Project Manager社

6K-8K/月

唐山市本科及以上

发布时间：2023-09-06

职位描述

职位描述：

PrimaryPurposesofPosition:

?Totakeresponsibilityforclinicalprojectsinrespectof:planning,implementation,coordinationandreporting.Toliaiseasrequiredwithseniorstaffonprojectstatus.

?Totakeresponsibilityforassignedlocaland/orinternationalclinicalstudiesinrespectof:planning,initiation,conduct,andreportingactivities.ToensuretheyarecompletedaccordingtoGoodClinicalPractice(GCP)guidelinesandSOPstothemostrigorousstandardsofquality,timelydeliveryandwithinbudgetinordertoassistinthedeliveryofDrugDevelopmentobjectivesandachieveclinicalexcellenceviacoordinationofthemulti-disciplinaryteamandCROs.

MainDutiestobeperformed:

?Totakeresponsibilityforpreparingdetailedtimelinesandestablishingclinicalstudies’milestonesforassignedprojects,ensuringtheyareperformedtothemostrigorousstandardsofquality,timelydeliveryandwithinbudget.
?Tofosteranddevelopateamapproachtoallactivitiesassociatedwiththeimplementationofclinicalstudies.
?ToestablishandmaintainexcellentprofessionalrelationshipsbetweenthecompanyandexternalexpertsinconjunctionwithMedicalSciences.
?Toidentifyandgainapprovalforhighqualityinvestigatorsandstudysitesfortheconductofclinicalstudies.
?ToparticipateintheselectionofCROandotherexternalvendorsandtakeresponsibilityforensuringthatCROs/vendorsdeliverinaccordancewiththespecification,qualitystandardandtimeframesetandmanageCROrelationshipasrequired.
?Toensurethatthenecessaryregulatory,safetyanddataevaluationrequirementsaremettoallowtheconductofclinicalrelatedactivitiesinconjunctionwiththeRegulatory,PharmacovigilanceandDataManagementDepartments.Toensurethatanyimportantsafetyissuesarediscussedwithlinemanagement.
?Totakeresponsibilityforinforminginvestigatorsofthestartofthestudyandendofrecruitment.
?Tooverseeregularnewsletterpreparationthatinformsandmotivatesinvestigatorstodelivertotimelinesandquality.
?Toprepareand/ormanagetheproductionofalldocumentsnecessarytoimplementandmonitorthestudyinaprofessional,highqualityandtimelymanner.
?Toreviewandrecommendamendmentstothestudyprotocolstoensurethestudyfeasibilityandtosubsequentlyplanandorganiseworkschedules.
?TocontributeproactivelytotheefficientoperationoftheDrugDevelopmentgroupandtosystemsandprocessesbeingplannedandimplemented.
?Toparticipateinthepreparation,review,updatingandtrainingofSOPs.
?Ifapplicable,co-monitorstudy,reviewandapprovesitevisitreports,ensuringtimelyandappropriatefollow-upofissuesraisedbymonitors.Conductsitevisitsasrequired.
?ToensurethatprojectstatusisupdatedandtoguaranteethatallrequirementstomeetregulatorybodyapprovalsareavailableontimeforthePharmacovigilanceandRegulatoryDepartments.
?Participateinthepreparationandreviewofclinicalstudyreportsasassigned;Participateinthepreparationandreviewofregulatorysubmissiondocumentsasneeded,includingIND/NDAsubmissions,IND/NDAupdateandsupplements.
?Whenleadinganyclinicalprojectensureregularandtimelyliaisonwithappropriateteams.Provideregularandtimelyreportsonallsiteperformancechangesincludingscope,schedulesandresources.
?Toensurepreparationofconfidentialityagreementsandcontractsandliaisewithlegalasappropriate.
?Providesupporttootherclinicaloperationssupportstaffsothattheadministrationactivitiesarecarriedoutefficientlyandeffectively.
?TocompletealloftheaboveactivitieswithintheframeworkandincompliancewithSOPsandotherdocumentationinforcewithinPegBio.
?Toperformanyotheractivityasmayreasonablyberequiredfromtimetotime.

DECISIONMAKINGAUTHORITY:
?TheprioritisingandschedulingofallmattersrelatedtotheclinicalstudiesforwhichthePMisresponsible.
?Thechairingofinternalandexternalmeetingsrelatedtotheclinicalstudyasdesignated.
?ThematrixresponsibilityforpersonnelandCROsbothwithinPegBio.

SpecificsofPosition:

?IntimateknowledgeofGoodClinicalPractice(GCP).
?Anunderstandingofthedrugdevelopmentprocess.
?Excellentorganisationalandmanagementskills.
?ExcellentverbalandwrittencommunicationskillsinEnglishandChinese.
?Goodcomputerliteracy.
?Travelasreqired.



Education:

-Lifescienceormedicalgraduateorotherrelevantqualifications
-Languages:fluentEnglishinverbalandwritten

Experience(Proficiency):

-Substantialrelevantexperienceofpharmaceuticaldrugdevelopmentandclinicalstudy/operationincludingprojectmanagementofnationalandinternationalprojects.
-Experienceinteammanagement.Experienceofpreparingclinicalstudydocumentation.
-Experienceofworkingwithmultidisciplinarygroupsandabilitytoworkwithinateamenvironment.
-ExperienceofmanaginganddevelopingrelationshipswithContractResearchOrganisations(CROs).
-Experienceofcompilingandmanagingclinicalstudybudgets.
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其他要求

招聘人数：1人
职能类别：生物工程

公司介绍

派格生物医药（苏州）有限公司位于风景优美的苏州工业园区生物纳米园（Biobay，位于独墅湖畔）,主要从事聚乙二醇技术（PEGylation）研究和聚乙二醇化药物研发。

公司业务主要分如下两块：1、用于药物修饰的各种聚乙二醇衍生的开发和制备；2、聚乙二醇化新药的研发。公司提供多种窄分布聚乙二醇衍生物，用于蛋白质、肽类和酶以及小分子药物的化学修饰；并能提供聚乙二醇化药物修饰的技术服务，同时进行自主的聚乙二醇化药物研发。

公司诚邀化学、制药领域的各路人才加盟，尤其是对聚乙二醇活性衍生物和药物的聚乙二醇化技术有经验者。公司给员工提供广阔的个人职业发展空间和具有竞争力的薪酬待遇。