Clinical Project Manager
“I want to create a better world and build a better business”
Nestlé Health Science Ltd, East Coast, USA Undefined period of time, 100%
Are you ready to join a multinational team? 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.
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, and gastrointestinal and brain health.
Contribute to the study and/or site budget development, protocol outline development (i.e. ensure operational aspects are realistic and feasible) Case Report Form development and Informed Consent Form template development. Submits to IRBs and Ethics Review Committees as required.
Oversee the site feasibility and qualification process for identification of qualified investigational sites per protocol requirements. Assess and pronounce on clinical site(s) and personnel suitability to conduct the protocol.
Serve as the liaison and/or Subject Matter Expert when defining the scope for vendor and/or site contracts. Facilitate obtaining the required legal, ethical and technical agreements with sites and vendors as needed.
Lead and co-ordinate all activities to operationalize the study protocol inclusive of CRO and other vendor oversight, in an independent fashion, leading to the delivery of clinical trial statistical report according to the agreed baseline timeline.
Manage overall activities to ensure compliance with internal SOPs, FDA regulations & ICH GCP guidelines. Adherence to vendor SOPs if defined in vendor contracts.
Track & manage study contracts per their defined scope and budget. Provide timely and accurate financial status to financial management system and stakeholders as required.
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 optimize efficiencies.
Ensure trial subject protection.
Education and experience
Minimum of 4-5 years clinical project management experience in Food/Pharma/CRO industry
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 continuous review and adjust to plans as required
Clinical experience, for example, any health care professional qualification
Fluent in English
Show us that you have the capability to prepare and/or review essential trial documents, maintenance of Trial Master Files and managing EC approval process. You demonstrate successful experience in leading and coordinating the activities of cross-functional operational teams and communication with internal & external trial stakeholders. You also have the 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. If you want to make a difference to our performance, apply in English atwww.nestle.com/jobs
The Nestlé Group is the World’s leading Nutrition, Health and Wellness Company with 88,8 billion Swiss Francs in sales in 2015, more than 335,000 employees worldwide and 436 factories in more than 85 countries. We offer an attractive and dynamic international working environment with constant opportunities for development, reflecting our conviction that people are our most important asset. Learn more about our Group and reasons to join us onwww.nestle.com