OUR GOAL: Treat our consultants and clients the way we would like others to treat us! Interested in joining our team? Check out the opportunity below and apply today!
Our South San Francisco, CA client has a contract opening for a Data Manager / Data Quality Leader within the USMA Data Management function who will work within a team of experts in data life‑cycle management who acquire and curate data for use in exploratory research, clinical development and evidence generation. Collaborates with peers within the function and across the organization to identify, design and execute fit‑for‑purpose data management solutions, adhering to F.A.I.R. (Findable, Accessible, Interoperable, Reusable) principles.
Location: Hybrid 3 days onsite / 2 days remote
Responsibilities:
- Ensure the timely completion of data management deliverables and partner with Functional Service Providers (FSPs), DM CROs and other vendors, overseeing and providing technical expertise in the delivery of high quality data.
- Contribute to functional, cross‑functional, enterprise‑wide or external initiatives that shape our technical landscape, business and healthcare environments.
- Require strong strategic, collaboration and communication skills, as well as an entrepreneurial mindset, to evolve the way we collect and deliver data and to develop and deliver medicines for our patients.
- DM lead will contribute to the development of new concepts, technologies, and standards. In addition to demonstrating high proficiency with core DM tasks (being able to work independently with minimum oversight/supervision), provides leadership and strategic direction to DM members and adapts strategies to meet changing needs of program objectives.
Minimum Qualifications:
- BS or MS in Life Sciences, Data/Computer Science, Bioinformatics OR equivalent industry experience.
- Demonstrated strong collaboration and excellent communication skills‑both written and oral (proficiency in English required)
- Knowledge of CDISC data standards
- Knowledge of ICH‑GCP and working in regulated environment
- Project Management skills
- Able to manage multiple requests and priorities
- Demonstrated leadership capabilities and decision‑making, negotiation, motivation (self and others) and influencing
- Experience with data analytics and/or visualization tools and techniques
- Demonstrated entrepreneurial mindset and self‑direction, ability to mentor others and willingness to learn new techniques
- Knowledge of biological principles, display interest and demonstrate scientific curiosity including understanding of data types and their scientific use (clinical, biomarker, WGS, RNA‑seq, etc.)
Preferred/Additional Qualifications:
- Experience in leading DM study teams and maintaining oversight of all start‑up, conduct and close‑out activities for multiple complex studies, ensuring fit‑for‑purpose quality.
- Experience in leading the collection of clinical trial and/or Real World Data.
- Good understanding of molecule and disease area strategies, healthcare environment, as well as strong scientific and technical expertise.
- Extensive technical and or industry experience (for senior and principal roles)
- Experience in enterprise level operating systems and familiarity with databases
- Fluency in programming languages (SAS, R, Python, SQL, etc)
- Some experience with advanced analytics approaches (e.g. machine learning, AI).
- Experience with tools related to technologies required to undertake analyses on large data sources with computationally intensive steps (SQL, parallelization, Hadoop, Spark, etc)
- Experience producing interactive outputs (e.g. Shiny, Tableau).
- Contributor to open source packages, libraries or functions.
- Experience implementing reproducible research practices like version control and literate programmer.
- Experience with SDTM implementation and CDISC standards.
- Experience with standardized technologies such as MedDRA and WHODrug.
- BSN, RN, RPh, Pharm D, PA or other applicable health professional qualification preferred.
Core Responsibilities:
Project Management: Develop risk management strategies and proactively manage timelines to ensure successful oversight and delivery of studies & projects, including the implementation and adoption of new technologies.
Stakeholder Management: Proactively engage with stakeholders across the business to understand their needs and influence their understanding of decisions made in our function. Inform stakeholders of key deliverables and act on changing milestones.
Vendor Management: Partner with relevant functions for external data vendor selection and management. Oversee development of data transfer agreements with vendors ensuring use of standards, fit‑for‑purpose data models and transfer intervals.
Data Collection and Acquisition: Act as experts for data collection, advising teams and stakeholders on best practices and proposing innovative solutions. Ensure high quality data and compliance with applicable