Clinical Specialist (Sustaining Engineering Group)

Unomedical s.r.o.

Place of work
Priemyselný park 3, Michalovce
Contract type
full-time
Start date
by agreement

Information about the position

Job description, responsibilities and duties

Co-ordinates and leads clinical activities on a project basis. This may include clinical representation on New Product Development Core Teams, development of clinical evaluation plans (clinical strategy) and clinical evaluation reports and responsibility for any clinical investigations in line with pre and post market product launch requirements. Clinical input and expertise will also be provided for change control activities, risk management activities (e.g. Product Risk Reviews), complaint evaluations, Health Hazard Evaluation (HHE) preparation, participating in project teams, reviewing Advertising and Promotional Materials from a Medical/Clinical perspective and providing ad hoc clinical advice to support other functions. Provide support for design history file/technical file remediation.

• Represent clinical affairs on core/project teams for product development and change control including risk assessments and IFU development. Review and provide input into design history file remediation activities including design verification/validation, hazard analyses, product risk reviews and to prepare and/or update Clinical Evaluation reports
• Prepare and update Clinical Evaluation Reports for inclusion in the technical file in accordance with MEDDEV 2.7.1 and GHTF Guidance and internal SOP’s. This will include preparing systematic literature reviews, complaint analysis and overall analysis of clinical evidence for presentation to the Clinical Evaluator
• Provide clinical input into Health Hazard analyses
• Provide medical review support for MRL approval for advertising and promotional material. Working closely with core/project team clinical members to ensure claims and intended use are accurately represented
• Support the complaint handling group, participating in Medical Device Complaint/Malfunction review, ensuring appropriate assessment and guidance in terms of reportability as required
• Coordinates and /or participates in the timely execution of a clinical investigation from a clinical study plan to final clinical study report within the established timeline and budget. Supports the following activities including but not limited to: country and site selection, investigator meetings, CRF development, data review plan, database validations, data listing requirements and review, monitoring site start up, monitoring patient recruitment, preparation and /or review of appropriate clinical documents, Clinical Study Report development, CRF distribution, timely data collection, delivery of final database, etc.
• Communicates and works closely with other departments such as R&D, Regulatory Affairs, Quality Management and Marketing to ensure timely completion of clinical documents for Regulatory filings and clinical responses to health authorities.
• Leads ad-hoc strategic projects.
• Optimize both expenses and resource allocation to achieve optimal profit ensuring fit with both short- and long-term goals.

Basic wage component (gross) and other rewards

minimum 950€ / monthly (depending on experiences and quality of the candidate) + quarterly bonus and other benefits in compliance with social benefit program of the company

Information about the selection process

Please send your CV only in english language.

Only candidates who meet our requirements will be invited for the interview. Data of not selected candidates will be deleted in compliance with data protection law.

Information about personal data processing of job seekers is located on link: http://www.convatec.sk/o-spolocnosti/kariera

Requirements for the employee

Candidates with education suit the position

University education (Bachelor's degree)
University education (Master's degree)
Postgraduate (Doctorate)

Educational Specialization

minimum Bachelor’s Degree in Life Sciences, Health, Pharmacy, or Nursing

Language skills

English - Upper intermediate (B2)

Number of years of experience

2

Personality requirements and skills

Required:
• A full understanding of the clinical product development process trial
• An understanding of the clinical trial process – the role may be required to support clinical trial activities
• Works both as a team member and independently, engages and supports other members of the team and willingly accepts support when required. Is able to make decisions, in consultation, if required, and accept accountability.
• Willingly embraces change and the need to adapt to new circumstances. Takes an innovative approach while maintaining compliance.
• Can establish strong working relationships with clinical Investigators and key opinion leaders.
• Has demonstrated principled leadership and sound business ethics: shows consistency among principles, values and behaviors.
• Seeks and welcomes feedback, responds to coaching, takes action to change.
• Effective use of oral and written communication skills to influence, inform or guide others.

In addition to:
• Understanding of the medical device industry and of the pre-clinical, clinical, marketing and regulatory components.
• An understanding of clinical research, including the protocol/project relationship and key milestones
• A proven ability to deliver results according to timelines. Anticipates problems and creates solutions to minimize potential delay.
• Solid understanding of project planning and project management methods and the ability to apply them.
• Knowledge of team building strategies, communication and interpersonal skills.

Advertiser

Brief description of the company

ConvaTec is a global medical products and technologies company, with leading market positions in ostomy care, wound therapeutics, continence and critical care, and infusion devices. Our products provide a range of clinical and economic benefits, including infection prevention, protection of at-risk skin, improved patient outcomes and reduced total cost of care.

Number of employees

500-999 employees

Company address

Unomedical, s. r. o.
Priemyselný park 3
071 01 Michalovce
http://www.convatec.sk
ID: 3608470   Dátum zverejnenia: 26.2.2019   Základná zložka mzdy (brutto) a ďalšie odmeny:   minimum 950€ / monthly (depending on experiences and quality of the candidate) + quarterly bonus and other benefits in compliance with social benefit program of the company