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Senior Clinical Project Manager

Senior Clinical Project Manager

Position Snapshot

 

Location: London (Paddington Area) / Remote
Company: Aimmune Nestlé Health Science
Permanent contract 
Full-time, Act. Rate 100%
BSc/BA, RN, or equivalent 
At least 8+ years of relevant clinical trial experience in the pharmaceutical industry.
5 + years as a Clinical Project Manager/ or equivalent in accordance with GCP and ICH Guidelines   
 

Position Summary

 

Nestlé Health Science is a leader in the science of nutrition, offering an extensive portfolio of science-based consumer health, medical nutrition, pharmaceutical therapies, and vitamin and supplement brands.  Headquartered in Switzerland, we have more than 11,000 employees around the world, with products available in more than 140 countries. 

 

Aimmune Therapeutics is the pharmaceutical unit of Nestle Health Science (NHSc), with a focus on the advancement of treatments for food allergy, GI disorders, and other food-mediated diseases. We are continuing to build a world-class R&D organization with a strong development infrastructure to support programs in gastroenterology, food allergies and other metabolic & inflammatory diseases. The R&D function within Aimmune Therapeutics drives development activities related to the pharmaceutical pipeline. 

 

As part of the Global Clinical Operations Organization, this role will work with core functions that support both Rx and non-Rx clinical trials. As a Senior Clinical Project Manager you will manage local or global clinical study(ies) to ensure studies are completed on time, within budget, per company goals and in compliance with SOPs, relevant Competent Authority (CA) regulations and ICH/GCP guidelines 
 

A day in the life of a Senior Clinical Project Manager

 

  • Selection, management and oversight of CROs and vendors including contributions to the preparation of Request For Proposals (RFPs) This activity would be carried out in partnership with the CRO Manager
  • Identification, feasibility oversight, and selection of study sites in relevant locations
  • Manage study team(s) and overall clinical aspects of study(ies); budgets and metrics, operations, study document development and review (e.g. study specific plans, eCRF guidelines, lab manuals, etc)
  • Involvement in the development of specifications and user acceptance testing of key trial tools such as IRT and eCRF 
  • Working closely with all relevant stakeholders to ensure information sharing and best practices are adopted 
  • Effectively interfacing locally and globally with other functional departments (regulatory, clinical development\science, medical affairs, CMC, biometrics, QA, Safety, etc) to facilitate timely execution of all study-related activities 
  • Other duties and assignments as required for the overall success of studies. Duties may change based on the current status of clinical studies and company needs.
  • Manage clinical operations personnel supporting assigned studies, as required
  • Mentoring of junior staff
  • Contribute to process improvements (SOP reviews, etc) as well as general infrastructure, integration activities and inspection readiness activities
     

 

What will make you successful

 

  • BSc/BA, RN, or equivalent with at least 8+ years of relevant clinical trial experience in the pharmaceutical industry, working in a Clinical Operations environment of which ~5+ years as a Clinical Project Manager or equivalent (e.g in-house CRA/study manager) in accordance with GCP and ICH Guidelines   
  • Experience as a global project manager/or equivalent (e.g in-house CRA), working on global studies is a must have
  • Hands on, flexible and used to working in a fast-paced environment with limited resources
  • Knowledge of GCP and ICH guidelines required 
  • Significant experience of CRO management and oversight. e.g. managing/oversight of large clinical studies.
  • Study start-up experience is essential 
  • Proficiency in the implementation, monitoring and management of clinical trials 
  • Able to work collegially within a team and carry out duties/responsibilities with general instruction 
  • Demonstrated track record in the oversight of all trial operational aspects including: budgets, timelines, resources, CRO/vendor selection and oversight of clinical team staff during study start-up, interim monitoring and closeout activities. 
  • Proficiency with MS Word, Excel, Outlook, Powerpoint and Microsoft Project
  • Excellent verbal and written communication skills.  
  • Excellent organizational, record retention, time management, decision making, customer service, and interpersonal skills.  
  • Good command of written and spoken English language 
  • Ability to travel as required
     

 

Benefits

Position Snapshot

 

Location: London (Paddington Area) / Remote
Company: Aimmune Nestlé Health Science
Permanent contract 
Full-time, Act. Rate 100%
BSc/BA, RN, or equivalent 
At least 8+ years of relevant clinical trial experience in the pharmaceutical industry.
5 + years as a Clinical Project Manager/ or equivalent in accordance with GCP and ICH Guidelines   
 

Position Summary

 

Nestlé Health Science is a leader in the science of nutrition, offering an extensive portfolio of science-based consumer health, medical nutrition, pharmaceutical therapies, and vitamin and supplement brands.  Headquartered in Switzerland, we have more than 11,000 employees around the world, with products available in more than 140 countries. 

 

Aimmune Therapeutics is the pharmaceutical unit of Nestle Health Science (NHSc), with a focus on the advancement of treatments for food allergy, GI disorders, and other food-mediated diseases. We are continuing to build a world-class R&D organization with a strong development infrastructure to support programs in gastroenterology, food allergies and other metabolic & inflammatory diseases. The R&D function within Aimmune Therapeutics drives development activities related to the pharmaceutical pipeline. 

 

As part of the Global Clinical Operations Organization, this role will work with core functions that support both Rx and non-Rx clinical trials. As a Senior Clinical Project Manager you will manage local or global clinical study(ies) to ensure studies are completed on time, within budget, per company goals and in compliance with SOPs, relevant Competent Authority (CA) regulations and ICH/GCP guidelines 
 

A day in the life of a Senior Clinical Project Manager

 

  • Selection, management and oversight of CROs and vendors including contributions to the preparation of Request For Proposals (RFPs) This activity would be carried out in partnership with the CRO Manager
  • Identification, feasibility oversight, and selection of study sites in relevant locations
  • Manage study team(s) and overall clinical aspects of study(ies); budgets and metrics, operations, study document development and review (e.g. study specific plans, eCRF guidelines, lab manuals, etc)
  • Involvement in the development of specifications and user acceptance testing of key trial tools such as IRT and eCRF 
  • Working closely with all relevant stakeholders to ensure information sharing and best practices are adopted 
  • Effectively interfacing locally and globally with other functional departments (regulatory, clinical development\science, medical affairs, CMC, biometrics, QA, Safety, etc) to facilitate timely execution of all study-related activities 
  • Other duties and assignments as required for the overall success of studies. Duties may change based on the current status of clinical studies and company needs.
  • Manage clinical operations personnel supporting assigned studies, as required
  • Mentoring of junior staff
  • Contribute to process improvements (SOP reviews, etc) as well as general infrastructure, integration activities and inspection readiness activities
     

 

What will make you successful

 

  • BSc/BA, RN, or equivalent with at least 8+ years of relevant clinical trial experience in the pharmaceutical industry, working in a Clinical Operations environment of which ~5+ years as a Clinical Project Manager or equivalent (e.g in-house CRA/study manager) in accordance with GCP and ICH Guidelines   
  • Experience as a global project manager/or equivalent (e.g in-house CRA), working on global studies is a must have
  • Hands on, flexible and used to working in a fast-paced environment with limited resources
  • Knowledge of GCP and ICH guidelines required 
  • Significant experience of CRO management and oversight. e.g. managing/oversight of large clinical studies.
  • Study start-up experience is essential 
  • Proficiency in the implementation, monitoring and management of clinical trials 
  • Able to work collegially within a team and carry out duties/responsibilities with general instruction 
  • Demonstrated track record in the oversight of all trial operational aspects including: budgets, timelines, resources, CRO/vendor selection and oversight of clinical team staff during study start-up, interim monitoring and closeout activities. 
  • Proficiency with MS Word, Excel, Outlook, Powerpoint and Microsoft Project
  • Excellent verbal and written communication skills.  
  • Excellent organizational, record retention, time management, decision making, customer service, and interpersonal skills.  
  • Good command of written and spoken English language 
  • Ability to travel as required
     

 

Benefits

Lausanne, CH

Lausanne, CH

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