Freelancer Clinical Trial Managers (Ukraine and Malaysia)
Our client is a well-established non-profit drug research and development organisation who partners with private industry, public institutions, academia and NGOs to advance new treatments in disease-endemic countries.
With a remarkable achievement of bringing 8 new treatments to the market, the organisation also benefits from a rich pipeline of new potential drugs, which are being investigated through their numerous affiliates worldwide.
We are looking for two Clinical Trial Managers (one in Ukraine and one in Malaysia) for an initial contract of 3 years.
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;
- Lead the preparation and follow-up after site, vendor or sponsor audits and inspections
- 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, ideally with experience in non-profit organisations;
- Fluent in both written and spoken English. Any additional language is an asset;
- Ability to work well in a changing, unstructured 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;
- Advanced computer literacy.