Sr. Clinical Data Manager - San Francisco, CA | Biospace
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Sr. Clinical Data Manager

FibroGen, Inc.

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Location:
San Francisco, CA
Posted Date:
8/9/2017
Position Type:
Full time
Job Code:
17-134
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Pharmaceutical,

Job Description

Scope of Responsibilities
The Senior Clinical Data Manager is responsible for overseeing Data Management (DM) operational activities, ensuring compliance with the corporate timeline and scope of work outsourced to the DM service provider (SP) and coordinating activities from other external vendors that may also provide
study data.
This position reports to the Head of Data Management and may report to Associate Director, Data Management or Senior Manager, Data Management.

Specific Duties
•   Oversee and manage DM related activities outsourced to DM Vendors as well as other external data sources (e.g. central and/or specialty labs, IVR vendors, etc.) from study start-up to study close-out and final database lock/transfer while ensuring that all study deliverables and milestones are met on time and within budget.
•   Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts
•    Coordinate and participate in the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications
•    Review data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, and CRF (eCRF) completion / monitoring conventions
•   Develop and test data management system edit / data validation checks (diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities
•   Participate with the Study Operations Teams (SOTs) for all study activities, and lead all DM functional activities using established FGN templates/processes as applicable.
•   Provide operational leadership to the direction, planning, execution, collection and handling of all clinical data to the highest quality standards.
•   Review study data for completeness and clinical sense. Assess the overall quality of data and identify key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns, e.g., increased frequency of queries, protocol deviations, and early treatment discontinuations.
•   Develop and manage the data review plan for each assigned study, including maintenance and tracking of findings from all team members through issue resolution and involving the data vendors as needed.
•   Ensure the receipt and proper filing, security and archiving of study related data, both paper and electronic media, at all times.
•   Able to cultivate effective and productive working relationships with colleagues, subordinates, vendors and management. Able to use clear judgment to solve problems and to escalate issues with proposed solutions, as necessary.

Requirements

Job Requirements
•   Bachelor’s degree in a relevant scientific discipline or equivalent
•   Minimum of 5 years of Data management experience in the pharmaceutical, biotech and/or CRO industries, with experience in managing data from Phase III clinical trials.
•   Skills present in core data management activities (e.g., Data Management Plans, data edit specifications, understanding of database dictionaries/specs, electronic data transfers, efforts/process in data quality assurance, use of medical coding dictionaries). CCDM Certification a plus
•   Knowledge and experience with various clinical databases (e.g., Medidata RAVE, Oracle InForm and key technologies (e.g., SAS, Scanning/Imaging, IVRS/IWRS, ePRO)
•   Knowledge of FDA regulations, GCP, GCDMP and ICH guidelines required
•   Phase III experience
•   Excellent communication, written and interpersonal skills
•   Self-sufficient and able to work with minimal oversight
•   Demonstrate leadership skills and the ability to lead teams and motivate team members, as needed
•   Able to prioritize and handle multiple tasks and studies simultaneously
•   Able to manage indirect staff, as needed. Ability to develop project management objectives, as needed
•   Proficiency with MS Word, Excel, Outlook, and PowerPoint, SAS programming a plus
•   Must be willing to travel as required


FibroGen, Inc., headquartered in San Francisco with subsidiary offices in Beijing and Shanghai, is a leading science-based biopharmaceutical company discovering and developing a pipeline of first-in-class therapeutics. The company applies its pioneering expertise in fibrosis and hypoxia-inducible factor (HIF) biology and clinical development to advance innovative medicines for the treatment of anemia, fibrotic disease, and cancer.  Roxadustat (FG-4592), the company’s most advanced product candidate, is an oral small molecule inhibitor of HIF prolyl hydroxylase activity in Phase 3 clinical development for the treatment of anemia in CKD. Pamrevlumab (FG-3019), a fully-human monoclonal antibody that inhibits the activity of connective tissue growth factor (CTGF), is in Phase 2 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), pancreatic cancer, and Duchenne’s muscular dystrophy (DMD). FibroGen is also developing a biosynthetic cornea in China. For more information, please visit www.fibrogen.com.