JOB TITLE: DIRECTOR / SENIOR DIRECTOR, CLINICAL DATA MANAGEMENT
LOCATION: SOUTH SAN FRANCISCO, CALIFORNIA / REMOTE
HI-Bio, Inc. is a clinical-stage biotechnology company based in South San Francisco, California. Our shared purpose is to transform the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. Our pipeline is strong and built through both in-licensing and discovery. HI-Bio's team is made up of industry experts from science and clinical drug development. We are on a path to building a leading immunology company. To accomplish this, we are seeking top taIent to join us on our journey.
We are seeking a Director / Senior Director of Clinical Data Management. The successful candidate will be able to provide leadership and direction for clinical data related activities, including outsourced activities, during study execution and according to ICH GCP and company SOPs. This position will report into the Vice President, Biometrics.
- Lead the Clinical Data Management organization at HI-Bio, and, in partnership with the Vice President, Biometrics, and other key stakeholders, help shape the overall Biometrics department strategy for the company as it pertains to systems infrastructure, standards and processes.
- Lead cross functional initiatives aimed at developing or improving Clinical Data Management processes and standard operating procedures.
- Serve as a Clinical Data Management expert and be responsible for providing data functional input and oversight (during designing, planning, initiating and closeout) at the clinical study and program level on multidisciplinary project teams.
- Lead Clinical Data Management CRO and technology evaluations, qualifications, selections, and Clinical Data Management execution
- Manage all aspects of Clinical Data Management owned systems that have cross-functional input and impact.
- Regularly and continuously oversee supplier performance.
- Manage and oversee the progress of Clinical Data Management activities on clinical studies, effectively ensuring adherence to appropriate plans, processes, internal procedures, timelines, and budget for Clinical Data Management deliverables.
- Develop and coordinate data management related plans for a clinical study or multiple clinical studies within a development program.
- Effectively manage process changes to minimize unanticipated impacts across programs and other stakeholders.
- Work with various stakeholders and functional teams regarding data management issues and implement appropriate resolution.
- Review and approve key clinical data management deliverables, including, but not limited to: CRF design, CRF completion guidelines, database design specifications, edit check specifications, IRT specifications, data management plans, SAE reconciliation plans, medical coding and electronic data transfer agreements (DTAs) for non-CRF data (e.g., PK, ADA, PD, additional translational biomarker, ePRO/eCOA/QoL, etc.).
- Adopt and exemplify a standards mindset for data collection and harmonization across studies and programs with an eye towards current industry standards (e.g., based on recent CDISC IGs, SDTM and ADaM standard conventions, etc.).
- Provide mentorship to staff and provide management responsibilities for Clinical Data Management staff.
- Collaborate with other data-facing parts of the organization in building a larger data infrastructure within HI-Bio.
EDUCATION AND QUALIFICATIONS:
Combination of degree and relevant industry experience within a pharmaceutical, biotech environment or relevant CRO, such as:
- Master’s degree and 12 years of direct related experience, or
- Bachelor’s degree and 14 years of direct related experience, and
- 10 years direct experience in Clinical Data Management related function/role (some sponsor experience preferred), and
- 8 years of direct managerial and/or leadership experience
HI-Bio, Inc. is an equal opportunity employer. We value diversity and do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We are committed to creating an inclusive environment for all employees.