Director, Clinical Data Management Operational Delivery

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Job Description

Lead global implementation and adoption of new/enhanced Clinical Data Management (CDM) processes, ways of working, and technology (e.g., CFDR), while providing enterprise-level oversight of data management (DM) delivery, study timelines standardization, and inspection readiness across assigned assets/TAportfolios.

• The Director will be expected to lead implementation of new and enhanced processes, new ways of working and technology implementation projects (e.g., CFDR) within clinical data management (CDM), including:
  • Lead oversight and partner across CDSO and CDOS to ensure roll out.
  • Identify risks and work with CDM LT and other Cross Function leaders to mitigate.
  • Coordinate with CDM LT to set initiative priorities.
  • Partner with Global Development Compliance (GDC) to implement and monitor rollout of new processes, tech, and ways of working.
• Championsharmonization, change management and user adoptioneffortsacrossregions,TAUsandserviceproviders.
• Serve as Functional Process Owner and Expert (FPE) in Takeda?s continuous improvement framework:
  • Partner with process Business Process Owner (BPO), GDC, and BSO to ensure controlled and business-controlled process documents are complete, meet regulatory compliance (as applicable), and are optimized for end user needs
• Lead champion/SME network (e.g., CFDR) to embed process and tech knowledge & proficiency in CDM functional members.
• Lead and/or participate in process excellent and/or initiatives through operational implementation.
• Partner across TAUs and roles to ensure consistent approach and implementation of process and ways of working.
• Serve as lead CDM standards governance representative
• Serve as lead CDM stakeholder and partner with BSO to ensure technology aligns with CDM roadmap,
• The Director is responsibleforeffectiveleadership of setting up framework for tracking project timeline deliverables at an enterprise levelfor DM activities globally within and across a key asset, franchise/portfolio and/or therapeutic area(s).
• Provides enterprise view of study timelines and status across the study lifecycle for DM end to end tasks from start-up through database lock at the TAU, program(s), and/or portfolio level.
• Develop and maintain FTE and/or FSP Resourcing model and algorithm in alignment with CDM TAU LT and ensure consistent implementation across TAU according to the CDM vision
• Drivessignificantlevelsofbusinesschange,withinCDMandacrossthebroaderorganizationto ensure the successful execution of the CDM strategy and operating models.
• ProvidesDMexpertiseinsupportofCDM operating model for TAU, program(s), and/or portfolio level.
• Develop and maintain CFDR stakeholder management across SET roles to support operational excellence and escalation activities
• Provide expert functional support guidance in audit readiness

FunctionalServiceProvider(FSP) :

• TheDirector mayhavedirectlinemanagementresponsibilitiesand/orsupervisoryresponsibilityfor global FSPs.
• ResponsibleforoversightofFSPresourceallocationandDM strategic vendor partnerships to effectively deliver on internal and/or outsourced projects.

In-Direct line management:

• Relationshipmanager, establishing and maintainingproductive partnershipswithinClinicalDataManagement(CDM),functionalleadersacrossR&D,andthird-party service providers.
• ChampionsCDMoperationalexcellencebyleadinganddevelopingflexible,scalableand innovative methods to internalize key CDM capabilities.

Responsibilities may include:

• Establish and maintainaframework for CDM Project Management to enable CDM LT and leads oversight fordatamanagementdeliveryacrossallglobaldevelopmentprogramswithin assigned asset and/or therapeutic area(s)
• Establish a mechanism for and enterprise view for study deliverable risks for Takeda.
• Provides mechanism for oversight and reporting out of achievement of major DM deliverables and milestones in coordination with other functionsincludingtheTherapeuticAreaUnits,ClinicalOperations,Pharmacovigilanceand Statistics:
  • ProvidesDMknowledgein CDM activities, including but not limited tothedesignandimplementationofdatacapturetools
  • Ensuringprocessesareinplace (e.g.,Dataprocessing,coding,reconciliation)
  • Accountableforoversight of deliverable readouts and guidance for the CDM program leads on capturing risk and mitigation collection and management
• Oversee CDM inspectionreadinesswithinassignedassetand/ortherapeuticarea(s).
• Representsfunctioninexternalprofessionalinitiativesandorganizations(e.g., SCDM,CDISC, DIA) to identify industry best practice and increase the visibility of Takeda.
• Identifies,recommendsanddriveschangesinindustrybestpracticesand/orregulatorytrends within and across TAUs.
• Otherdutiesasassigned.

DIMENSIONSANDASPECTS

Technical/Functional(Line)Expertise

• Participatesintheevaluationandselectionofnewtechnologiestodriveinnovativeandefficient working practices for DM that enable high quality delivery.
• Implementsbestpracticesfor CDMprocessesthatarealignedwithindustryandevolvingregulatory expectations.

Leadership

• Excellentcommunicator,abletopersuasivelyconveybothideasanddata,verballyandinwriting.
• ChampionsRiskBasedapproachestoDMprocesses,suchascleaningandreviewofdata.
• ProvidesoversightandleadstheeffortstoimplementanddevelopDMprocessesandtoolsbased on emerging trends, technology, and best practices.
• Abilityto influenceaGlobalWorkforceandTalentstrategyforcolleaguesintheGlobal, Regional and Local organizations.
• Abilitytodistillcomplexissuesandideasdowntosimplecomprehensibleterms.
• Embracesanddemonstratesadiversityandinclusionmindsetandrolemodelsthesebehaviors for the organization.

Decision-makingandAutonomy

• Abilitytomakehighlycomplexdecisionsthatimpacttheenterprise.
• Accountablefor operational decisionmakingfordesignatedareaofresponsibility as well as aligning across TAUs to ensure consistency within the functional area.
• Abilitytoseekdiverseinputfromstakeholdersto lead anddriveinnovativesolutions.
• Seekdiverseinputfrommultiplestakeholderstohelpdriveinnovativesolutions.
• Incorporatefeedbackandensuredecisionsaremadeswiftlytoyieldflawlessexecution.

Interaction

• EffectivelyrepresentTakedainHigh-levelnegotiationswiththeabilitytoresolveconflictinaconstructive manner.

Innovation

• Possesesavisionaryandforwardthinkingmindsetwiththeabilitytoinfluenceandeffectively drive organizational change and continuous innovation.
• Promotesautomation,innovation,processimprovementandtechnologyenhancementinDMto increase Drug Development efficiency.

Complexity

• Abilitytoworkinaglobalecosystem(internalandexternal)withahighdegreeofcomplexity.
• Posessesabreadthofknowledgeacrosstherapeuticareas,indications,and/ormodalities.
• Domestic/internationaltravel(5-20%)tootherTakedasites,strategicpartners,andtherapeutic area events may be required.

EDUCATION,BEHAVIOURALCOMPETENCIESANDSKILLS:

• Bachelor?s/MS Degree or international equivalent preferred, or equivalent combinationofeducation,trainingandexperience10+yearsofdatamanagement experience in the pharmaceutical industry.
• Expertknowledgeandsuccessfulexperiencemanagingvendorrelationshipsand alliance partnerships with at least 7 years experience in this area.
• Excellentverbal/writtencommunicationskillsandabilitytoinfluenceatalllevels across functions and build effective relationships.
• Seasonedleaderwithapassionforpeopledevelopmentandanabilityperformina highly dynamic environment.
• Exceptionalinterpersonalskills,outstandingnegotiationandproblemsolvingskills.
• Focusedandversatileleaderwhoexcelsunderpressure,ambiguity,frequentchange, or unpredictability.
• Entrepreneurialandinnovative;takesmeasuredrisks;thinksoutsidethebox; challenge the status quo.
• 5+yearsoflinemanagementexperience(priorsecond-levelmanagementexperience preferred).
• ExpertknowledgeofFDAandICHregulationsandindustrystandardsapplicableto data capture and data management process.
• Experiencewithbudgetplanning.
• Strongknowledgeofrelationaldatabasesandexperienceusingmultipleclinicaldata management systems.
• Strongknowledgeofelectronicdatacaptureanddatawarehousetechnologiesas applied to clinical trials.
• Advancedknowledgeofbroaddrugdevelopmentprocesswithexpertiseinthecross- functional interfaces with the data management function.

ADDITIONAL INFORMATION

• Location: Remote

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Massachusetts - Virtual

U.S. Base Salary Range:

$177,000.00 - $278,080.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.?The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Massachusetts - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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