Job Description
Innova Solutions has a client that is immediately hiring for a Clinical Trials Disclosure Specialist Position type: Full-time Contract Duration: 12 months Location: Giralda Farms (or) Lawrenceville, NJ As a Clinical Trials Disclosure Specialist, you will: The Clinical Trial Disclosure Senior Specialist will provide the operational support of: * Redaction of clinical trial documents in accordance with evolving global regulations. Key business partners are Clinical Development/Early Development Leads, Global Development Operations, Global Biostatisticians, Publications, Information Technology, Alliance Partners, Medical Writing, and Submission Managers. Key Responsibilities and Major Duties: * Manage and Coordinate redaction of clinical documents in accordance with EMA Policy 0070, Health Canada Public Release of Clinical Information (PRCI), EU Clinical Trial Regulation, and other global regulations. * Collaborate with Global Development Operations, Global Biostatisticians, Medical Writing, Submission Managers, and other stakeholders to operationalize redaction requirements * Provide vendor oversight to support document redactions * Work with IT, as needed, to implement technology solutions related to clinical trial disclosure * Manage and track redaction book-of-work; compile and report on volume and performance metrics * Provide operational support to CT Results Specialists, as required * Assists in monitoring the global regulatory environment and maintains working knowledge of disclosure requirements * Communicates with internal and external stakeholders to improve on processes and manage unmet need * Trains new staff and develops job aids, work instructions, and user guides, as needed Candidate requirements: * BA/BS or MA/MS in scientific or medical field * 2-3 years of document redaction and 3+ years relevant work experience in a scientific or medical field with BA/BS * Deep understanding of US/Canada and EU requirements for clinical trial disclosure as well as other related policies (ICMJE, PhRMA/EFPIA principles for responsible data sharing, etc.) * Familiarity and comfortability working with and discussing scientific data * Project and stakeholder management experience. Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible. We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW. Thank you! Sara Almas Team Recruitment Sara.Almas@innovasolutions.com PAY RANGE AND BENEFITS: Pay Range*: Between $30.00- $ 37.06 per hour *Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc. Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP). ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields. Recent Recognitions: * Named One of America's Best Employers for New Grads by Forbes (2024 * Named One of the Best Companies to Work for by U.S. Ne