|Job title :||Field Clinical Specialist|
|Job type :||Contract/Freelance|
|Salary :||Up to £0.00 per annum|
|Contact name :||Camille Sandres|
|Contact number :||+44 (0) 207 255 6620|
|Contact email :||email@example.com|
12 month contract renewable
Home-based anywhere in Germany
Key job description:
* Assist in the development and update of the Physicians Training Plan (per product) as well as the product instruction for use.
* Provide clinical education support (product and associated therapies) through education of current and potential clinical sites
* Collaborate and participate with the clinical monitors (Field CRAs), in-house CRA during site selection, qualification and initiation visits as well as the scheduling of procedures (ensure good case coverage across investigator sites during study enrollment phase).
* Train interventionalists, catheter lab staff and ancillary personnel
* Provide technical support to physicians during the use of the procedures, per training plan, ensuring procedural success.
* Ability to maintain blinding element during the monitoring of Randomized and blinded clinical trials (act as an unblinded monitor of study data and investigational product/medical device accountability). Ensure high quality, completeness and compliance of unblinded study data through on-site monitoring.
* Report physicians' experience to the engineers, quality and clinical team after each case support only when open label studies or as needed for product complaint per complain handling procedure.
* Work closely with the company's R&D Engineers to obtain latest product change and identify additional needs for training.
* Inform customers of the latest product, therapy and technology developments in the industry including competing clinical trials.
* Responsible for compliance with applicable Corporate and Divisional Policies and procedures including the clinical protocol and study blinding/unblinding plans.
Position Accountability / Scope
* This position requires a strong clinical orientations and ease for public speaking with the ability to influence a variety of clinician personality types.
BS/BA or equivalent experience required. Degree in life sciences or medical training (research nurse etc.) preferred.
* Training on GCP-ICH guidelines required and local applicable regulations for clinical conduct for medical and drug regulations.
Minimum Experience / Training
* 9+ years of related work experience required, medical, (device, pharmaceutical) industry preferred.
* 5+ years in clinical trials experience including monitoring.
* Strong clinical orientation, experience with products for use in interventional cardiology