Senior Clinical Trial Manager

Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation. 

Job Title:  Senior Clinical Trial Manager       

Location:   Melbourne 

Function:  Clinical Operations        

ESSENTIAL DUTIES AND RESPONSIBILITIES:

The Senior Clinical Trial Manager (CTM) will oversee one or more clinical trials and ensure that project milestones are met on time, within budget, and in compliance with best practices. The CTM will also be responsible for maintaining high-quality standards throughout the project. 

• Develop and manage project plans, timelines, and budgets for clinical trials. Ensure that all project activities align with regulatory guidelines and organizational goals


• Lead and coordinate cross-functional teams, including clinical research associates, data managers, and other stakeholders, to ensure effective collaboration and communication throughout the project lifecycle


• Designing and executing study plans and protocols 


• Managing study budgets 


• Ensure that all clinical trials adhere to Good Clinical Practice (GCP) and other regulatory requirements. Prepare and submit necessary documentation to regulatory authorities


• Supervising trial sites and the various teams involved in the clinical trial’s operations. 


• Coordinating trial tasks and timelines, ensuring all teams and tasks are on schedule. 


• Ensuring compliance with regulatory requirements 


• Overseeing patient recruitment 


• Collaborating with Project managers to establish targets. 


• Recruiting staff and participants for studies 


• Coordinating communications with regulatory organizations 


• Ensuring safety of all involved parties 


• Ensuring adherence to all protocols and procedures
  


• Lead internal clinical operations calls


• Lead and support on client calls


• Oversee vendors in support of ongoing clinical trial projects


• Train and mentor Clinical Trial Managers, Clinical Research Associates, and Clinical Trial Associates

EDUCATION AND EXPERIENCE REQUIRED:

• Bachelors Degree or 6 years relevant experience with a CRO, Biotech, or Pharma Manufacturer


• At least 3 years in a clinical trial management role


• Previous experience CRA experience independently monitoring drug trials is highly preferred


• Experience with CNS (Central Nervous System) drug trials is highly preferred

COMPENSATION & BENEFITS:

Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits.

EMPLOYMENT TYPE:

Full Time, Permanent

COMMITMENTS:

• Standard Hours 40 hours per week, one hour lunch, Monday – Friday. Additional hours as needed.


• Willing to work in shifts as and when needed

DISCLAIMER: 

Sitero is an equal opportunity employer and welcomes all job applicants.  All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors .