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.
In consultation and collaboration with the Clinical Project Lead or Clinical Manager 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.
Principal Duties and Responsibilities
Support Clinical Study Site Management:
Identify and assess suitability of clinical study sites and investigators
Prepare documentation and present nominations of site/investigator to research review committee 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, and 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
Support and assist with Clinical Project Management:
Collaborate with Clinical Strategy team to identify product clinical needs
Create study protocol, study synopsis/summary, CRF and Informed Consents documents
Prepare for internal protocol 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
Support Process Management:
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
Expected Areas of Competence
Basic understanding and willingness to comply with Regional and Global regulations (ICH/FDA/MDR)
Attention to details with outstanding organizational skills
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; works well as part of a team
Initiates and exchanges best practices with other team members and business partners
Assists in the efficient use of available resources to accomplish project goals
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
Possesses positive attitude and self-awareness of impact of actions on others
Willingness to learn and progress
Above average reading comprehension
Understanding and willingness to follow Zimmer Biomet policies, procedures, standard operating procedures, and work instructions
Education/Experience Requirements
Bachelor’s Degree (or non-US equivalent), required. Concentration in nursing, life sciences, engineering or other medical sciences
A minimum of 3+ years of applicable experience, required, such as clinical research or clinical study management.
Established knowledge of Good Clinical Practice (GCP) and local government-related guidelines and regulations
A combination of education and experience may be considered
Travel Requirements
Up to 50%
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.