Clinical Services Associate

0-5 years

Not Disclosed

Bridgewater

12 June 17, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Location: US-NJ-Bridgewater, New Jersey, US

Company: Bausch + Lomb

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.

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 170-year history. We have a significant global research, development, manufacturing, and commercial footprint of approximately 13,000 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.

Position Objectives

Reporting directly to VP, Clinical Services, this role is responsible for providing administrative support to the Clinical Services department, coordinating logistics for the department, and support related to the implementation and execution of clinical studies.

Responsibilities

Provides direct technical and administrative support to the VP, Clinical Services on required tasks related to the clinical services department
Assists the clinical services team in the conduct and execution of clinical trials that include, but are not limited to: clinical planning, protocol development, essential document development, IRB submissions, CDAs and investigator agreements, and Trial Master File preparation and oversight
Supports Clinical Operations team to ensure compliance with FDA and other applicable international regulatory requirements and company standard operating procedures (SOPs) during all clinical investigations and post-market studies 
Supports clinical operations in communication with clinical trial sites regarding study conduct, monitoring, logistical management of follow-up and close out study visits to ensure compliance with protocols and GCP requirements 
Assists in tracking study specific payments and invoices
Assists in ensuring training for department requirements are met (including but not limited to: SOP training, GCP training, corporate training)
Assists in planning department meetings and providing logistical support related to Clinical Services meetings (in-person or remote)
Provides operational or work flow support to assure that departmental and cross functional systems and procedures are efficiently and correctly completed 
Collaborates on project teams, primarily with Research and Development, Regulatory, Safety, and Quality/Compliance 
Supports clinical operations members with administrative documents related to all clinical study programs, TMFs, and study start up activities
Provides support for registration and maintenance of clinical trials on registration sites, including CT.Gov and other registration websites
Assists and supports clinical operations team in presentations of clinical information concerning specific projects 
Works on projects of moderate-to-high degree of difficulty in which analysis of situation or appropriate judgment and flexibility is required and should be exercised.

Requirements

Bachelor’s degree in a health profession or science.
Experience with administrative support and planning.
Knowledge of medical terminology.

Ability to effectively work independently and good organizational skills.
Excellent verbal and written communication skills plus computer proficiency (Word, Excel, Outlook CTMS & eTMF). 
Travel may be required (minimal)

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

This position may be available in the following location(s): US - Bridgewater, NJ

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.

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

To learn more please read Bausch+Lomb's Job Offer Fraud Statement.

Our Benefit Programs: https://www.bausch.com/careers/benefits/

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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