Associate Medical Manager THV

Associate Medical Manager THV

Edwards Lifesciences

Czech Republic

Role Purpose:

Management and development of investigator initiated research program and related processes within Medical Affairs in THV, mainly in area of investigator initiated trials (IIT) but also other grant activities – from development, submission to the final output (collection, analysis , exchange as well as follow-up on data outcomes and budget tracking in IITs conducted in the region of responsibility). Development and maintenance of grant management related e-tools (Grant Portal, Clickview).

Major Job Functions:

  • Investigator initiated trials (IIT) program development and management (incl. regular budget tracking and FUps);
  • E-tools management;
  • Customer reach-out;
  • Publication/Educational support.

Investigator initiated trials (IIT) program development and management (incl. regular budget tracking and FUps)

  • Manages Grant Application Review Committee meetings, sets up the monthly agenda, follows-up as appropriate;
  • Manages all necessary steps of IIT lifecycle internally and externally, provides necessary documentation and distributes contracts including its obligations e.g. financial obligations( sets up milestones/timelines/payment schedule/deliverables);
  • Assist the institution in trial initiation and implementation;
  • Maintains contact with key institutional departments and investigators;
  • Monitors and reports site enrollment progress;
  • Monitors adverse events and device-related complications in accordance with regulatory and internal requirements;
  • Coordinates investigator meetings, statistical analysis and publication support where needed;
  • Maintains internal documentation in accordance with established Standard Operating Procedures (SOP´s)and other internal regulations for agency/internal auditing;
  • Serves as the key contact to the sponsor/principal investigator throughout the study process until site closeout;
  • Facilitates information exchange within Edwards THV BUs;
  • Manages dedicated budget on a regular (monthly) basis;
  • Prepares monthly reports, enrollment/progress reports etc. as requested and needed.

E-tools management

  • Further develops and maintains dedicated medical affairs e-tools ( Grant Portal project co-lead; provides support across business units and departments).

Customer reach-out

  • Understands scientific needs of internal and external stakeholders (internal, patients, health care providers and payors);
  • Helps to develop areas of Edwards scientific interest and helps centers to target these through dedicated discussions on potential projects of interest;
  • Assists during scientific discussions , protocols reviews etc.

Publication/Educational support

  • Manages IIT publication plan;
  • Reviews and comments scientific outputs from IIT program;
  • Supports the principal investigator during the preparation of the IIT data presentation/publication as needed;
  • Prepares training materials/provides internal trainings.

General responsibilities

  • Keeps up to date with current THV related trends and topics of interest within the medical community;
  • Foster strong collaboration between Medical Affairs and other business units (Sales, Marketing, Clinical);
  • Be a credible ambassador for Edwards Lifesciences products and live Edwards Lifesciences culture/credo;
  • Apply rigorous scientific methodology while understanding the commercial ramifications/implications.

Required Education/Skills/Experience:

  • Master degree (possibly bioscience background);
  • Minimum 3 years of experience in Medical Device and/or Pharma industry (preferably Clinical research)/CRO;
  • Fluent in English, each additional language is an advantage;
  • Experience to work in a complex matrix organization;
  • Self-driven, able to manage workload, well organized, motivated;
  • Eager to learn and help, positive mindset;
  • Strong communication and interpersonal skills;
  • Passion for detail, excellent analytical skills;
  • Team oriented;
  • Willing to travel up to 30%, mainly EU countries.

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© EuroJobsites 2019

EuroJobsites is a 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

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