Clinical Project Manager

About the role

Nestle R&D, Singapore is looking for a Clinical Project Manager based in Jurong. The role manages the operational phase of clinical trials so that quality data is delivered on time, in line with internal Standard Operating Procedures, applicable laws and ICH Good Clinical Practice. The company describes itself as the largest food and beverage company in the world.

Key responsibilities

• Contribute to the study protocol outline and budget development, and assess and approve clinical sites and staff suitability, securing stakeholder agreement.
• Lead and coordinate all activities to operationalise the protocol and deliver the clinical trial statistical report within the agreed timeline.
• Carry out operational activities according to internal SOPs and ICH GCP guidelines, documenting the quality of collected data.
• Track and manage study contracts, feed timely and accurate information into financial systems and report on budget to the SBU or business project manager.
• Prepare, review and quality control study documents, collate them in the Trial Master File (TMF) and ensure compliance with ICH GCP and applicable laws.
• Ensure trial subject protection and contribute to continuous improvement of working processes.

Required profile

• GCP certified.
• Minimum of 4-5 years of clinical project management experience in the food, pharma or CRO industry.
• Experience managing multi-site, international clinical studies and working with clinical sites to execute protocols.
• Experience managing and coaching CRAs and other clinical trial personnel.
• Ability to negotiate and manage the expectations of internal and external stakeholders, including business project managers, the medical development team and key opinion leaders.

Required skills

• Budget and contract management.
• Vendor and clinical site selection, oversight and management.
• Management of investigational product preparation, logistics and supply, and biological sample logistics.
• Maintaining Trial Master Files and managing EC approval processes.
• Risk assessment, implementation of mitigation plans and continuous review and adjustment of plans.