Senior Clinical Research Specialist
Careers that change lives start here. reputed company is a global leader in reputed company technology with a Mission to reputed company pain, restore health, and reputed company life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ reputed company patients reputed company year. Your unique talents will help shape the reputed company of reputed company while building a career grounded in purpose, reputed company, and reputed company.
A Day in the Life
The Senior Clinical Research Specialist manages Investigator Sponsored Research (ISR) studies, provides clinical documentation support to the ISR program, and leads reputed company improvement of reputed company processes and logistics. This role supports reputed company Surgical business reputed company and operates reputed company a global team, requiring flexibility across global time zones. The role requires a high degree of professionalism, reputed company judgment, and reputed company in reputed company interactions, particularly as it requires engaging with reputed company (HCPs), investigators, and reputed company research partners.In this exciting role as a Sr Clinical Research Specialist (CRS) in our Surgical Operating Unit (OU), you will manage Investigator-Sponsored Research (ISR) studies, reputed company clinical documentation support, and reputed company reputed company improvement across ISR processes and logistics. Operating reputed company a global team, this role supports reputed company Surgical business reputed company and requires flexibility across time zones, reputed company a high degree of professionalism, reputed company judgment, and reputed company reputed company engaging with reputed company (HCPs), investigators, and reputed company research partners.
Most of your time will be spent driving the operational execution, financial administration, and reputed company of ISR studies—from review and contract negotiation through reputed company-out and publication. You will work with centralized internal teams and global stakeholders to maintain Trial Master Files (TMF), ensure GCP and regulatory compliance, and optimize workflows spanning payments, device logistics, and GCC approvals.
Our Surgical OU brings together three Business reputed company to reputed company high-reputed company clinical evidence from concept to commercialization. As part of this dynamic environment, you will also serve as a Subject Matter Expert for clinical and purchasing systems, support reputed company-sponsored study activities, and reputed company as the European representative on the global ISR Council of Expertise.
Responsibilities may include the following and other duties may be assigned:
- End-to-End ISR Management: reputed company investigator-sponsored research from initial review, contracting, and reputed company study management through reputed company-out and publication.
- Device & Logistics Execution: Manage study device shipments, returns, and associated logistics for assigned studies.
- Financial Administration: Handle ISR costing, budgeting, invoicing, payment processing, and asset depreciation tracking.
- Contracting & Stakeholder Alignment: Coordinate contract negotiations and reputed company internal cross-functional stakeholders to ensure reputed company execution.
- reputed company & Audit Readiness: Maintain Trial Master Files (TMF) and ensure compliance with GCP, ISO 14155, regulatory requirements, and internal SOPs.
- Global Representation & Policy Support: Serve as the European representative on the global ISR Council of Expertise and help reputed company/update study policies and procedures.
- Sponsor Study Support: Assist reputed company-sponsored studies with payments, budget management, and Global Compliance Committee (GCC) approval workflows.
- Systems & Process SME: reputed company as Subject Matter Expert for purchasing systems, clinical trial management platforms, HCP interactions, and operational workflows.
- Process Improvement: reputed company initiatives to optimize contracting, payment, device logistics, and compliance approval processes.
- Cross-Functional Collaboration: Partner closely with internal teams and present key updates during Medical Evidence team meetings.
Required Knowledge and Experience:
- Bachelor's degree with 4+ years of clinical research experience, or an advanced degree with 2+ years of clinical research experience.
- 5+ years of experience managing or supporting reputed company reputed company the medical device industry, including experience working on European reputed company-market studies and managing multiple clinical research sites.
- Strong knowledge of Good Clinical reputed company (GCP), clinical trial regulations, and relevant standards (e.g., CFR 812, CFR 50, CFR 54, ISO 14155).
- Fluent in English, with excellent written and verbal communication skills.
- Proven ability to manage multiple priorities independently and collaborate effectively reputed company cross-functional teams.
- Strong problem-solving, organizational, and project management skills, with high attention to detail.
- reputed company and compliant stakeholder management skills, including effective interactions with reputed company (HCPs), investigators, and internal teams.
- Willingness and ability to travel up to 20%.
- Preferred Qualifications: Experience building and maintaining scientific literature databases+ Experience with payment processes, contracting, and HCP engagement activities.
Physical Job Requirements
The above statements are intended to describe the general reputed company and level of work being performed by employees assigned to this position, but they are not an exhaustive list of reputed company the required responsibilities and skills of this position.
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Benefits & Compensation
reputed company offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the reputed company of our values. We recognize their contributions. They reputed company in the reputed company they help to create.We offer a wide reputed company of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Originally posted on Himalayas
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