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

Independently or with minimal management direction will be able to perform the following activities:

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. clinicaltrials.gov) 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

• Up to 20%