Avanir Pharmaceuticals

Clinical Data Associate II

Location
Aliso Viejo, CA, United States
Posted
Oct 15, 2020
Ref
R2064
Discipline
Clinical, Clinical Data
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
The primary responsibilities of this position will be to coordinate clinical data management activities for phase I-IV clinical trials by supervising outside vendors and contractors, as well as performing data quality checks to ensure the integrity of the clinical data.

Essential Job Functions:
  • Oversee clinical data management activities across multiple studies
  • Perform thorough reviews of critical CDM documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, edit check specifications, and data management plans.
  • Perform User Acceptance Testing (UAT) on development of eCRFs and IRT systems
  • Review data transfers for consistency with available specifications, e.g. SDTM specifications
  • Participate in study document reviews, e.g. clinical study protocols, statistical analysis plans, Mock Tables, Figures and Listings (TFL) shells
  • Perform supplemental data reviews according to the data quality checks outlined in the edit check specifications document
  • Participate in reviews of blinded TFL output prior to final database locks
  • Report query trends and data/query metrics
  • Prioritize projects and coordinate data management activities in support of corporate goals and objectives
  • Contribute to departmental compliance with regulatory and ICH guidelines, GCPs, company guidelines and Standard Operating Procedures, and CDM best practices
  • Address the business needs of CDM functional customers


This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.

Education/Qualifications:
  • BA/BS in the life sciences, related discipline, and/or equivalent education and clinical data management experience
  • 5+ years of experience working in a pharmaceutical, biotech, or CRO
  • 5+ years of clinical data management experience
  • 5+ years of hands-on Electronic Data Capture (EDC) experience
  • Knowledgeable in GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and recommended CDM best practices
  • Experience writing Data Management Plans and Guidelines
  • Proficient in the use of the MS Word and MS Excel
  • Experience with SAS or SQL programming techniques with clinical data management application a plus
  • Ability to work effectively within a team matrix as well as independently
  • Excellent written and verbal communication skills and strong interpersonal skills necessary to interface with outside vendors and team members
  • Ability to thrive in a fast-paced environment with a sense of urgency and commitment to meet deadlines
  • Demonstrated strengths in planning, organizational, analytical skills, time management, conflict management, problem solving, and attention to detail
  • Proficiency with MS Office (e.g., Outlook, Word, Excel, PowerPoint, Visio, etc.).


Physical Requirements:

This position primarily works in an office environment. It requires the ability to sit or stand for long periods of time and frequent walking. Daily use of a computer, phone, office equipment and other computing and digital devices is required. May be required to stand for extended periods when facilitating meetings or walking in the facilities. Some local travel may be necessary, so the ability to travel by plane, operate a motor vehicle and maintain a valid Driver's license and/or effectively navigate public transportation is required. While performing the responsibilities of the job, the employee must be able to read and respond to interoffice communications as well as effectively participate in meetings. The employee is often required to sit and use their hands and fingers, to lift up to 20 lbs., pull, push, carry, handle or feel. The employee is required to carry, handle items, reach with arms and hands, to stoop, kneel, or crouch; talk or hear. Mental demands may require prolonged concentration, reading comprehension, understanding and interpretation of concepts, ideas and philosophies. The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described unless such accommodations would cause Avanir an undue burden.

Work Environment:

While performing the responsibilities of the job, these work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job unless such accommodations would cause Avanir an undue burden. While performing the duties of this job, the employee is occasionally exposed to moving carts, mechanical equipment (copiers, computers, coffee machines) and vehicles. May be subject to smells and odors. The noise level in the work environment is usually quiet to moderate. The passage of employees through the work area is average and normal.

EEO Statement:

As an equal opportunity employer, Avanir Pharmaceuticals is committed to providing all applicants and employees with equal access to employment opportunities, regardless of sex, race, age, color, national origin, ancestry, disability, pregnancy, religion, genetic information, sexual orientation transgender status, gender identity, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law. All Avanir Pharmaceuticals employees, officers, principles, agents, and representatives are expressly prohibited from engaging in unlawful discrimination. Consistent with federal, state, and local requirements, Avanir Pharmaceuticals will reasonably accommodate any qualified individual with a disability if such accommodation would allow the individual to perform the essential functions or the job, unless doing so would create an undue hardship.

Avanir Pharmaceuticals shall abide by the requirements of 41 CFR-60-300.5(a) and 60-741.5(a). These regulations prohibit discrimination against qualified individuals on the basis of protected veteran status or disability, and require affirmative action by covered prime contractors and subcontractors to employ and advance in employment qualified protected veterans and individuals with disabilities.