Role Summary: As Clinical Research Scientist the individual will have extensive cross-functional interaction within the Company, ranging from R&D through to clinical, regulatory and commercial functions. The role holder will provide advice, council & support one or more strategic business groups in truly understanding the value of shrewdly designed and executed clinical development plans across the global businesses.
Essential Responsibilities: -To be responsible that project activities and milestones are planned, agreed and achieved according to the overall clinical development plan, to include pre and post marketing activities. -To be responsible for the timely and accurate completion of project documentation such as protocols, amendments, case report forms and study reports, etc. -Verifies scientific accuracy of safety and efficacy summaries for regulatory/ commercial purposes and assists with the clinical sections of regulatory dossiers and or product specific scientific discussion, depending on pre or post-marketing activities -Responsibility for developing and maintaining the overall medical strategy of the assigned product(s), for validating this strategy with appropriate internal or external experts and for agreeing the strategy with the appropriate internal business stakeholders. -To provide clinical leadership in cross functional project and product teams -Working with the Quality Assurance and Regulatory Affairs teams to establish and maintain strong risk assessment and management processes for decision-making -Input into Risk Management reviews as it relates to patient safety, the performance of risk assessment in the design of new products, and the interpretation of patient safety and risk in the post-market environment. -Collaborating with multiple functions to ensure patient safety, minimize risk, select products for development with the greatest clinical unmet needs, work with teams and outside experts to design robust products and to support clinical research strategies for regulatory approval, reimbursement and adoption
Quality Specific Goals:
1.Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position 2.Complete all planned Quality & Compliance training within the defined deadlines 3.Identify and report any quality or compliance concerns and take immediate corrective action as required 4.Drive compliance/closure of Regulatory and Quality requirements before approving Design Control Functional Design Reviews and New Product Introduction program milestones 5.Identify continuous improvement activities by initiating the implementation of process and product quality improvement initiatives
Qualifications/Requirements: 1.Medical Degree or equivalent with relevant Clinical experience 2.Experience in GCP Clinical trials 3.Post –Graduate training or Medical experience in Radiology is desirable 4.Good written and oral communication skills, 5.Ability to work independently and systematically 6.Good interpersonal skills to build good working relationships both internally and externally 7.Experience managing complex projects and/or across global regions desirable 8.A minimum of 5 years Medical Diagnostic (Cardiology) or Pharmaceutical industry experience 9.Excellent team player with global mindset 10.Prior experience working with Microsoft office products (Word, Excel, PowerPoint) 11.Must be willing to travel as required
Desired Characteristics: 1.Excellent skills in written and verbal presentation 2.Board-certification in Neurology, Cardiology or Nuclear Medicine, with industry experience
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