Clinical Study Coordinator

The Clinical Study Coordinator/Clinical Trial Manager (CSC/CTM) role is to define clinical execution plans and delivery of high quality clinical studies for the Baby, Family and Feminine Care (BFF) business units as part of Research & Development at P&G. Clinical studies are used in claims, safety and credentialing. The CSC/CTM works closely within a cross-functional team with Clinical Scientists/Project leaders, Clinical Data Managers, Clinical Statisticians, Safety, Regulatory and Product Development partners to drive Life Science methods and capability for clinical study work within the BFF Sector. As an integral member of the clinical team, the CSC/CTM will lead:

• Study execution planning and logistics of timelines, budget development, expense tracking, training and capability-building at clinical sites on study protocols, procedures and methods
• Monitor studies during execution according to clinical standard operating procedures (SOPs) with Good Clinical Practices (GCP) study conduct and documentation standards for compliance.
• Some of the work of the CSC/CTM within BFF will be on internal study executions and some of the work will be with external clinical sites, CROs and academic/hospital partners.

Qualifications

• Scientific and/or allied health/medical background and/or experience preferred, e.g. nurse, medical lab technician, or other relevant life sciences training and experience, i.e. lab experience and/or scientific background and training.
• People skills for working directly with functional expert team members in a research setting. This could include direct contact and work with moms/parents and babies as clinical subjects and/or working in areas of health research including women’s intimate health. Accordingly, work could be done in a BSL1 or BSL2 research lab.
• Ability to form strong collaborative networks to lead study planning and study execution across diverse technical functions and global teams.
• Excellent written and verbal communication skills for networking with medical professionals, researchers and/or consumers. This position requires professionalism to represent P&G at external clinical sites. The CSC/CTM coordinates status updates on studies and timelines to team members and managers and is the interface to the clinical study site throughout project life.
• Ability to learn and grow technical mastery of clinical endpoints, clinical instrumentations (e.g. skin measures of TEWL, pH, corneometry,) and measures (e.g. train in expert skin assessments/ grading) to enable training on these endpoints and instruments at clinical sites.
• Agility in problem-solving and change management skills when adjustments to the plan are needed in a fast-paced innovation environment.
• Detail-orientated and ability to lead study documentation and maintain critical documents for Clinical Trial Master File compliance audits.
• Prior experience as a Clinical Study Coordinator and/or Clinical Trial Manager a plus.
• Standard skills in working with Microsoft office (Word, excel, outlook and internal databases and/or documentation systems e.g. Veeva).
• Ability to travel in role to conduct trainings, start up and monitoring at clinical sites. Some business travel could be global 

   

  Our consumers are diverse and our talents – internally – mirror this diversity to best serve it. That is why we’re committed to building a winning culture based on Inclusion and our ideal candidate is passionate about the same principle: you will join our daily effort of being “in touch” so we craft brands and products to improve the lives of the world’s consumers now and in the future. We want you to inspire us with your unrivaled ideas.

• All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, disability status, age, sexual orientation, gender identity and expression, marital status, citizenship, HIV/AIDS status or any other legally protected factor.
• Immigration sponsorship is not available for this role. As a general matter, Procter & Gamble does not sponsor candidates for nonimmigrant visas or permanent residency. However, Procter & Gamble may make exceptions on a discretionary basis. Any exceptions would be based on the Company’s specific business needs at the time and place of recruitment as well as the particular qualifications of the individual.
• Procter & Gamble participates in e-verify as required by law.
• Qualified individuals will not be disadvantaged based on being unemployed.