Clinical Research Scientist

Overview:

The Clinical Research Scientist will review and interpret clinical data for query resolution by contacting clinical study site personnel including the principal investigator.

Responsible for authoring, editing, and reviewing complex clinical study documents in collaboration with the Global Medical Monitor and Medical Writers, as well as ensure the accuracy and quality of applicable written deliverables and their compliance with ethical, legal, regulatory, and client standards.

The role also involves writing, editing, reviewing, and compiling complex clinical study documents in collaboration with the Global Medical Monitor and Medical Writers. Collaboratively, ensure accuracy, quality, and compliance with ethical, legal, regulatory, and client standards.

Provides scientific contribution from a medical perspective in the development of global clinical trials by reviewing IB, full trial protocol, amendments, informed consent documents, Case report forms (eCRFs), Medical monitoring plan, safety management plan and other study related documents.

Responsibilities:

• Communicate with clinical study site personnel including principal investigators for resolution and finalization of data interpretation and identification of key missing information.
• Work with the Medical Monitor and the Medical Lead to review and interpret clinical data through EDC and relevant databases, and draft concise patient narratives utilizing SAE forms, medical records, MedDRA to a level that would be ultimately acceptable for submission for NDA applications.
• Liaise with cross-functional teams (Clinical Operations, Data Management, Product Safety & Pharmacovigilance, Regulatory, Medical Writing, and Project Management) to ensure timely and high-quality deliverables.
• Support the Global Trial Lead during marketing and clinical/medical advisory panels, steering committees, and investigator meetings.
• Define, collect, track, and report on study metrics, and ensure proper version control of all applicable documents.
• Assist in the reconciliation of clinical and safety databases.
• Provides oversight of Clinical Research Organizations (CROs) to ensure the collection of high quality of critical trial data. Queries databases for missing information and reviews all follow up responses- escalates to Medical Monitor critical issues.
• Partners with global cross function trial team to mitigate issues in initiation and management of clinical trials from a medical perspective.
• Assist in the preparation of medical presentations for DSMB, SIV, investigator meetings, and other study governance forums.
• Track and document action items from DSMB/Safety reviews and follow-up with study teams.
• Perform structured review of protocol deviations and escalate trends or critical deviations to the Medical Monitor.
• Support the ongoing review of study safety listings, adverse event line listings, and TLFs for accuracy and medical relevance.
• Contribute to review of key clinical documents (IB, ICF, SIV deck, CSR, protocol, amendments, clinical narratives).
• Support any other activities requested or delegated by the Medical Monitor.
• May Lead in activities for Inspection Readiness for the Study.
• Mentors as needed new employees, contractors on procedures and policies based on standard operating procedures.
• Travel (approximately 5%) domestic and/or international.

Qualifications

• BSN/RN, MSN/DNP, Pharm.D., or PA.
• Minimum of 3 years' experience in the pharmaceutical industry, CRO, or similar organization focusing on clinical study or research activities.

Competencies

• Experience in infectious disease, intensive/ emergency care or pulmonology preferred, minimum 3-5 years.
• Excellent written and verbal communication, data interpretation, and interpersonal skills.
• Medical writing experience such as authoring or co-authoring protocols, CSRs, IBs, or narratives preferred.
• Knowledge of scientific and regulatory requirements as they apply to clinical studies.
• Ability to identify discrepancies in trial data and write medically relevant queries.
• Some experience/exposure to Copilot.
• Strong organizational and document management skills including version control and field updating.
• Proficiency in MS Word, Excel, PowerPoint, Outlook, and Adobe Acrobat.

Other Requirements

• Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ. Office presence required at least 50% of the time per month

Additional Information

The base salary range for this full-time position is $140,000- $170,000. Individual pay is determined by several factors, which include but are not limited to: job-related skills, experience, and relevant education or training. The range does not include the comprehensive benefits, bonus, long-term incentive, applicable allowances, or any additional compensation that may be associated with this role.

EEO:

Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action for protected veterans and individuals with disabilities in compliance with all federal, state, and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are, in fact, non-discriminatory.

If you are qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by calling or by sending an email to