Scientist III (Scientific) - First Shift

ZipRecruiter; Cambridge; On-site; GBP 80,000 - 100,000; Full time

Job summary

A leading company is seeking a Clinical Scientist to support Clinical Research Directors in managing clinical studies. The role involves protocol development, data validation, and collaboration with cross-functional teams to ensure data quality. Candidates should have significant experience in clinical research and a strong understanding of data processes.

Benefits

Health coverage

Incentive programs

401K contributions

Qualifications

• Minimum 5 years of clinical research experience in the pharmaceutical industry or CRO.
• Senior-level experience in clinical data review, operations, and quality control.

Responsibilities

• Provide scientific support for the conduct of clinical studies.
• Contribute to the preparation and review of study-related documents.
• Support CRDs in preparing medical responses to inquiries.

Skills

Pharmacovigilance

Data Validation Plan

Clinical Data Management

Education

Doctorate

Job description

Job Description

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.

Additional Preferred Qualifications:

• Previous experience in neurology or neuroscience.
• Medical writing experience (drafting consents or protocols).
• Medical safety experience.

Skills:

Pharmacovigilance, Data Validation Plan, Clinical Data Management

Additional Information:

Equal Opportunity Employer: We welcome people of all abilities and backgrounds. For accommodations during the application process, contact [e-mail].

Pay is based on various factors including education, experience, and location. Benefits include health coverage, incentive programs, and 401K contributions.

This posting is open for thirty (30) days.

Massachusetts law prohibits requiring or administering lie detector tests as a condition of employment. Violations may result in penalties.