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Job Summary

Zimmer Biomet is a global medical technology leader. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.

The primary responsibility of the Clinical Affairs Manager is to oversee clinical study operations for studies of Zimmer Biomet products supporting global regulatory submissions, publications, and other clinical data requirements. The Clinical Affairs Manager will supervise clinical team members within the department to ensure studies are compliant with regulations, company SOPs, project plans and timelines. This position will oversee multiple, simultaneous studies and have routine interaction with clinical strategy, post-market surveillance and medical writing, research, regulatory, and marketing management.

Principal Duties and Responsibilities

• Manages all aspects of studies in accordance with established timelines, applicable regulations and standards, and Zimmer Biomet standard operating procedures; including, protocol, CRF and database development, site recruitment, internal compliance approvals, budget and agreement negotiation, study initiation, trial maintenance, data monitoring, data reporting, vendor selection and management, trial master file maintenance, and product and payment tracking.
• Maintains detailed project plans, dashboards, timelines, and budget reviews for all projects; assists Director with plans and reports for senior management
• Oversees and/or contributes to the preparation of clinical documents, e.g., protocols, investigator brochure, annual report updates, case report forms and clinical study reports, monitoring plans, and budgets;
• Utilizes communications, reports, EDC, and CTMS systems to proactively identify potential barriers to project completion and data integrity and proactively implements effective strategies to correct/avoid such barriers
• Demonstrates problem-solving strategies, mentors junior team members in developing alternative solutions and contingencies to address issues as they occur; instills a practice of continuous improvement with team
• Drafts/updates, reviews standard operating procedures, work instructions, and controlled forms
• Develops and implements training plans for team, ensuring skills and certifications are timely relative to assigned projects
• Manages External Research proposals- overseeing corporate approval processes, execution of agreements, completion of milestones and reports, and payments or in-kind contributions
• Contributes to review and approval of risk management plans, design reviews, and IFUs, where clinical input is needed
• Supports coaching and feedback and as appropriate, provides performance input to senior management

Expected Areas of Competence

• Comprehensive knowledge of device clinical trial regulations, guidances and standard processes
• Extensive experience with electronic clinical trial database systems and CTMS, including CRF development, query resolution and report extraction
• Ability to effectively manage multiple projects with competing timelines and a wide variety of deliverables required
• Demonstrated ability to impact and influence others within a team to take action; interact effectively with various functional groups of the project team;
• Detail oriented with analytical mind-set, capable of root-cause analysis and problem-solving
• Excellent written and verbal communication skills with the ability to effectively communicate to all levels of the organization

Education/Experience Requirements

• Bachelor’s degree or equivalent education required. Education concentration in nursing, life sciences, engineering or a similar scientific/technical discipline is preferred
• 7+ years of experience with clinical studies
• Established knowledge of medical device regulations and international standards required
• Demonstrated experience in the oversight of clinical trial monitoring, audits and/or inspections
• Certification as a Clinical Research Professional is preferred

Travel Requirements

Up to 30%

Additional Information

At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. This is why we offer you a competitive rewards package that includes medical, dental, vision, life and disability insurance, wellness incentives, employee assistance programs as well as paid time off for vacation and holidays.

EOE/M/F/Vet/Disability

Compensation Range: $126,000 - $140,000