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Bristol Myers Squibb Global Trial Manager- Full Development in Plainsboro, New Jersey

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Position Summary / Objective

  • Leads successfuland timelyoperationalexecution of globalinsourcedoroutsourced, Non-RegistrationalDataGenerating or RegistrationalDataGenerating interventionalclinical trialsfromconcepttofinalclinicalstudy report.

  • Acts as the primaryoperationalcontact for thestudyand leads thecross-functionalglobalteamforexecution of thestudy.

  • May providequalityoversight of one or moreContractResearch Organization(CRO)teams and vendors.

  • Focuses on projectmanagementconcepts to supportmanagement of issues, risks, timelines,and budget and ensuresqualitycompliancewithICH/GCP,RegulatoryAuthorities'regulations/guidelines, and applicableSOPs/WPs.

Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned.

Position Responsibilities

Responsibilities involve a combination of execution and oversight, dependent on the sourcing model, to ensure deliverables and may include, but are not limited to, the following:

Project Management

· Directs and delegates to assigned Global Trial Management staff as applicable.

  • Drivesstudyexecution utilizing availableperformancemetricsand qualityindicators(e.g.CTMS,eTMFreports,RBMreports),and studymilestones and drivers.

  • Develops,manages, andmaintainsstudydeliverables (i.e.timelines,studyplans, etc.) through collaboration with internal and externalstakeholdersusing data and strong interpersonalinfluencingskillsto makerobustdatadriven decisions.

  • Proactivelyidentifiespotential risks, develops/implementsactions,and makes the appropriatetrade-offs of balancing riskswithstudydeliverables and costs.

  • Maintainsand updatesdata as appropriate in projectmanagement tools including CTMS.

  • Informsoperationalprogramlead(s) and other leadership (as appropriate) on overall clinical trial plansand recruitment statusand raisespotentialissues/mitigation.

  • Requiresminimaloversight to lead/manageprojects.

  • Identifies,participatesand/or leads initiativeswithcross-functional/globalteams.

  • Leads StudyTeam meetings,defines the agenda,capturesmeeting minutes,and facilitatescross-functionaldiscussions.

  • Creates,maintains, and implementsprojectmanagement tools at thestudy level (e.g.actions,decisions, issues log and riskmanagement plan).

Study Planning and Conduct Insourced Studies

  • Providesinputtodata,protocoldeviation review,andpatient tracker.

  • ProvidesstrategicinputintoStudy Team – e.g., on studydocuments.

  • Collaborates with CSO on globalinvestigationalproduct[IP]supplyforecasting/management.

  • Participates in the subjectrecruitment/retentionstrategyand relatedinitiatives(e.g.recruitmentmaterial).

  • Participates in clinical serviceprovider(vendor)selection,specificationdevelopment, and management / oversight.

  • OverseesTMFset-up,ongoing qualityreview,andoperationaloversightmemo and requestsfinalreconciliation

  • OverseeseCOAactivitiesthroughout the lifecycle of the study.

  • Providesinputto and reviewsstudytraining forStudyTeam,investigationalsites,andvendors in collaboration with the Clinical Scientist.

  • OverseestudyspecificCSRappendices.

  • Providesinputand communicates with theappropriateteams for response to country/regulatory and IRB/IEC.

  • Promptlysharesinformation with keyinternal/externalstakeholders at regular meetings.

  • Proactivelyidentifies andanticipatesissuesand risksandoversees the creation of mitigation plans and implementsresolutions.

  • Overseesserviceproviders with minimalsupervision.

  • Leads AuditResponseTeamand CAPAand participates in inspections.

  • Supports the development/management/review of thevendorscope of work(SOW),invoices, accrualsasperthecontract,quality requirements, andbudget.

Study Planning and Conduct Outsourced Studies

  • Reviews/approvesfunctionalplans(e.g.SAEmanagement plan,PSV waivers, BMS confidentialityagreement for sites with masteragreements with BMS).

  • Providesinformation totheCRO and reviewsCROdeliverables.

  • Setsup and maintainsProtocolLeveltraining curriculum in SuccessFactors.

  • ReviewsProtocolLeveltraining for IM and SIV.

  • Ownsoverall and end-to-end studyprojectmanagement responsibilities.

  • Providesoversight and reviews all outsourcedactivities(protocol to CSR) in Clinical Pharmacology(NHV)studies.

Relationship Management

  • Proactivelydevelops/maintainscollaborativerelationships with internalpartners/stakeholdersacrossthemultidisciplinaryteams.

  • Managesexternalpartnersincluding ContractResearchOrganizations(CROs),AcademicResearchOrganizations(AROs), and otherclinical serviceproviders as applicable.

  • Ensuresappropriatemethods are usedwhencommunicating with keystakeholdersandcrossfunctionalpartners.

Leadership Competencies

  • Createsrealisticplans that clearly definegoals,milestones,responsibilities,and results.

  • Maintainsfocus on strategicobjectiveswhileaccomplishing operationalgoals.

  • Places a priority on gettingresults with an emphasison high qualityoutcomes.

  • Holds self and othersaccountableforaccomplishing goals.

  • Makestimely,data-drivendecisionswhilebalancing againstdailypriorities.

  • Develops and maintainseffectiveworking relationships with peopleacrosscultures.

  • Incorporatesglobalconsiderations in everydaydecision-making.

  • Encouragescollaboration acrossteams,functions, and geographies.

  • Ensures that conflict is handled constructivelyso that performance is notimpacted.

  • Displays a willingnesstochallenge the statusquo and take risks.

  • Respondsresourcefullyto changing businessdemands and opportunities,proactivelylooking forwaystheteam can contribute.

  • Maintainsoptimism and composure in times of change,uncertainty, or stress.

  • Executestodeliver on corporateobjectives.

  • Acts as a mentorfortheStudyTeam and function.

  • Supportsdevelopment of GDO bestpractices.

  • Activelymanagesteambehaviorby mediating internaldisputes,promotingenergy/commitment,and recognizing and rewarding accomplishments.

  • Seeksopportunitiesforcontinuedlearning as to how strategy is shaped in the organization.

Degree Requirements

BA/BS or equivalent degree in relevant discipline

Experience Requirements

  • Minimum 4 years of demonstrated projectmanagement experience of which at least 2 should havebeen in the pharmaceutical or healthcareindustry.

  • Experience in leading globalclinical trials and multi-functionalteams.

  • Demonstratedproject managementandorganizationalskillswithstrongpresentation and communication abilities.

  • Experiencewithelectronicquality,complianceand CTMSsystems.Experience in managingCROs is a plus.

  • Risk managementexperiencepreferred.

Key Competency Requirements

Technical Competencies

  • Clinical trialproject management skills.

  • Financial budgeting and forecasting skillsare a plus.

  • In depth knowledge of ICH/GCP,regulatoryguidelines/directives,and drugdevelopment and clinicalresearchprocesses.

  • Provensuccess in using oral/written communicationskillstoinfluence,inform, or guideothers.

  • Computerskills - Microsoftapplicationsincluding (butnotlimitedto), Word and Exceland PowerPoint

  • Proficiency in study tools including electronicsystem skills – e.g.CTMS/eTMF.

  • Demonstratedproject managementandorganizationalskillswithstrongpresentation and communication abilities.

  • Abilityto managemultipledeliverables and nimblyrespond to changingbusinessdemands.

Management Competencies

  • Understandsinterdependencies,linkspossiblesolutions,and escalatesissues with proposedsolutions to appropriatepeople.

  • Reacts with a sense of urgency and respondsappropriately.

  • Critical thinking skillsforproblemsolving and thelateralandstrategicthinkingcapacity to drive the study(ies)and understanding the upstream,downstreamand lateral implications of decisions that affectstudyoutcomesandtimelines.

  • Leveragesinterpersonaland influencing skillstofosterpartnershipsacrossmultidisciplinaryteams.

  • Adaptableand flexible—willing/abletoadjust to multipledemands and shifting prioritiesand demonstratesabilityto meetday-to-daychallenges with confidence and professionalism.

  • Hasthecommand of theprojects,theabilitytozoomin and out as thesituation demands and deliverhigh qualitypresentationstoseniorandexecutiveleadership within and outside of BMS (as appropriate).

  • Hastheabilitytoreview, interpret, and analyzeinformation tosupportdiscussions and makedecisions.

  • Abilitytoeffectively lead a cross-functionalteam in a matrix environment.

  • Timemanagement skills - abilitytoeffectivelymulti-taskand setpriorities with minimalguidance.

  • Comes with ideas or perspectives when seeking guidancefromOperationsPortfolio Leads and/orotherteammembers.

  • Fosters a continuouslearning mindset.

Travel Required

Up to 25%

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Company: Bristol Myers Squibb

Req Number: R1544238

Updated: 2021-08-01 02:50:49.382 UTC

Location: Plainsboro,New Jersey

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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