Clinical Scientist

Beacon Hill; Cambridge (MA); On-site; USD 120,000 - 160,000; Full time

Job summary

Beacon Hill is seeking a Clinical Scientist within the Clinical Development organization in Cambridge, MA. The role involves contributing scientific expertise to clinical development plans, trial designs, and study protocols, while communicating results to stakeholders.

You will collaborate with Clinical Operations, Data Management, Biostatistics, Safety, and Regulatory Affairs to maintain high standards of data quality and trial integrity.

Qualifications

• Masters, PharmD or PhD preferred.
• 2+ years of Clinical Research experience required.
• Study execution, data review and data management experience required.
• Experience with domestic and international clinical trials design and study data reporting.
• Knowledge of GCP and ICH requirements.
• Ability to work independently and collaboratively in a fast-paced team.

Responsibilities

• Plan and execute clinical trial activities.
• Develop data collection, review, and interpretation processes.
• Partner with Clinical Safety Scientists for safety review and communication.
• Prepare internal and external scientific presentations and manuscripts.
• Ensure data consistency, quality, and integrity across departments.
• Conduct literature searches and distill data into concise analyses/reports.
• Organize training for departments/vendors on scientific/development improvements.
• Coordinate training for protocol execution with study teams.

Skills

Clinical trial design

Data management

Study execution

ICH/GCP knowledge

Communication & presentation

Cross-functional collaboration

Independent work

Education

Master's degree in a relevant field

PhD

PharmD

Tools

Excel

Job description

As a Clinical Scientist within the Clinical Development organization, you will report into the Senior Director.

The Clinical Scientist works closely with the Clinical Development Physicians, as well as the rest of the Development Organization and is responsible for contributing scientific insight and expertise to develop and implement clinical development plans, as well as clinical trial designs, study protocols and related documents (e.g. investigator brochure, ICF etc.) and communication of study results The Clinical Scientist is to work collaboratively with other study team members including but not limited to Clinical Operations, Data Management, Biostatistics, Safety, and Regulatory Affairs.

You will be responsible for:

• plan and execute clinical trial activities
• develop data collection, review, and interpretation processes
• partner with Clinical Safety Scientists and participate in safety review and communication
• prepare internal (including DMC or steering committee) and external scientific presentations, research manuscripts and review articles, as required
• partner with Clinical Operations and Data Management to ensure data consistency, quality, integrity, safety, and alignment with company values
• Scientific literature searches and to distill data into concise analysis / reports
• Organize and provide training assistance to departments/vendors (scientific/development improvements).
• Serve as a liaison with internal/external scientific and medical experts to ensure protocol execution is consistent with intent. Coordinate and oversee medical or endpoint-specific training for study protocols.
• Assist with planning of, and participate in, Investigator Meetings and Advisory/Scientific boards.
• Prepare Data Monitoring Committee (DMC) and/or adjudication charters. Prepare deliverables and participate in periodic review meetings.
• Provide scientific expertise to other departments and functions

About You

• Masters, PharmD, or PhD preferred
• 2+ years of relevant Clinical Research experience required
• Study execution, data review and data management experience are required
• Experience with domestic and international clinical trials design and study data reporting.
• Understanding of the clinical trial stages and key data needs for program progression.
• Knowledge of the drug development process including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) requirements.
• Ability to work independently and collaboratively with internal teams, CROs and other key stakeholders, as required, in a fast-paced, multi-disciplinary team environment.
• Exemplary critical thinking, planning, organization, and time management skills including the ability to support and prioritize multiple projects.
• Solid communication and presentation skills.
• Proficient in the use of software relevant to above tasks including Excel