Clinical Project Manager, Clinical Affairs, Global Medical Products

What Clinical Research contributes to Cardinal Health

Clinical Research is a discipline that integrates medical practice, compliance with regulatory requirements, and a research-based evaluation of drug therapy.

  • This individual will assume a leadership role in the development and implementation of Post Market Follow-up (PMCF) deliverables for EU MDR requirements as well as device clinical trials to ensure the safety of patients/subjects, the quality and integrity of data, and the proper management of study procedures according to ISO14155, GCP, regulatory guidelines and Cardinal Health and Clinical Affairs Standard Operating Procedures.  This position interfaces with R&D, Marketing, Regulatory, Legal, and Medical Affairs, as well as various healthcare professionals, biostatisticians, clinical operations, and other consultants.  Responsibilities may also include managing contract research organizations (CROs) and other trial related vendors. 

    ESSENTIAL FUNCTIONS

  • Develop and/or oversee the development of Clinical Affairs deliverables required for EU MDR: PMCF Plans, surveys, survey protocols and PMCF Evaluation Reports.
  • Collaborate with Medical Writing and Medical Safety teams for completion of the PMCF determination tool.
  • Assist in data analysis and preparation of clinical reports for clinical studies or PMCF evaluations.
  • Serve as a key member of the team in planning and executing clinical trials.
  • Coordinate all aspects of domestic and international clinical trials from study start-up through close-out.  This includes responsibilities across operations, study development, and project management.
  • Manage budgets, timelines, and resources across assigned trials and surveys.
  • Oversee the strategy of the clinical trials and ensure that studies are developed in a professional manner to permit publication at professional conferences or in medical journals.
  • Collaborate with independent clinical advisors to create regulatory and non-regulatory protocols.
  • Recruit, negotiate compensation, manage deliverables and provide feedback to CROs, biostatisticians, independent laboratory managers, clinical experts, clinical operations, and medical writers who perform consultative duties for projects.
  • Manage tracking of study supplies and usage, enrollment of subjects, regulatory document flow, study timelines, financial information, Adverse Events, performance metrics, data flow, etc.
  • Cross functional management/participation (e.g., data management, clinical science, statistics, etc) for the duration of trials.
  • Serve on cross-functional project teams and interact externally with clinical investigators, investigational sites, CROs, etc.
  • Develop and/or review protocols, protocol amendments, Case Report Forms (CRFs), investigator brochures, informed consent, and other study related documents.
  • Maintain clinical project files to ensure compliance with internal procedures and Federal regulations.
  • Involved in the preparation of documents for publications, submissions and the coordination of submissions with appropriate site staff and Program Manager.
  • Assist internal departments and study investigator(s) as needed to write final reports for clinical studies.
  • Assist in the preparation of Institutional Review Boards (IRB) submissions for clinical studies.
  • Maintain Standard Operating Procedures (SOPs) for the department as assigned by management.
  • Oversee the planning of study training meetings (e.g., Investigator and/or Study Coordinator Meetings)
  • Develop training materials for Clinical Affairs personnel.
  • Oversee the internal review of protocol deviations and follow-up to ensure appropriate corrective actions are implemented, as appropriate.
  • DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS

  • Other duties as assigned with or without accommodations.
  • MINIMUM REQUIREMENTS:
  • Bachelor’s degree required (nursing, biology, or scientific field is preferred).
  • Experience in clinical research is highly preferred.
  • Knowledge of FDA and international regulatory requirements is required.
  • Excellent written communication skills (correspondence, reports, protocols, etc.).
  • Knowledge and proficient use of Microsoft Office Suite Applications (Word, Excel, Power Point,).
  • Demonstrates proficiency in presenting scientific/technical data.
  • Effective time management.
  • Strong leadership and effective interpersonal skills are essential.
  • Ability to coordinate and lead multiple projects simultaneously.
  • Ability to train and mentor others.
  • Ability to travel up to 25%

What is expected of you and others at this level

  • Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects
  • May contribute to the development of policies and procedures
  • Works on complex projects of large scope
  • Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives
  • Completes work independently receives general guidance on new projects
  • Work reviewed for purpose of meeting objectives
  • May act as a mentor to less experienced colleagues

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.