Bausch + Lomb Senior Manager, Clinical Trials in Parsippany, New Jersey
Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the worldfrom the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.
Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our nearly 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 12,500 employees and a presence in approximately 100 countries , extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.
Leads or collaborates on required tasks prior to commencement of clinical trials that include, but are not limited to: clinical planning, protocol development, case report form (CRF) development, IRB submissions, investigator agreements, informed consent form (ICF) development, site selection and communication with clinical trial sites regarding all logistics including contract agreements, support materials and training.
Provides clinical oversight and management for clinical trials to facilitate compliance with FDA and other applicable international regulatory requirements and company standard operating procedures (SOPs) during all company clinical investigations and post-market studies.
Communicates with vendors and clinical trial sites regarding study conduct, data monitoring, logistical management of follow-up and close out study visits to ensure compliance with protocols and GCP requirements.
Collaborates on clinical data processing in accordance with departmental SOPs and guidelines.
Verifies, reviews and tracks CRFs and generates Data Clarification Forms (DCFs) for all missing or inaccurate data; ensure that data changes are properly implemented and captured in the database or data system.
Assists in the evaluation and analysis of clinical trial data to facilitate completion of clinical trial reporting requirements, including report writing, clinical photo-documentation, FDA and manuscript submissions.
Assists in tracking study specific payments.
Provides operational or workflow support to assure that departmental and cross functional systems and procedures are efficiently and correctly completed.
Collaborates on project teams, primarily with Clinical Operations, Research and Development, Safety, Clinical Trial Materials, Marketing, Regulatory and Quality/Compliance.
Leads or collaborates on technical writing projects which include white papers, abstracts, manuscripts, and literature reviews.
Liaison between internal and external stakeholders to facilitate cooperation of others.
Conducts presentations of clinical information concerning specific projects.
Works on projects of moderate-to-high degree of difficulty in which analysis of situation or data requires review of identifiable clinical factors and in which scientific and clinical perspectives should be incorporated.
Bachelor’s degree in a health profession or science. Advanced degree preferred.
At least 5 years of on-going clinical trials experience in the pharmaceutical or device industry. Both is preferred.
Demonstrated proficiency in knowledge of GCPs and knowledge of FDA regulatory requirements.
Knowledge of medical terminology.
Ability to effectively work independently.
Excellent verbal and written communication skills plus computer proficiency (Word, Excel, Outlook) and data management experience.
10%-30% travel required.
Language and Verbal Skills:
Individual must have good verbal skills and written skills plus a demonstrated ability to communicate clearly and professionally.
Analytical and Reading Skills:
Ability to read analyze interpret and assist in the creation and refinement of company procedures. Ability to identify problems, collect data, draw valid conclusions, and report on findings. Ability to assist in analysis of clinical trial data. Ability to interpret articles published in medical and scientific journals relative to projects and activities in Clinical Programs. Responsible for ensuring accuracy of medical and scientific information.
This position may be available in the following location(s): [[location_obj]]
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
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