Associate Director, Clinical Data Management
Clinical Development | San Francisco, Ca | Full Time
The Parker Institute for Cancer Immunotherapy (PICI) is radically changing the way cancer research is done. Founded in 2016 through a $250 million gift from Silicon Valley entrepreneur and philanthropist Sean Parker, the San Francisco-based nonprofit is an unprecedented collaboration between the country’s leading immunotherapy researchers and cancer centers, including Memorial Sloan Kettering Cancer Center, Stanford Medicine, the University of California, Los Angeles, the University of California, San Francisco, the University of Pennsylvania and The University of Texas MD Anderson Cancer Center. The institute also supports top researchers at other institutions, including City of Hope, Dana-Farber Cancer Institute, Fred Hutchinson Cancer Research Center, Icahn School of Medicine at Mount Sinai, Institute for Systems Biology and Washington University School of Medicine in St. Louis.
By forging alliances with academic, industry and nonprofit partners, PICI makes big bets on bold research to fulfill its mission: to accelerate the development of breakthrough immune therapies to turn all cancers into curable diseases.
Help us create a world that doesn’t fear cancer. Join us. www.parkerici.org
Overview of the Role
The Associate Director (AD), Clinical Data Management (CDM) is responsible for managing a team of Clinical Data Managers and vendors to support the effective collection and management of clinical study data used for reporting and analysis. The functional team that this position leads is responsible for utilizing a variety of different data sources, electronic platforms, and environments to handle clinical data acquisition, cleaning, processing, and archiving.
This role is responsible for ensuring efficient and effective CDM deliverables through the development of procedures and best practices. The AD, CDM also performs hands-on data management support in the collection and review of clinical data. The AD, CDM works closely with cross-functional groups to ensure work for individual clinical trials is uniform, complete, and successfully delivered. Dependent on experience and skills, a Director-level role will be considered.
Reporting Structure and Team
The AD, CDM reports to the Director of Biostatistics and Data Management and is a key member of the Clinical Development team. We offer this role remotely with agree upon visits to the San Francisco office Post COVID.
FLSA Status: Exempt
Essential Job Functions
- Manage a team of in-house Data Managers, ensuring timely delivery on their projects and providing career mentorship
- Assess the CDM resource needs to develop and right-size a team to support study activities
- Provide oversight and management of CDM and electronic data capture (EDC) Service Providers contracted to provide services for clinical trials, and to ensure timely receipt of high-quality deliverables from the CROs
- Develop CDM-related SOPs, Work Instructions, Job Aids and Data Management Templates in alignment with industry standards and best practices (CDISC, CDASH and ICH)
- Initiate continuous efforts in reviewing and identifying best practices among study teams and enforcing standardization among teams and studies
- Prepare and deliver standard clinical data management documents such as Case Report Forms (CRFs), Data Management Plans, Data Validation Plans, Data Review Plans, SAE/AE Reconciliation Plans, CRF Completion Guidelines, and Edit Check Development and Validation Specifications
- Review and contribute to SOPs, clinical protocols, study plans, and other study conduct related clinical documents
- Accountable for overseeing the setup of clinical trial databases, including database clinical trial specifications, including CRF design, user requirements, edit rules/checks, query logic, and data validation
- Accountable for overseeing data integrity, quality, and consistency of clinical database closeout activities. This includes performing closeout audits, as specified, for closing out trials in EDC.
- Oversee medical coding activities within the EDC environment
- Proactively interface with EDC Programming, Clinical Operations, Biostatistics, and other members of the Clinical Development team to understand the scope, priority, and timelines for each deliverable, and negotiate alternative timelines based on resourcing constraints
- Collaborate with IT and implementation teams to address clinical application requests and/or changes to clinical database systems
- Ensure data system compliance by following the established guidelines of national regulatory authorities with a focus on CDISC/CDASH standards
Knowledge, Skills, and Experience
- Bachelor’s degree or equivalent combination of education and experience
- 8+ years of CDM work experience in the biotech/pharmaceutical/CRO or healthcare setting
- 2+ years management, supervision, or mentoring experience
- Experience as a Lead Data Manager for oncology studies including managing study start up, conduct, and database lock. Experience leading CDM activities for adaptive studies, including platform studies, is a plus.
- Expertise with Clinical Systems including Medidata Solutions clinical software suite (iMedidata, RaveX, Coder, Reporter and Architect) and Veeva CDMS as well as integrations between EDC and IRT systems (such as endpoint) and reporting systems (such as JReview)
- Working knowledge of GCP, ICH, and related regulatory requirements and terminology
- Advanced ability to effectively manage one or more projects with competing timelines to meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities.
- Critical thinking skills to evaluate issues and identify a potential solution. Ability to creatively address complex or new problems.
- Effective communication and collaboration skills, including interpersonal skills to contribute effectively in cross-functional team settings, ability to influence others without authority, and ability to build strong collaborative relationships with external partners