Allergan Sr. Clinical Scientist in Jersey City, New Jersey
Sr. Clinical Scientist
Jersey City, New Jersey, United States at http://agn.referrals.selectminds.com/jobs/727/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 Senior Clinical Scientist is to guide and participate in all aspects of clinical development and study management under the direction of the study director, which includes providing logistic and scientific support to planned and ongoing Phase II-IV clinical trials. May support more than one clinical protocol. Work cross-functionally to ensure alignment across studies and to achieve the corporate objectives for programs.
Main Areas of Responsibilities
Manage and monitor the progress and deliverables of clinical trials through the clinical team’s regular contact with sites/Regional Site Managers/vendors, standard and ad-hoc tracking tools, and site/project status reports.
Actively contribute to the design of clinical protocols. Author/oversee/review study documents (e.g. synopsis, protocol, informed consent, investigator brochures).
Assist with reviewing the monitoring plan, data management plan, and statistical analysis plan.
Support the development and management of study budgets for clinical programs. Track and manage site budgets efficiently and provide timely resolution to financial inquires.
Work with Project Management to establish, report, and update timelines.
Support site feasibility and the identification/selection of qualified investigators and study sites in collaboration with Global Monitoring/Clinical Operations.
Assist with the development of patient recruitment and retention strategies.
Evaluate potential vendors. Work with Contracts Management/Procurement to receive/review bid proposals, meet vendors, and contribute to vendor specifications development. Address any escalated issues related to contract negotiations as needed.
Review, test, and approve specifications and edit checks for internal [electronic data capture (EDC)] and external [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.
Interact with PR&D to ensure adequate clinical supplies for the clinical trial. Oversee the shipment of drug supply, packaging, and labeling.
Monitor and review clinical data for trends/errors during the course of the study.
Identify potential clinical data issues and provide management with feedback to remediate issues.
Collaborate with the Study Physician and Global Drug Safety in the review and management of safety related issues and serious adverse events.
Generate and oversee clinical queries in EDC when needed.
Manage interactions and drive results of vendors and CROs for studies outsourced.
Oversee enrollment projections and work with sites having enrollment challenges.
Serve as primary contact for sites, Regional Site Managers, and vendors.
Respond to high-level/escalated issues, recommend corrective actions, follow up, and document results.Support 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.
Review TFLs and SAS outputs of cleaned data at test runs and database close.
Assist with reviewing topline results and preparing presentations for senior management as needed.
Contribute to the development of clinical study report, Annual Reports, ISE/ISS.
Ensure appropriate information is reflected and posted on Clinicaltrials.gov and the Forest trials registry.
Lead/facilitate clinical team meetings, RSM meetings, and site staff meetings. Coordinate the timely execution of milestones and discuss important study related information.
May manage direct reports or supervise clinical study team member(s) as assigned.
Recruit, develop, and supervise direct report(s).
Conduct employee performance evaluations and provide direct report(s) with guidance on technical/project related issues and employee relations.
Mentor and guide junior staff members to improve quality and maintain team morale.
May develop and deliver training related to study execution and Forest policy and procedures within department and cross-functionally.
Contribute to process improvement efforts including task forces and committees.
Contribute to the review for SOPs, training guidances, and templates as needed.
May contribute to the development of clinical development plans for assigned program.
May provide direct oversight and management over a number of clinical sites as part of study.
May assist with preparations for Advisory Board and Steering Committee meetings.
May contribute to scientific/clinical evaluation of potential in-licensing candidates.
May interact with Medical Affairs regarding publications support.
May perform clinical research and contribute to submissions activities and/or responses to FDA inquiries as needed.
5 years of drug development experience in the pharmaceutical industry or CRO
Demonstrated experience supporting and managing the development, implementation, and completion of clinical trials and/or programs
Experience with Phase II-IV clinical trials
Some document authorship experience (e.g., protocols, study reports, manuscripts)
Site/vendor management and data review experience
Knowledge of drug development and FDA GCP/ICH regulatory guidelines
Strong 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
Developing People and Staffing
Initiative and Accountability
Promoting Innovation and Process Improvement
Certification in Clinical Research is a plus
Expertise in specific therapeutic area or broad scientific/medical knowledge is preferred
Project management experience is preferred
Supervisory experience is a plus
Prior field monitoring experience/background is a plus
Experience with CROs and working on global studies is a plus
Management skill/ability in the following is a plus:
Assigning work, Reviewing work, Planning other’s work
Maintaining activities and Coordinating activities
Recommending salary actions, transfers/promotions/demotions, discharges
Doing performance evaluations and participating in performance evaluations
Selecting new employees, Training new employees
Ability to identify issues, analyze situations and provide effective solutions
Ability to manage multiple tasks in a timely, budget-conscious manner in a matrix environment
Participation in multi-disciplinary project teams
- Bachelor’s or advanced degree (Master’s, PharmD, PhD) in life sciences/health-related field