Clinical Scientist - Immunology (Expertise in Ulcerative Colitis, Crohn’s disease and Rheumatol

Clinical Scientist - Immunology (Expertise in Ulcerative Colitis, Crohn’s disease and Rheumatology + Excel) – Clinical Drug Trial Exp – Must Have

Updated:
Yesterday

Location:

Morrisville, NC, United States

Job :

-OTHLOC-1500-2

DAR-2DR

Partners with Medical Director to provide clinical and scientific input to early and late-stage clinical development programs, with an emphasis on protocol-specific requirements, and ensuring the scientific integrity and data quality of clinical trials by using scientific knowledge. Collaborates with Medical Directors and other team members on data reviews and other Medical Management activities to ensure the successful execution and conduct of clinical trials.

• Works with Medical Director to develop medical plans (Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan). Engages with outside experts/consultants/advisors to coordinate the acquisition of necessary medical/scientific input to prepare the respective medical plans.
• Performs regular and ad-hoc medical review of data listings and data visualization as needed; analyzes the data to identify risks and data patterns/trends and supports documentation of medical reviews.
• Authors medical data queries and reviews query responses, approves query closure in association with Medical Director.
• May assist Medical Director in patient profiles review, scientific review of other study level data, protocol deviation review, creation of Medical Review Summary report as needed.
• Partners with Medical Directors for medical data review meetings and safety review meetings including slide preparation as needed.
• Manages project scope of work, objectives, and quality of deliverables to ensure the project specific milestones and timelines are met. Serves as primary interface between internal team, customers, and vendors in the areas of medical data review and eligibility review.
• Collaborates with study team members including Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management (set-up and/or lead meetings as appropriate) to identify risks related to data integrity and subject safety. Escalates ongoing and newly developed study concerns such as at-risk project deliverables and out of-scope tasks to the project leads in a timely manner.
• Attends at Trusted Process meetings and may participate in internal and external audits.
• Acquires basic understanding and knowledge of ongoing protocol designs and disease related terminology and pathology.
• Adheres to all data privacy guidelines, International Committee on Harmonization (ICH), and Good Clinical Practices (GCPs), all enterprise policies, standard operating procedures, work instructions, and project plans. Adheres to customer policies and standard operating procedures, as required in project plans.

• Company car or car allowance.
• Medical, Dental and Vision health benefits.
• Company match 401(k).
• Eligibility to participate in Employee Stock Purchase Plan.
• Eligibility to earn commissions/bonus based on company and individual performance.
• Flexible paid time off (PTO) and sick time.

The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. The Company complies with the EU Equality Directive and all applicable federal, state, and municipal paid sick time requirements.