Clinical Site Manager Jobs

Working knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring.

Strong communication, interpersonal, and relationship management skills.

Comfortable working with different levels of the company including senior level management.

Facilitate identification of clinical trial site and community educational needs for Pliant clinical trials.

Maintain business and clinical knowledge of the treatment landscape including current treatment strategies, current and pending competitors, and new therapeutic developments.

Advanced degree (DO/MD/ PharmD/PhD) with at least 6 years clinical trial experience including leadership roles.

Experience working in a similar support role in a complex organisation as an effective team member.

Salary Packaging – up to $9k for living expenses + $2.6k meal & entertainment + Novated leasing

Corporate Health and Fitness program

11% Superannuation on top of your gross income

Ability to make good decisions about work priorities and achieve key tasks effectively in a busy work area.

Understanding of, and commitment to, providing an excellent customer service and maintaining patient privacy and confidentiality.

- Behave as local expert and consultant on site management and monitoring topics.

- Issue management / oversight on country level.

-Communication and training of CT Managers and CRAs. Performing re- training as necessary.

- Deliver Risk-based Site Monitoring approach and local training for the trial.

Including but not limited to:

- Continuous review, risk identification, evaluation/ analysis and communication on a country level as applicable.

·3+ years of clinical monitoring or site management experience.

Delivers high quality and timely reports following each site management or site monitoring visit.

May include managing query resolution process with clinical sites and data management groups.

·Thorough knowledge and understanding of ICH/GCPs and applicable regulatory requirements.

·Solid computer skills, including working knowledge of Microsoft Office applications (Word, Excel Outlook, etc.).

Prepares for and conducts site qualification and site initiation, visits. May also include interim and closeout monitoring visits.

Bachelor’s Degree in nursing/clinical profession or equivalent combination of education/related experience: Required

Five years' leadership experience and Five years' experience in the areas of teaching complex curriculum design, development and education: Preferred

Seven years' technical experience: Preferred

Graduate from an accredited school/college of nursing, as applicable: Required

Registered Nurse (RN) licensure in state of practice: Required

Oversees the New Graduate Nurse Residency Program.

Knowledge and experience in supporting device pre- and/or post-market clinical studies is required including experience running investigational device exemption (IDE) trials.

Shockwave Medical offers a competitive total compensation package as well as the following benefits and perks -

Manage key study investigators; foster and maintain strong relationships through direct interactions with medical advisors and clinical leaders.

Administrative activities including training to procedures, manage territory travel and budgets.

Minimum of 8 years of experience directly supporting interventional or surgical procedures within a hospital.

Thorough knowledge of Good Clinical Practice (GCP) is required.