The Clinical Lead (CL) provide direction and guidance to multi-country clinical teams in assigned project(s), coordinate site management and monitoring activities, and provide operational leadership to achieve on-time clinical deliverables on a project. They are accountable for developing the clinical monitoring plan, participant recruitment strategy, clinical team training and assurance of high-quality data on a clinical trial. They do this by ensuring high quality site selection, review and approval of monitoring visit reports, review of data management plan, resolution of data queries and trending/analysis of protocol compliance.
Responsibilities:
- Manages the day-to-day clinical project team ensuring compliance of project deliverables and any mentoring required.
- Lead site identification and site selection activities.
- Participate in client calls to lead the discussion on clinical deliverables (e.g. progress and risk) and relevant mitigation plans.
- Proactive identification of risks to clinical deliverables and development of risk management strategies within clinical scope.
- Work with PM to manage clinical resources to ensure monitoring activities are within budget notifying the PM of any changes required or changes in scope. Identify out of scope tasks for clinical lead function and work with PM to resolve.
Minimum Qualifications & Experience: - At least 5 years of experience as CRA (Clinical Research Associate).
- Must have performed advanced clinical monitoring tasks and site management tasks at a Senior CRA level and demonstrated effective leadership, organization, communication, problem-solving and time management skills with solid understanding of risk management principles.
- Experienced in coaching and mentoring clinical teams.
- Must have an in-depth understanding of multi-country clinical trial regulations as well as site monitoring practices.
- Excellent problem-solving skills, with proven ability to identify/manage risks at both site and regional levels.
Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.
Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.
We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to talking to you about working at Novotech.
