Allergan Global Lead Site Manager - Site Management Operations - field based in United States
Global Lead Site Manager - Site Management Operations - field based
United States at http://agn.referrals.selectminds.com/jobs/325/other-jobs-matching/location-only
Aug 23, 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.
The Global Lead Site Manager (GLSM), supports Global Site Management Operations (GSMO) on trial execution, provides monitoring oversight expertise to the team and ensures patient safety, data integrity, and timely delivery of Allergan-sponsored clinical trials when the monitoring function is outsourced to a service provider (e.g. CRO). Through transparent communication and oversight, the GLSM oversees site management execution activities outlined in the CRO scope of work, and in compliance with GCP/ICH and local laws and regulations governing the conduct of clinical research.
Main Areas of Responsibilities
Provide CRO Monitoring Oversight for the following duties and responsibilities:
Provide regular status updates to key stakeholders.
Coordinate with Global Lead colleagues, around the world, if applicable, to maintain consistency and quality.
Facilitate issue escalation within the study team and GSMO Management Team.
Participate in CRO selection activities.
Review and provide feedback on performance dashboard.
Present Site Management Expectations to CRO, providing examples and timelines for deliverables.
Ensure access is obtained to any CRO systems that will be used during the study (e.g. EDC, CTMS, IWRS).
Review and approve CVs for CRAs and proposed CRO staff as needed throughout trial.
Review and provide feedback on all project plans provided by the CRO including the Project
Plan, Communication Plan, Monitoring Plan, CRA Training Plan, Recruitment Plan, Risk Mitigation Plan.
Review and approve site selection documents.
Review and approve a percentage of sites proposed for Site Selection Visits.
Review and approve 100% of Sites recommended for Selection into the trial.
Track approvals and non-approvals.
Develop a study-specific Monitoring Oversight Plan.
Review and approve agenda and training materials/presentations to be used during CRA Training.
Provide input and feedback on Investigator Meeting agenda.
Attend the Investigator Meeting and present behalf of Allergan GSMO Team.
Monitor enrollment and verify that monitoring frequency thresholds are met per documented plans; mitigate or escalate non-compliance as needed.
Review a percentage of monitoring visit reports (Initiation -Closeout) to ensure proper reporting and escalation of events as well as compliance with visit conduct.
Track visit compliance, report compliance, and report review.
Monitor SDV and query status, Action Item resolution, protocol deviation/violation for trends and drive compliance with established expectations and scope of work.
Conduct Monitoring Oversight Visits as needed.
Hold/Attend regular meetings with the CRO to discuss monitoring deliverables and overall study management.
Verify minutes are posted and tracked.
Hold/ attend regular Site Issues meetings with CRO and escalate issues as appropriate to Director of GSMO supporting CRO Oversight.
Report overall study status through metrics via a Quarterly Monitoring Oversight Report, which is incorporated into the TMF.
Verify CRO's compliance with distribution of IND Safety Letters, as applicable.
Ensure that the TMF Transfer Agreement assigns responsibility for the study files at the end of the trial.
Reconcile aspects assigned to GSMO per Pre-Approval lnspection Readiness guidelines outlined in the CRO Oversight Manual.
Bachelor’s degree in Life Sciences or related field with 6 years of experience; MS/MD/PhD with 4 years of experience.
Six (6) years clinical study site monitoring experience.
Four (4) years’ work experience in life science or medically related field including one (1) year clinical research experience (e.g., study coordinator), preferred.
Previous experience as a Regional Lead CRA in the pharmaceutical industry preferred
One year of monitor leadership experience, preferred.
Ability to travel at least 30%.
Good understanding of Good Clinical Practices (GCP), ICH guidelines, PhRMA code, FDA CFR, clinical research ethics, HIP AA and patient privacy laws, EU Directive and other applicable local regulations.
Good understanding of the drug development process.
Knowledge of concepts of clinical research and drug development.
General therapeutic area education and training.
- Advanced computer skills (web-based programs, CTMS, Excel spreadsheets, Microsoft Project, graphics, presentation slides, electronic data capture).
Must possess excellent skill/ability in the following:
Self-starter with ability to work independently with remote or minimal supervision.
Ability to work effectively in a team/matrix environment.
Ability to influence others without direct reporting relationships.
Ability to understand technical, scientific and medical information.
Demonstrated strengths in the following areas:
Planning, organizational, project management and analytical skills
Oral and written communication
Conflict management and resolution
Attention to detail
Interpersonal and networking skills
Customer Service Orientation
Cross Functional Relationships
Strategic Decision Making