Director, Clinical Field Operations #730-22064
South Jordan , UT
(8 am to 5 pm) M-F
Area of Interest
SUMMARY OF DUTIES
The purpose of this position is to drive enrollment goals and
quality outcomes for Company clinical trials. This position also
provides leadership and guidance to team members to ensure safe
execution of clinical field operations including procedure
training, case support, and protocol compliance.
ESSENTIAL FUNCTIONS PERFORMED
Manages field operations for all clinical research projects
assigned to Medical Affairs, including other field specialists.
Develops training materials, programs, presentations, etc. for
assigned clinical research projects.
Provides case support, including Operating Room/procedure
Prepares and reviews pre-procedure imaging, case screening and
plans, identify recommended devices based on preoperative/operative
imaging studies to support physician planning and treatment of
patients, proper device sizing and strategy, if applicable.
Develops and maintains relationships with physicians and staff
in assigned sites by providing a high level of service and
responsiveness and by providing ongoing education and clinical
expertise regarding the use of company's products.
Escalates issues related to study conduct, quality, timelines or
budget to senior management and develops and implements appropriate
actions to address issues.
Partner with Quality on assessment of all complaints to ensure
proper training follow up is completed, up to and including
execution any training related to CAPAs.
Assess knowledge base of Company Clinical Field Specialists and
adjust training curriculum based on business or country specific
Provide ongoing study-wide activity updates to VP Medical
Develops Global Study reporting, case calendars, and
Responsible for driving patient enrollment with optimal
outcomes, including development of enrollment plans and projections
for assigned projects.
Educates and trains physicians and clinical site personnel on
the proper use of Company products.
Interfaces with clinical site physicians and research team as
the face of the company.
Assist with the collection and dissemination of information or
feedback provided by investigators and staff.
Represents the Company at various trade shows or educational
Hires and manages clinical field specialists.
Builds and maintains technical and clinical expertise across
Performs other duties and tasks, as required.
ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS
Lifting -- Not to exceed 50 lbs. -- local practice may
Field of vision/peripheral
SUMMARY OF MINIMUM QUALIFICATIONS
Education and/or experience equivalent to a bachelor's degree in
a biological science and eight years of clinical trial or related
operational experience to include five years of management
Proven track record of leadership responsibilities in a clinical
Proven skills in governance, management and communication.
Self-motivated, self-directing, strong attention to detail and
excellent time management skills.
Excellent writing and oral presentation skills.
Strong analytical skills.
Strong interpersonal skills.
Excellent knowledge of ICH/GCP including relevant Guidance
documents from (FDA, ICH, and EMEA etc.)
Strong leadership skills, ability to lead, mentor, coach and
Ability to effectively collaborate across all relevant functions
involved in clinical trials.
Excellent time management skills, ability to handle and oversee
multiple tasks simultaneously and to prioritize projects.
Demonstrated computer skills preferably spreadsheets, word
processing, database, internet research and other applicable
Up to 80% domestic and foreign travel required.
Experience in the medical device industry.
Infectious Control Risk Category II:
The risk category explains whether or not employees are likely
to come into contact with blood or body fluids while performing
their jobs. Risk category II states employment and procedures that
may require exposure.