Sr. Manager / Associate Director, Clinical Data & Analytics QA
Location: San Francisco, California
Type: Full Time
Required Education: Masters
Life Science & Biopharmaceutical Companies
Internal Number: 3048001
Sr. Manager / Associate Director, Clinical Data & Analytics QA
Job Number: 2022274
APPROVED FOR REMOTE WORK WITHIN U.S. Company Overview FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing, and commercializing a pipeline of first-in-class therapeutics. The Company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology to advance innovative medicines for the treatment of unmet needs. The Company is currently developing and commercializing Roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD). Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA).
Additionally, Pamrevlumab, an anti-CTGF human monoclonal antibody, is in phase III clinical development for the treatment of idiopathic pulmonary fibrosis, locally advanced unresectable pancreatic cancer (LAPC), and Duchenne muscular dystrophy (DMD).
Description Responsible for planning, implementation, and coordination of a quality assurance program to minimize, prevent, detect, and correct problems affecting the ALCOA principles of GxP data created by FibroGen or FibroGen contractors. (ALCOA - attributable, legible, contemporaneous, original, and accurate.)
You will support regulatory compliance and quality related activities including investigation and resolution of study level quality issues, and CAPAs across biometrics and medical writing. You will also support process development and improvement, risk assessment, creation, and monitoring of KQIs, KPIs, trending of CAPAs, functional inspection readiness, and internal and external process and vendor audits.
You will oversee end-to-end quality deliverables across biometrics and medical writing and ensure that the biometrics and medical writing responsibilities and accountabilities within the clinical quality management system.
Responsibilities: -Provide guidance and clinical data integrity oversight support to clinical data management, biostatistics, medical writing staff on quality and process concerns, regulatory compliance, and best practices.
-Serve as a liaison between biometrics, medical writing, and Clinical Quality Assurance.
-Support process owners, SMEs, and cross-functional teams in revision of existing processes or development of new processes.
-Ensure that all process maps and controlled and uncontrolled documents meet departmental standards and are kept up to date.
-Evaluate the potential for data integrity problems related to data capture, transfer, biometrics deliverables, and hand-generated tables from medical writers at FibroGen, FibroGen contractors
-Identify and evaluate the data integrity of all aspects of clinical study development including a full end to end data quality implementation, inclusive of the following: raw data, SAP, analysis data sets, TFLs, hand-generated tables, etc.
-Assess the process and format of data, data blinding & un-blinding, TFLs transfer procedures between locations or companies
-Perform clinical data integrity review for medical work products (i.e. manuscripts, posters, etc.)
-Evaluate data security associated with users and users' access
-Evaluate procedures and software supporting database lock, integrated database, and all biometrics activities
-Assess development and deliver training to implement data security and data integrity procedures
-Facilitate biometrics -related internal and external audits and inspections.
-Provide leadership, training, and support to biometrics inspection teams.
-Ensure that training materials and assignments support all processes and adjust as needed to ensure compliance.
-Support larger quality investigations, including understanding of root cause, discussion with key stakeholders and process owners and conduct of CAPA
-Effectiveness Checks after larger quality issues are closed Conduct GLP and GCP audits to investigate data integrity Evaluate CROs, vendors for their ability to support data integrity processes
-Understand data integrity-related FDA requirements (e.g., 21 CFR Part 11) and ICH guidelines
-Understand data integrity-related regulatory requirements as implemented outside of US
Educational & Experience Requirements: - Master's degree in Statistics, Mathematics, Science or a related field,
- Minimum of 5 or more years of clinical development experience in biotech, pharmaceutical or health related industry is required.
- Detailed knowledge of Data Management, Biostatistics, Statistical Programming or Biomarkers processes.
-Knowledge of GCP and other regulations required
-Experience developing analysis and reporting statistical programming deliverables using statistical analytics tools (i.e. SAS, R)
-Experience developing processes and writing controlled documents
-Solid understanding of drug development and biopharmaceutical industry
-High attention to detail including proven ability to manage multiple, competing priorities
- Must possess ability to work effectively with and motivate virtual teams in matrix environment and solid understanding of cross-functional activities.
Note: This job description is not intended to list a set of must-have requirements for the job holder. Instead, it describes a set of job characteristics that the job holder should meet or has the capability to meet.
FibroGen is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender identity/expression, creed, national origin/ancestry, age, alienage or citizenship, status, age, sex, sexual orientation, marital or domestic/civil partnership status, disability, veteran status, genetic information, or any other basis protected by law.FibroGen will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.
E-Verify: Notice to all Prospective Employees
Notice to Recruiters and Search Firms FibroGen makes every effort to source and hire its staff through direct recruitment methods. Employment opportunities at FibroGen are managed by our internal human resources team. Please do not contact hiring managers or other FibroGen employees.
FibroGen does not accept unsolicited resumes from any source other than from the candidates themselves. FibroGen does not accept unsolicited communications from external recruiters. If there is a specific business need, a human resources team member will contact external recruiters directly.
An agency or independent recruiter must have a current, signed agreement and a work order for a specific position with FibroGen before presenting candidates and must be presented to human resources. Submission of unsolicited resumes without a signed agreement and an applicable work order will not create an obligation on the part of FibroGen to pay a fee of any kind.