securely;

    • supervising the work of less experienced and less qualified staff;

    • answering questions about medicines from within the Hospital, other Hospitals and the general public;

    • keeping up to date with, and contributing to, Research and development;

    • writing guidelines for drug use within the Hospital and implementing Hospital regulations;

    • providing information on expenditure on drugs;

    • preparing and quality-checking sterile medications, for example, intravenous medications;

    • supervising and Accounting medication for Clinical trials.

  • Pharmacist on internship Palma de Mallorca, Spain

    June 2011 --- October 2011

  • Research fellow

    September 2010 --- July 2011

    Preclinical studies on achillea wilhelmsii c. koch with tlc and HPLC.

    extractions within the pharmacognosy department.

    Lab experience.

Knowledge

LinkedIn Assessment :
GCPsCROCRAClinical trialsICH-GCPClinical monitoringIndustria FarmacEnsayos clOrganizaci

Education

  • Clinical Research Basis Course in Clinical Trials from Zentrum für Klinische Studien der Universität zu Köln in 2015
  • Intensive Seminar of Clinical Monitoring in Clinical Trials from Mibeg-Institut Medizin in 2015
  • Master's degree in Medical and scientific Translation from Universitat Jaume I in 2014
  • Degree in Translation and Interpreting from Universidad Alfonso X El Sabio in 2013
  • Master in Pharmacy from Universidad de Barcelona in 2011

Area / Region

Mannheim, Germany

Others

Driving License
  • Yes

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