Clinical Trial Services

Precision Health Economics Seattle , WA 98113

Posted 2 months ago

Precision for Medicine, Oncology & Rare Disease 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.

You will oversee the work of the CRAs on assigned clinical protocols. We encourage high-energy, dedicated professionals who enjoy a challenge, thrive in the details and flourish in dynamic environments to explore this opportunity. If you are no stranger to taking charge and seek positive partnerships to deliver phenomenal work, we have an opportunity for you.

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 in case things go wrong

  • Last minute requests and shifting priorities don't rattle you

  • You are extraordinary at handling study budgets, and timelines while never 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 with minimal direction and happily take responsibility for the outcomes of your work

How we will keep you busy and support your 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

Sr Clinical Trial Managers are 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 at least two (2) years in oncology

Other Required:

  • 2+ years clinical trial monitoring experience

  • Clinical trial experience in pharmaceutical, biotech or CRO and/or healthcare setting; 5+ years for Clinical Trial Managers and 8+ years experience for Senior Clinical Trial Managers

  • 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 Oncology's SOPs, and regulatory guidance, as well as the ability to implement

Precision medicine is revolutionizing the attack on cancerand 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 decisionsand optimize the oncology development pathway.


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Clinical Trial Services

Precision Health Economics