Senior Manager, Clinical Data Management
Harpoon Therapeutics (ticker: HARP) is a clinical-stage immunotherapy company developing a novel class of T cell engagers that harness the power of the body’s immune system to treat patients suffering from cancer and other diseases. T cell engagers are engineered proteins that direct a patient’s own T cells to kill target cells that express specific proteins, or antigens, carried by the target cells. Using its proprietary Tri-specific T cell Activating Construct (TriTAC®) platform, Harpoon is developing a pipeline of novel TriTACs initially focused on the treatment of solid tumors and hematologic malignancies. HPN217 targets BCMA and is in a Phase 1/2 trial for relapsed, refractory multiple myeloma. HPN328 targets DLL3 and is in a Phase 1/2 trial for cancers expressing DLL3, initially focused on small cell lung cancer and other tumors with high-grade neuroendocrine features. Harpoon is led by an experienced management team. The company emphasizes a collegial, collaborative environment and has a strong record of scientific innovation, pioneering protein engineering, expertise in tumor immunology and pre-clinical and clinical research. For additional information about Harpoon Therapeutics, please visit www.harpoontx.com.
Reporting into the Head of Clinical Data Management, this individual will: Accountable for all Clinical data management activities for one or more Harpoon Clinical Programs. Provide oversight of vendors performing Data Management activities. Provide input to protocol design and lead CRF design, so data collection is efficient and appropriate per the protocol. Ensure all clinical data are complete, consistent and of the highest quality. Contribute proactively to the evaluation and reporting of safety data. Develop innovative ideas and tests new processes and systems for the management of clinical data.
The Senior Manager Clinical Data Management is part of the Study Team for their Clinical Program(s) and interacts closely with other team members, Harpoon colleagues, consultants and at CROs. They collaborate professionally with team members to ensure high quality data collection, data review and reporting.
- Ensures high quality and timely data delivery by data management consultants and DM staff at CROs.
- Provides leadership and technical data management input.
- Represents data management at internal Study and Program Meetings.
- Keeps team members and senior management fully appraised of clinical data management issues on Harpoon studies in a timely and professional manner.
- Adherence to Harpoon SOPs and Policies.
- Serves as contact point for other departments and external contacts (eg CROs) on project data management issues as required.
- Assists in review of vendor proposals, budgets, scopes of work; Provides input to protocols, and other clinical study documents during development
- Function as internal Study Data Manager, overseeing all data management activities performed by CROs including generation and review of metric status and patient tracking reports; ensuring major DM deliverables and milestones are met
- Reviews and manages key documents such as data management plans, guidelines for CRF completion, data review, SAE reconciliation, Vendor Oversight, TMF plans, and data audits.
- Maintains protocol level documentation of data management activities.
- Reviews draft protocol and provides input to ensure that the data collection, databasing and reporting requirements can be met.
- Following CDISC conventions, oversees or performs eCRF design and annotation, database design specifications; Develop or oversee CRO generation of data edit check specifications (DVS); Participate in user acceptance testing (UAT) of the clinical database, including edit check testing
- Leads development of CRF completion instructions.
- Co-ordinates User Acceptance Test (UAT) activities for the clinical database..
- Liaises with the CRO data management team to define and implement edit checks on the data.
- Tracks and monitor the flow of the data from the source to the CRO and/or Harpoon.
- Leads internal study team in data review; Perform data review for quality issues and general data trends; generate queries as necessary.
- Work with programming to produce in-process data reports and data visualization tools to facilitate decision making on clinical trials (e.g., safety reviews). Provide input on standard tools and reports.
- Study DM liaison with cross-functional team members and external vendors to ensure completion of all timelines and study-related tasks; Ability to work independently as well as within a cross-functional team environment
- Performs review and appropriate quality checks of data presentations
- Supports and responds appropriately to any audit (notably on clinical data management process or products), internal or external.
- Participates in the development of processes for new initiatives and refine existing processes related to data management.
- Participates in SOP development, training, process mapping, implementation of standardized work processes and other departmental activities.
Skills and QUALIFICATIONS
- Preferred: 6+ years in a pharmaceutical/biotech or CRO setting; global/international experience a plus.
- Bachelor's Degree in a scientific discipline (Advanced degree preferred)
- Experience supporting phase 1 to 3 clinical trials. Oncology experience preferred.
- Knowledge and experience in EDC, key technologies (eg, IXRS) and industry standards including regulatory regulations, ICH-GCP guidelines, and CDISC-conformant clinical data standards with understanding of SAS, SQL and/or other clinical programming applications.
- Experience working in EDC systems (Rave)
- Solid understanding of clinical drug development process and knowledge of regulatory requirements and ICH/GCP guidelines
- Strong understanding of medical data coding classification systems, e.g., MedDRA, WHO-Drug
- Proficiency with MS Word, Outlook, and PowerPoint
- Experience in core DM activities (e.g., DM Plans, data edit specifications, understanding of database dictionaries/specs, electronic data transfers, efforts/process in data quality assurance, use of medical coding dictionaries). SCDM Certification a plus.
- Strong skills in collaboration, communication, organization, attention to detail and multi-tasking
- Sound analytical and problem-solving skills; ability to act with a consistent sense of urgency
- Ability to prioritize and to adapt quickly to changing business conditions with a positive attitude
- Willing to travel if required
- Ability to prioritize workload and meet deadlines, demonstrate effective use of time and handle multiple assignments simultaneously
- Capable of proactively identifying project challenges and risks and proposing appropriate and strategic solutions to issues.
Harpoon anticipates that the annual base salary for this position could range from between $150,000.00 - $190,000.00 and will depend, in part, on the successful candidate’s credentials for the role, including education, qualifications, and type as well as length of experience. Any offered salary is also based on internal equity, internal salary ranges, market data, and the position’s wage range. The salary range listed does not include any applicable bonuses or long-term incentives, differential pay or other forms of compensation or benefits. Harpoon is a multistate employer and the salary offered will be market competitive. At Harpoon, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.