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Job Information
Zimmer Biomet Clinical Research Specialist in Warsaw, Indiana
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 talented 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 inspired, invested, cared for, valued, and have a strong sense of belonging.
What You Can Expect
In consultation and collaboration with the Clinical Project Lead or Clinical Manager, you will be able to oversee and support the conduct of clinical studies including but not limited to: study management tasks of site qualification, contract and budget negotiations, preparation and presentation of committee documentation, study initiation and management 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 Study Site Management
In consultation and collaboration with the Clinical Project Lead and other in-house personnel Clinical team member will be able to assist with the following activities:
Identify and assess suitability of clinical study sites and investigators
Prepare documentation and present nominations of site/investigator to CRRC for approval
Finalize budget and negotiate study contract with sites
Support and coordinate with PI on IRB/EC review
Prepare site subject binders, study visit documents and PowerPoint presentations
Resolve site issues and data discrepancies / queries with investigators and site coordinators
Conduct site visits (SQV, IMV, COV) as required per Monitoring Plan to perform source data/document verification
Complete clinical study site visit reports
Prepare and distribute Patient Due Listings as appropriate
Clinical study product and material accountability
Close out clinical study sites on completion of the study
Will primarily be responsible for non-regulated clinical studies, but may be introduced to regulated study activities as appropriate
How You'll Create Impact
Clinical Project Management
In consultation and collaboration with the Clinical Project Lead and other in-house personnel Clinical team member will be able to assist with the following activities:
Collaborate with Clinical Strategy team to identify product clinical needs
Create study protocol, study synopsis/summary, CRF and Informed Consents documents
Prepare for CIRC review and approval
Establish clinical database and CRF discrepancy parameters for each study with close collaboration of the Data Management team
Maintain study requirements for posting to clinicaltrials.gov
Maintain and update Clinical Trials Management System (CTMS) as needed
Maintain completeness of site documents in trial master file
Able to assist in the creation and maintenance of the study annual budget
Able to complete a literature search and international registry review to assess product performance
Review and provide input on Post Market Plan, Post Market Reports and other study reports as necessary
Oversee Investigator Initiated Research (IIR) projects as assigned
Able to create and edit a study report (annual or ad hoc) as needed
Assist other team member participating in the cross-training opportunities with study-related activities
How You'll Create Impact
Process Management
In consultation and collaboration with the Clinical Project Lead and other in-house personnel Clinical team member will be able to assist with the following activities:
Works with team members to identify process improvements
Participate in regional and global process improvement initiatives
Maintain standard operating procedures
Actively participates in departmental and business unit meetings and scheduled activities
Willing to assist and mentor other team members
Ability to effectively identify and resolve conflicts and disagreements regarding clinical research matters
Impacts project teams and business units through quality work and leadership of projects or portions of projects
Keep current on learning requirements without lapse or overdue assignments
What Makes You Stand Out
Works well as part of a team
Positive attitude
Self-awareness of the impact of actions on others
Willingness to learn and progress
Basic command of English (written and oral) language
Understanding and willingness to follow Zimmer Biomet policies, procedures, standard operating procedures, and work instructions
Basic understanding and willingness to comply with Regional and Global regulations (ICH/FDA/MDR)
Basic understanding of medical terminology
Ability to prioritize assignments, manage time efficiently and assist in project oversight to meet established deadlines
Develop competencies with CTMS, Medispend, electronic data capture systems and other electronic systems used for clinical research
Proficient in Microsoft Office including Word, Excel, and PowerPoint
Ability to multi-task in fast paced environment is essential.
Must be able to perform in a diverse cross-functional team environment
Initiates and exchanges best practices with other team members and business partners
Able to adapt behaviors and attitude to improve performance of the team and to have a positive effect on the outcome of the project
Development of project management skills
Your Background
Bachelor's Degree or postgraduate degree or in nursing, life sciences, engineering or medical sciences
Clinical research experience (sponsor) or clinical study management (site) (3 – 5 year)
Established knowledge on Good Clinical Practice (GCP) and local government related guidelines / regulations
Travel Expectations
Up to 35-50%
EOE/M/F/Vet/Disability
Zimmer Biomet
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