Clinical Outcomes Analyst, Sr. jobs in Newark, NJ

Company Description

SGS is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. With over 97,000 employees in 130 countries and operating a network of more than 2,400 offices and laboratories, we provide services to almost every industry by assuring quality and safety of products and services.

Trusted all over the world, SGS is a market leader because we put 100% passion, pride and innovation into everything we do. We encourage new ideas. We welcome people who challenge the way we do things. And we will be 100% committed to helping you reach your full potential.

Job Description

The Sr Clinical Investigator, CRS oversees the clinical research of consumer products involving healthy paid volunteers. Develops research studies and creates standards and guidelines for clinical research services and programs. Ensures adherence to standard operating procedures, good clinical practice and FDA regulations. Manages staff directly and through subordinate managers, has full authority for personnel actions.

• Oversees the clinical research of consumer products involving healthy paid volunteers.
• Writes protocols, collects and reviews data, prepares progress reports, analyzes results, writes summaries and conclusions and issues reports.
• Develops, maintains and reviews Standard Operating Procedures (SOPs). Ensures that study personnel have access to SOPs and that SOPs are followed.
• Conducts and / or supervises studies in accordance with the protocol and SOP’s.
• Protects the rights, safety and welfare of subjects.
• Interfaces with the Sponsor, staff, contractors, professional societies, Institutional / Investigational Review Board (IRB), subjects, government agents / agencies and other business units. Obtains appropriate information, documentation and signatures.
• Notifies the Sponsor and / or IRB of any changes to or deviations from the protocol and document changes and deviations.
• Delegates duties, as appropriate. Ensures that all individuals working on the study have necessary credentials, are adequately trained, understand their obligations and are properly supervised.
• Provides a sufficient number of trained staff members to be assigned to each study. Maintains training records of staff members.
• Ensures that the Informed Consent (IC) is clear and accurate so that subjects can understand the IC. Provides the opportunity for subjects to ask questions about the IC. Ensures that subjects have signed the IC.
• Maintains appropriate accurate and complete records of test materials, including amount received, amount dispensed and disposition, both current and historical. Assures confidentiality of records.
• Maintains a safe and hygienic facility.
• Handles any unanticipated occurrences on a case-by-case basis.
• Notifies the Sponsor and the IRB about Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Reactions (ARs).  Follows events and reactions to resolution.
• Maintains Quality Assurance (QA). Ensures that QA Department is fulfilling all job duties.
• Provides reasonable medical care for any medical problems that are related to the research.
• Provides general direction, motivates and manages subordinate staff in the day-to-day performance of their jobs.
• Has full supervisory responsibility of direct and indirect reports (hiring: interviewing, selection; planning work, scheduling, performance evaluations, performance management and termination)
• Instructs employees on the confidentiality aspects of analytical reports and information, and perform periodic reviews
• Possesses knowledge and complies with applicable FDA / Governmental / International regulations.
• Adheres to internal standards, policies and procedures.
• Performs other duties as assigned.
• Manages staff directly and through subordinate managers, displays an entrepreneurial "hands-on" management approach
• Has full authority for personnel actions

Qualifications

• Must possess a PhD, M.D., D.O., or similar post-graduate degree in Science, Medicine, or Engineering (Required)

• 7 years of experience in a related field (Required)

• 5 years of managerial experience (Required)

• Dermatology background, sunscreen and cosmetic testing experience (Required)

Additional Information

SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.

This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company’s rights to assign or reassign duties and responsibilities to this job at any time.

If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call 201-508-3149 for assistance and leave a message. You will receive a call back.  Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.