Clinical Data Manager

Position Summary

Responsible for ensuring the completeness, accuracy and timeliness of data collected during Biomea Fusion sponsored clinical trials. This role is hybrid, located in San Carlos, CA.

Essential Responsibilities

• Provide Clinical Data Management (CDM) expertise to cross-functional team members and CRO.
• Perform detailed and thorough data review of clinical trial data when necessary.
• Provide oversight to CRO CDM activities.
• Review and provide feedback to CDM and study documents, including but not limited to the Data Management Plan, data transfer agreements and data validation specifications.
• Assure the design and functionality of electronic case report forms (eCRFs) and electronic data capture (EDC) system are in accordance with the study protocol and other supporting documentation and requirements.
• Oversee database and validation check creation process, including but not limited to review of specifications, validation documents and user acceptance testing (UAT).
• Provide feedback on cross-functional documents such as study protocols and safety management plans.
• Represent the CDM team at cross-functional and clinical study team meetings.
• Assure timeliness of assigned deliverables.
• Contribute to Clinical Data Management Department improvement/enhancement initiatives.

Education and Experience Requirements

• Minimum 4-6 years of Clinical Data Management experience in biotechnology or pharmaceutical industry with excellent understanding of clinical drug development processes required.
• Bachelor’s degree from an accredited institution or equivalent practical experience.
• Ability to understand complex clinical trial protocols.
• Ability to work independently with minimal supervision.
• Strong verbal and written communication skills.
• Consistent, detail oriented, communicative, dedicated to do a job well done.
• CRO and vendor oversight experience preferred.
• Strong knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements.
• Strong experience working with electronic data capture (EDC) databases.
• Highly proficient using Microsoft Office Suites. Knowledge of MS Teams is a plus.
• Collaborative, team-oriented mindset with strong verbal and written communication skills.
• Self-motivated, detail-oriented leader with exceptional organizational, leadership and interpersonal skills.

Industry

• Biotechnology

Employment Type

• Full-time

Compensation

The anticipated salary range for fully qualified candidates applying for this position is $145,000 to $165,000. Factors such as relevant experience, education, duration of experience, and length of industry experience will influence the actual salary offered. In addition to a competitive market-based salary, Biomea Fusion offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package.

Equal Employment Opportunity

At Biomea Fusion, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.