Allergan Sr Clinical Trial Management Associate in Irvine, California

Sr Clinical Trial Management Associate

Irvine, California, United States at https://agn.referrals.selectminds.com/jobs/6206/other-jobs-matching/location-only

Aug 03, 2018Post Date

182111Requisition #

Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.

Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.

Position Overview

The Sr Clinical Trial Management Associate assists the Clinical Trial Manager (CTM) or Operations Study Lead (OSL) in the operational execution of assigned clinical studies. Depending on the experience of the incumbent, they may be assigned to manage a small study as a Clinical Trial Manager (CTM).

The employee is expected to be fully capable of performing all the roles encompassed in the preceding grade levels within the job family as required by the organization. Other activities, special projects and assignments may be assigned as required. As a result, the percentage of time spent across key duties listed below for which the employee is responsible for or assisting with will vary.

The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Allergan policies and procedures.

Main Areas of Responsibilities:

Clinical Trial Management Associate

The incumbent supports the CTM/OSL in ensuring the assigned clinical study(ies) are run to time and budget and are completed in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Allergan policies and procedures. The incumbent may also be asked to participate as a Global Clinical Trial Representative in cross-functional teams such as Case Report Form Review Team and Clinical Trial Team.

The incumbent assists the CTM/OSL in all aspects of a clinical study(ies) including, but not limited, to the tasks specified below.

Study Concept, Planning and Strategy Phase

The incumbent is responsible to assist the CTM/OSL and FACT team with regional study feasibility, the initial assessment of any vendors, supplies planning and the development of study specific documents and timelines as required.

Study Initiation Phase

The incumbent assists the CTM/OSL in region-specific document development including the informed consent forms; regional investigator meetings/presentation of materials; the development of regional enrollment initiatives; and planning regional clinical study supplies. They assist in obtaining the required translations, collecting non-essential documents from site and ensuring sites are trained in collaboration with the site monitor.

Study Management/Conduct Phase

The incumbent assists the CTM/OSL in: regional financial management; database lock activities; regional study drug management; regional trial master file management; regional study enrollment management (e.g. contingency plan execution); periodic review of protocol deviations; regional vendor management; and ensuring adverse event reporting.

Clinical Trial Manager

The incumbent ensures the assigned clinical study is run to time and budget and is completed in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Allergan policies and procedures. The incumbent is responsible for all aspects of the clinical study including, but not limited, to the tasks specified below.

Study Concept, Planning and Strategy Phase

The incumbent is responsible to work with the FACT team to conduct study feasibility. They are responsible for the initial assessment of any vendors, supplies planning and the development of study specific documents and timelines as required.

Study Initiation Phase

The incumbent is responsible for document development including the informed consent forms; regional investigator meetings/presentation of materials; the development of regional enrollment initiatives; and planning regional clinical study supplies. They are overall responsible in obtaining the required translations, collecting non-essential documents from site and ensuring sites are trained in collaboration with the site monitor.

Study Management/Conduct Phase

The incumbent is overall responsible for the following: study financial management; database lock activities; study drug management; trial master file management; study enrollment management (e.g. contingency plan execution); ongoing review of protocol deviations; vendor management; and ensuring adverse event reporting.

Close-Out Phase

The incumbent is overall responsible for the following activities: database lock activities; ensuring all documents are filed in the TMF appropriately; ensuring all close-out activities are completed; ensuring study documentation is properly archived when the study is considered completed.

The incumbent is expected to complete their assigned tasks within agreed upon project priorities, timelines and quality specifications.

Global R&D personnel

The incumbent is responsible for completing all required training to execute their job and maintain their training records. They are responsible for reporting any potential GCP violations either internally or externally to their manager and participate in any corrective and preventative action plans as appropriate. They are responsible for reporting any safety concerns to the appropriate department including but not limited to Serious Adverse Events. In addition, the employee is responsible for documenting key communications from either internal or external sources in the study file.

General Compliance and Other Role

The incumbent is responsible for adherence to all relevant regulations including ICH, PhRMA and CFR guidelines, as well as Allergan’s policies, SOPs and Work Instructions. Ongoing training in compliance areas and therapeutic specific knowledge is expected in order to maintain a solid knowledge base for performing assigned tasks.

Requirements

  • Good Clinical Practices, ICH guidelines, PhRMA code, CFR Guidelines, clinical research ethics, HIPAA and patient privacy laws (plus applicable local regulations, when country-based),

  • Knowledge of concepts of clinical research and drug development, and

  • General therapeutic area education and training .

  • Ability to travel up to 20% of time

  • Note: While this job description is intended to be an accurate reflection of the job requirements, management reserves the right to modify, add or remove duties from a particular job and to assign other duties as necessary and at any time.

Preferred Skills/Qualification

  • Previous experience of working on a clinical study

  • Oversight or mentoring of more junior staff (direct or indirect) preferred

  • Handle and prioritize multiple tasks simultaneously,

  • Work effectively in a team/matrix environment,

  • Understand technical, scientific and medical information,

  • Handle conflict management and resolution,

  • Understand clinical study budgets,

  • Plan, organize, project manage and analyze data, and demonstrate full competency in Microsoft Office programs.

Education

  • Science degree preferably in science or health-related field

LI -AL1*

Equal Employment Opportunity Employer

Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.