Looking to get in the door with a great company? MERIT is a global clinical trial endpoint expert specializing in multiple therapeutic areas. We’re committed to making a difference and are seeking talented people to join our team. Collaboration and customer focus are at the core of everything we do. We value diversity and are interested in people with drive, dedication, and creative problem-solving skills. We offer flexible schedules and remote opportunities
The Development Product Specialist will support the EXCELSIOR platform’s product development, focusing on gathering, documenting, and verifying requirements for the support of clinical trials. This role involves collaborating closely with subject matter experts (SMEs) to confirm that business and technical requirements are met and acting as the primary liaison between SMEs and the development team. The Specialist will be responsible for translating user stories and business needs into clear, actionable requirements for the development team. They will also ensure compliance with regulatory standards such as FDA 510(k), 21 CFR Part 11, and Good Clinical Practices (GCP).
ESSENTIAL DUTIES AND RESPONSIBILITIES: (Other duties may be assigned.)
- Extensively understand MERIT proprietary products and conduct of clinical trials in sufficient detail to be able to confidently discuss and manage tasks with Product Operations and Management (POM), development, and validation team members
- Comply fully with MERIT policies and Standard Operating Procedures (SOPs)
- Requirement Gathering & Documentation
- Collaborate with stakeholders to gather business and technical requirements
- Ensure requirements are prioritized in collaboration with product operations and development teams
- Organize and Track EXCELSIOR development requests
- Collaborate directly with development team to communicate user stories and requirements
- Clarify ambiguities and ensure development stays aligned with project goals
- Write requirements in collaboration with subject matter experts (SMEs), development and validation teams
- Guide audit trail requirements gathering to align with Good Documentation Practices (GDP)
- Assist with Research and Development projects
- Work closely with development project management to prioritize development efforts
- EXCELSIOR administrative support
- Provide training and guidance to POM personnel for Clinical trial configuration as new functionality is introduced
- Assist POM in troubleshooting and reporting of bugs/defects to development team
- Assist in permissions configurations related to new functionality in preparation for software updates
- Act as SME in areas where directly involved in requirements writing and implementation of new functionality
- Participate in continuous improvement initiatives to refine internal processes, improve product quality, and optimize user experience
Other:
- Comply fully with company policies and SOPs
- Other responsibilities may be assigned as required
The following are the essential functions of the position but are not all-inclusive.
- Practices and responds with commitment and sensitivity toward satisfying the needs of internal and external customers. Promotes quality and continuous improvement philosophy.
- Demonstrates a commitment to maintain safe, clean and orderly work area. Promotes and follows safety regulations and actively contributes to work safety.
QUALIFICATION REQUIREMENTS:
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 the essential functions.
Education and Experience:
Minimum of a high school diploma, work experience in a health related, biological science, computer science, data entry, customer service or business management field.
A minimum of five (5) years of work experience in health related, biological science, computer science, data entry, customer service or business management field and Oncology clinical trial background
Other Skills and Abilities:
Strong interpersonal and organizational skills, excellent attention to detail, ability to follow direction, assess company needs and work independently. Computer skills to include proficiency in Microsoft Office software, ability to troubleshoot new applications and ability to learn company specific software. Project a professional attitude and image appropriate for the work environment.
Experience with clinical trial imaging software and/or familiarity with DICOM standards
Ability to participate and contribute in a team environment. Oral and written communication is clear, concise, and effective. Distinguish between technical and general end-user communication.
Licenses or Certifications Required:
None.
Physical Requirements:
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
While performing the duties of this job, the employee is regularly required to use hands; to touch, finger and grasp, handle or feel, with repetitive motions, and talk or hear. The employee is frequently required to stand; walk and sit. The employee is occasionally required to reach with hands and arms, stoop, crouch, kneel and climb. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
Benefits Offered:
401(k)
Dental insurance
Disability insurance
Health insurance
Life insurance
Paid time off
Vision insurance
MERIT CRO, Inc. is an equal opportunity employer, and we are committed to hiring a diverse and talented workforce.
It is the employment policy and practice of Merit to recruit and hire qualified employees without discrimination based on race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, national origin, ancestry, citizenship status, age, mental and physical disability, pregnancy, medical condition, genetic information, political affiliation, union membership, status as a parent, marital status, military or veteran status, or other classes protected by applicable law, and to not discriminate concerning compensation and opportunities for advancement, including upgrading, promotion, and transfers. We will provide reasonable accommodation to qualified individuals throughout the application, interviewing, and employment process. If you require reasonable accommodation, please contact us.
