Clinical Project Manager III

• Plan, implement, evaluate, and complete full execution of assigned clinical trials; oftenfunctionsas a global triallead.
• Set goals,and timelines,provideoversightandpositive leadership tofoster motivation within the team toaccomplishgoals within defined timelines and with high quality in the execution of assigned clinical trials.
• Provide oversight and coordination of the operational aspects of the functional areas on assigned projects to ensure compliance with International Council for Harmonization (ICH) guidelines, Good Clinical Practices (GCP), applicable regulatoryguidelinesand trialprocedures.
• Provide management of a full scope clinical trial projects including global trials from start-up through analysis phase; provide oversight of functionally assigned teams members on clinical trials projects; able to effectively manage multiple projectssimultaneously.
• Provide coordination of a clinical trial project including organization, implementation, and management of scoped activities
• Implement project activities according toscopeof contracted work.
• Evaluate and manage projectbudgetagainst project milestones and scope and collaborate with the trialassignedDirector as needed to take corrective measures where necessary to keep project in line with budget.
• Regularly assess project profit margins with trial-assignedDirector at the project and project service levels and work with the trial-assignedDirector and project team to understand deficiencies; support and mitigation strategies to positivelyimpactproject profitmargins.
• Assess scope of work against client contractual agreement and inform trialassignedDirector of any concerns;facilitatechange of scope orders whenappropriate.
• Prepare or provide oversightand supportto the development of trial plans, timelines, schedules, resources, and budgets; work with team and trialassignedDirector to provide effective solutions to challenges that arise during the clinical trialproject.
• Prepare or provide oversight and guidance in the development of trial requireddeliverables.
• Serve as client contact at project operationallevel.
• Provide oversight to contracted vendors; review contracted specifications andmaintainregular interactions with vendors to ensure meeting timelines and expectations.Provide oversight and management of third-party vendors' financialspend.
• Closely reviews and assessestrial'sKPI to ensure project progressing in a positive manner and actively works with team to mitigate activities that are outside the expected ranges.
• Provide oversight ofappropriate projecttracking using computer-assisted programs and ensuretimelyentry of project information by all trial team members to enableaccuratereporting to clients and CTI executivemanagement.
• Monitor ongoing resource needstothe project; keepappropriate functionaldepartment heads apprised of any identified resource needs or performanceissues.
• Ensure thattheassigned clinical trial team receivesappropriate trainingtofacilitateeffective implementation,conductand execution of the protocol.
• Provide oversight of Clinical Research Associate (CRA) tasks on assigned projects; provide oversight of the CRA's management of sites and monitoring of the clinical trial data; review and approve site tripreportsand elevate site issues as needed to trialassignedDirector, CTI executive management and/or client/sponsor in accordance with the trial'sProject andCommunication Plan
• Attend site visits on an as-needed basis to provide support tothe trials,CTIstaffand/or site staff.
• Lead client and team meetings to enable effective information sharing,discussion,and decision-making; ensureaccurateand complete documentation of the meeting discussions,decisionsand outcomes.
• Prepare or provide oversight/approval of project status reports for assigned projects.
• Participate and provide oversight in the planning of Investigator meetings; develop and/or approve meeting agendas or related materials andconductspresentations.
• Ensure completeness of the TMF through management and maintenance of the TMF for assigned studies ensuring that all trial assigned staff regularlysubmitdocuments and complete regular audits of the TMF to ensure accuracy and completeness as defined in the trial's TMF Plan.
• Participate in business development activities asrequested(RFP development, bid defense presentations, clientmeetingsetc.).
• Suggest,participateinand/or leadprocess improvement activities and initiatives.
• Mentor other CPM staff.
• As required per region, review site and vendor invoices, approve subject milestones payments per scope; assist in the preparation of payment projections, and in the maintenance of payment records per regional needs. Support or conduct site budget negotiation for sites in their region as needed.

Regionally Specific Essential Functions Europe:

• In the EU, preparation and negotiation of site budgets, site payments and payment of site invoices are handled by the EU Clinical Trial Budget Management Team with theassistanceof regional CRAs or Study Start-up Specialists to support country specific language communications.

LATAM

• Provideexpertiseand support for country specific regulations and submissions as needed.
• Conduct regional feasibility activities as needed in the identification of regions and sites for trial and RWE work.
• Conduct RWE activities as needed in the region.
• Provide Importer of Record services as needed in the region

MEA

• Provideexpertiseand support for country specific regulations and submissions as needed.
• Conduct regional feasibility activities as needed in the identification of regions and sites for trial and RWE work.
• Conduct RWE activities as needed in the region.

APAC

• Provideexpertiseand support for country specific regulations and submissions as needed.
• Conduct regional feasibility activities as needed in the identification of regions and sites for trial and RWE work.
• Conduct RWE activities as needed in the region.
• Provide Importer of Record services as needed in the region.

What You'll Bring:

• Bachelor's degree in allied health fields such as nursing,pharmacy,healthornatural sciences, preferably with clinical trial management experience or an equal combination of education and relevant work experience
• At least 6 years of clinical research experience (CRO CRA or Research Manager, Site Research Manager, Central Clinical Research Laboratory Manager) or possesses transferrable skills and experience in project management in a clinical setting or relatable industry

About CTI

• Advance Your Career

Weinvestinyourprofessionalgrowth.Ourstructuredmentoringprogram,leadershipdevelopmentcourses,anddedicatedtrainingdepartmentprovidethesupportyouneedtoexcel.Wealsoencourageongoingeducationtohelpyouachieveyourprofessionalgoals.

• JoinanAward-WinningTeam-Joinaglobalteamspanning60countries,recognizedforitsaward-winningculturethatprioritizespeople.Wesupportyourwork-lifebalancewithhybridworkopportunities.ThroughourCTICaresprogram,you'llhaveopportunitiestogivebacktoyourcommunityandtheworld.
• Make a Lasting Impact

AtCTI,yourworkdirectlycontributestoadvancingmedicine.You'llplayavitalroleindevelopinglife-changingtreatmentsforpatientswithchronicandcriticalillnesses.Together,wemovemedicineforward,makingdifferenceforthosewhoneeditmost.

ImportantNote

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PleaseNote

• WewillnevercommunicatewithyouviaMicrosoftTeamsortextmessage
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