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Clinical trial operations specialist

Sydney
beBeeSite
Posted: 12 September
Offer description

Site Manager Job Description

We are seeking a skilled Site Manager to oversee the execution of clinical trials within our organization. As a key member of our team, you will be responsible for ensuring seamless trial operations, managing site relationships, and delivering high-quality data.

Job Responsibilities:

1. Manage assigned study sites, conducting Phase I-IV protocols according to the Monitoring Plan and organizational procedures.
2. Perform Site Initiation Visits, ensure site personnel is fully trained on all trial-related aspects, and conduct continuous training for amendments and new site personnel as required.
3. Implement site management activities to ensure compliance with protocol, ICH/GCP, global and local regulations, including Health Authorities, IRB/EC, data privacy requirements, global and local processes as applicable.
4. Identify deficiencies in site processes, monitor site processes performed outside the site, work in close collaboration with site on risk mitigation and process improvements.
5. Proactively collaborate with internal stakeholders and site personnel to manage data query resolution process and to ensure timely and accurate data entry.

Requirements:

* Bachelor's degree in a scientific or healthcare discipline (or relevant, related healthcare experience).
* Fluent in both written and spoken English and country language.

Benefits:

* Achieve next-level site collaboration measured by patient density at site, achievements of commitments and targets, and deliver customer satisfaction results.
* Meet study milestones and ensure delivery of high-quality data according to agreed timelines with adherence to prevailing legislation, GCP, Ethical Committee, and SOP requirements.
* Quality and timeliness of updating the Novartis systems, monitoring reports, and communication efforts as defined by global KPIs and KQIs.

About Us:

We value diversity, equity, and inclusion and are committed to creating an environment where everyone can thrive.

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