Title: Senior Manager, Integrated Clinical Trial Data Process Excellence and Delivery
Location: Cambridge, MA 02139
Duration: 6+ Months (Possible Extension)
ACCOUNTABILITIES
The Consultant, CTD and PV Process Excellence responsibilities include:
• Partner with accountable Takeda stakeholders to execute assigned process-development and improvement activities for CTD and PV initiatives.
• Develop process content packages, including process maps, RACIs, procedures, work instructions, job aids, implementation materials, and other supporting documentation, as applicable.
• Create and update Lucid process maps using approved requirements, existing documentation, and stakeholder input.
• Facilitate cross-functional workshops and subject matter expert interviews to gather requirements, document process steps, clarify roles and handoffs, and confirm proposed content.
• Draft and revise process documentation with document owners and subject matter experts in accordance with applicable quality and document-control requirements.
• Coordinate activities for assigned PleaseReview workflows, including preparation of review packages, tracking comments, scheduling comment-reconciliation discussions, and maintaining review records.
• Maintain project plans, status reports, action and decision logs, RAID logs, and deliverable trackers for assigned initiatives.
• Identify and document risks, dependencies, unresolved questions, and required decisions for assigned initiatives.
• Provide process-development expertise and recommendations within the assigned scope, escalating prioritization needs, complex decisions, governance matters, and items requiring final approval to accountable Takeda stakeholders.
CORE ELEMENTS RELATED TO THIS ROLE
• Operational experience in Clinical Operations, Study Management, Data Management, and/or Pharmacovigilance; Global Regulatory Affairs experience is beneficial but not required.
• Demonstrated experience translating complex operational requirements and existing documentation into clear process maps, RACIs, procedures, work instructions, job aids, and related process content.
• Working knowledge of GxP quality systems, controlled-document practices, clinical trial and/or PV processes, and applicable regulatory expectations, including ICH GCP.
• Experience facilitating cross-functional workshops and subject matter expert discussions to gather requirements, clarify roles and handoffs, and confirm proposed process content.
• Ability to independently develop assigned deliverables within agreed requirements and scope.
• Experience with process-mapping tools such as Lucid and document-review workflows such as PleaseReview is preferred.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
• Bachelor’s degree or international equivalent required; degree in life sciences or a related discipline preferred.
• Six or more years of relevant experience in the pharmaceutical industry, biotechnology industry, or a clinical research organization.
• Strong written and verbal communication, organization, facilitation, interpersonal, conflict-resolution, and problem-solving skills.
• Demonstrated ability to collaborate effectively in a global, cross-functional, and matrixed environment.
• Ability to organize and manage multiple assigned deliverables, meet agreed timelines, and provide clear and timely status updates.
• Ability to adapt to changing priorities, incorporate stakeholder feedback, and work independently within established scope and direction.
• Global or international experience preferred, including the ability to collaborate with stakeholders across locations and time zones.
Benefits:
We offer a competitive compensation package that includes:
• [Pay Rate]: $82 - $85 per Hour
o Note: Pay rate will be commensurate with experience.
• Medical for full time employees
• Dental, and Vision Insurance
• Life Insurance, Short-Term Disability, Long-Term Disability, etc.