Clinical Trial Manager Vaccines Business Division (Singapore)
Takeda Pharmaceuticals - Singapore

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OBJECTIVE:
  • 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.

ACCOUNTABILITIES:
  • 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
Qualifications EDUCATION, EXPERIENCE AND SKILLS:
  • 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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www.takedajobs.com

We are an equal opportunity employer.

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Schedule
Regular Full-time

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