Job Summary This role supports Clinical Research Directors (CRDs) in the medical supervision and scientific management of clinical studies, primarily for Riliprubart in CIDP. The Clinical Scientist assists in various aspects of clinical trial execution, including protocol development, data validation, study plan review, and report preparation. The role requires familiarity with late-stage clinical trials, digital reporting tools, and the ability to adapt to evolving project needs. The Clinical Scientist collaborates with cross-functional teams (e.g., Biostatistics, Data Management) to ensure data quality and compliance. location: Cambridge, Massachusetts job type: Contract salary: $85.00 - 88.26 per hour work hours: 9 to 5 education: Doctorate Responsibilities • Provide scientific support for the conduct of clinical studies, ensuring the operationalization of the medical validation/review plan. • Contribute to the definition of the centralized monitoring strategy, study data validation, and clinical case review. • Contribute to the preparation and review of study-related documents (e.g., protocols, patient information, study plans, study reports). • Support CRDs in preparing medical responses to inquiries from health authorities, ethics committees, investigators, and experts. • Ensure the quality and accuracy of study documents and the adequacy of CRFs. • Assist in the preparation, organization, and conduct of study committee meetings. • Support regulatory document filing and archiving. • Assist in assessing study support costs and contribute to planning management. • Review incoming data, listings, and deviations. • Review adverse events. Qualifications Required: • MD, Ph.D., Pharm.D., or similar; Bachelor's degree considered for candidates with relevant experience. • Minimum 5 years of clinical research experience in the pharmaceutical industry or CRO, including experience with Phase 2 and 3 trials. • Senior-level experience in clinical data review, operations, and quality control. • Experience with protocol and consent development, quality deviations, and medical monitoring. • Strong understanding of data collection, data flow, and data validation processes. • Ability to develop and implement quality management practices for medical data review. • Digital and data-oriented mindset. • Scientific expertise or interest in the relevant therapeutic area. • Ability to take responsibility for medical activities and support CRD decisions. Preferred • Previous experience in neurology or neuroscience. • Medical writing experience (drafting consents or protocols). • Medical safety experience. skills: Pharmacovigilance, Data Validation Plan, Clinical Data Management Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. u9000030197