Clinical Trial Manager

6 months ago

Sydney, Australia Precision Medicine Group Full time

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 continued growth we have an opportunity for a Clinical Trial Manager to be remotely based in Australia.

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
- 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, enrolment 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
- Sr Clinical Trial Managers may be responsible for the independent clinical project delivery for small studies without an allocated Project Manager.

**Qualifications**:
Minimum Required:

- Bachelor'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.
- 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

Precision medicine is revolutionizing the attack on cancer—and we are passionate about helping you harness its power. We strike tumours 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.

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

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made wit

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