Clinical Research Program Manager

SUMMARY:

In this exciting role as a Clinical Research Program Manager, your primary focus will be to drive cross-functional initiatives for IRRAS resulting in efficiency gains and effective study execution for the clinical trial platform and commercial needs.

ESSENTIAL FUNCTIONS:

  • Responsible for planning, prioritizing, initiating, and executing clinical research projects that drive impactful clinical evidence on-time and within budget execution.
  • Sets clear direction and operates in a manner that aligns with defined best clinical practices and enhances the organization’s clinical objectives.
  • Establish and maintain full scientific, medical and commercial understanding of the company and competitors’ products and services in neuroscience/radiosurgery. Act as IRRAS expert with comprehensive understanding of anatomy, indications, current therapies and ongoing research.
  • Respond to internal and external requests for clinical information. Generate and maintain core database of relevant clinical research relating to company’s business. Stay abreast of evolving clinical research dynamics, communicate key publications and other relevant clinical activities to commercial colleagues on a regular basis.
  • Work closely with commercial colleagues to provide proactive input into the business by communicating medical insight and knowledge about the disease states and customer base globally.
  • Provide clinical input into the development of global medical marketing and sales campaigns and materials (either in partnership with Marketing or with direct accountability). Translate clinical information into meaningful competitive messaging.
  • Provide medical input into the development of congress activities and healthcare professional education events to communicate the value of company’s products.
  • Assure development of internal education and training materials for sales force, etc. Present at training courses, sales conferences, etc. to develop high level of medical knowledge within sales force.
  • Develop and maintain a strong network of key opinion leaders to support the successful launch and life cycle management of the company’s programs and products. Participate in the development and execution of advisory boards to gain market and medical input to medical-marketing programs and deliver scientifically credible messaging.
  • Participate in identification of research opportunities (R&D testing, investigator-initiated research) in line with company product strategies. Manage independent research activities and foster publication of clinical data.
  • Interacts and works closely with other departments, including but not limited to Quality, Commercial, and Regulatory Affairs, to ensure program execution to achieve business goals within regulatory requirements.
  • Establishes meaningful metrics that highlight growing evidence base for company’s product portfolio.
  • Responsible for project performance, risk management, administration, financial management, budgeting and issue resolution.

EDUCATION & EXPERIENCE:

  • 2 years of clinical research experience or advanced degree with a minimum of 2 years of clinical research experience.
  • Bachelor’s degree in engineering, life sciences, or related medical/scientific field.
  • Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials.
  • Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology.
  • Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; and web-based applications.
  • Ability to identify and implement solutions in addressing study issues.
  • Excellent prioritization and organization skills.
  • Ability to competently represent the Company at professional functions and customer meetings.
  • Decisive and autonomous leader who can set priorities for the team that are consistent with the priorities of the business.
  • Ability to work on multiple projects simultaneously and be flexible enough to change priorities with short notice when necessary.
  • Sets a standard of ethics and excellence in alignment with the company’s Code of Conduct.
  • Acts as an ambassador of professional standards, seeking continuous improvement in ways of working to drive greater efficiency and purpose.
  • Ability to succeed in a rapidly changing, agile environment where continuous innovation is a requisite to success.

REQUIRED COMPETENCIES:

  • Performance Orientation – Driven by personal performance; comfortable with quantifiable assessments.
  • Impact Orientation – Performs to stated objectives and driven to make an impact on company goals and patients’ lives.
  • Competitive – Dedicated to a competitive spirit that supports the IRRAS’ goal of being domain dominant in neurocritical care.
  • Sense of Urgency – Has the speed and agility dedicated to win.
  • Ability to Handle Pressure and Ambiguity – Comfortable with the pressure to be the best and the ability to maintain composure and focus in situations of ambiguity and uncertainty.
  • Confidence – Confident in one’s skills and abilities; pursues everything with energy; demonstrates the drive and a need to finish especially in the face of resistance or setbacks.
  • Multitasking – Capable of performing multiple tasks over a certain period of time by executing them concurrently.

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit.
  • The employee is occasionally required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. Transition from standing and sitting often.
  • Required specific vision abilities might include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
  • The employee might occasionally lift and/or move up to 10 pounds.
  • The employee will be asked to participate in international and domestic travel which may find them sitting for long periods of time.
  • The employee may be asked to stand for 4+ hours during visits to hospitals.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • General office environment.
  • Daily exposure to PCs and networks.
  • The noise level in the work environment is usually moderate.
  • International and domestic travel up to 50% required.
  • Exposure to operating room and patient care environments in the hospital setting.

Disclaimer:

The physical demands and work environment characteristics described above representative those an employee may encounter while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.

If you are interested in applying for employment with IRRAS please apply here »

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