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Clinical Scientist - Diegem, Belgium
Eingestellt von Elevate Direct
Gesuchte Skills: Support, Engineering
Projektbeschreibung
Clinical Scientist - Diegem, Belgium
On behalf of the Medical Device Group, this clinical research professional will contribute to the development of clinical evidence generation and dissemination strategies (EGS/EDS) across assigned New Product Development (NPD), life cycle Management (LCM) projects and Procedural Support.
POSITION DUTIES
Plan for study budgets and collaborate with Clinical Operations to manage the development of Investigator agreements and site contracts within fair market value (FMV), vendor agreements, payments, and financial disclosures;
Contribute to delivery of assigned clinical projects, through effective partnership with the Clinical Operations and BSDM teams, to enable optimized engagement leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOP);
Develop strong collaborative relationships with the study core team and others to ensure study progress for assigned projects and that issues are identified and communicated to leaders;
Draft study reports for assigned studies to include any annual reports, study close out reports as well as clinical sections for IDE, PMA, 510(k), and other regulatory submissions;
Contribute to critical assessment of the literature and drafting Clinical Evaluation Reports (CERs) for new products;
Support clinical scientific discussions with regulatory agencies/notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc, including during sponsor regulatory inspections;
Contribute in the interpretation and dissemination of all evidence generated, including abstracts, manuscripts, and use of clinical data/evidence for market access and reimbursement;
Support the collaboration with investigators to deliver and disseminate evidence;
Ensure registration on clinicaltrials.gov from study initiation through posting of results;
Develop a strong understanding of the pipeline, product portfolio and business needs.
Keep management informed of key developments and issues that impact clinical strategy and portfolio management.
May be involved in other tasks to support clinical research activities as needed.
Generally manages work with supervision, dependent on project complexity. Independent decision-making for simple situations but requires guidance for complex situations.
To support the customer in the use of Biosense Webster products used in Clinical studies:
Non Technical Skills and Additional Details
Good understanding of clinical research science and processes along with an understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations;
Ability to provide scientifically strategic and scientific clinical research input across NPD and LCM projects;
Proven track record in delivering clinical projects within clinical/surgical research setting, on time, within budget and in compliance to SOPs and regulations;
Ability to lead small study teams to deliver critical milestones, as may be assigned;
Ability to collaborate across different functional areas within Clinical R&D to ensure alignment with governance processes (assigning roles and responsibilities, setting priorities, managing deliverables, etc). and to meet business objectives
Develop ability to build collaborative relationships with key internal and external partners and stakeholders
Develop ability to influence, shape and lead without direct reporting authority
Good capacity to coaching and training
Self-Motivated
High flexibility expected
Analytical thinking and problem solving skills
Team player
Creative/innovative
Written and verbal English communication
Computer software package skills (Word, Excel, PowerPoint)
Willing to travel in EMEA region up to 50%
EDUCATION & EXPERIENCE REQUIREMENTS:
A Bachelor's degree in Biological Science or related discipline.
A minimum of 4 years related scientific/technical or engineering/clinical research experience.
Electrophysiology Procedural knowledge
Electrophysiology Product knowledge is a plus
Project management experience
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services
If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly
On behalf of the Medical Device Group, this clinical research professional will contribute to the development of clinical evidence generation and dissemination strategies (EGS/EDS) across assigned New Product Development (NPD), life cycle Management (LCM) projects and Procedural Support.
POSITION DUTIES
Plan for study budgets and collaborate with Clinical Operations to manage the development of Investigator agreements and site contracts within fair market value (FMV), vendor agreements, payments, and financial disclosures;
Contribute to delivery of assigned clinical projects, through effective partnership with the Clinical Operations and BSDM teams, to enable optimized engagement leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOP);
Develop strong collaborative relationships with the study core team and others to ensure study progress for assigned projects and that issues are identified and communicated to leaders;
Draft study reports for assigned studies to include any annual reports, study close out reports as well as clinical sections for IDE, PMA, 510(k), and other regulatory submissions;
Contribute to critical assessment of the literature and drafting Clinical Evaluation Reports (CERs) for new products;
Support clinical scientific discussions with regulatory agencies/notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc, including during sponsor regulatory inspections;
Contribute in the interpretation and dissemination of all evidence generated, including abstracts, manuscripts, and use of clinical data/evidence for market access and reimbursement;
Support the collaboration with investigators to deliver and disseminate evidence;
Ensure registration on clinicaltrials.gov from study initiation through posting of results;
Develop a strong understanding of the pipeline, product portfolio and business needs.
Keep management informed of key developments and issues that impact clinical strategy and portfolio management.
May be involved in other tasks to support clinical research activities as needed.
Generally manages work with supervision, dependent on project complexity. Independent decision-making for simple situations but requires guidance for complex situations.
To support the customer in the use of Biosense Webster products used in Clinical studies:
Non Technical Skills and Additional Details
Good understanding of clinical research science and processes along with an understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations;
Ability to provide scientifically strategic and scientific clinical research input across NPD and LCM projects;
Proven track record in delivering clinical projects within clinical/surgical research setting, on time, within budget and in compliance to SOPs and regulations;
Ability to lead small study teams to deliver critical milestones, as may be assigned;
Ability to collaborate across different functional areas within Clinical R&D to ensure alignment with governance processes (assigning roles and responsibilities, setting priorities, managing deliverables, etc). and to meet business objectives
Develop ability to build collaborative relationships with key internal and external partners and stakeholders
Develop ability to influence, shape and lead without direct reporting authority
Good capacity to coaching and training
Self-Motivated
High flexibility expected
Analytical thinking and problem solving skills
Team player
Creative/innovative
Written and verbal English communication
Computer software package skills (Word, Excel, PowerPoint)
Willing to travel in EMEA region up to 50%
EDUCATION & EXPERIENCE REQUIREMENTS:
A Bachelor's degree in Biological Science or related discipline.
A minimum of 4 years related scientific/technical or engineering/clinical research experience.
Electrophysiology Procedural knowledge
Electrophysiology Product knowledge is a plus
Project management experience
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services
If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges