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Clinical Project Senior Lead (REMOTE) at Zimmer Inc.

Posted in General Business 30+ days ago.

Type: Full-Time
Location: Warsaw, Indiana





Job Description:

Job Summary

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.

Compensation range: $92,300 - $124,000





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