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Manager, Clinical Data Management - United States  

Company managed [?] Still accepting applications

Posted on : 10 April 2017

Project Description

Description

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 Development Sciences group is responsible for everything from research and discovery to post-market clinical development. Development Sciences 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 Manager, Clinical Data Management is responsible for study lead data management for a number of concurrent clinical trials, utilizing Medidata RAVE EDC.  The candidate will be accountable for hands-on management of trials and resources to while maintaining a high level of data quality adhering to corporate, industry and regulatory agency standards.  Additionally the candidate will manage and lead in the design, implementation and ongoing practice of clinical data management processes with internal study resource and/or vendors, ensuring quality, timeliness and consistency according to BioMarin standards. This role has a high degree of collaboration with Development Sciences Operations team members.

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 timeline

Experience

  • Ability to work independently
  • Minimum of 8 - 10 years’ experience in clinical data management in progressive roles of leadership
  • Attention to detail
  • 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
  • Experience using commercial clinical data management and/or EDC products (e.g. Medidata Rave, Inform, Oracle Clinical/RDC, etc.)
  • Previous work in rare diseases is highly desirable
  • Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials required
  • Strong computer skills including knowledge of Microsoft Office Suite
  • Demonstrated comprehension of medical terminology

Education

Bachelor’s Degree or higher, in Life Science, Nursing, or related disciplines to Clinical Data Management.

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.