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Job DescriptionObjective / Purpose
- Local face of Takeda by contributing to an effective partnership between Takeda study teams, study sites and the Clinical Research Organization (CRO) (i.e., the Clinical Research Associate (CRA)/Monitor). Establishes communication with regional/country Associate Director, Study Site Engagement, and Medical Affairs (MA), provides updates on study/site status, and establishes site engagement study specific strategies.
- Supports study teams with trial operations from Feasibility through Clinical Study Report (CSR) within the assigned region or countries across Takeda therapeutic areas.
- Enhances engagement and offers added value by providing guidance and sharing knowledge with study sites, while establishing and nurturing long-term relationships with investigators and study site personnel. Supports country and site identification, feasibility, site selection, study start-up, study recruitment strategies, and mitigates barriers at the direction of Clinical Programs.
- Supports Takeda study teams as part of their day-to-day responsibilities and may act as an SSE-Study Lead (SSE-SL).
Accountabilities
Study Specific Engagement Activities
Early engagement - Country and Site Feasibility
- Supports the Study Site Engagement Lead (SSEL)/ SSE Program Lead (SSE-PL)/SSE Study Lead (SSE-SL) with the development of study site list for feasibility - site selection and aids in tracking feasibility progress and escalations for SSEL/LOC support.
- Reports any discrepancy on feasibility progress to SSE-PL/SSE-SL
- Liaises with SSE-PL/SSE-SL, MA, local Clinical Operations team (if available) and CRO staff for site identification and feasibility support in alignment with global study team.
- Attends Pre-Study Visit (PSV) as requested or agreed upon with the SSE-SL.
- Helps to follow up with country MA, local Clinical Operations team and keep track country and site selection activities.
Study Startup Phase - Post Site Selection to Site Initiation
- Supports the SSE-PL/SSE-SL in tracking start-up hurdles escalated to the team and their resolution to ensure Site Initiation Visits (SIVs) and site activations are achieved as planned.
- Attends and/or supports SIVs.
- Helps SSE-PL/SSE-SL in tracking resolution of any follow-up item needed post SIV until resolved by site and or CRO/Takeda study team.
- As invited, attends Investigator Meetings (in the region) and liaises with sites / CRO.
Enrollment and Study Conduct Phase
- Supports recruitment strategy and activities when targets are not met (e.g. utilization of Patient Recruitment & Retention materials, booster visits, phone contacts).
- Interacts closely with local CRO team throughout the lifecycle of the study.
- Helps coordinate and/or attends the SSE booster visit requested by SSE-PL/SSE-SL.
- Regularly interacts with priority sites in assigned trials.
- Helps to maintain study specific trackers (booster visits) as needed or requested.
Training
- Applicable local regulations
- SOP trainings (Takeda and CRO, as applicable)
- TA/Study specific training
You are expected to comply with internal guidelines and utilize company-provided tools, for applicable tasks and reporting.
Non-Study Specific Engagement Activities
Participation in following activities may vary depending on assignment by Line Manager
SSE Study Lead for Assigned Programs
- Helps to develop the global Site Engagement Strategy for the assigned trial, adapting it as necessary to meet specific requirements of each country.
- Attends program and study level meetings, as applicable, and provides relevant updates to SSE team members.
- Attends kick-off meetings, investigator meetings (in region).
Development of Strategic Site Relationships
- May be responsible for developing and maintaining long-term strategic relationships with selected sites/site networks to improve the site and Takeda experience.
Conferences, Congresses, Other Site Facing Events
- May be tasked to help the Associate Director, Study Site Engagement with developing and executing the SSE strategy for non-study specific activities within their designated Therapeutic Area (TA) or Country.
- Through participation in conferences or congresses, utilizes these key site-facing events to connect with sites beyond their physical locations. This role involves engaging with new clinical trial investigators or those unfamiliar with Takeda, thereby promoting support for the advancement of our pipeline.
Dimensions and Aspects
Technical/Functional (Line) Expertise
Understanding of clinical trials and advanced knowledge of ICH-GCP, Clinical trials regulations, and applicable global and regional/country requirements.
Decision-making and Autonomy
Able to make sound decisions after identification of an issue and being able to make careful consideration of various courses of action towards resolution. Considers the short and long-term impact of those decisions in terms of risk to Takeda from a regulatory, legal, financial and business acumen perspective. Influencing and motivational skills are needed for tactful and business smart communication with key internal- and external stakeholders.
Interaction
Regularly interacts with internal and external stakeholders. Key stakeholders for this role include but are not limited to Takeda Clinical Operations, Takeda Clinical Study Start-up and Engagement (CSSE) functions, Takeda Clinical Science, Takeda Medical Affairs, local R&D functions, site and CRO personnel.
Innovation
Foster enhanced site engagement by executing the global engagement strategy. Utilize innovative thinking to overcome obstacles and achieve goals.
Complexity
Possesses inter-cultural competencies and ability to work cross-functionally in a complex global organization.
Education & Competencies (Technical and Behavioral)
Education
Bachelor's Degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences or drug development is required. A clinical or advanced degree (BSN, MS, MA, MBA, PharmD) is preferred.
Experience
7+ years of experience in clinical research, either with a CRO or a pharmaceutical company, focusing on clinical trials. Experience may also include roles such as Study Coordinator or Study Nurse, where close collaboration with Clinical Research Associates was involved. While experience in a Lead CRA or managerial role is preferred, it is not mandatory. The total cumulative work experience of the candidate may also be taken into consideration. Experience in Oncology clinical trials is preferred.
Essential Qualifications
- Extensive site management and/or monitoring experience across a range of highly complex disease areas
- Demonstrated capability of effective site oversight
- Solid knowledge of clinical development processes with strong emphasis on site management
- Ability to lead, troubleshoot and influence for quality and delivery
- Proven experience in effectively communicating with site staff including KOLs
- Experience in all study phases and in multiple indications preferred
- Comprehensive and current regulatory knowledge, including GCPs
Additional Skills
- Good organizational skills and ability to deal with competing priorities
- Effective communication skills (written, verbal in English and local language)
- Creative thinker, curious and unafraid to ask questions
- Innovator, willing to initiate changes, introduce new ideas, and creatively problem solve
- Proficient with MS Office Suite (Excel, Word and PowerPoint).
Additional Information
- Demonstrates flexibility in schedule and willingness to travel frequently (at least 30% and as high as 50% during busy periods).
- Due to the location of the LOC and national/international travel, the following locations are recommended: Australia: Sydney (preferred), Melbourne, and Brisbane acceptable.
- On average, monthly LOC visits to meet with Medical/local teams
Skills Required
- Bachelor's degree or equivalent in clinical practice, healthcare, life sciences, or drug development
- 7+ years of clinical research experience with a CRO or pharmaceutical company focused on clinical trials
- Extensive site management and/or clinical trial monitoring experience across complex disease areas
- Demonstrated capability in effective site oversight
- Solid knowledge of clinical development processes, especially site management
- Ability to lead, troubleshoot, influence, and deliver quality results
- Experience communicating effectively with site staff, including key opinion leaders
- Current knowledge of clinical trial regulations and Good Clinical Practice requirements
- Strong organizational and prioritization skills
- Effective written and verbal communication skills in English and the local language
- Proficiency with Microsoft Office Suite, including Excel, Word, and PowerPoint
- Willingness to travel at least 30% and up to 50% during busy periods
- Clinical or advanced degree such as BSN, MS, MA, MBA, or PharmD
- Lead CRA or managerial experience
- Oncology clinical trial experience
- Experience across all study phases and multiple indications
Takeda Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Takeda and has not been reviewed or approved by Takeda.
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Retirement Support — Employer-funded retirement is described as notably strong, combining a dollar-for-dollar 401(k) match with an additional company contribution that scales with age and service. Access to an employee stock purchase plan further supports long-term wealth building.
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Parental & Family Support — Paid bonding leave for all parents, substantial adoption/surrogacy reimbursement, and robust caregiver resources (backup care and Maven family-forming support) are emphasized as core strengths. These offerings create a comprehensive safety net for a range of family situations.
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Healthcare Strength — Multiple medical plan options (nationwide PPO/HSA and regional HMOs), employer HSA funding, and integrated mental-health and well-being programs signal depth in coverage. Preventive care is covered in-network, and plan choices by state expand access.
Takeda Insights
What We Do
For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation, and as a future-focused organization, we’re continuing to drive forward with endurance in our steadfast pursuit to achieve the best outcomes for our patients in a rapidly changing world. We have been preparing for this period of value creation by investing in data, digital and technology, and we’re proud of our employees and their commitment to turning groundbreaking ideas into life-changing impacts. Since our founding in Japan, integrity and putting patients first have been at the heart of our identity, and we will emerge ready for our future as one of the most trusted and science-driven digital biopharmaceutical companies. Join a team where your innovation impacts lives. Together, we’ll realize improved outcomes by improving data quality, enhancing launch execution and improving the patient journey. You’ll play a critical role in accelerating data collection and increasing accuracy across all parts of the business. Patients across the globe will benefit from access to treatments afforded by greater opportunities and efficiency in our research and development.
Why Work With Us
We connect to our history and Japanese heritage through everything we do to bring our purpose, values, vision, and imperatives to life. We are committed to bringing better health and a brighter future to patients. Being a part of Takeda means having the opportunity to be a part of something bigger than yourself.
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