Allergan Clinical Scientist in Jersey City, New Jersey
Jersey City, New Jersey, United States at http://agn.referrals.selectminds.com/jobs/725/other-jobs-matching/location-only
Sep 30, 2016Post Date
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 pharmaceuticals and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular 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.
Our success is powered by our world-class team’s commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.
Join one of the world’s fastest growing pharmaceutical companies!
At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn’t just welcomed, it’s encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.
Join our bold team! Learn more at www.Allergan.com at http://www.allergan.com/ .
The role of the Clinical Scientist is to participate in all aspects of clinical development and study management under the direction of the study director or designee, which includes providing logistical and scientific support to planned and ongoing Phase II-IV clinical trials. Primary point of contact for clinical sites and vendors. Work cross-functionally and address study related issues.
Main Areas of Responsibilities
Manage the successful and timely execution of clinical trial activities through regular phone contact with sites/Regional Site Managers (RSM)/vendors, standard and ad-hoc tracking tools, and site/project status reports.
Support the development of clinical protocols. Author/review study documents (e.g. synopsis, protocol, informed consent, investigator brochures).
May assist with reviewing the monitoring plan, data management plan, and statistical analysis plan.
Track and manage study budgets efficiently and provide timely resolution to financial inquiries.
Contribute to site feasibility and the identification/selection of qualified investigators and study sites in collaboration with Global Monitoring/Clinical Operations.
Support the development/implementation of patient recruitment and retention strategies.
Support vendor selection activities. Work with Contracts Management/Procurement to receive/review bid proposals, meet vendors, and contribute to vendor specifications development.
Participate in reviewing and testing of specifications and edit checks for internal (i.e. electronic data capture (EDC) and external (e.g. Interactive Voice/Web Response Systems (IVRS/IWRS), laboratory vendors) systems.
Support the planning of investigator meetings with Meeting Planning. Develop and deliver study specific training presentations as needed.
Oversee the shipment of drug supply, packaging, and labeling. Work with PR&D to ensure no delays occur.
Monitor data during the course of the study. Identify potential clinical data issues and provide senior team members with feedback to remediate issues.
Generate/resolve clinical queries in EDC when needed. Participate in SAE reconciliation with Data Management, Medical Coding, and Global Drug Safety.
Support CRO management as required for studies outsourced. Manage CRO regulatory documents, review work performed, and monitor CRO performance.
Support enrollment projections and work with sites having enrollment challenges.
Serve as initial contact for sites, Regional Site Managers, IRBs, and vendors.
Review monitoring visit reports and follow up letters. Provide Lead RSM with feedback on monitoring activity and RSM trends.
Respond to all issues, recommend corrective actions, follow up, and document results.
Report high-level issues to senior staff with an organized approach. Provide viable options for resolution based on prior experience and current study trends.
Participate in site audits and review findings to resolve issues. Perform clinical site visits with study coordinators and principal investigators as needed to address/resolve issues.
Provide necessary training/retraining to sites as the study warrants.
Work with Biostatistics and Data Management to ensure data collected meets standard requirements and can be analyzed.
Assist in the review TFLs and SAS outputs of cleaned data at test runs and database close.
Contribute to the development of clinical study report.
Oversee reporting and updates to Clinicaltrials.gov and the Forest trials registry.
Participate in and contribute to clinical team meetings, RSM meetings, and site staff meetings. Support the timely execution of milestones and discuss important study related information.
Oversee work performed by junior staff members and support the review and assignment of activities.
Mentor junior staff members to improve quality and maintain team morale.
Contribute to process improvement efforts including task forces and committees.
May contribute to the review for SOPs, training guidances, and templates as needed.
May deliver training related to day-to-day responsibilities, study execution and Forest policy and procedures for new hires within department.
May perform clinical research related to study design and assist with submissions activities and/or responses to FDA inquiries as required.
At least 3-4 years clinical research experience in the pharmaceutical industry or CRO
Demonstrated experience supporting the development, implementation, and completion of clinical trials
Knowledge of drug development and FDA GCP/ICH regulatory guidelines
Understanding of clinical trial design and basic knowledge of statistics
Proficiency with Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, and Adobe Acrobat
Electronic data capture (EDC) system (PhaseForward InForm) background
Must possess excellent skill/ability in the following:
Oral and Written Communication
Planning and Organizing
Decision Making, Judgment, and Problem Solving
People Relationships, Team Building, Motivating Employees, and Influencing Others
Initiative and Accountability
Ability to interact with different functional groups
Experience in Phase II-IV clinical trials is preferred
Medical and/or scientific knowledge in specific therapeutic area is a plus
Some document authorship experience (e.g., protocols) is preferred
Site/vendor management and data review experience is preferred
Prior field monitoring experience/background is a plus
Facilitation and Presentation skills is preferred
Skill/ability Mentoring/Training new employees is preferred
- Bachelor’s degree in life sciences/health-related field