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 world from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.
Key Activities/Responsibilities:- Leads or collaborates on required tasks prior to commencement of clinical trials that include 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.
Requirements:- Bachelor’s degree in a health profession or science.
- Minimum 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.
We offer competitive salary & excellent benefits including:- Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date.
- 401K Plan with company match and ongoing company contribution.
- Paid time off – vacation (3 weeks - prorated upon hire), floating holidays and sick time.
- Employee Stock Purchase Plan with company match.
- Employee Incentive Bonus.
- Tuition Reimbursement (select degrees).
- Ongoing performance feedback and annual compensation review.
Salary Transparency:As required by various state laws, Bausch + Lomb provides a good faith minimum and maximum salary range of compensation for roles that can or will be performed in specific states. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location. For Colorado, New York City, California, Washington, and New York State, the range of starting annual base pay for this role is $100,000 - $140,000.
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.
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
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