My client is a large clinical stage biopharmaceutical firm and is looking for an experienced Clinical Projects Operations Manager
- Assume responsibility for planning and executing trials for Clinical Operations
- Oversee CROs and other third-party vendors
- Ensure that global clinical strategies are translated to study specific strategies
- Ensure that the trials are run in adherence to all relevant regulations including GCP, ICH, local regulatory requirements
- Oversee the execution and adherence to all integrated study operation plans
- Monitor KPIs and metrics to track the quality and performance of the studies.
- Identify quality and deliverable risks, roll mitigation plans together with the relevant stakeholders, to ensure risks are minimized.
- Provide inputs into site audit report responses and responsible for oversight of associated plans
- Degree in Biomedical Science, Biotechnology, Pharmacy, or equivalent with at least 6 years' experience working in clinical research
- At least 3-5 years of experience leading clinical operations related work in oncology studies.
- In depth knowledge of oncology trials requirements, clinical research principles such as ICH GCP as well as regulatory requirements.
- Prior experience as Senior CRA/Team Lead
- Experiences in immuno-oncology or gene and cell therapy studies is a plus
- Strong communication and influencing skills
- Effective presentation skills
- Travel of up to 20% post Covid
Please send your resume in WORD format by clicking the apply button below or contact Abhik Damani on +65 6701 1527 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1544061 (Abhik Damani).