Associate Director Clinical Data Management

Location: South San Francisco, CA

Department Name: Biometrics 

HR Designations: Pay Status – Exempt

Objective of Position

The Associate Director, Clinical Data Management is a key role in the day-to-day management of all Clinical Data Management activities and staff including timely and professional ongoing management of clinical trial data for all relevant Phases.

Essential Duties/ Responsibilities

  • Represents Data Management in International Clinical team meetings
  • Defines project-level data management strategy and manages clinical trials and clinical projects
  • Identifies requirements for capturing and processing of clinical data ensuring accuracy, consistency and completeness
  • Manages external vendors who provide clinical data.
  • Prepares material for and presents at Investigator meetings
  • Performs Data Management tasks to ensure that databases can be declared clean and locked according to strict quality standards; including SAE reconciliation, third party vendor data reconciliation, medical coding processing, protocol deviation collection
  • Queries management to identify errors and inconsistencies in clinical data and ensure their resolution
  • Provides clinical data management oversight of outsourced and partner-resourced clinical trials including: scoping trials, project management, relationship management, approval of deliverables, and coordination of internal reviewers
  • Oversees all data management and clinical programming support activities for a clinical program to ensure timely and accurate data acquisition, integration, analysis and interpretation of results
  • Assures team is adhering to guidelines, budgets and timelines of projects
  • Directs the development, review and implementation of SOPs, templates and processes and other departmental and/or cross functional initiatives
  • Recruits, trains and manages employees and consultants within area of responsibility, sets training standards
  • Acts as primary liaison with CROs, third party data vendors, EDC vendors
  • Reviews clinical protocols and CRO proposals
  • Serves as primary reviewer or author of CRFs/ eCRFs, form completion guidelines, oversees and/or performs testing
  • Develops and reviews Data Management Plans including Edit Check Specifications, Database Specifications, Coding Guidelines, Data QC processes
  • Ensures Data Management Plans are followed through the course of the studies
  • Sets and manages Data Management project timelines
  • Provides comprehensive status updates to biometrics and project team members
  • Implements data standardization and maintains data model across projects
  • Manages quality system applicable to requirements for clinical data management
  • Ensures users are qualified by education, training, and experience

Requirements

  • Demonstrated proficiency initiating and managing clinical data projects; global experience preferred
  • Knowledge of and experience with databases, standards, medical terminology, medical coding dictionaries, quality control processes and auditing procedures
  • Familiarity with GCP, ICH and FDA requirements as they apply to clinical data
  • Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint) and knowledge of industry standards (CDISC, SDTM, CDASH)
  • Regular interaction with Clinical Operations, Biostatistics, Project Management and Quality Assurance groups
  • Excellent written and oral communication skills

Education/ Training

  • Bachelors or Masters Degree in a Life Sciences, Computer Sciences, Mathematics, or health- related field
  • Minimum of 10 years of DM experience in the pharmaceutical or biotechnology industry; depth and exposure to DM related tasks considered in lieu of minimum requirement
  • 3 year of staff management desired
  • CRO management experience
  • Prior oncology/hematology experience highly desirable


Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be constructed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. 

Acerta Pharma is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity and expression, age, disability, or Vietnam era, or other eligible veteran status, or any other protected factor.