Clinical Literature Monitoring Consultant
Clinical Literature Monitoring Consultant
at ClinChoice (View all jobs)United States
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds....
ClinChoice is searching for a Sr. Specialist, Clinical Literature Monitoring Consultant (Remote) to join one of our clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
Position Description: Sr. Specialist, Clinical Literature Monitoring
Provides pertinent and timely information on our Company’s products and interests from the world’s biomedical literature in support of regulatory, clinical research, marketing, and legal functions. Performs screening, abstracting, indexing, and other project work as needed.Plans, organizes, trains, monitors, coordinates, and evaluates the work of screening/abstracting/indexing workload to ensure effective and efficient collection, storage, and dissemination of literature-related information. Maintains up-to-date awareness in the areas of literature-related copyright compliance, adverse event reporting, and information storage and retrieval systems.
Engages stakeholders and supports their requests.
Main Job Tasks and Responsibilities:
- Performs screening, abstracting, indexing, and editing functions
- Monitors the quality, accuracy, and timeliness of biomedical literature screening, adverse event reporting, abstracting, and indexing
- Assists with the acquisition and, where applicable, translation of published biomedical literature, including conference abstracts
- Develops, with input from internal stakeholders and knowledge of current regulatory requirements, article selection, adverse event reporting, editorial, and indexing policies and procedures
- Ensures comprehensive creation, maintenance, and communication of all standard operating procedures (SOPs), guidelines, and job aids related to these functions
- Assists with the training of screeners/abstractors/indexers, and internal team members
- Assists with end-user training and request fulfillment
- Participates in the management of published literature and conference abstract acquisition and translation
- Liaises with regulatory groups to ensure search request results meet current regulatory requirements
- Collaborates with pharmacovigilance teams to meet current literature-related adverse event monitoring requirements, including collaboration with ex-US PV groups to develop of journal lists for adverse event screening
- Assists in the evaluation of proposals and developments sponsored by intra-company information or systems units for applicability to the specific information needs of Clinical Literature Information Center (CLIC) end-users
- Collaborates with internal and external organizations in the development and integration of literature-related systems and information
- Maintains personal awareness of developments in the fields of medical information, regulatory policy, adverse event reporting, information storage and retrieval, and information services
- Participates in the collaboration with our Company's IT to maintain the Company Product Literature Database to ensure the maximum performance, reliability, data integrity, security, copyright compliance, and precision and recall of the database. Leads end-user and system application development
- Participates in data processing, harmonization, deduplication, and standardization activities
- Participates in the development, maintenance, and control activities of CLIC terminology to ensure optimal precision and recall of CLIC data
Education and Experience:
Degree in life sciences, information science, pharmacy, or related scientific discipline plus literature-related regulatory reporting
Bachelor’s and 5+ years
3+ years of work with biomedical literature and pharmacovigilance activities
Basic working knowledge of biomedical literature and information storage and retrieval systems; an understanding of US and ex-US pharmaceutical regulations (specific knowledge of literature-related adverse event reporting preferred); good writing skills; attention to detail; good time management skills; foreign language proficiency is desirable
Working knowledge of information storage and retrieval systems.
Preferred Experience and Skills:
- Experience with audits and inspections
- Knowledge of biomedical literature sources, content, and indexing
- Knowledge of commercial biomedical database structure, content, and content search/retrieval
- Familiarity with copyright compliance
- Familiarity with the application of semantic technologies, Natural Language Processing (NLP), Machine Learning (ML) or Artificial Intelligence (AI)
- Experience with the SDLC (system development lifecycle)
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific .
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel.The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities.We recognize this is our strength and celebrate it.