Clinical Lead II
Premier Research helps highly innovative bio-pharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research.
Working at Premier Research means being an individual - you will be recognised for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority.
Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
We’re looking for a talented and energetic Clinical Manager II to join our team. This will be a permanent role to be home based in Australia.
Imagine. Inspire. Innovate. Impact. With Us.
As a Clinical Manager, you will have the opportunity to make a great impact on the most innovative programs in our industry. You’ll direct, supervise and support all clinical staff on the project team; liaise with the customer’s clinical team and collaborate with project team members in other functional areas to ensure delivery within contractual obligations and Premier's standards of excellence.
You’ll be accountable to:
- Drive the successful activation of trial sites according to time, quality/scope and budget parameters
- Understand the proper escalation points based on the circumstances and keeps other departments informed of developments affecting their functions
- Plan and drive both patient recruitment and retention, together with the PM
- Ensure that the clinical team adheres to the appropriate training needs and performance indicators to ensure the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP, protocol and client requirements
- Take the initiative to move the project/program forward and leads in country and global projects where applicable
- Lead and manage the clinical monitoring teams with focus on quality and timely deliverables
- Work with the Project Manager to ensure transparent and proactive sponsor and internal communication regarding study progress and trial issues
- Plan and conduct initial and ongoing training for the study team on project-specific matters and enlists therapeutic assistance
- Apply clinical and monitoring expertise in the design of case report forms
- Create and maintain a study specific clinical monitoring plan (CMP)
- Prepare and execute a site and patient recruitment and retention plan
- Serve as initial point of contact for all clinical management and monitoring issues, vendors and other functional areas, escalating as required
- Ensure effective communication plans are in place for the clinical team and are actioned
- Monitor the preparation and timely completion of all monitoring visit reports, review them for appropriate content, and ensure effective follow up and resolution of site issues
- Monitor the quality of clinical deliverables and address quality issues with the appropriate team member
- Work with the Data Management team to identify data related issues and risks to clinical activities; assist in the development of mitigation plans to minimize risk
- Escalate issues and provide escalation path for the team
- Perform any other duties required to ensure the success of the trial and Premier Research
- May serve in a dual CM/PM role on smaller studies
You’ll need this background to be considered:
- Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required.
- Prior experience working as a Clinical Manager / Lead CRA is required
- Ideally you will have experience attending bid defenses
- Global Clinical Management experience is preferred
- Experience presenting information to various levels of stakeholders
- Providing performance feedback on CRAs for annual appraisals
- Effectively communicating expectations using proper oral and written language
- Budget/finance experience on a project level and demonstrates a full understanding of project financials
- Professional and interpersonal skills with the energy, vision and drive to motivate and manage a number of stakeholders and contributors to meet deadlines and to deliver services
- Ability to establish and maintain effective working relationships with colleagues and customers
- Enthusiasm and willingness to accept responsibility, take ownership of assigned projects and see them through to on-time completion
- Detail oriented and well organized with excellent task organizational skills
- Ability to multitask and work effectively in a fast-paced environment with changing priorities