Global Clinical Research Manager
A collective energy and ambition. A place where you can make a real difference.
We’re a company that genuinely cares about our people, our products, our consumers and the environment.
Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and ownership. We have a shared passion to work hard, innovate and push boundaries.
United by the belief that when we strive for growth, anything is possible. While we might not be the largest company in our industry, we believe we can have the biggest impact because: Together We Have the Power to Win.
The individual will supervise global clinical Affairs group in the Corporate Global Product Safety & Clinical Affairs Department of Church & Dwight.
The individual will supervise three clinical staff, responsible for development of clinical program strategy, design and supervision of over 100 safety, efficacy and claim substantiation studies per year across a diverse product portfolio worldwide for North and Latin America, Europe, and Far East.
Role Accountabilities and Responsibilities
Drive innovation in product claims and strategize clinical claim substantiation based on literature data and/or testing programs
Scientifically robust design of clinical efficacy and claim substantiation studies to meet regulatory requirements and industry standards in North America, Europe and Far East for Fabric care, home care, cosmetics, personal care, medical devices, and dietary supplements.
Collaborate with multifunctional teams to develop scientifically sound testing strategies, regulatory and GLP or GCP/ICH compliant protocols to meet project goals and timing; and communicate with Product Development, Regulatory, Legal and Marketing counterparts on progress, results and interpretation of results to qualify product safety and efficacy.
Oversee global clinical standard operating procedures and collaborate with Quality Compliance Dept and clinical auditors to ensure compliance
Supervise, develop and grow clinical staff, establish/grow a network of external health care professionals, clinical expert consultants and clinical site auditors and clinical research associates across the globe and effectively collaborate with principal investigators
Responsible for protocol development and monitoring, data management, interpretation of statistical results, reporting and study closure
Monitor external literature and activities to ensure consistency and best standards for clinical safety, efficacy and claim substantiation
Education and Experience
PhD/Masters/BS from an accredited institution in biological science related field with at least 10 years of experience in consumer product/medical device/pharmaceutical industry.
Clinical study management experience with Clinical research Organizations in Europe, Latin America and Far East.
Certification in CRA or CRC is a plus.
Working knowledge of CER/BER preparation is a plus.
Skills and Competencies
Excellent oral and written communication and problem-solving skills; Flexibility to manage a wide range of product categories with different levels of complexity; well-organized, managing multiple projects simultaneously in a fast-paced environment; track record of presentations at scientific conferences and peer reviewed publications
Church & Dwight is proud to be an Equal Opportunity Employer/Veterans/Individuals with Disabilities.
For more information on our company, our brands and our culture visit us at http://www.churchdwight.com/
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DIVERSITY At Church & Dwight
Church & Dwight strives to create an environment where everyone feels free to bring their authentic self to work every day.
We win when we respect every employee for who they are – regardless of gender, age, race, ethnicity, religion, disability, veteran status, sexual orientation or any other differences. We believe that our employees’ contributions are richer because of their diversity. We aim to be a diverse, inclusive and equitable company and are determined to build a culture where people have the power to win together.
CULTURE At Church & Dwight
We care - about our people, our products, our consumers and our environment. To honor these priorities, we’ve built our culture around the tenants of courage, determination and team spirit. We’re united by our small company feel and inspired by opportunities to make our mark.Learn More
Equal Employment Opportunity for the Disabled At Church & Dwight
As an equal opportunity employer, Church & Dwight is committed to providing access and opportunities to individuals with disabilities. Applicants who require accommodation in the job application process may contact 877-809-8449 or email their resume and cover letter to firstname.lastname@example.org. Please note that these options are available only to those needing an accommodation because of a medical condition or disability. All email submissions should include “Accommodation needed” in the subject line as well as information related to the specific position you are interested in (requisition number, job title, location, etc.). Church & Dwight will not respond to inquiries made to email@example.com or 877-809-8449 that are not related to accessibility of the online application system by persons with medical conditions or disabilities. To review Church & Dwight’s Equal Opportunities Employer Policy, click link below.Learn More