Senior Specialist Clinical Trial Information Disclosure (Vineland)
Employment Type: Full-Time
Join a Legacy of Innovation 110 Years and Counting!
With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group's 2025 Vision to become a "Global Pharma Innovator with a Competitive Advantage in Oncology," Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases. Job Summary:
The Senior Specialist Clinical Trial Information Disclosure manages and performs Global Clinical Trial Registration & Results Disclosure activities including registration of protocols and results postings on appropriate clinical trial registries, and development and implementation of clinical trial transparency activities in accordance with relevant laws, regulations, and SOPs. The Senior Specialist Clinical Trial Information Disclosure consults with functional groups to meet internal public disclosure processes and global regulatory requirements for registrations and results disclosure, as needed to facilitate the company's compliance with current disclosure and subsequent requirements. Responsibilities:
- Consults with relevant team functions within Clinical Development and Clinical Development Operations and other stakeholders such as Medical, IP/Legal, Biostatistics, Regulatory Affairs, and Medical Writing to review protocol information to obtain accurate, appropriate information for public disclosure. Provides teams with requirements from applicable disclosure laws and guidance and internal processes, and interprets registry/template requirements as appropriate for the study
- Enters the initial protocol information and revised protocol information on clinicaltrials.gov and other websites as required by international law/guidance Policy
- Updates existing registries with changes in ongoing clinical trial status including recruitment status, protocol amendments, site updates and actual dates
- Consults with relevant team functions to assimilate the required results data fields for posting. Ensures information is entered in appropriate databases and reviews information for accuracy.
- Ensures sponsored studies are disclosed according to applicable laws, regulatory requirements and policies
- Monitors and tracks existing clinical trial registrations for future results postings and notifies appropriate team members of upcoming deadlines
- Archives registration and results posting documentation in the trial master file
- Communicates registrations and results dates and links to relevant stakeholders
- Participates in group initiatives and authoring of training manuals, checklist documents, business practices, or standard operating procedures (SOPs)
- Works with vendors and CROs, as needed
- Effectively communicates internal compliance metrics within Daiichi Sankyo.
- Member of Global Clinical Trial Disclosure Function and Operations Committee.
- Assist in coordinating Data Sharing operations with external sources and internal SMEs.
- Facilitate prompt responses to queries for information or documents from external sources.
- Ensure company clinical trial data on the Vivli Portal and Global CTID website is current.
- Assist in global process development and procedural document revisions, as appropriate.
- Drafting agendas and minutes, leading actions as appropriate and ensuring deliverables are completed on time and within budget.
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education/Experience:
- Degree (Bachelor, State Examination, Diploma) in pharmacy, biology, chemistry, medicine, or equivalent; or Master preferred.
- 3+ years (with Bachelors' degree) or 1+ years (with Master's degree) experience in the pharmaceutical industry, experience in the area of clinical trial information disclosure highly desirable.
- Understands the legal/regulatory requirements and guidelines regarding clinical trial disclosure, as well as on-going discussions of pending changes Understands the clinical drug development process, including clinical trial design, operations and results analysis
- Excellent organizational, interpersonal and communication skills, and can develop and present varied and unique ideas
- Exceptional attention to details and ability to analyze and assess data
- Good working knowledge of MS WORD, Excel and Power Point
- Strong organizational, interpersonal and communication skills
Ability to travel up to 5%
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.Job Title
Senior Specialist Clinical Trial Information DisclosureCity
Basking RidgeFunctional Area
Regulatory Management OperationsState
Associated topics: clinical, clinical development, clinical informatics, clinical trial, coordinator, lab, laboratory, research, research coordinator
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