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Director, Clinical Field Operations

Company: Merit Medical Systems, Inc
Location: South Jordan
Posted on: September 13, 2020

Job Description:

Director, Clinical Field Operations #730-22064

South Jordan , UT

Working Hours

(8 am to 5 pm) M-F

Shift

1st

Area of Interest

Clinical Affairs

Job Description

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 support.

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 needs.

Provide ongoing study-wide activity updates to VP Medical Affairs.

Develops Global Study reporting, case calendars, and coordination.

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 meetings.

Hires and manages clinical field specialists.

Builds and maintains technical and clinical expertise across therapeutic areas.

Performs other duties and tasks, as required.

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS

Lifting -- Not to exceed 50 lbs. -- local practice may apply.

Writing

Standing

Depth perception

Reading

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 experience.

Proven track record of leadership responsibilities in a clinical development organization.

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 manage teams.

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 software programs.

Up to 80% domestic and foreign travel required.

PREFERRED QUALIFICATIONS

Experience in the medical device industry.

COMPETENCIES

COMMENTS

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.

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Keywords: Merit Medical Systems, Inc, South Jordan , Director, Clinical Field Operations, Other , South Jordan, Utah

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