Zimmer Biomet • Warsaw, IN 46582
Job #2684345124
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered, and recognized.
What You Can Expect
Independently or with minimal management direction, this team member will be responsible for broad aspects of clinical study development, management and support including but not limited to: study management tasks of site qualification, contract and budget negotiations, preparation and presentation of committee documentation, study initiation including pre-monitoring, remote and on-site monitoring, tracking, organizing, filing and maintaining study related documents, maintaining IRB approvals in accordance with applicable compliance regulations and standards (i.e. GCP, ICH, ISO, FDA and MDR). Excellent communication skills needed to provide excellent customer service to surgeon investigators and coordinators as well as internal Zimmer Biomet divisions.
How You'll Create Impact
Clinical Site Management
Conduct clinical study site identification and qualification activities, including approval processes for sites/investigators in accordance with applicable Zimmer Biomet procedures
Train investigators, research coordinators, nurses, and other office staff on protocol requirements and data collection methods
Able to successfully negotiate study contract terms and finalize the budget with study sites
Support and coordinate with clinical study site regarding IRB/EC review
Direct the preparation of site subject binders, other study materials, and required site documents
Create study initiation documents and PowerPoint presentations
Conduct study site qualification and initiation visits
Conduct or oversee interim remote and on-site study site monitoring, including evaluation of performance/compliance to written protocol, source data/document verification, regulatory document review, and timely completion of required visit reports
Use of independent discretion and judgment in the resolution of identified site concerns/ issues with investigator and/or site coordinator
Conduct or oversee central data review activities, including, but not limited to: subject accountability/visits due, query resolution, adverse event management and complaint reporting
Clinical study product and material accountability, as required
Close out clinical study sites on completion of the study
How You'll Create Impact
Clinical Project Management
Coordinate with Clinical Strategy to establish a product specific clinical evidence plan
Clinical study planning including defining objectives, study design, endpoints and evaluation methods
Literature research, protocol development, case report form design, and development of patient information and consent forms
Prepare Fair Market Value (FMV) and Project Needs Assessment (PNA) documents for submission and approval by required internal committees for assigned studies
Coordinate with Post Market Surveillance group to coordinate and review Postmarket Surveillance Plans and clinical activity requirements
Prepare, update and assess progress of key performance indicators (KPIs) for assigned clinical studies
Assess, prepare and update annual budget study needs
Establish an appropriate Monitoring Plan/schedule for each clinical study as needed
Manage regulatory authority applications and approvals where applicable
Ensure study information and documents in Trial Master File (TMF) and applicable databases (e.g. Clinical Trials Management System) and registries (e.g. ~~~) are updated and maintained
Coordinate data analysis with biostatistician and compile routine study status update reports, annual reports, and final reports as required for internal and external customers
Consult with outside consultants and vendors (e.g. independent radiologist) as required for study progress
Annual or ad hoc review of study data reports, including identification and escalation of trending concerns in reported clinical data to the appropriate management team
Coordinate manuscript preparation for journal submission or podium presentations where applicable
Plan and present at Investigator and/or Coordinator Meetings
Oversee and manage contract research organizations (CROs) as needed
Consult with appropriate Zimmer Biomet staff in R&D, Regulatory, Quality and any other appropriate staff regarding risk analysis, clinical assessments, development, status, and results of the clinical trial.
Able to effectively communicate non-compliance of surgeon and/or site to the appropriate management team(s) and develop/implement a corrective action plan
Able to complete a site or study termination as necessary for study closure or site compliance issues (to determine if all necessary federal and company requirements are complete at the termination of a study).
Responsible for the study management and data reports for clinical trials being conducted to support applications for research or marketing permits for devices
Attends and actively participates in departmental and product management meetings when assigned
Able to articulate and collaborate regarding execution plan to meet the clinical needs of business partners
How You'll Create Impact
Process Management
Train and mentor new and junior team members
Lead and/or participate in regional and/or global process improvement initiatives
Assist in creating and maintaining standard operating procedures and work instructions
Contribute to the formulation of clinical research strategy
Takes initiative to further own knowledge of product offerings
Takes initiative in developing interpersonal relationships with business partners (i.e. RA, MA, Development, Marketing, etc.)
Ability to utilize available resources to increase industry knowledge
Develop an in-depth knowledge of assigned study statistics (i.e. current enrollment, # of sites, study outcomes, etc.)
Full working knowledge of all clinical procedures & processes
Has ability to handle assignments of increasing complexity
Full working knowledge and demonstrated experience with all supporting department needs and capabilities, including the ability to discern when inaccurate information is supplied and offer ideas for how to correct it
Complete knowledge base of Zimmer Biomet and competitive products.
Is aware of new and future project strategies for the department in order to deliver a successful new project plan
Demonstrates ability to monitor project budgets and monitor progress per a budget goal
Takes steps to understand external customer and/or internal client needs and translate this knowledge into effective decisions
Delivers results and drives for continuous improvement
Possess high performance expectations and holds others accountable for results
Takes action to enhance performance based on experiences and feedback
This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.
What Makes You Stand Out
Excellent communication and interpersonal skills
Able to identify problems and offer possible solutions
Willingness to assist others with job assignments and/or responsibilities
Enthusiasm in mentoring others in developing good clinical research skills
Excellent time management skills
Positive attitude
Work well without supervision
Takes independent responsibility for learning and career progression
Able to think quickly and act decisively
Must be able to function independently with remote manager or team members
Good command of English (written and oral) language
Good command of local language (written and oral)
Conducts self in a compliant and ethical manner
Interactions with business partners (internal and external) are ethical and transparent
Manages change and adapts to new procedures and processes
Demonstrates a collaborative attitude and is open to suggestion and change
Has a genuine eagerness for performing well even in the most difficult of situations
Ability to manage difficult conversations with co-workers, clinical sites and surgeons
Your Background
Bachelor's Degree or postgraduate degree in nursing, life sciences, engineering, medical sciences, or research-related field
Certification as a Clinical Research Professional is preferred
Clinical research experience (sponsor) or clinical study management (site) (5+ years, preferred)
Established knowledge on Good Clinical Practice (GCP), applicable standards, and local government-related guidelines/regulations
Senior Clinical Project Lead
Travel Expectations
EOE/M/F/Vet/Disability
Compensation Range: $100,000 - $115,000
The compensation for this position may vary depending on location.
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