|Location:||Philadelphia, PA (19019)|
|Job Type:||Full Time|
|Posted:||2 days ago|
Takeda is advancing an exciting product pipeline and wants to ensure that we have the infrastructure and talent in place to support it. Our overall goal is to get our therapeutics to patients safely and quickly via an optimized operational model and integrated clinical data pipeline.
T he Project Lead, Trial Operations Data is responsible for leading projects related to the systems, process, and governance transformation for clinical trial data as part of a transformational data program. This data program will include an integrated data flow with end-to end control of data, internalization of numerous systems and processes, broad enablement of automation and near-time data access, efficient and automated data quality checks, and enablement of disruptive technologies for next-gen trial op erations and insights. The data program will encompass all systems, platforms and tools involved in the collection, processing, review, analysis, and downstream reporting or consumption of t rial operations data and will be inclusive of all Takeda therapeutic areas and relevant business units.
DELIVERY & BUSINESS ACCOUNTABILITIES:
The Project Lead, Trial Operations Data is expected to:
Manage the trial operations data transformation for clinical trial management system(s) to support Takeda R&D's vision to create a development engine and ecosystem that provides optimal operational data control and quality in a predictable, automated & cost-effective way
Help lead multi-faceted business process mapping to inform future-state trial operations data flow and system and architecture design; Work with other leaders to ensure business impact is well-understood and accounted for within broader future fit development workstreams
Support the selection and implementation of trial operations data vendors, systems, platforms, and tools to support a transformed global data program
Help define and embed appropriate quality oversight and governance tools and processes throughout data program in accordance with R&D policies
Lead the clinical trial management system(s) data transformation team and serve as a key representative for the operational data ecosystem
Engage with stakeholders for all systems, data models and tools within operational data ecosystem
Help facilitate the transition plans from former state to transformed state and contribute to future-state processes
Serve as a leader within Takeda and outside of Takeda with vendors and partners
Help shape the strategic vision for long-term delivery innovation
Communicate challenges and successes within project groups
Leverage strong leadership and interpersonal skills in managing analyst teams.
CORE ELEMENTS RELATED TO THIS ROLE:
Strategic Planning and Execution:
Helps develop and reach trial operations data goals, priorities, plans and schedules.
Engages with leadership and analysis teams to ensure transformational impact
Manages and reports expenditures, being cognizant of variance between budgeted and actual expenditures of time, dollars, and personnel while meeting overall Takeda financial objectives.
Resource and Issue Management:
Helps manage internal and external resources (people, information, technologies, time, and capital) within the operational data team
Proactively identifies project issues before they arise and develops contingency plans; communicates project-related issues to Trial Operations Data Lead
Supports strategies for effecting change, controlling change, and helping people to adapt to change.
Matrix Team Management:
Provides strategic and tactical leadership across the clinical trial management systems/operational data projects
DIMENSIONS AND ASPECTS:
Technical/Functional (Line) Expertise:
Executes R&D leadership with background in clinical trial execution and operational data systems, processes and reporting
Inspires, motivates and drives results
Communicates clearly, persuasively conveying both ideas and data, verbally and in writing
Decision-making and Autonomy:
Provides input to highly complex decisions that impact overall trial operational data management and R&D
Seeks diverse input from multiple constituents and stakeholders to drive innovative solutions
Incorporates feedback and ensure decisions are implemented swiftly to yield flawless execution
Effectively represents program in negotiations with the ability to resolve conflict in a constructive manner
Builds strong relationships and collaborates effectively with other interfacing Takeda functions
Recommends, influences and implements organizational change and continuous innovation
Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business.
Serves as a role model, demonstrating respect and inclusion, creating a culture that fosters innovation
Works in a global ecosystem (internal and external) with a high degree of complexity
Recognizes broad, enterprise level perspective
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Advanced degree with 7+ years experience?in data-related field and experience in pharmaceutical industry or health related field
Experience with identifying and implementing organization-wide initiatives, standards, and processes?
Experience within clinical trial execution and clinical trial lifecycle
Strong experience in process development management, inspection readiness, and clinical trial systems such as TMF and CTMS; Experience with Veeva Vault Clinical Platforms desired
Solid understanding of system development lifecycle requirements and of US CFR, GCP and ICH
Experience working in Cloud Computing environments (ex AWS, Azure, etc.)
Strong leadership skills with wide range of global R&D stakeholders
Tolerance of ambiguity and willingness to work through complex issues
Ability to work with global internal and external partners to achieve desired goals
Ability to develop solutions to complex issues and challenges
Promotes teamwork while working through solutions
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 Cambridge, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time