Senior Clinical Affairs Specialist

3 weeks ago

Eden Prairie, United States ACIST Medical Systems Full time
Job Description

Through collaborations with customer clinicians and cross-functional internal relationships, establish the scientific clinical evidence and support for Bracco Medical Technologies (BMT) product differentiation. Execute product-specific clinical research strategies and provide analytical, scientific, and strategic support to product roadmaps for BMT's medical devices. The scope of responsibility spans pre-clinical, clinical, post-market and life-cycle development programs for global geographies. Support regulatory, marketing, sales, and product development initiatives with current knowledge state-of-the art and clinical applications for assigned products. Professionally and credibly represent BMT when presenting to numerous audiences: physicians, clinical staff, vendors, clinical and advisory boards, and internal customers. Ensure clinical claims are appropriate and supported by valid scientific evidence for assigned products. Contribute to sales and marketing materials intended to educate and inform customers.

Regulatory and Marketing Collaboration Activities
  • Consistently meet compliance deliverables relevant to clinical studies and research, including the development of Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF) Plans and Reports, and Summary of Safety and Clinical Performance (SSCP) Reports. Deliverables should reflect excellent writing and accurate, complete and relevant information.
  • Support the development of medical device labeling, including promotional materials. Provide appropriate clinical references and support based on valid scientific evidence.
  • Review and appropriately edit promotional materials including speaker decks, advertising materials, and white papers.
Scientific Evidence Activities
  • Participate in product-specific cross-functional teams to develop, interpret, and utilize clinical evidence of BMT products throughout the company.
  • Serve as the clinical lead for creating/editing clinical claims matrices for multiple products, working collaboratively on inter-departmental teams.
  • Develop reports, presentations, and reviews to support scientific communications.
  • Maintain comprehensive literature database for BMT products.
  • Identify clinical evidence gaps to help form BMT's clinical research strategy.
  • Maintain and disseminate clinical evidence summaries/briefs.
Clinical Affairs Activities
  • Create and/or revised Clinical Affairs Standard Operating Procedures (SOPs) as needed.
  • Review proposals for investigator-initiated studies for alignment with business needs and in collaboration with marketing.
  • Facilitate review of proposals in accordance with standard operating procedures.
  • Participate in annual budget planning.
  • Collaborate with biostatisticians on the creation of statistical analysis plans and reports.
  • Provide ad-hoc literature reviews as requested by cross-functional colleagues or teams.
  • Effectively manage third-party vendors for outsourced Clinical Affairs work.
  • Initiate and write position papers on Clinical Affairs related subjects, with management approval.
Product Development Activities
  • Provide competitive clinical trial analysis on assigned products as needed.
  • Support development of communications and labeling materials.
  • Serve as an internal expert on emerging, leading and market differentiating clinical topics.
Required Skills

Minimum
  • Bachelor's degree in health sciences or physical sciences.
  • 5+ years of experience in medical device industry and/or clinical research field.
  • Advanced knowledge of medical terminology.
  • Ability to assess scientific clinical evidence and perform relevant clinical literature searches.
  • Demonstrated ability to develop collaborative working relationships with physicians, expert consultants, and contracted vendors.
  • Strong analytical mind, attention to detail and organizational skills.
  • Strong document management skills including proficiency with MS Word, Outlook, Excel, etc.
  • Strong written and verbal communication skills and interpersonal skills to effectively convey ideas, concepts and information across all levels of the organization.
  • Ability to work with internal and external customers in a professional manner.
  • Proven experience to work cross-functionally across an organization.
  • Willingness to present to a group of peers, other company employees and customers.
Preferred:
  • Master's degree in health sciences.
  • Professional certification (e.g. SoCRA or ACRP certification)
  • Experience in data (statistical) analysis and/or clinical trial operations.
  • Experience authoring Clinical Evaluation Plans and Reports.
  • Experience supporting domestic and international regulatory audits of clinical or regulatory activities.
  • Clinical experience in diagnostic/interventional cardiology, preferably in the cardiac catheterization laboratory.
  • Working knowledge and experience with clinical research study design, Good Clinical Practices (GCP) and global clinical regulations, including FDA regulations and ICH guidelines for medical devices.
  • Expert knowledge of cardiovascular interventional and diagnostics products and the ability to teach both internally and externally.
  • Understanding of the product development process.
  • Working knowledge and experience with global quality systems regulations and guidelines.
  • Experience in providing case support to collect clinical research data in diagnostic/interventional cardiology procedures.
Other:
  • Able to travel to approximately 1-2 conferences or meetings per year, domestic and international.

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