Manager/Associate Director, Clinical Data Management
Harpoon Therapeutics is a clinical-stage immuno-oncology company focused on the discovery and development of novel, proprietary bispecific T cell engaging biologic drug candidates for the treatment of various cancers. Harpoon’s first product, HPN424, is in clinical development for prostate cancer, and the second product HPN536 is in clinical testing for mesothelin over-expressing tumors, such as lung, pancreatic and ovarian cancers . Harpoon currently has two additional products in development and intends to introduce these into clinical development by the end of 2020. Harpoon is led by an experienced management team and has raised more than $200 million from leading life science investors. The company emphasizes a collegial, collaborative environment and has a strong record of scientific innovation, pioneering protein engineering, expertise in tumor immunology and clinical research.
We are seeking a highly motivated individual to oversee Clinical Data Management. This individual will report into the Chief Medical Officer and play an essential role in directing the planning, implementation and overall direction of executing/achieving clinical trial data management activities including CRF/eCRF design, database development, validation programming, discrepancy management, and database release.
- Oversee all clinical data management activities or equivalent, leads strategic initiatives for the function and serves as a working data manager
- Manage and lead the design and implementation of CDM processes with vendors
- Set up and maintain standardized processes for EDC Build, Edit Check Specifications, UAT, and EDC Validation
- Ensure completeness, accuracy and consistency of clinical data and data structure
- Lead the data review cycle and field ad hoc requests for data listings from other functions
- Plan, manage and coordinate all global data management activities to ensure consistency of clinical data standards across programs
- Oversee the development of study-specific data management plans, identify potential data issues, and identify and mitigate risks to data quality
- Ensure that all data components are conducted in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the master trial file
- Works collaboratively with Clinical Development, Clinical Operations and other functions to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting
- Monitor project progress and ensure proper resource allocation for successful project deliverables against goals and timelines
Skills and Qualifications
- Bachelor’s degree or higher with 10+ years of CDM experience in the biotechnology/pharmaceutical industry, 8+ years with an advanced degree; oncology clinical trial experience strongly preferred
- At least 4 years experience managing CRO’s
- Solid understanding of data management collection tools
- Hands-on extensive knowledge and experience with development, validation, execution, maintenance, documentation, and archival of clinical data targeted for regulatory submission is required.
- Full knowledge of FDA/EMA regulations, web-based Electronic Data Capture (EDC) and clinical data management systems is preferred
- Good problem-solving skills, as well as the ability to evaluate resource needs
- Ability to document deliverables following procedures with the utmost rigor and attention to detail
- Excellent verbal and written communication, strong organizational and interpersonal skills
- Ability to work both independently and collaboratively with cross-functional teams
- Ability to work in a dynamic, fast-paced, timeline-based environment