at Takeda Pharmaceuticals in Montpelier, Vermont, United States
Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Senior Manager, Site Budgeting and Contracting in Cambridge, MA or remotely reporting to the Director, Site Budgeting and Contracting.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.
Here, you will be a necessary contributor to our inspiring, bold mission.
+ Support delivery of global site contracting and budgeting (SB&C) tasks, partnering with Sites, CRO and internal/external Study and Startup team members.
+ Manage setup, escalations and review of global site budgets and contracts from CRO partners and internal team members to ensure contract execution and study startup forecasts are achieved.
+ Guide negotiation and administration of master clinical trial contracts
+ Support the development and mentoring of creative processes, methodologies, data, and technologies that will ensure ongoing improvements in the delivery of SB&C services.
+ Manage negotiations, finalization and administration of Master Clinical Trial Agreements.
+ Responsible for assigned study level site contracting and budgeting function to develop, negotiate, administrate and execute assigned Clinical Trial Agreements and budgets.
+ Partner with Study Start up Managers, CROs, Clinical Operations teams, and TAU partners to improve overall SB&C metrics and implement processes.
+ Guide, oversee, and train internal and external partners regarding delivering site budgeting and contracting activities to support Clinical Programs.
+ Ensure standards are developed and applied to the site budgeting and contracting process across project portfolios and support continuous improvement activities while developing TA-aligned strategies.
+ Partner with Study Startup, CRO and Clinical Operations teams as an escalation point for global budget escalations outside of budget parameters.
+ Leverage leading industry tools and data sources to provide budget and contract feedback aligned with Takeda parameters and fair market value guidance.
+ Recognize and improve potential delays and escalate non-performance.
+ Manage site contracts and budgets negotiation timelines to ensure sites are “Ready To Enroll” to the Startup Project Plan.
+ Resolve escalated issues identified by the site activation sub-team in partnership with the Study Manager through the Study Management Operations Sub-team with the CRO.
+ Mentor and support development of internal Study Startup team members.
EDUCATION AND EXPERIENCE:
+ BS degree or international equivalent
+ 6 or more years of experience in clinical research site contracting and budgeting with evidence of increasing responsibility within a pharmaceutical company, CRO or relevant industry vendor.
+ At least 3 years of global site budgeting and contracting oversight or negotiation.
+ Experience with the pharmaceutical industry and clinical drug development.
+ Experience with Clinical Trial Agreements, budgeting and fair market value principles.
+ Knowledge of FDA and ICH-GCP guidelines for conducting clinical research.
+ Explain data, facilitate decision-making processes to be data-driven.
+ Expertise in principles driving country/site budgeting and contracting strategies.
WHAT TAKEDA OFFERS YOU:
Base Salary Range: $130,200 – $186,000. Employees may also be eligible for Short-term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days and Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.
The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.
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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