Clinical R&D Scientist (Senior)
That's XPE. For one of our clients we are looking for: Clinical R&D Scientist (Senior) Organisation description:
Ready to start your career as a consultant? Our client in Beerse is looking for a Senior Clinical R&D Scientist.
On behalf of the Medical Device Group, you 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.Job description:
- Contribute to the development and delivery of appropriate global EGS / EDS to support NPD and LCM within the assigned projects;
- 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 www.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. 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
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;
- 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;
- Leadership requirement – develop ability to influence, shape and lead without direct reporting authority; •
- Good capacity to coaching and training
- Presentation skills
- High flexibility
- Analytical thinking and problem solving skills
- Computer software package skills (Word, Excel, PowerPoint) • Willing to travel in EMEA region up to 50% Leadership Competencies: Leadership required in alignment with J&J Leadership Imperatives: Connect, Shape, Lead, Deliver as noted below.
- Connect - foster strategic partnerships with key internal & external stakeholders to ensure development and timely delivery of innovative EGS / EDS • Shape – build strong relationships with external stakeholders to shape and influence relevant policies • Lead – critical scientific thinking to develop innovative EGS
- Deliver – ensure clinical projects are delivered on time, within budget and in compliance to regulations and SOPs
- Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times. • Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
Education & experience requirements:
- 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
- Project management
Will you be our new consultant at XPE Pharma & Science? Take the chance to start your career as a consultant - Clinical R&D Scientist. You will get a very interesting salary package with a contract of unlimited term and the opportunity to develop yourself.
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002 XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713