Clinical Operations Study Manager

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Job Title:  Clinical Operations Study Manager

Location:  Seoul, Korea

About the role: 

• This position will manage the overall conduct of assigned clinical studies in the LOC including clinical trials (Medical Affairs Conducted – MACS, supporting Externally Sponsored Collaborative Research - CCR and Investigator Initiated Research - IIR) and Post-Marketing Surveillance (PMS) studies in accordance with all applicable laws and regulations.

• Responsibilities include oversight of adverse event reporting, safety responsibilities, monitoring, adherence to protocols and determining study completion. 

• This position will typically be involved in all stages of the clinical trial, including assisting with site identification, site initiation, monitoring and closing the trial.

• This position will provide ongoing support to the study sites as well as be the liaison between the study sites and the LOC by ensuring appropriate communication.  

How you will contribute: 

Overall

• Plan, set-up, monitor and coordinate clinical studies to the required standards of GCP, KGCP, and the company

• Manage the CRO for outsourced clinical studies or PMS and track the progress of study to ensure it is conducted, recorded, and reported in accordance with the protocol, SOPs, ICH GCP, KGCP, applicable regulatory requirements and within the given budget and timeline

• Responsible for the management of designated clinical trials including investigator selection, analysis of potential patient recruitment, preparation of trial related documentation and organizing Ethics Committee submissions

• Ensure procedures are in place for appropriate optimization of patients into the clinical trial

• Track and ensure timeline completion of trials and ensure trials are completed in accordance with local regulations and guidance

• Support Investigator Initiated Research (IIR) in terms of drug management and contract related activities

Strategic Planning

• Collaborate with management to ensure that clinical projects conducted are aligned with business needs

• Support the development and implementation of clinical studies to align with the product life-cycle and strategy

Developing Business Through Science

• Develop protocol for PMS or clinical studies with CRO and conduct Start-up Activities in collaboration with the relevant counterparts and the outsourced CRO

• Manage patient recruitment strategies to increase patient recruitment into the trial as needed

• Review and submit periodic PMS reports and re-examination reports to MFDS periodically

External Stakeholder Management

• Support ongoing investigators’ queries such as patient inclusion / exclusion criteria for ongoing trials

Use Of Digital Tools And Ai

• Integrate AI-enabled platforms and digital clinical trial management tools to enhance study planning, execution, monitoring, and reporting.

• Use AI for trend identification and predictive analytics to optimize recruitment.

• Drive the adoption of remote monitoring and quality control using digital platforms to ensure data integrity and compliance.

• Use AI-powered tools for efficient communication and real-time support.

• Conduct training on digital and AI applications in clinical trials.

• Engage with global and regional teams to evaluate, pilot, and implement AI-driven innovations in local study operations.

What you bring to Takeda: 

Education Required

• Basic Degree in Pharmacy, Life Sciences or similar discipline

Required Experience

• Experience in relevant therapeutic area (including oncology)

• Clinical Project Manager experience in pharmaceutical company

Skills & personal characteristics

• Good Clinical Practice (GCP) trained and certified

• Excellent verbal and written communication skills in English

• Excellent interpersonal skills with the ability to develop relationships easily, even with challenging people

• Independent and self-driven with a positive work ethic

• Results oriented with high sense of urgency and adherence to timelines

• High integrity, ethical & professional mindset

• Planning, organization, and project management skills

• Meticulous and strong analytical skills

• Acts with integrity, fairness, honesty, and perseverance (“Takeda-ism”)

• Knowledge of regulatory environment including key regulatory agencies and approval processes

• Knowledge of pharmacovigilance processes and requirements

• As with all Takeda positions, the Study Manager is expected to conduct themselves in line with the Company culture and Takeda-ism

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Worker Type

Worker Sub-Type

Time Type