Zimmer Biomet is a world leader in musculoskeletal health solutions. 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.
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 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).
This position has flexibility to work remote within the continental US.
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 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
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 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
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
Expected Areas of Competence
Demonstrates a collaborative and positive attitude
Excellent communication and interpersonal skills; ability to manage difficult conversations with co-workers, clinical sites and surgeons
Able to identify problems and research possible solutions
Willingness to assist others with job assignments and/or responsibilities
Excellent time management skills
Willingness to learn and progress
Able to think fast and act decisively
Must be able to function independently with remote manager or team members, and work without supervision
Conducts self in a compliant and ethical manner; Interactions with business partners (internal and external) are ethical and transparent
Strong change management and adaptability to new procedures and processes
Education/Experience Requirements
Bachelor’s Degree (or non-US equivalent), required. Concentration in nursing, life sciences, engineering or other medical sciences preferred
A minimum of 5 years of applicable experience required, including a minimum of 2 years of field monitoring experience strongly preferred
Established knowledge of Good Clinical Practice (GCP) and local government-related guidelines and regulations
Clinical Research Professional certification is preferred
Travel Requirements
Up to 40%
Additional Information
EOE M/W/Vet/Disability
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.
