Senior Manager, Clinical Data Management
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. HPN424 targets PSMA and is in a Phase 1/2a trial for metastatic castration-resistant prostate cancer. HPN536 targets mesothelin and is in a Phase 1/2a trial for cancers expressing mesothelin, initially focused on ovarian and pancreatic cancers. 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 Associate Director, Clinical Data Management, this individual will: Execute and oversee all Clinical data management activities for one or more Harpoon Clinical Programs. Provides input to protocol design and influences CRF design, so data collection is efficient and the study collects only the patient data defined in the study protocol(s). Ensures data in the clinical trial database are complete, consistent and of the highest quality. Contributes proactively to the evaluation and reporting of safety data. Develops 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. He/she collaborates professionally with team members to ensure high quality data collection, data review and reporting.
- Ensures 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.
- Coordinates contributions to, provides input and oversees quality of data management documentation (Data Management Plan, Annotated CRFs, CRF Completion Guidelines et al)
- Maintains protocol level documentation of data management activities.
- Reviews draft protocol to ensure that the data collection, databasing and reporting requirements can be met.
- Plays a leading role in the design/review of the case report form (eCRF).
- Provides input into CRF completion instructions.
- Co-ordinates User Acceptance Test (UAT) activities for all clinical databases created and updated.
- 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 site to the database and develops and distributes clinical data management Key Performance Indicators/Metrics (KPIs) to study team members, as needed.
- Carries out appropriate computer assisted and manual reviews of the database to identify data quality issues.
- Issues data queries related to data quality, track and apply resolutions to the database.
- Produces and reviews data listings and ad hoc data summaries and listings of the data as required.
- Performs review and appropriate quality checks of data presentations (TLGs)
- Supports and responds appropriately to any audit (notably on clinical data management process or products), internal or external.
- Develops 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: 8+ 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.
- Hands-on Medidata RAVE experience essential.
- 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 proficiency in MS Excel including: ability to employ functions and generate pivot tables.
- Strong interpersonal, organizational, and communication (oral and written) skills
- Ability to work effectively in both a team setting and independently with minimal oversight
- Logical thinking, attention to detail and accuracy, good organizational skills, and problem-solving abilities
- 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.