- Responsible for the execution of Phase II - IV and other approved US and ex-US clinical studies, according to ICH-GCP and required regional regulations as applicable in support of the clinical strategies defined in the Takeda Integrated Development Plan Responsible for the execution of Phase II-IV and other (IDP)
- Responsible for the overall management of assigned study conduct, including oversight of the CRO and all other clinical vendors.
Qualifications EDUCATION, EXPERIENCE AND SKILLS:
- Manage full scope of study conduct ensuring studies are conducted according to the Code of federal Regulations, Good Clinical Practices, ICH Guidelines, local regulatory requirements and Takeda SOPs
- Member of the Regional Study Team, coordinating cross-functional efforts of Trial Operations Management, Site Operations, Analytical Sciences, Pharmacovigilance and all other appropriate functional departments to achieve study objectives and goals
- Collaborates with all relevant groups (Trial Operations Management, Site Operations, Clinical Sciences, Analytical Sciences etc) to develop and manage clinical project timelines
- Coordinates meetings with study team members as appropriate for the project. Disseminates clinical project communication to all functional groups as appropriate
- Contributes to protocol synopsis development and Clinical Operations feasibility assessments
- Writing of study protocols, amendments and administrative changes based on approved protocol synopsis, in collaboration with Program Manager and other cross functional groups
- Participation in the selection of CRO and all clinical vendors for assigned studies.
- For studies outsourced to a CRO, may work with Trial Operations Management to ensure adequate evaluation by the CRO of study investigators
- Provides oversight of vendors which includes communicating expectations and timelines, ensuring deliverables are on time, with no quality issues.
- Identify resource issues with external providers and escalate issues to Program Manager
- Planning and participation in investigator meetings in collaboration with all cross-functional team members
- Ensure training of all cross-functional team members and vendors on the protocol and expectations of the study
- Responsible for managing assigned studies within budget; provides latest best estimate of study budget and provides guidance to Program Manager on changes to study budget
- Responsible for identifying vendor issues and bringing to the attention of the Program Manager for discussion. Provides input to problem-solving and implements corrective action plan when necessary
- Partners with Trial Operations Management and CRO, where applicable, to resolve site issues
- Partners with Trial Operations Management and/or vendors for resolution of corrective actions as a result of QA audit and/or regulatory inspections
- Escalate issues relevant to medical personnel as appropriate for medical monitoring, safety, and exemptions/deviations
- Maintain project tracking system with current study status and provide accurate progress reports on assigned studies as requested
- Collaborate with clinical supplies to ensure appropriate and timely drug supply for assigned studies
- Review and input to Clinical Study Report
- May participate in Clinical Operations initiatives to enhance processes
- Bachelor's degree or RN required; MS, PharmD, or PhD preferred
- Minimum of three years experience in clinical research. CRA experience and practical experience in protocol development (study design) and a good understanding of the operational execution of clinical protocols
- Good comprehension of drug development and clinical trial methodology
- Good understanding of GCP/ICH/FDA requirements and an ability to assess compliance to these guidelines
- Willing to travel as necessary (i.e. investigator meetings, seminars or company meetings etc)
- Must exercise good judgment to maintain confidentiality and ensure integrity of data
- Must work effectively in a matrix team environment and be flexible to contribute to the needs of the group
Knowledge and Skills
- Communication skills- ability to be clear, direct, and tactful when communicating
- Basic business and medical writing skills required for protocols amendments, study summaries, and progress reports.
- Ability to organize and manage multiple vendors participating in clinical studies
- Ability to prioritize work effectively to meet timelines
- Budget Management - ability to develop an study budget to monitor and control expenditures; provides justification/rationale for budget variances
- Demonstrates basic presentation skills at Investigator or team meetings
- Analytical skills - ability to identify study-related, CRO-related or site-related issues, determines the causes and possible solutions to the problem. Responsible for resolving issues with study conduct with appropriate staff and CRO for a clinical study. Good judgment, professionalism and independence are needed in interfacing with staff, CROs, study coordinators, and investigators
- Technical Competency - displays in-depth knowledge of clinical study procedures and maintains an awareness of environment as it affects clinical study execution
- Ability to provide input to managing external vendor resources related to study conduct
TRAVEL REQUIREMENTS :
- Access to transportation to attend various meetings held in proximity to the Takeda offices
- Able to fly to various meetings at investigator, vendor or regulatory agency sites
- Some international travel will be required
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