Clinical Trial 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 Clinical Trial Manager, for a permanent position to be based in the Lucerne area, Switzerland.
The ideal candidate should have 6 years of previous experience in the field of clinical trials, including CRA-level experience (both CRO and industry experience are acceptable).
The Clinical Trial Manager is responsible for providing strategic leadership and oversight of clinical trials to ensure completion on time, within budget and of high quality in compliance with all applicable regulations, guidelines and Standard Operating Procedures. The CTM 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 level according to agreed timelines, scope and budget which includes:
- Identification and selection of site;
- Coordination of submissions to Competent Authorities, enrollment activities on a global, country and site level;
- Ensuring timely data collection, cleaning and lock;
- Oversight of the clinical monitoring activities and of CROs and other vendors;
- Focus on quality:
- Ensure clinical trials are conducted in accordance with applicable regulations, ICH GCP, FDA CFR and internal Standard Operating Procedures;
- Lead the preparation and follow-up after site, vendor or sponsor audits and inspections
- 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 6 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;
- Fluent in both written and spoken English. Any additional language is an asset;
- Ability to work well in a team environment
- Strong critical thinking and problem solving skills
- Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines;
- Excellent organizational and record-keeping skills;
- Ability to maintain excellent working relationships with a broad range of trial staff;
- Flexibility in work hours and readiness to travel abroad on a routine basis;
- Advanced computer literacy;
- Relevant working/residency permit or Swiss/EU-Citizenship required.