Job Description
InnovaBio Pharmaceuticals, a leader in innovative biopharmaceutical solutions, is seeking a highly motivated and experienced Senior Clinical Data Manager to join our dynamic Clinical Operations team in Boston, MA. This pivotal role offers the opportunity to drive the success of groundbreaking clinical trials by ensuring the highest standards of data quality, integrity, and regulatory compliance.
You will be instrumental in shaping our data management strategies, working collaboratively with cross-functional teams including Clinical Operations, Biostatistics, and Regulatory Affairs. If you are passionate about advancing medical science through meticulous data management and thrive in a fast-paced, cutting-edge environment, we invite you to contribute your expertise to our mission of delivering life-changing therapies.
We offer a supportive culture, competitive compensation, and comprehensive benefits designed to foster your professional growth and well-being.
Responsibilities
- Lead and oversee all data management activities for assigned clinical trials from study start-up to close-out.
- Develop, review, and finalize critical data management documentation including Data Management Plans (DMPs), Data Review Guidelines, and Data Transfer Agreements.
- Design and implement Electronic Data Capture (EDC) systems, including CRF design, edit checks, and user acceptance testing (UAT).
- Perform ongoing data review, query management, and reconciliation activities to ensure data quality and integrity.
- Collaborate closely with internal stakeholders and external vendors (e.g., CROs, central labs) to ensure seamless data flow and compliance.
- Contribute to the development and standardization of departmental SOPs, working instructions, and best practices.
- Provide mentorship and guidance to junior data management staff, fostering a collaborative and high-performing team environment.
- Participate in regulatory submissions and inspections, providing expert input on data management processes and documentation.
Qualifications
- Bachelor's degree in a life science, health science, computer science, or a related field. Master's degree preferred.
- Minimum of 5-7 years of progressive experience in clinical data management within the pharmaceutical, biotechnology, or CRO industry.
- In-depth knowledge of ICH-GCP guidelines, 21 CFR Part 11, and other relevant regulatory requirements.
- Proficiency with leading EDC systems (e.g., Medidata Rave, Oracle InForm, Veeva Vault CDMS) and experience in system build and UAT.
- Strong understanding of CDISC standards (SDTM, ADaM) and their application in clinical trials.
- Demonstrated ability to lead projects, manage timelines, and prioritize multiple tasks effectively.
- Excellent communication, interpersonal, and problem-solving skills with a keen attention to detail.
- Experience with data reporting tools and programming languages (e.g., SAS, SQL) is a plus.