Lead Clinical Data Manager

Data Management · Redwood City, California
Department Data Management
Employment Type Full-Time
Minimum Experience Experienced

Position Summary: 

 Responsible for ensuring the completeness, accuracy and timeliness of data collected during Biomea Fusion sponsored clinical trials.

 

Essential Responsibilities:

 

  • Provide Clinical Data Management (CDM) expertise to cross-functional team members and CRO.
  • 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.
  • Perform detailed and thorough data review of clinical trial data when necessary.
  • 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 5 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


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.

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  • Location
    Redwood City, California
  • Department
    Data Management
  • Employment Type
    Full-Time
  • Minimum Experience
    Experienced