Clinical - Clinical Trials Disclosure Specialist - Net2Source
Madison, NJ 07940
About the Job
Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap Right Talent Right Time Right Place Right Price and acting as a Career Coach to our consultants.
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
Why work with us - At Net2Source, we believe everyone has an opportunity to lead. We see the importance of your perspective and your ability to create value. We want you to fit in with an inclusive culture, focus on work-life fit and well-being, and a supportive, connected environment; but we also want you to stand out with opportunities to have a strategic impact, innovate, and take necessary steps to make your mark. We help clients with new skilling, talent strategy, leadership development, employee experience, transformational change management and beyond.
Equal Employment Opportunity Statement:
Net2Source is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion or sexual orientation. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.
Awards and Accolades:
" America's Most Honored Businesses (Top 10%)
" Awarded by USPAAC for Fastest Growing Business in the US
" 12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020)
" Fastest 50 by NJ Biz (2020, 2019, 2020)
" INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list)
" Top 100 by Dallas Business Journal (2020 and 2019)
" Proven Supplier of the Year by Workforce Logiq (2020 and 2019)
" 2019 Spirit of Alliance Award by Agile1
" 2018 Best of the Best Platinum Award by Agile1
" 2018 TechServe Alliance Excellence Awards Winner
" 2017 Best of the Best Gold Award by Agile1(Act1 Group)
Regards
Recruiter name
Designation
Office: (201) 340-8700 x XXX | Cell: (201) xxx xxxx | Fax: (201) 221-8131| Email:
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
Why work with us - At Net2Source, we believe everyone has an opportunity to lead. We see the importance of your perspective and your ability to create value. We want you to fit in with an inclusive culture, focus on work-life fit and well-being, and a supportive, connected environment; but we also want you to stand out with opportunities to have a strategic impact, innovate, and take necessary steps to make your mark. We help clients with new skilling, talent strategy, leadership development, employee experience, transformational change management and beyond.
Equal Employment Opportunity Statement:
Net2Source is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion or sexual orientation. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.
Awards and Accolades:
" America's Most Honored Businesses (Top 10%)
" Awarded by USPAAC for Fastest Growing Business in the US
" 12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020)
" Fastest 50 by NJ Biz (2020, 2019, 2020)
" INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list)
" Top 100 by Dallas Business Journal (2020 and 2019)
" Proven Supplier of the Year by Workforce Logiq (2020 and 2019)
" 2019 Spirit of Alliance Award by Agile1
" 2018 Best of the Best Platinum Award by Agile1
" 2018 TechServe Alliance Excellence Awards Winner
" 2017 Best of the Best Gold Award by Agile1(Act1 Group)
Regards
Recruiter name
Designation
Office: (201) 340-8700 x XXX | Cell: (201) xxx xxxx | Fax: (201) 221-8131| Email:
Source : Net2Source