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Summary

current role at statens serum institut, denmark (since march 2015)

-Medical Writer: science)" >Protocol, ib, Clinical Trial reports and eudract entry

-assisting Clinical Trial managers in Clinical operations

-project lead for short term projects

 

past experience:

-senior publication writer at glaxosmithkline Vaccines, india (2011-2014)

-Researcher at various academic institutes (2008-2009)

 

Education:

-MSc in Immunology and immunogenetics from the University of manchester, uk (2010)

-be in Biotechnology from m. s. ramaiah institute of technology, india (2008)

 

Publications: review articles:9 book chapters: 2 abstracts in congresses: 3

Experiences

Current Experience

  • Medical Writer


    Since March 2015
    key responsibilities: • as part of Training attended the european medical writers association workshop in may-2015 at dublin, ireland • wrote and coordinated Clinical study reports in accordance with appropriate guidelines and internal sops for both Diagnostic products and prophylactic Vaccines • published results on the eudract registry • assisted in writing a science)" rel="nofollow">Protocol for a Phase I trial • simultaneously wrote and coordinated an investigators brochure for a first in human Clinical Trial additional responsibilities: • assisted Clinical Trial managers and acted as trial manager’s backup with trial-related tasks: teleconferences relating to trial Operations, pre-initiation trial site visit, selection of contract Research organizations for various activities, initiated the trial master file, completed the documents for the Clinical Trial application, eudract number application, registration of a trial, and dsmb meetings • led a project of archiving all electronic data relating to Clinical trials for long-term storage in Compliance with good clinical practices • in collaboration with a colleague wrote an internal SOP Key responsibilities: • As part of training attended the European Medical Writers Association workshop in May-2015 at Dublin, Ireland • Wrote and coordinated clinical study reports in accordance with appropriate guidelines and internal SOPs for both diagnostic products and prophylactic vaccines • Published results on the EudraCT registry • Assisted in writing a Protocol for a Phase I trial • Simultaneously wrote and coordinated an Investigators Brochure for a First in Human Clinical Trial Additional Responsibilities: • Assisted Clinical Trial Managers and acted as Trial Manager’s backup with trial-related tasks: teleconferences relating to trial operations, pre-initiation trial site visit, selection of contract research organizations for various activities, initiated the trial master file, completed the documents for the clinical trial application, EudraCT number application, registration of a trial, and DSMB meetings • Led a Project of archiving all electronic data relating to clinical trials for long-term storage in compliance with Good Clinical Practices • In collaboration with a colleague wrote an internal SOP

Past Experience

  • Senior Publication Writer and Congress Coordinator

    February 2011 --- August 2014
    key responsibilities: •extensively performed literature and background search on project areas, disease- and vaccine-related information on various Databases, Research articles and web-based references and created a local database for archives. •drafted manuscripts, ensuring consistency and Quality Assurance of articles, book chapters, abstracts, Presentations and posters for clinical and epidemiological projects with high rate of acceptance. •ensured all the comments received from journal editors and peer-reviewers are addressed upon discussions with various members within a clinical study team, thereby publishing articles in international, scientific and peer-reviewed journals. •performed redaction and qc of redaction of full protocols and study reports which were disclosed into regulatory registries including european post-authorization safety studies and gsk’s Clinical Trial registry. •involvement in Clinical trials (phases i–iv), Clinical Development plan, Clinical Data Management, interpretation of clinical data and Compliance with international committee on harmonization and good clinical practices. •as part of publication coordination, followed up with external scientists to review the documents and provide their feedback which were then incorporated to finalize completion. •Training and mentoring newcomers to perform their roles and responsibilities independently.

Personality

Self Assessment :
AdaptabilityAuthenticityCollaborationCommunicativeCompetitivenessCoordinationDependabilityInterest in knowledgeOrientationProactivityProblem solvingWillingness to compromiseTrust

Knowledge

Self Assessment :
Phase I Scientific writingAntibodiesClinical DevelopmentClinical operationsClinical researchClinical study reportsClinical trial managementClinical trialsCommunication SkillseCRFEfficacy trialsELISAEnglishEpidemiologyGood Clinical Practice (GCP)Good Publication Practice (GPP)ImmunologyInfectious diseasesMedical writingMicrosoft ExcelMicrosoft OfficeMicrosoft PowerpointMicrosoft WordMicrosoft ProjectOperations ManagementOutlookOutsourcingPharmaceutical IndustryPhase IPhase IIPhase IIIPhase IVPhases of clinical development (phase I to IV)PowerPointPresentation SkillsPresentationsProject CoordinationProject ManagementProject PlanningQuality Control (QC)Randomization and blindingReport WritingRegulatory submissionsSafety trialsSafety reportingScientific CommunicationsScientific WritingSPSSStudy protocolsTechnical reportsTeamworkTrainingVaccines
LinkedIn Assessment :
Clinical trialsMedical writingBiotechnologyClinical researchImmunologyPharmacovigilanceVaccinesPharmaceutical IndustryScientific WritingResearchmolecular biologyProtocolClinical Data ManagementClinical DevelopmentLifesciencesCell CultureEpidemiologyInfectious diseasesICH-GCPGCPPharmaceuticsDiabetesData AnalysisEDCMicrobiologyRegulatory submissionsDrug DiscoverySOPRegulatory affairsCROIn VitroBiochemistryCell biologyGeneticsQuality ControlMicrosoft OfficeMicrosoft ExcelMicrosoft WordMicrosoft OutlookMicrosoft Project

Skills and Expertise

Self Assessment :
Analytical skills Develop clinical trial protocols Interact with physicians Interpret data Interact with nurses Report data Search literature on clinical trials Write protocols Write papersArchive study documentsArchive documentationArchive trial documentation and correspondence.Attend at steering committee meetingsBuild trial master file (TMF)Calculate timelines for conducting and completing the trialCalculate trial timelinesCollaborate with principal investigatorCollaborate with project teamCommunicate with investigatorCommunicationConduct literature searchesConduct literature searches.Confirm protocol complianceControl protocol versionsControl studiesCoordinate projectsCoordinate with the ethics commiteecoordinating research projectsCoordinationCreate clinical documentsCreate clinical project documents according to the protocolCreate SOPsCreate standard operating procedure (SOP)Create study documentsDesign protocolDesign protocolsDesign trial master file (TMF)Develop study timelinesDevelop training materialsEnsure data consistencyEnsure data integrityEnsure consistency between the protocol and CRFEnsure good clinical practice (GCP)Establish professional relationships with partnersEthics committee applicationEthics committee submissionsInteract with computer specialistsInteract with CROsInteract with ethics committeeInteract with nursesInteract with regulatory stakeholdersInteract with statisticiansInterpret analytical resultsInterpret dataInterpret scientific dataManage clinical trial files/documentsManage publication strategy of clinical trial resultsManage trial master file (TMF)Manuscript preparation and reviewManuscript preparationManuscript reviewNegotiate protocol details NegotiationNetworkPlan work to meet objectives and deadlinesPrepare final reportPrepare investigator brochuresPrepare manuscriptPrepare regulatory documentsPrepare responses to health authority queriesPreparing referral lettersPresent clinical resultsproject managementProtocol managementPublication of articlesPublish scientific projectsQuality control processRead medical literatureRead medical literature to maintain current awareness and knowledgeReport serious adverse events (SAE)Report non-compliance incidentsReport study conclusionsReport technical problemsResolves queriesReview clinical study reportsReview dataReview data interpretationReview protocolsReview reportsReview study protocolsSearch literature on clinical trialsSupport due diligence assessmentsTranslate protocol into packaging and labeling requirementsValidate dataWrite documentsWrite final reportsWrite medical reportsWrite papers

Education

  • M.Sc. in Immunology from The University of Manchester in 2010
  • B.E. in Biotechnology from M.S.Ramaiah Institute of Technology in 2008
  • in from Sri Vidya Mandir, Malleswaram, Bangalore in 2002

Languages

BrightOwl Assessment:
Self Assessment:
English
Professional Proficiency
Hindi
Elementary Proficiency

Work Preferences

  • Notice Period:
    4 weeks
  • Positions I am interested in:
    Clinical Operations Manager Clinical Project Leader Clinical Project Manager (CPM) Clinical Research Associate (CRA) Clinical Trial Assistant (CTA) Clinical Research Coordinator Clinical Trial Coordinator (CTC) Clinical Trial Manager (CTM) Operations Scientific Writer Senior Medical Writer Medical Writer
  • Work From Home:
    No
  • Work Regime:
    Permanent position
    BrightOwl freelancer
    BrightOwl employee
  • International:
    Yes

Area / Region

Copenhagen, Denmark

Others

Driving License
  • No

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