Title: Clinical Trial Manager

Location: Remote, South Korea

Job Description:

Precision for Medicine is a precision medicine CRO. Precision's uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.

Due to our growth we are seeking a Clinical Trial Manager.

You will be the hub of central intelligence for the studies you will be managing, and will lead CRAs and oversee all clinical aspects of your study across multiple countries, ensuring timeline adherence and scope, whilst ensuring quality delivery. We encourage high-energy, dedicated professionals who enjoy a challenge, thrive in the details and flourish in dynamic environments to explore this opportunity.

We are addressing the challenges facing the research and development of novel compounds in Oncology and are dedicated to positively impacting the health and lives of patients around the world. If you take a consultative approach to trial management, proving to be a valuable partner in the trial operational delivery process, don't miss exploring working with us.

About You:

You love having responsibility and a say in how clinical trials are run
You plan ahead, but have alternative options and a flexible approach
You are client focused and 
You are well organised and able to manage timelines and shifting priorities, without sacrificing quality.
You communicate clearly, often and concisely and know that your role is crucial in keeping the trial running smoothly
You are a master at identifying any risks that threaten projects and handle them resolutely
You thrive and work with autonomy and ownership to deliver successful outcomes

The day-to-day role, and how we will support your continued growth:

Management and operational delivery of the clinical elements within a trial including site selection, start-up, enrollment management, site engagement and support, monitoring planning and execution, data cleaning activities and close-out
Successful execution of assigned trials and ensuring completion of trial deliverables
Ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned trial(s) by working in close collaboration with other functional team members
Mentoring and training of team members
Identify challenges to study timelines/deliverables and offer creative action plans to the team/sponsor
Lead CRAs as they establish relationships with their sites for high quality oversight of monitoring, regulatory, IP, site payment and overall site correspondence activities
Maintain team focus on study priorities through efficient cross-functional partnerships and effective communication to achieve the highest level of client satisfaction

Qualifications:

Minimum Required:

Bachelor&#39;s degree or equivalent combination of education/experience in science or health-related field, including experience in the field of oncology

Other Required:

Demonstrable experience leading clinical aspects of your studies across multiple countries in a CRO / Pharma or Biotech company (in a dedicated &#39;clinical lead&#39; role).
Experience overseeing studies within the Asia Pacific region including Australia
Working knowledge of GCP/ICH guidelines and the clinical development process
Availability for domestic and international travel including overnight stays

Skills:

Demonstrated computer skills (MS Office, MS Project, PowerPoint) and software experience (CTMS, eTMF, EDC, IXRS)
Demonstrated ability to develop positive working relationships with internal and external organizations
Demonstrates core understanding of medical terminology and clinical trial activities as it relates to the execution of a clinical development plan

Competencies:

Demonstrates mastery knowledge of ICH-GCP, meaningful Precision SOPs, and regulatory guidance, as well as the ability to implement

LI-OS1 #LI-Remote

Precision medicine is revolutionizing the attack on cancer-and we are passionate about helping you harness its power. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions-and optimize the oncology development pathway.

Any data provided as a part of this application will be stored in accordance with our Privacy Policy.

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. 2020 Precision Medicine Group, LLC

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

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