Clinical Operations Manager Regenesis Biomedical
THIS JOB HAS EXPIRED Level: ExperiencedSalary Range: Undisclosed
Job Location: US-AZ-ScottsdaleTravel %: Up to 50%
Position Type: Full TimeJob Shift: Day
Education Level: 4 Year DegreeJob Category: Research
The Clinical Operations Manager plays an essential role in the development and implementation of clinical research projects by managing the clinical operations activities of assigned studies. Responsibilities include the planning, execution and interpretation of clinical research and data collection activities. This position plays a key role in the collection of post-market clinical data and the execution of regulatory registration studies. Participates in the development and execution of pilot and pivotal RCTs intended to support regulatory registration of new indications and new devices, as well as physician-initiated and company sponsored on-label RCTs, case series and other projects. Performs managerial functions of moderate to significant scope with a high level of independence.
Participates in strategic discussions regarding the design of clinical programs and in the development of research protocols.
Prepares trial-related documents including case report forms, investigator brochures, consent documents, letters of agreement, confidentiality agreements.
Develops the clinical sections for submissions to regulatory bodies and IRB.
Identifies prospective investigators and investigative sites with appropriate patient populations, research interest, experience, and willingness to collaborate in clinical research.
Evaluates and qualifies vendors, consultants, CROs, etc. for assigned studies.
Manages clinical operations activities to meet enrollment targets according to the projected timeline and budget.
Develops monitoring plans to assure quality monitoring activities.
Monitors clinical projects to assure they are conducted in compliance with the protocol, Regenesis Standard Operating Procedures, Good Clinical Practice and appropriate regulatory requirements.
Works with Medical Affairs to identify opportunities for physician-initiated on-label studies and ensures that studies are screened for strategic fit, and conducted per established policies, procedures, and Good Clinical Practice requirements.
Writes clinical standard operating procedures and provides training departmental and other personnel.
Maintains up to date extensive knowledge and understanding of Good Clinical Practice regulations, FDA guidance documents and industry trends/best practices.
Develops and maintains relationships with key opinion leaders (KOLs) and clinical scientists to support Regenesis development activities on a global basis.
Other responsibilities as determined by management
KNOWLEDGE AND SKILL REQUIREMENTS
Demonstrated project management skills and ability to recognize problems and react quickly
High level of planning and organizational skills and fine attention to detail
Engaging personality with people-skills needed for successful relationship building and collaboration with physician-investigators and internal business partners
Substantial knowledge of FDA and ICH requirements
Basic level of understanding of scientific and statistical principles vis-a-vis clinical program design and analysis/presentation/reporting of data collected
Flexible team player with the ability to work independently in a changing environment
Show Drive & Initiative: Establishes aggressive goals and drives for results; readily puts in extra time and effort; tackles problems and works to resolve them without delay; establishes high standards of performance
Show Adaptability: Responds resourcefully to new demands and challenges; works effectively in ambiguous situations; adapts behavior in response to feedback and experience; deals constructively with own failures and mistakes
Act Strategically: Balances big-picture concerns with day-to-day activities; stays informed about industry practices and new developments; understands the organization?s mission and strategies.
Displays Organizational Savvy: Develops effective give and take relationships with others; understands the agenda and perspectives of others; recognizes and effectively balances the interest and needs of one?s own group with those of the broader organization.
Commitment to Quality: Emphasizes the need to deliver quality products and/or services; defines standards for quality and evaluates products, processes and/or services against those standards; manages quality.
Analysis of Issues: Gathers relevant information systematically; considers a broad range of issues or factors; grasps complexities and perceives relationships among problems or issues; seeks input from others; uses accurate logic in analyses.
Innovation: Generates new ideas; goes beyond the status quo; recognizes the need for new of modified approaches; brings perspectives and approaches together combining them in creative ways.
EDUCATION, EXPERIENCE & TRAINING REQUIRED
Undergraduate degree in clinical, science or health-related field from an accredited institution; higher degree and/or licensure in nursing or other health-related field preferred
Certification as a clinical research coordinator or clinical research associate is desirable.
Five (5+) or more years of experience in clinical operations in the medical device, biological or pharmaceutical industry, preferably in pain management
Experience in managing clinical operations of investigative sites as well as sponsors preferred.
Experience with sponsor aspects of physician-initiated studies preferred.
Must be able to operate personal computer and printer
Able to work standard office equipment (photocopy machine, fax machine, etc.)
Ability to work on a computer up to 8 hours a day.
Ability to travel up to 40% of the time in vehicles, airplanes and other modes of transportation, with some travel on weekends, as necessary.
||1435 North Hayden Road |
Scottsdale, AZ 85257
THIS JOB HAS EXPIRED