What are the responsibilities and job description for the 2025 Summer Internship - Biometrics, Clinical Data Management position at Humacyte Inc?
DEPARTMENT : Clinical OperationsLOCATION : Durham, NC; Partially RemoteCOMPANY : Humacyte Inc (Nasdaq : HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte's initial opportunity, a portfolio of Acellular Tissue Engineered Vessel (ATEVs), is currently approved for use in vascular trauma repair and is in late-stage clinical trials targeting multiple other applications including AV access for hemodialysis and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte's 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte's 6mm ATEV for urgent arterial repair following extremity vascular trauma also received the RMAT designation. For more information, visit www.Humacyte.com.JOB SUMMARY : We are seeking a highly motivated Biometrics / Data Management Intern to support our clinical trial data management efforts. This internship will provide hands-on experience in clinical data cleaning, quality assurance, and analytics, offering exposure to various aspects of clinical trial data review and regulatory compliance.By the end of your internship, you will :
- Gain hands-on experience in clinical data management and biometrics in an innovative biotech environment.
- Work alongside industry experts and contribute to the development of pioneering medical technologies.
- Develop technical skills in data cleaning, clinical data listings, and statistical analysis.
- Enhance professional development through mentorship and networking opportunities.ESSENTIAL FUNCTIONS :
- Assist in "cleaning" clinical trial data entered by our clinical sites by identifying logical inconsistencies and errors to ensure high-quality data.
- Participate in User Acceptance Testing (UAT) for new clinical trial databases to validate functionality and accuracy.
- Assist in database user administration.
- Learn to program clinical data listings in JReview to support data review and quality assessments.
- Take detailed meeting notes and summarize key points for team reference.
- Collaborate with the biostatistics team to review data from an analytic perspective, ensuring consistency and validity.
- Support data management and biometrics team members in various tasks related to clinical data integrity and analysis.
- Develop and maintain a strong working relationship with Clinical Operations, including clinical trial project managers, to ensure seamless data management and communication.
- Other Duties as assigned.EXPERIENCE & QUALIFICATIONS :
- Currently pursuing a Bachelor's or Master's degree in Biostatistics, Data Science, Clinical Research, Health Informatics, or a related field.
- Strong analytical and problem-solving skills with attention to detail.
- Basic understanding of clinical research and clinical trials is a plus.
- Familiarity with data visualization tools or programming languages (e.g., SQL, SAS, R, or Python) is an advantage.
- Ability to work collaboratively in a team environment and communicate effectively.
- Willingness to learn new technologies and concepts in clinical data management.
- Excellent communication and interpersonal skills.
- Possess a positive roll-up-the-sleeves attitude and optimistic outlook.
- Strong ability to work in a fast-paced team environment with fluctuating priorities and demonstrated ability to collaborate within cross functional teams.
- Excellent organizational and time management skills with ability to set own priorities in a timely manner.
- High degree of flexibility and adaptability.
- Self-motivated and organized critical thinker with solid interpersonal and business communication skills.
- Represents the organization in a positive and highly professional manner.COMPENSATION & BENEFITS HIGHLIGHTS :
- Stock Options
- 401k Plan with 4% Match and no Vesting Schedule
- Medical, Vision and Dental Plans
- Company Paid Long Term / Short Term Disability
- Company Paid Life Insurance
- 23 Days Paid Time Off (PTO)
- 10 Company Designated Holidays 2 Floating Holidays
- Paid Parental Leave PoliciesPlease note, Humacyte does not provide U.S. employment sponsorship and does not accept unsolicited resumes from 3rd party firms and / or agency recruiters.The statements in this position profile are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time. Humacyte is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and / or other protected class characteristics. Additionally, Humacyte is committed to achieving its business objectives in compliance with all federal, state and local law. Learn More
