Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Join Us as a Clinical Trial Coordinator – Make an Impact at the Forefront of Innovation. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

OBJECTIVES/PURPOSE:

The Clinical Study Associate (CSA) will perform tasks related to planning and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan. The Clinical Study Associate (CSA) will perform tasks related to supporting planning, and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan. The CSA will provide support for critical day-to-day clinical study activities, including regulatory inspection readiness, in accordance with established protocols under supervision of the CSA Manager. The CSA will collaborate with FSA and Clinical Operations Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the operating model. The CSA will also perform departmental tasks as needed.

• Provide support for critical day-to-day clinical study activities, including regulatory inspection readiness, in accordance with established protocols under the general supervision of the Functional Service Provider (FSP) Manager and in collaboration with Takeda CTA Manager(s)
• Collaborate with Clinical Operations/Study Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model.
• Perform departmental tasks as needed

ACCOUNTABILITIES:

For assigned business critical, non-critical or and/or regional studies, provide support for study activities, including but not limited to:

• Review of study documentation, including essential document packets, study plans, informed consent forms, etc.
• Supporting/oversight of risk-based monitoring.
• Attendance of key team meetings as required, including Minutes for selected studies
• Supporting regulatory inspection readiness (e.g. SOP Lists, storyboard collation.)
• Support clinical trial systems (e.g. CTMS/TMF associated activities for selected studies
• Supporting vendor contract administration as required.
• Support study close-out activities, e.g. financial reconciliation
• Supporting additional ad-hoc activities as needed, as agreed with Manager(s).

For all assigned studies, provide support including:

• Collaboration with internal departments (Legal, Insurance, R&D functions, etc.), CROs, and external vendors.
• Supporting vendor contract administration as required.

Provide support for departmental tasks, including but not limited to:

• Maintaining knowledge of systems and processes.
• Attending internal and external trainings as needed and maintaining up-to-date training record.

Technical/Functional (Line) Expertise

• Understanding and application of GCP, ICH, and applicable regulatory standards governing clinical research.
• Comfortable with technology and able to learn new systems quickly.
• Strong knowledge of MS Word, Excel, PowerPoint, and Outlook.

Decision-making and Autonomy

• Ability to work in a fast-paced environment with demonstrated ability to manage multiple competing tasks and demands.
• Ability to work with timelines and complete tasks according to deadline.
• Problem solving study-related issues; escalation of issues as needed.

Interaction

• Must be able to professionally interact and communicate with internal departments (Legal, Insurance, R&D functions, etc.), CROs, and external vendors.
• Ability to effectively collaborate with both internal and external study team.
• Ability to work in a matrix environment.
• Coordination with external vendors as needed.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Education

• Bachelor’s degree or equivalent international degree required.

Experience

• 1-2 years’ experience in pharmaceutical industry, clinical research organization, or related role.
• Experience in Phase 2 and 3 studies and global/international studies is advantageous.
• Experience working across multiple therapeutic areas (including oncology) is advantageous.
• Experience in study start up field.

Skills

• Knowledge in global/regional regulatory and compliance requirements for clinical research.
• Demonstrated excellence in task management and cross-functional collaboration.
• Excellent communication skills.
• Excellent teamwork, organizational, interpersonal, and problem-solving skills.
• Fluent business English (oral and written).