Senior Clinical Research Scientist
Duties and Responsibilities:
The Clinical Research Scientist (CRS) contributes to the design, data collection, data review and reporting of clinical studies. This position has a key role in support of clinical development.
The primary responsibilities for the CRS include:
• Responsible for the relevance and accuracy of clinical science planning and guidance for a clinical study (e.g., study concepts/synopsis, eligibility, database elements, protocol and product-related training, investigative site questions, literature benchmarks) to clinical study teams
• Works closely with internal and external stakeholders to accumulate scientific and clinical knowledge necessary to support clinical development execution of clinical protocols and data collection
• Leads/reviews key product and study related documents and deliverables including study synopsis, clinical protocols/amendments, study manuals, Investigator’s Brochures, informed consent forms, Case Report Forms, Clinical Study Reports, Annual Reports, Statistical Analysis Plans, and regulatory submissions
• Works with investigative sites and/or study teams to answer protocol related questions, resolve study conduct issues
• Prepare and may present protocol designs, clinical data and other information at advisory boards, investigator meetings, site initiations and other internal and external settings
• Reviews clinical data listings, patient profiles and summaries to ensure data collection proceeds in a manner consistent with the protocol and strategic objectives.
• Assists the project team in the monitoring and analysis of emerging data trends.
• Participates in review and management of safety reports and submissions
• Support the development of clinical sections for regulatory correspondence and submissions including but not limited to Information Requests, Meeting Information Packages and presentation materials, and IND/NDAs
• Supports project team with conduct of clinical studies including clinical trials registration and results reporting, data management deliverables, clinical monitoring activities, interim analyses planning and Data Safety Monitoring Board or Steering Committee meetings as applicable.
• Interacts with internal and external stakeholders (Key Opinion Leaders, Medical Director, vendors, committees) in support of clinical trial objectives and deliverables, including investigator-sponsored trials.
• Conducts literature reviews to support clinical development programs and regulatory submissions.
• Support Medical Information request and Medical Affairs ad hoc requests; review of abstracts/publications and presentations
• Attends scientific meetings to remain abreast of clinical developments, interact with investigators, and advisors
Education: Masters degree, PharmD or PhD is required.
Experience: Candidates should have a minimum of five years of experience in clinical research development. Oncology experience preferred.
• Has authored industry documents and/or has published in medical/scientific peer-reviewed journals.
• Has medical writing and data management/analysis experience
• Understanding of GCP/ICH
Technical Skills Required:
• Must possess highly effective analytical, communication (verbal and written), and presentation skills
• Proficient in MS Office Suite and have the ability to multi-task and work effectively in a team or independently on assigned tasks.
• Demonstrated problem solving and sound decision-making skills
• Ability to be well organized, detail oriented, and flexible
• Must be able to work productively in an extremely fast-paced collaborative environment;
• Adaptable to multiple demands, shifting priorities, and be agile to operate at-risk based on available supported information