Palo Alto, CA
QED therapeutics – a BridgeBio company, focuses on precision medicine for FGFR-driven cancers and diseases.
With singular focus, QED is devoted to the development of our investigational candidate, infigratinib. A first-in-class, selective, tyrosine kinase inhibitor, infigratinib has promising early clinical data in patients with previously treated, FGFR-driven cholangiocarcinoma and metastatic urothelial carcinoma, as well as preclinical studies in achondroplasia. Future studies will investigate infigratinib for additional FGFR-driven tumor types and rare disorders.
FGFR=fibroblast growth factor receptor.
The Senior Manager, Data Management (Sr.Mgr., DM) is responsible for all aspects of the DM process from project planning, the development of project documentation, system set-up, UAT through database lock. This person is a department-level contributor and may have oversight of junior DM staff. The core duties and responsibilities of the Sr.Mgr., DM are delineated below.
- Contributes to technical infrastructure of DM
- Responsible for timelines and quality of deliverables
- Provides feedback and task assignment to meet department and company objectives
- May have oversight of internal DM and/or consultant DM staff
- Directs the activities of direct reports as applicable
- Supports budget and resource planning across assigned projects and/or projects assigned to direct reports
- Participates in CRO/vendor selection process for outsourced activities
- Participates in the development, review, and implementation of departmental/company SOPs, templates, etc.
- Participate in department or cross-functional initiatives DM/Study Tasks:
- Represents DM in study team meetings
- Manages DM timelines to coordinate and synchronize deliverables with the overall study timelines
- Generates and/or reviews/approves study documents (e.g. study protocols, Data Management Plans, Case Report Forms, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions)
- Oversight of DM CRO/service providers (e.g. reviewing vendor SOPs, invoices)
- Monitors the progress of all DM activities for the project to ensure project timelines are met
- Executes and/or distributes DM metrics, listings, and reports, as required
- Provides training on the CRF completion guidelines and EDC system at Investigator meetings and to internal or external team members, as needed
- Proactively identifies potential systemic and study issues/risks and recommends/implements solutions
- Responsible for the accuracy and completeness of the clinical data collected during a clinical trial, able to work independently towards the assigned goal
- Provide DM support to Statisticians and Statistical Programmers in production of clinical trial reports
- Perform duties as assigned by CDM management/Head of Department
- Requires in-depth knowledge of clinical DM principles, clinical trials process and regulatory requirements
- Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment
- Able to communicate and collaborate effectively with cross-functional teams in face-to- face conversation, by telephone, and by email
- Good working knowledge of ICH, FDA, and GCP regulations and guidelines
- Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint) and knowledge of industry standards (CDISC, SDTM, CDASH)
- Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug.
- Proven ability to work both independently and in a team setting
- Bachelor degree in Life Sciences, Computer Sciences, Mathematics, or health-related field
- 10 years of DM experience in the pharmaceutical or biotechnology industry
- 3 year of staff management desired
- CRO management experience
- Prior oncology/hematology experience highly desirable
What we offer:
- Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to how we can improve our efforts.
- A culture inspired by our values: put patients first; think independently, be radically transparent; act nimbly; and let science speak.
- Learning and development training to help employees be the best version of themselves.
- Collaborative business environment.
- Excellent compensation package (Base, Performance Bonus, Stock, RSU programs).
- Excellent benefits package.
- Flexible PTO.
- With office locations in San Francisco, Boston, New York and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs.
- Fast-paced, data-driven, work environment with world-class R&D minds and capabilities.
- Work with the most productive groups of R&D operators in the industry.
- Partnerships with leading institutions.
- A platform for meaningful scientific contributions to shine.
- Commitment to Diversity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead and supported in their efforts to do so.