Sr. Clinical Affairs Specialist

A Sr Clinical Affairs Specialist is focused on planning, execution, and management of clinical documentation and new product development. Additionally, with assistance from leadership they manage clinical studies, develop clinical strategies, and build relationships with key stakeholders like investigators and medical advisors. Their role is crucial in demonstrating the safety and efficacy of medical device products.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following (Other duties may be assigned):

Maintain and Grow Clinical Knowledge

• Maintain and grow knowledge of relevant regulations as they apply to the clinical role.
• Continuously monitor subject, similar and equivalent devices, alternative clinical techniques and methods through:
  • Post-Market Clinical Follow-up activities which serve to collect and evaluate long-term safety and performance
  • EMBASE congress and literature publications
  • Maintaining and growing clinical knowledge of competitive devices including alternative treatment methods

Develop Clinical Strategy and Scientific Methods

• Develop strategies for preparing and submitting new products in global markets while maintaining existing products by:
  • Working with leadership and Regulatory Affairs develop strategies for preparing and submitting new and existing product plans and reports
  • Establish and approve scientific methods for clinical literature search protocols, data collection.

Improve and Expand Clinical Communication

• Communicate clinical information to cross-functional departments (project team) and stakeholders (KOL) while ensuring it’s interpreted correctly
  • Provide guidance to development teams on clinical requirements for design, development, and marketing.
  • Collaborates with NPD team to develop validation, testing plans, and protocols as required.
  • Responsible for conducting new product validation, internal testing, and approval of respective reports. Seeks CLM support as required for validation testing activities. Collaborates with CLM and KOLs for ECE (external clinical evaluations), studies and research as required.
  • Conduct systematic literature searches to determine hazards and risks for the product (group)
  • Ensure devices are both safe and effective for the intended use of the product and comply with Regulatory requirements.
  • Collaborate with key opinion leaders (KOLs) on clinical evaluations, studies, and research as required
  • Identify opportunities for clinical acceptance of new technologies with KOLs as required

Ensure Long-Term Clinical and Regulatory Compliance

• Ensure products meet clinical standards at every stage of development, from research to distribution by:
  • Continuously monitor and evaluate changes to global Regulatory and Clinical requirements
  • Plan and monitor clinical evaluations by overseeing the entire clinical evaluation process for medical devices including review of health hazard assessments
  • Prepare and submit clinical documents including required plans, reports, and correspondence to Notified Bodies and other regulatory agencies as required
  • Ensure safety and performance of the device which is required for Regulatory approval

Support Clinical Studies and Investigations

• Manage clinical studies and investigations, reviewing and presenting submissions of protocols and reports to the relevant Research Review Committee for acceptance by the company.
• Analyzes and interprets data from clinical studies to ensure quality of the data. Document assessment of published White Paper and/or study results.

Support Audits and Investigations Related to Clinical Requirements

• Assesses current state of compliance to standards (ISO 13485, MDSAP, (EU) MDR 2017/745, and (UK) MDR 2002)
• Supports audits as required
• Ensures Preventative and Corrective Actions are taken as required

Advertising and Promotions

• Supports Clinical Marketing and Marketing by providing up-stream development of clinical claims, clinical benefit statements, and criteria for development and trending of the medical device benefit-risk ratio
• Review promotional and educational materials for accuracy and compliance. Work with Regulatory Affairs as necessary for consultant reviews
• Provide upstream clinical guidance for marketing and advertising activities as required

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

 

EDUCATION AND/OR EXPERIENCE:

BA or BS degree in a science related field, a Regulatory or Clinical Affairs related field or equivalent combination of education and experience. Preferred Sonographer credentialed by ARDMS. Demonstrated project management and planning experience, problem solving capability and results orientation.

 

TRAVEL:

National and international travel may be required up to 10% (4-8 travel trips per year) of the time.

 

SKILLS, KNOWLEDGE, AND ABILITIES:

• Remain current on Domestic and International Regulations and Standards in accordance with role and/or projects.
• Knowledge of major uses of ultrasound including: OB/GYN, urology, radiology, surgery, cardiology, point-of-care and infection control practices.
• Excellent technical writing and oral communications and organizational skills, performing effective demonstrations.
• Must possess good “people skills” for collaboration and reporting.
• Must be able to interact in dynamic, fast paced environment and make quick effective decisions.
• Ability to work issues independently to root cause as well as work well in a dynamic collaborative team environment
• PC for office applications and ability to perform literature and web-based research.
• Strong analytical skills.
• Self-motivated and willingness to learn and proactively problem solve.
• Possess an understanding of compliance to Corporate and Regulatory procedures/ requirements and goals.

 

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 individual will primarily remain in a stationary position, often standing or sitting for prolonged period. The individual must frequently lift and/or move equipment and supplies up to 25 pounds. The individual must operate laboratory instruments and mechanical equipment. The individual may perform constant repeating motions that include the wrists, hands, and/or fingers. The individual is required to perceive attributes of objects and materials.

 

WORK ENVIRONMENT:

This is a field-based position requiring a home office. 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. The noise level in the work environment is usually moderate.

 

PAY AND BENEFITS:

CIVCO offers a complete benefits package including company-sponsored health plans and 401k plans with company matching starting day one, lifestyle and tuition reimbursements, paid leave, generous vacation plans (minimum of 17 days annually), and the advantages of an environment that encourages your development, recognizes your achievements, and supports a work-life balance.

The anticipated compensation for this role includes an annualized base salary range of $95,000 - $140,000 plus a 10% variable incentive compensation target. The provided base salary range is used nationally. The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business or organizational needs.

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Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)