Clinical Scientist We're a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit. The Clinical Scientist is responsible for the review, interpretation, and assessment of clinical data with key findings communicated to Clients and study team. The Clinical Scientist works closely with the Medical Monitor as appropriate. This role communicates and presents clinical trends and findings to the Study Team and Clients while working collaboratively to ensure high quality data, maintain the highest integrity of the clinical database and clinical study reports (e.g., CSR). The Clinical Scientist partners with Clients, subcontractors, and internal study team members to meet project timelines and expectations related to clinical data review.
What You Will Do:
Develop clinical data review plans for assigned studies.
Collaborate with cross-functional study team members to ensure protocol-defined variables are collected and reported accurately.
Conduct ongoing review and analysis of clinical data, (e.g., efficacy, safety related data components) utilizing listings, tables, figures, graphs, and EDC as needed.
Track and analyze potential safety events in collaboration with Pharmacovigilance and Medical Monitoring.
Contribute to discussions on potential study or strategy modifications based on clinical data review.
Create data summary slides for Safety Review Committee Meetings, Data Review Meetings with support from Director.
Present key data trends and findings to the Medical Monitor, Study Team, and Client.
Query data as appropriate on EDC data as needed during Clinical review with timely follow up, and identification of potential protocol deviations.
Partner with vendors and study team members to ensure accurate endpoint reporting.
Serve as a point of contact for site staff and monitors for protocol and clinical inquiries.
Collaborate with Data Management on CRF design, CRF instructions, and data quality plans.
Review data-driven sections of regulatory and clinical reporting documents (e.g., CSRs, INDs, NDAs/BLAs, annual reports, IBs, etc.).Provide scientific writing support, including patient narratives, abstracts, posters, and presentations.
Mentor and train junior staff.
Utilize visual analytics tools to interpret and communicate data insights.
The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
What You Bring To The RoleStrong knowledge of clinical development processes and study design principles.
Deep understanding of product profiles and safety concepts.
Skilled in clinical data analysis, interpretation, and assessing clinical relevance in human clinical trials, within the neuroscience therapeutic area.
Proficient with electronic data capture systems and data visualization tools.
Solid understanding of GCP, ICH guidelines, and regulatory requirements.
Excellent written, oral communication, and presentation skills.
Strong organizational, analytical, and problem-solving abilities.
Ability to manage multiple priorities and adapt to changing demands.
Strong interpersonal skills and the ability to collaborate across teams and levels.
Demonstrated ability to work independently and within teams.
Good judgment and decision-making skills.
Willingness to travel as needed.
Your Experience:
Advanced clinical or scientific degree preferred (e.g., PharmD, PhD, MSN, MPH) with 8+ years of industry-related experience in neuroscience (psychiatry or neurology)OR Bachelor's degree with 12+ years of relevant industry/research experience in the relevant therapeutic area, including data review and interpretation. Proficiency in Microsoft Office Suite. Experience with EDC systems and data visualization platforms. Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently. At Worldwide Clinical Trials, we are committed to fostering an inclusive and equitable workplace by providing transparent compensation. The salary range for this position is annually (For hourly paid positions, the stated salary range reflects hourly rates): United States of America - $79,000.00 - $157,000.00. The salary range provided is intended to give candidates an understanding of potential earnings. Compensation will fall within the provided range, and it not a guarantee of exact salary. The final salary will be determined based on relevant experience, performance, education, and internal equity. In addition to base salary, we offer a competitive benefits package depending on location. We ensure pay equity and transparency and comply with all applicable labor laws. Salary information will be discussed during the interview process, and we encourage candidates to inquire about compensation at any stage.
