Clinical Project Manager

Clinical Project Manager

LivaNova

Milan, Italy

POSITION SUMMARY

Responsible for ensuring the timely, efficient and effective execution of clinical studies that will meet all regulatory requirements for product approvals. Responsible for the management of the clinical studies in accordance with the applicable domestic and international government regulations, Investigational Plans (IP), and Standard Operating Procedures. Assist with the development of effective clinical trial strategies, preliminary project timelines, and budgets for multiple new projects to ensure successful product development and worldwide marketing efforts.

Included in the management of each study are study design, protocol development, and coordinating, managing and working with clinical support resources such as a clinical research monitors, Field Clinical Engineers, and Clinical Research Associates. Provide clinical support to Sales and Marketing Departments as required. Work closely with Clinical Management to recommend and implement improved methods by developing and/or modifying department procedures, systems, and in-house training that ensure compliance with regulatory requirements.

ESSENTIAL JOB FUNCTIONS

Clinical Management

  • Responsible for development of clinical studies with regard to clinical study design, protocol development and related study documents;
  • Assist with preparation of regulatory applications, amendments, supplements, reports, and advisory panel presentations needed to conduct studies and approve products;
  • Assure clinical studies are adequately managed to meet the protocol objectives and schedules;
  • Establish and maintain first-line contact with investigators, site coordinators, etc.;
  • Oversees study compliance/safety including: protocol deviations, adverse events, etc.;
  • Ensure sponsor and site compliance to domestic and international government regulations;
  • Prepare, review, and distribute study agreements, informed consent forms, and pre-study visit materials;
  • Assist data management staff with clinical data review and collection of data from sites.

Project Management

  • Responsible for development, implementation and conduct of multiple projects that include project timelines, study budgets, and initial study designs;
  • Applies principles, concepts and techniques for effective project management of a clinical study;
  • Tracks and measures project variances;
  • Develop clinical study budget and may assist in annual department budget preparations;
  • Work with PMO and Clinical Management to recommend and implement methods for improving processes and addressing issues within the clinical research department;
  • Develops programmatic solutions.

KNOWLEDGE, SKILLS AND ABILITIES REQUIRED

  • Knowledgeable of applicable regulations, GCP/ICH guidelines, and clinical study design and implementation;
  • Knowledgeable in the field of cardiac surgery/electrophysiology and human anatomy;
  • Good level of business English (writing and speaking);
  • Proficient with MS Office Suite and MS Project;
  • Strong analytical, organization, and project management skills;
  • Proficient with electronic data capture (EDC) and clinical trial management systems (CTMS);
  • Travel as necessary to clinical centers to establish and manage clinical studies. Able to travel at a minimum of 25%.

EDUCATION

  • Five years degree in science (Preferably in the medical, biological and/or bio-engineering concentrations).

EXPERIENCE

  • 2-3 years Direct project management experience with clinical studies.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

More Job Searches

Italy     Clinical Research     Manager and Executive     Pharmacovigilance and Medical Information     LivaNova    

© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

Newsletter | Recruit | Advertise | Privacy | Contact Us

© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

This website uses cookies to make your experience better. Continued use of this website means you accept our cookie policy.  Accept Cookies