Senior Clinical Trial Manager/ Clinical Trial Manager (897258 - MS)
3 days left
- Experience Level
- Experienced (non-manager)
Our Client is an innovative R&D Biotech that has many agents at various trial phases and successfully achieved FDA Approval in 2015 for a new medical device within Oncology. They have a start up feel about them which creates a fast-paced, highly dynamic and entrepreneurial culture with an emphasis on being patient centric. They went “live” in 2015, so they are still setting and building up the structures and processes and are now in a role out phase for their new product. They are looking for a Senior Clinical Trial Manager/Clinical Trial Manager for a permanent position to be based in the Lucerne area.
As a Senior Clinical Trial Manager/ Clinical Trial Manager you will be responsible for providing strategic leadership and oversight of clinical trials conducted in Europe (and other regions as needed) to ensure completion on time, within budget and of high quality in compliance with all applicable regulations, guidelines and Standard Operating Procedures. You must have a very good understanding of the project status, be able to proactively identify risks and address them appropriately (including escalation to senior management).
- Drive execution of the assigned clinical trial(s) on a regional/global level according to agreed timelines, scope and budget while assuring quality.
- site identification, selection, oversight of the clinical monitoring activities;
- oversight of the enrollment activities on a global, country and site level;
- coordination of submissions to Competent Authorities;
- ensure that clinical trials are conducted in accordance with applicable regulations, ICH GCP, FDA CFR and internal Standard Operating Procedures;
- ensuring timely data collection, cleaning and lock;
- oversight of CROs and other vendors;
- lead the preparation and follow-up after site, vendor or sponsor audits and inspections;
- be able to work with moderate supervision;
- develop and negotiate site budgets;
- prepare study reports and ensure required tools and tracking databases are kept up to date as required;
- ensure activities comply with the applicable Quality System requirements;
Qualifications and Experience
- Bachelor's degree in Nursing, Medicine or other Life Sciences, or RN degree from an accredited school;
- Minimum of 10 years’ experience working in different positions in the field of clinical trials, including CRA-level experience (both CRO and industry experience are acceptable);
- Accredited GCP course desirable;
- Fluency in English (verbal and written) and excellent communication skills;
- Relevant working/residency permit or Swiss/EU-Citizenship required.
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