at Takeda Pharmaceuticals in Montpelier, Vermont, United States
Senior Project Manager – Process, Training & Digital Solution Management
LOCATION: Cambridge, MA or 100% Virtual
As the Senior Project Manager – Process, Training & Digital Solution Management, you will provide support and technical expertise focused on bridging people, process and technology for the implementation, optimization and maintenance of Takeda’s clinical trial delivery operating model.
+ Maximize clinical trial delivery process efficiency and regulatory compliance by supporting development of integrated training experience
+ Coordinate, manage and maintain training plans in system of record for supported functional areas
+ Analyze, design, develop and implement high quality high value training and communications programs in alignment with functional area goals and initiatives
+ Manage communication with stakeholder and customers in relation to GxP training and training compliance
+ Represent clinical trial delivery supported functions on company-wide/R&D-wide training initiatives
+ Manage system development and maintenance process for supported functional areas with relevant SMEs, stakeholders, and Quality; ensure consistency in document portfolios
+ Maximize clinical trial delivery process efficiency and regulatory compliance by leading process improvement activities and initiatives in global clinical trial delivery functions
+ Champion change and provide direct change management support for project and initiatives associated with functional area initiatives
+ Ensures consistency and alignment across interdependent processes to provide holistic oversight
+ Manage communications related to process and SOP changes
+ Serve as clinical trial delivery Process SME for inspections and internal audits
+ Ensure all aspects projects are planned and executed in line with goals, timeline, and budget
+ Proactively identify potential issues or obstacles and plans contingencies. Follow issues through to resolution ensuring that all key stakeholders are informed of outcomes and implications.
+ Develop and prepare key communications to strengthen and support change management efforts
+ Proactively manage key stakeholders and facilitate relevant communications to appropriate teams, functions.
+ Support implementation of global initiatives
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
+ Minimum of 8 years’ clinical research experience in pharmaceutical or biotechnology field
+ Minimum of 5 years’ program/project management experience leading complex in a multi-disciplinary, global environment
+ BS, MS or equivalent in scientific field
+ Experience with clinical trial management and/or GCP compliance processes
+ Experience in problem solving, negotiations and collaborative team building with non- direct reports and other stakeholders is required
+ Experience with regulatory requirements governing clinical trials and industry best practices
+ Experience with drug development and clinical trial processes, including related standards and documents.
+ Experience with clinical development training management, methods, and tools
+ Experience with application of program management and digital dashboard tools
+ PMP (Project Management Professional) certification is a plus
+ Experience with matrix organization, business projects, multi-disciplinary teams or strategic change management projects
WHAT TAKEDA CAN OFFER YOU:
+ 401(k) with company match and Annual Retirement Contribution Plan
+ Tuition reimbursement Company match of charitable contributions
+ Health & Wellness programs including onsite flu shots and health screenings
+ Generous time off for vacation and the option to purchase additional vacation days
+ Community Outreach Programs
Location: Cambridge, MA or 100% Virtual
Base Salary Range: $100-125K, based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.
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.
Massachusetts – Virtual
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