Avanir Pharmaceuticals

Associate Manager, Clinical Recruitment

Location
Aliso Viejo, CA, United States
Posted
Feb 11, 2021
Ref
R2600
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
The Associate Manager, Clinical Recruitment is responsible for planning, coordinating, and implementing patient recruitment and retention operational plans and/or patient recruitment vendors on assigned Avanir Pharmaceuticals studies. The Associate Manager, Clinical Recruitment collaborates with internal human resources and external providers to ensure alignment on recruitment/retention tactical plans, KPIs, and reporting. This role also facilitates the MLR material review process for Clinical Recruitment materials. The MLR review process requires close collaboration with the clinical teams, MLR members, and external vendors to ensure successful coordination of all patient recruitment/retention material submissions.

Essential Job Functions:

MLR Material Submissions
  • Works cross-functionally to ensure materials meet basic approval objectives prior to MLR submission. Monitors progress, identifies risks and proposes solutions/improvements
  • Prepares materials and provides support for applicable meetings, audits/inspections, and other related activity
  • Initiates and/or implements internal or client procedures, processes or programs that result in continuous improvements for material review and business requirements
  • Ensures that change control processes are followed to maintain accuracy of change during versioning of documents
  • Supports the preparation of domestic and/or international materials for submission to MLR and prepares materials for subsequent regulatory submission and/or translations
  • Updates designated databases/internal sites containing department information according to SOPs
  • Compiles department metrics; prepares summary reports for department management and designated stakeholders
  • Attends MLR meetings to support department activities and ensures applicable study team designee is available for MLR meeting
  • Performs quality check of materials for regulatory compliance


Patient Recruitment/Retention Tactical Support
  • Support identification, selection and management of external patient recruitment vendor partners in completion of the scope of work, objectives, quality of deliverables, and other activities of projects as deemed necessary
  • Coordinate and track project activities and resources to ensure that project deliverables and milestones are met
  • Support content development and present materials during internal and external meetings as requested
  • Communicate with sites regarding Recruitment and Retention activities, including but not limited to; making follow-up calls regarding patient referrals, tracking logs, processing of Recruitment and Retention materials, etc.
  • May represent Patient Recruitment with sites on the conduct of centralized Recruitment and Retention efforts (e.g. follow up with sites for missing documents, answer site questions, conduct Recruitment and Retention teleconferences with sites, etc.)
  • Maintain data tracking entries into designated tracking systems and tools in accordance with project requirements
  • Ensure all patient recruitment and retention tools are processed through internal review and internal approvals are submitted for ethics review
  • Manage tracking patient recruitment and retention materials to ensure the current approved versions are available in the shared drive for team members
  • Provide Management with periodic report generation and review
  • Other duties as assigned by Management
  • 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:
  • Minimum BA/BS preferably in a scientific or health-related discipline or equivalent combination of education, training, and/or commensurate experience in the clinical research industry
  • 5+ years of experience in the pharmaceutical/biotechnology industry
  • Strong understanding of industry practice, scientific principles and regulatory/quality systems in the drug development process.
  • Experience with contracting activities and managing vendors
  • Experience in process development/management
  • Experience working on process improvement initiatives
  • Demonstrated strengths in planning, organizational, analytical skills, oral and written communication, time management, conflict management, problem solving, and attention to detail
  • Excellent written and verbal communication skills and strong interpersonal skills necessary to interface with team members and direct reports
  • Understanding of FDA and ICH regulations
  • Ability to work effectively within a team matrix as well as independently
  • Some travel may be required


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.