Allergan is a multi-specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life?s potential. Today, we have 11,000+ employees highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics, medical devices and over-the-counter consumer products, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including eye care, neurosciences, medical aesthetics, medical dermatology, breast aesthetics, and urologics, Allergan is proud to celebrate 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work.
About the Position:
The Clinical Study Management Associate is expected to assist the Global / Regional Study Manager in the operational execution of clinical studies. The employee is responsible for performing tasks as assigned by their manager which includes but is not limited to preparing, collecting, and tracking master study level documents and site non-regulatory documents, reviewing, updating, and testing clinical systems, producing reports on clinical status, trends, and metrics, facilitating communication across Allergan departments, supporting the monitoring team and study sites with relevant study information, and supporting clinical operations. The employee is expected to complete their assigned tasks within agreed upon project priorities, timelines and quality specifications.
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 given as required. As a result the percentage of time spent across both roles for which the employee is responsible for or assisting with will vary depending on project assignments, current development projects and the requirements within the organization as a whole.
The employee must conduct their work activities in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines as well as all Allergan policies, and procedures. Allergan policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
Study Management Associate
The employee ensures all site related activities and files are completed per the SOPs. The employee is a key point of contact for study specific questions from both internal (eg, site monitors, clinical services specialist) and external (eg, site personnel, vendors) customers. They facilitate communication across departments and elevate site and study issues as appropriate.
The employee reviews clinical data through monitoring reports and data listings in order to monitor overall clinical data quality and identify and resolve potential study or site issues as appropriate. They perform quality checks of all study plans (eg, monitoring plan) and study reports. They review and code protocol deviations.
The employee sets-up, tests, reviews, and updates clinical systems (eg, CTMS) and tracking tools. They are responsible for collecting and tracking study specific data and producing clinical status, trend, and metric reports to assist the manager in proactive study management and contingency planning.
The employee is responsible for the logistical tasks associated with the preparation, collection, review and tracking of the master and site non-regulatory file documents. They will ensure the accuracy and completeness of all study files prior to final archival.
The employee is responsible for completing all required training to execute their job and maintain 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 employee 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.
Preferred candidates will have:
* B.A./B.S. preferably in science or health-related field
* Two (2) years clinical research experience or related experience with a Bachelor's Degree, or
* No clinical research experience with a Master?s or higher level degree
* Monitoring experience is preferred
* 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
* Competencies and essential skills in the following: cross functional relationships, communication, decision making, execution/results/process improvement, customer satisfaction
* Ability to handle and prioritize multiple tasks simultaneously
* Work effectively in a team/matrix environment
* Understand technical, scientific and medical information
* Handle conflict management and resolution
* Advanced computer skills in Microsoft Office
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