Senior Manager, Technical Data Management

Company: Avanir Pharmaceuticals Inc.
Location: Aliso Viejo
Posted on: February 18, 2021

Job Description:

Senior Manager, Technical Data Management This role will be responsible for implementing and post-production change controls on all study data collecting systems. This role will work closely with the lead clinical data manager (LDM) and clinical study management on implementation and maintenance of clinical data collection technologies in accordance with CDISC standards and processing of clinical data in support of scientific, clinical, regulatory and commercial goals. Additionally, the role will lead and develop their direct reports in their career development when applicable. Role is office based; however, will consider remote.Essential Job Functions:

• Collaborate with the Head of Data Management on process improvement, implementing new technology, SOP and Work Instructions development associated with the data collecting technologies.
• In collaboration with the Lead Data Manager, Clinical Study Management, and external data vendors, develop data collecting systems (i.e., eSource, EDC, IRT, eCOA, and ePRO).--
• Review and maintain data management plans and specifications associated with data collecting systems, such as, Database Specifications, User requirements, Edit Check Specifications, Report Specifications, data integration specifications, and any other data collecting requirements documents required.
• Design and implement Electronic Case Report Forms in accordance with CDASH.
• Design and implement Interactive Response Technology (i.e., IWRS)
• Oversee UAT of data-capturing systems.
• Manage change control requests on the data collecting systems.
• Oversee and provide support of the Saama data analytical tool (including creating reports).
• Manage and train junior staff for career success and development.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:
  • BS/BA desired
  • 8+ years of Clinical Data Management experience in the pharmaceutical industry
  • 2+ years of people leader experience
  • 5+ years of hands-on Electronic Data Capture (EDC) experience
  • Proven experience with the implementation of industry data standards (CDISC, CDASH, and SDTM)
  • Proven ability and prior experience implementing data collecting systems, such as, IRT, EDC, eSource, and eCOA
  • Experience with writing SOPs, Work Instructions, Data Management Plans and Guidelines
  • Analytical and problem-solving skills, with good attention to detail
  • Excellent communication skills (oral and written) and interpersonal skills
  • Ability to thrive in a fast-paced environment with a sense of urgency and commitment to meet deadlines
  • Ability to juggle multiple tasks and prioritiesPhysical 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. Posted 3 Days Ago Full time R2601 About Us Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones. For more information about Avanir, please visit http://www.avanir.com
    
    Avanir is a subsidiary of Otsuka America, Inc. (OAI), a holding company established in the U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd. The Otsuka Group employs approximately 42,000 people globally, and its products are available in more than 80 countries worldwide. Otsuka welcomes you to visit its global website at https://www.otsuka.co.jp/en
    
    Avanir-- is a trademark or registered trademark of Avanir Pharmaceuticals, Inc. in the United States and other countries

Keywords: Avanir Pharmaceuticals Inc., Aliso Viejo , Senior Manager, Technical Data Management, Executive , Aliso Viejo, California