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Sr. Manager, Clinical Data Management

Location Brisbane, California
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.

Summary

The Senior Manager provides leadership, and direction for clinical data management activities along with executing different stages of data management procedures for clinical trials.

Responsibilities

  • Project level coordination of CDM tasks, while demonstrating knowledge of hands-on work
  • Participates in recruiting efforts
  • Directs the activities of CDM team members to complete project deliverables on schedule and according to quality standards, and requirements from study start-up through archival
  • Provides or arranges for project specific training for CDM team members
  • Monitors quality of work performed by CDM project team; coaches staff where necessary
  • Assists in the training of other Clinical Data Managers or CDM associates through mentoring or developing/conducting training
  • Contributes to performance reviews of project team members
  • Ensures quality timely delivery and consistency of clinical data and data outputs across all assigned projects
  • Ensures projects are conducted in compliance with operating procedures and good
  • clinical practices
  • Ensures CDM project documentation is in an audit-ready state
  • Ensures projects are conducted in compliance with operating procedures and good clinical practices
  • Author and review company documents such as SOPs, WIs, Forms, and associated documents affecting CDM
  • Review and provide input for reports and clinical documents such as clinical protocols, informed consent, Investigator Brochure, yearly updates to the regulatory authorities and status updates
  • Participate in cross-functional initiative teams
  • Represents data management on project teams and manages scheduling and time constraints across multiple projects/resources
  • Maintains positive working relationship with internal customers and vendors
  • Recommends alternative work processes to improve the quality or speed of internal customer deliverables and responds to customer/team questions on CDM process, timelines and data quality
  • Communicates and escalates project level issues including processes, timelines, resourcing, performance, etc. and establish appropriate course of action with Senior Management.
  • Provide guidance and training to CROs, vendors, investigators, and study coordinators on study requirements
  • Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines
  • Assist in preparation and support of clinical documentation for IND and NDA submissions as appropriate
  • Support regulatory submission activities for assigned projects
  • Identify potential solutions to project and staff issues and assist leadership to promote a positive, productive, and collaborative team
  • Perform job responsibilities with a high level of accuracy and quality, and within established timelines

Experience

  • 10 - 12 years’ experience in clinical data management in progressive roles of leadership
  • Demonstrated ability to translate project plans into goals and objectives for own function
  • Demonstrated leadership skills and ability to effectively prioritize own group's activities for development projects and clinical trial performance
  • Ability to identify and develop operating guidelines and procedures
  • Management experience of CROs, Vendors and Consultants preferred
  • Previous work in rare diseases is highly desirable

Education

  • A Bachelor’s or Masters degree is preferred.


We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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Brisbane

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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