Clinical Project Manager

Joining Nestlé means you are joining the largest Food and Beverage Company in the world. At our very core, we are a human environment - passionate people driven by the purpose of enhancing the quality of life and contributing to a healthier future. A Nestle career empowers you to make an impact locally and globally, as you are provided with the opportunity to make a mark and stand out, as long as you seek it. With Nestle, you are enabled and encouraged to grow not only as professionals, but also as people.

The Clinical Project Manager will be responsible for Project management of the operational phase of clinical trials to ensure the timely delivery of quality data while complying with internal Standard Operating Procedures, applicable laws and ICH Good Clinical Practice.

A day in the life of a Clinical Project Manager...

1. Contribute to the study protocol outline (ie. ensure operational aspects are realistic and feasible) and budget development. Assess & pronounce on clinical site(s) & staff's suitability to conduct the protocol. Secure stakeholders agreement with the assessment outcome.
2. Lead and co-ordinate all activities to operationalise the study protocol, in an independant fashion, leading to the delivery of clinical trial statistical report according to the agreed Clinical Development Unit baseline timeline.
3. Conduct all operational activities according to internal SOPs & ICH GCP guidelines to ensure and document quality of collected data.
4. Track & manage study contracts to provide timely and accurate input into financial management systems and so delivering study to agreed budget. Reporting on budget to concerned SBU or business Project Manager.
5. Prepare, review & quality control essential study documents and collate all in Trial Master File. TMF documents collectively demonstrate adherence to ICH GCP guidelines and applicable laws. Required in case of inspection by national regulatory bodies or audit by IRB/EC or others.
6. Ensure trial subject protection.
7. Contribute to continuous improvement of working processes.

What Will Make You Successful...

• Good Clinical Practice (GCP) Certified
• Minimum of 4-5 years clinical project management experience in Food/Pharma/CRO industry.
• Leading & co-ordinating the activities of cross-functional operational teams and communication with internal & external trial stakeholders.
• Preparing and/or reviewing essential trial documents, maintanance of Trial Master Files and managing EC approval process.
• Budget and contract management.
• Vendor and clinical site selection, oversight and management.
• Co-ordination of investigational product preparation, logistics and management of supply throughout trial. Management of biological sample logistics.
• Experience of working with clinical sites to execute protocols.
• Management & coaching of CRAs and other clinical trial personnel.
• Experience of managing multi-site, international clinical studies.
• Experience of risk assessment, implementation of mitigation plans and continous review and adjust to plans as required.
• Ability to convince, negotiate with and manage the expectations of key clinical trial stakeholders including business/NRC project manager colleagues, the internal medical development team and external KOLs and their teams.