Associate Director, Site Start Up

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Job Description

Objective / Purpose:

Responsible for line management of assigned Takeda Site Start Up staff, as well as defining, developing, and delivery of the global site start up project plan in APAC by partnering with the CRO and site start up team on site start up.

Provide guidance to staff and oversee the analysis of clinical trial intelligence data in APAC region and its application to effectively conduct accurate and effective site start up forecasts, robust scenarios, and accurate planning.

Directly support priority or highly complex projects through the site start up process.

Champion the creation and implementation of innovative processes, methodologies, data and technologies that will ensure ongoing delivery of valued site start up services.

Accountabilities:

Responsible for line management, mentoring, and development of assigned Takeda Site Start Up staff

Responsible for oversight of project deliverables of FSP

Accountable for defining, developing, and delivery of the Global Site Start Up Project Plan.

Partners with CROs, Clinical Operations teams, and TAU partners to improve overall site start up metrics and implement processes

Provides guidance, oversight, and training to the Site Start Up team, delivering activities in support of Clinical Programs, including data and methodologies for protocol site start up, site start up planning, and modeling

Ensures consistent standards are applied to the site start up process across project portfolios and supports continuous improvement activities while developing and implementing TA-aligned strategies / approaches

Drives the creation and implementation of innovative solutions to improve processes and accelerate site start up timelines

Leverages leading industry tools and data sources to provide data on start up timelines and performance (data quality, start up cycle time) to assist project teams with site initiation timeline forecasting

Agrees to deliverables on a country and site-level basis with the CRO and monitor adherence to these. Promptly recognize and remediate potential delays, and escalate non-performance as needed.

Leads the cross-functional site activation team - internal plus CRO, utilizing the appropriate team members to support the implementation of the Start up Project Plan

Serves as point of escalation and assist in resolution of issues identified by Takeda or CRO staff during the start up process

Act as a role model for Takeda’s values

Education & Competencies:

BS degree or international equivalent in a life science required, advanced degree preferred

Extensive experience (≥ 8 years) in Clinical Operations, Project Management, site start up, and / or trial optimization with evidence of increasing responsibility within a pharmaceutical company, CRO or relevant industry vendor required

More than 5 years of direct responsibility in site management, activation and oversight of the site start up processes of clinical research studies at a sponsor or CRO

Expertise in clinical trial regulations and ethics committee submissions across APAC region

Experience in line management and working in a matrix environment

Expertise with leading edge trial optimization vendors, tools, and methods

Proficiency with software models and database structures

Expertise in principles driving site start up and site start up strategies

Direct experience in the pharmaceutical industry or related field required

Ability to strongly demonstrate, interpret, explain, represent, and drive unbiased data insights into clinical trials operational planning

Ability to develop deep insights, uncover unmet needs, drive innovation, inspire, develop, collaborate and lead within a global matrixed team

Ability to explain data, facilitate decision making processes to be data driven

Locations

IND - Bengaluru - Research and Development

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time