4 days ago

Clinical Project Manager

Nestle

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Clinical Project Manager

Clinical Project Manager
Clinical Project Manager "Join an organization that brings people together to create new outcomes in health" Nestlé Health Science based in Bridgewater USA or in Epalinges Switzerland Undefined period of time contract act rate 100% Are you ready to join a transformational company in healthcare Nestlé Health Science is an innovative and fundamentally different type of company a health science company engaged in advancing the role of nutritional therapy to change the management of health for consumers patients and our partners in healthcare. Nestlé Health Science is accelerating the development of its established portfolio of consumer and medical nutrition brands and is investing in research and partnerships to build a pipeline of truly novel therapeutic nutrition. Our intent is to bring forward nutritional therapies that have proven clinical and health economic value and improve the quality of people's lives. Nestlé Health Science plays a key role in the Nutrition Health Wellness ambition of our parent company Nestlé. We have privileged access to Nestlé's R D network including the Nestlé Institute of Health Sciences a biomedical research Institute established at the same time as Nestlé Health Science in January 2011. With global headquarters in Epalinges Switzerland Nestlé Health Science already employs around 3 000 people. Our portfolio of nutrition solutions diagnostics devices and drugs targets health areas including inborn errors of metabolism paediatric and acute care obesity healthy ageing gastrointestinal and brain health. Bold collaborative and focused professionals passionate about helping build a transformational company fit well in our organisation. As Clinical Project Manager you are in charge of the 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. Key responsibilities Lead clinical trial execution in collaboration with members from other functional areas activities including but not limited to protocol development study timeline and budget generation study initiation maintenance and closeout activities. Responsible for study-level decision making management updates issue and risks identification and ensuring escalation and resolution as appropriate. Ensure trial conduct is in compliance with internal SOPs FDA regulations ICH GCP guidelines and other local regulations to protect trial subjects' welfare and data integrity. Oversee site selection process from site identification feasibility assessment to site qualification with input from key stakeholders. Make final decision on clinical site s site contracts and personnel suitability to conduct the protocol. Manage CRO and vendors who provide trial-related services. Responsibilities include vendor selection contract negotiation and execution as well as vendor oversight. Responsible for adhering to study timelines by monitoring subject recruitment and retention. Lead subject recruitment initiatives to support recruitment when necessary. Anticipate schedule impacts and adjusting project team activities as required. Ensure clinical data are collected reviewed and cleaned according to study plan. Prepare review quality control essential study documents and collate all in Trial Master File or confirm that CRO provides adequate TMF documentation. 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. Contribute to continuous improvement of working processes to ensure quality deliveries and to optimize efficiencies. Required Profile Bachelor's degree is required an advanced degree is preferred Educational background in biological science or other relevant science Minimum of 6-8 years clinical project management experience in Food/Pharma/CRO industry CRO selection oversight and management including study plans vendors sites systems and staff for compliance with protocol and best practices Leading coordinating the activities of cross-functional operational teams and communication with internal external trial stakeholders at international level Clinical experience for example any health care professional qualification Experience in Co-ordination of investigational product preparation logistics and management of supply throughout trial and management of biological sample logistics Fluent in English Show us that you are at ease in both a matrix and hierarchical environment including transversal leadership. You demonstrate the courage to challenge stakeholders as well as team members for the best results. Your ability to think outside the box and your passion for Innovation and Renovation will contribute to your and our success. Furthermore you are flexible to ever-changing priorities internally and externally and you are adaptable to objectives shifting during the project. If you are interested about this position and want to make a difference fulfilling Nestlé Nutrition's mission to nurture the health of the next generation apply in English on www.nestle.com/jobs.

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