Field Clinical Manager CP, Central Asia

Описание

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The primary objective of the Field Clinical Manager (FCM) is to be responsible for training health care professionals in the use of pre- and post-market medical devices and associated surgical procedures; for installing and troubleshooting the Company's products in the field; for programming devices and providing technical expertise in the clinical development of new products. The candidate will perform these duties and develop the necessary training materials in compliance with corporate standards and government/industry regulations.

General Responsibilities :

· Provides resource for surgical case coverage, follow-up support and troubleshooting of LivaNova Products.

· Conducts in-services for LivaNova products.

· Conducting required training for new and existing centers.

· Conduct training for LivaNova employees.

· Develops, implements, and manages product and system training for all commercial personnel including new hire training, systems training, product launch and ancillary follow-up training.

· Identifying and implementing ongoing training needs.

· Participates in the development and implementation of medical education programs to advance the knowledge and skill set of healthcare providers.

· Collaborate in the development and implementation of the KOL plan and of local/market specific KOL plans.

· Participates in Livanova’s activities in Congresses activities.

Clinical and Technical Support :

• Represents LivaNova during surgeries, implants, and device programming

• Demonstrates expertise in all aspects of implanted medical devices and troubleshooting techniques

• Provides support and follow-ups in hospitals and clinics, as specified in study protocols or through commercialization efforts

• Receives technical inquiries by telephone. Research solutions to questions or problems

• Provides on-call support as needed for surgeries, reprogramming, troubleshooting, follow-up, etc

Educational/Research Support

• Build professional and technical knowledge by engaging with customers, attending scientific conferences, educational workshops, delivering presentations and training to field personnel and reviewing professional publications.

• Regularly educates and updates physicians/clinicians and clinic follow-up staff on new product releases of device systems and features, including both hardware and software modifications

• Liaison between R&D and physicians to coordinate beta testing– develop protocols and recruit centers.

• Facilitate submission of research for presentations; work with internal contacts and physicians to prepare scripts, slides, overheads, PowerPoint presentations

• Aid physicians with technology – literature searches, suggest LivaNova technology

• Maintain open, effective communication with all LivaNova functions, including Regulatory Assurance, Quality Assurance, and Product Development, as well as with employees

• Create and update instructions for use, physician and patient manuals, and other system documentation as required

• Generate literature/training materials – create tech memos, facilitate Sales and Marketing personnel with Marketing literature review

• Assist sales to identify and target physicians

KNOWLEDGE, SKILLS & ABILITIES

Candidate must have:

• Ability to communicate effectively with health care professionals, in both English and local language

• Ability to instruct/coach others on use of products and clinical applications

• Strong interpersonal skills and professional demeanor

• Effective problem solving and trouble shooting skills

• Excellent organizational skills, ability to prioritize under pressure

• Solid MS Office skills including PowerPoint, preferably with data management tools 9PowerBI, etc.)

• The ability to manage multiple tasks simultaneously

Medical Expert PDP and Compliance Activities

• Consult on defining clinical/user needs for product development inputs

• Provide expert input on Clinical Strategy and study design

• Clinical evaluation and post-market follow-up planning/reporting. Reviewer and approver.

• Promotional material reviewer and approver

• Consult on providing evidence for promotional claims/ claims matrices

• Risk documents (including harms, severity, occurrence) consultant, reviewer, and approver

• PMS Complaint reviewer

• Clinical study report reviewer and approver

• Clinical Analysis Report (for PMCF clinical activities) reviewer and approver

• Training of internal colleagues involved in product development and compliance activities

• Consult on clinical/medical questions coming from regulators

• Clinical Assessment for adverse events

Requirements for Clinical evaluation medical expert approvers:

• Knowledge of EU-MDR

• Should have at least the following training and experience in the relevant field: a degree from higher education in the respective field and 5 years of documented professional experience; or 10 years of documented professional experience if a degree is not a prerequisite for a given task.

• Knowledge of: Diagnosis and management of the conditions intended to be diagnosed or managed by the device, knowledge of medical alternatives, treatment standards and technology (e.g. specialist clinical expertise in the relevant medical specialty).

EDUCATION

Bachelor's degree in health care related field. Advanced degree in health sciences preferred.

EXPERIENCE

Previous experience of a minimum of three years in clinical practice of Cardiovascular Perfusion, ECMO coordinator or similar position. Must have surgical experience

TRAVEL REQUIREMENTS

Passport holder from a country which does not offer travel restrictions in the Middle East, Africa, Central Asia, and Russia. Be available to travel extensively, up to 80% of the time.

Valuing different backgrounds:

LivaNova values equality and diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination. Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate’s sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification.

Notice to third party agencies:

Please note that we do not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee. In the event that a recruiter or agency submits a resume or candidate without a previously signed agreement, we explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.

Beware of Job Scams:

Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons posing as LivaNova recruiters or employees. The scammers may attempt to solicit confidential, personal information, such as a social security number, or your financial information. LivaNova will never ask for fees prior/during/after the application process, nor will we ask for banking details or personal financial information in return for the assurance of employment. If you are concerned that an offer of employment might be a scam or that the recruiter is not legitimate, please verify by searching for “See Open Jobs” on, and check that all recruitment emails come from an @livanova.com email address.