Clinical Trials Disclosure Specialist
Company: Innova Solutions
Location: Madison
Posted on: October 27, 2024
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Job Description:
Innova Solutions has a client that is immediately hiring for a
Clinical Trials Disclosure SpecialistPosition type: Full-time
ContractDuration: 12 monthsLocation: Giralda Farms (or)
Lawrenceville, NJAs 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 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:
Keywords: Innova Solutions, Greenwich , Clinical Trials Disclosure Specialist, Healthcare , Madison, Connecticut
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