Avanir Pharmaceuticals, Inc Aliso Viejo , CA 92698
Clinical Study Manager is responsible for the oversight and management of Avanir clinical studies, including coordination with other relevant parties (e.g., other Avanir departments, contract vendors, etc.). Responsibilities include the planning, execution and completion of clinical trials according to applicable regulations and guidance; ICH Guidelines Good Clinical Practices (GCP), and Avanir SOPs, within agreed-upon timeframes and budget.
Essential Job Functions:
Provides oversight and project management of clinical studies at Avanir, including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Avanir SOPs.
Manage and facilitate development/review of all critical clinical study documents, including clinical protocols, informed consent forms, or other study-related clinical documents (e.g. Study Plans, Case Report Forms, Source Documents, Monitoring Plans, Data Management Plan, Project Management Plan, etc.)
Provide clinical operations oversight in the identification, evaluation, and selection of CROs, outside vendors (e.g., central labs, central IRB, IVRS, etc.), and investigative sites.
Supervise clinical team to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH GCP, and Avanir SOPs.
Manage, coordinate, and provide ongoing assessment, evaluation, and communication with other Avanir departments (e.g., Regulatory, Drug Safety, and Clinical Trial Materials) and external vendors (CRO, consultants, etc.) to ensure study objectives/timelines are accomplished.
Provide management personnel with timely updates on progress and changes in scope, schedule, and resources as required.
Participate in forecasting study expenditures and resourcing needs.
Ensure internal clinical team and vendors manage and monitor study-related budget and expenses to meet forecast.
Provide timely communication of any variances in budget forecast to the Clinical Department Head.
Establish communication flow with CRO and investigative sites to maximize compliance with study protocol.
Manage recruitment efforts and activities to meet study enrollment goals and timelines.
Minimum BA/BS in life sciences or equivalent college program, and/or commensurate experience in the clinical research industry; Master's Degree preferred
8+ years related experience in the pharmaceutical/biotechnology industry, including 2+ years of management experience
3+ years demonstrated work experience of successfully managing clinical trials within the pharmaceutical industry, including CRO and contract vendor management, preferably in the CNS therapeutic area.
Experience in management of international or global clinical trials is preferred
Strong project management skills
Experience in clinical site monitoring is preferred
Experience in development of essential clinical study documents, including informed consent, monitoring plans, source documents, Case Report Forms (CRFs), study recruitment plans, etc.
Experience in protocol development/writing is preferred
Both working and theoretical knowledge of ICH GCP, clinical trials management with exposure to various phases of drug/trial development life cycle preferred (e.g., Phase I- IV, start-up through close-out), scientific methods, research design, regulatory compliance, and clinical data management.
Demonstrated strengths in planning, organizational, analytical skills, oral and written communication, time management, conflict management, problem solving, and attention to detail.
Ability to supervise, direct and lead team members as well as interact with other internal staff.
Strong planning and organizational skills with ability to multi-task and plan activities as they relate to the management of clinical trials, ability to problem-solve.
Excellent written and verbal communication skills and strong interpersonal skills necessary to interface with physicians, outside vendors, consultants, and team members.
Possess advanced computer skills (Microsoft applications, spreadsheets, etc.)
Ability to work effectively within a team matrix as well as independently.
Financial management skills as applicable to oversee project expenditures.
Ability to travel up to 25% travel including ground and air required
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.
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.
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.