Senior Clinical Study Manager

This is a fully remote position, open to applicants in Spain.

📋 Description

• Oversee designated clinical research activities

• Collaborate with stakeholders, investigators, and KOLs to create study designs, concepts, protocols, and outlines

• Plan and implement clinical studies both pre-market and post-market

• Manage site selection, projections for patient recruitment, site initiation, enrollment, and follow-up

• Prepare study protocols, case report forms, informed consent documents, clinical trial agreements, and study reports

• Organize IRB/EC submissions and monitor the progress of studies

• Execute studies on time, within budget, while maintaining high quality and compliance

• Conduct site qualification, initiation, interim monitoring, and close-out visits, both in person and remotely

• Ensure regulatory and protocol compliance and data accuracy through monitoring

• Complete source data verification in EDC systems, case report forms, or data listings

• Act as a liaison with sites and assist with internal audits, inspections, and sponsor audit readiness

• Negotiate contracts and budgets with vendors and sites in collaboration with legal and management

• Monitor study progress, provide status updates, and manage site payments and financial tracking

• Work with biostatisticians on data analysis, interpretation, clinical study reports, and scientific publications

• Coordinate study meetings and related activities

• Mentor junior clinical study managers and offer guidance to CRAs and CTAs

• Adhere to corporate SOPs, GCP, and US/OUS regulatory standards

• Conduct literature reviews, critically evaluate scientific literature, and write clinical summaries

• Review and amend Clinical Operations SOPs for process enhancement

• Assist with post-market research, market trend analysis, and Health Economics and Outcomes Research activities

• Collaborate with investigators on manuscripts, abstracts, slide presentations, and posters

• Aid in regulatory submissions and approvals for pre-market studies and 510(k)s, including responding to regulatory inquiries

⛳️ Requirements

• Prior experience in implementing, assisting, and managing medical device trials

• Extensive knowledge of clinical and/or outcomes research study design

• Proven expertise in protocol and ICF development and in writing clinical sections for regulatory submissions

• Demonstrated experience in conducting literature searches, reviews, and evaluations of scientific data

• Familiarity with Good Clinical Practice ICH/GCP and other relevant regulations

• Basic understanding of clinical research and monitoring requirements

• Experience in negotiating clinical research contracts and budgets

• Ability to work effectively within cross-functional teams

• Willingness to travel 25–40% or as needed for business purposes

• Capability to manage multiple projects and prioritize effectively

• Strong communication, presentation, and interpersonal skills with meticulous attention to detail and organization

• Quick learner, adaptable to changing requirements, and self-educating on surgical specialties

• Ability to lead project teams comprising CRAs and CTAs

• Minimum of an advanced degree in a scientific/bioengineering discipline (M.S., Ph.D., or M.D.) with at least 5 years of clinical research experience, or a Bachelor's degree in a scientific/bioengineering field with a minimum of 8 years of experience in clinical research is preferred, or at least 10 years of relevant experience in clinical research with appropriate training

• Preferred knowledge of statistics, statistical methods, and experimental design

• Experience in a hospital setting and familiarity with nurses and surgeons is preferred

• Current proof of vaccination against certain diseases, including COVID-19, may be necessary

• Must comply with applicable export control regulations where relevant

🏝️ Benefits

• Remote work option; employees are expected to come onsite when requested by leadership

• Incentives

• Benefits

• Equity

• Reasonable accommodations for qualified individuals with disabilities

• Equal employment opportunity and protections against discrimination

• Potential vaccination coverage requirements based on the role