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Senior Clinical Research Scientist - Diegem, Belgium

Eingestellt von Elevate Direct

Gesuchte Skills: Support, Engineering

Projektbeschreibung

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

Contribute towards development of clinical trial protocols, informed consents, investigator brochures, and other study materials;

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 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. Senior staff member will review work during development, dependent on level of complexity, and upon completion.

To support the customer in the use of Biosense Webster products used in Clinical studies:

Clinical Support to customers during cases performed with Biosense Webster products

Focus on physician and study team "training" to achieve independence on the use of BW products under study within agreed time frames with the CTL's.

Optimize physician's efficiency through optimal product usage

Non Technical Skills and Additional Details

Functional and Technical Competencies: 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; Develop ability to build collaborative relationships with key internal and external partners and stakeholders;

Leadership requirement - develop ability to influence, shape and lead without direct reporting authority; Good capacity to coaching and training Presentation skills Self-Motivated High flexibility expected Project management 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

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 is a plus Electrophysiology Product knowledge is a plus

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

  • Einsatzort:

    Belgien

  • Projektbeginn:

    asap

  • Projektdauer:

    11 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Elevate Direct