Job Description
Job Description
: Role is 50% onsite
CW can work from Giralda Farms, NJ. or Lawrenceville, NJ
Position Summary:
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
• Demonstrated ability to work independently and seek out support when needed
• Exceptional written and oral communication skills
• Strong organizational skills with the ability to multitask and prioritize
Job Tags
Work experience placement,
Similar Jobs
Compass Group
...STOP to opt out or HELP for help. Terms and conditions: Founded in 2005 as Hudson Yards Catering, Union Square Events is a culinary and operations leader in the hospitality industry, partnering with a diverse portfolio of best-in-class clients. We produce one-of...
Johns Dental Lab
...Digital Dental Technician Job Description: Johns Dental Laboratories is seeking a Digital Dental Technician. Since 1939, our mission has been to provide the highest level of quality in all of our dental prosthetics and appliances-one case at a time. We do this by employing...
LingaTech
...onsite), Fulltime Contract Length: 6+ Months Location: The Dynamics 365 CE Developer shall be 100% allocated to this project and... ...Responsibilities: Configure and develop the clients Microsoft CE CRM system based on the functional and technical tasks developed as...
State of Minnesota
...Working Title: Live Chat Agent Job Class: Office and Administrative Specialist, Intermediate Agency: Public Safety Dept... ...state agencies are equal opportunity, affirmative action, and veteran-friendly employers. State agencies are committed to creating...
Gpac
My client is looking to hire a Building Maintenance Supervisor! I'm partnered with a well-established and reputable Real Estate Investment firm looking to add to add a Building Maintenance Supervisor to their growing team. This is a successful and growing company specializing...