BrightOwl Loader Loading

Associate Director, Clinical Data Management San Rafael United States,  

Biomarin (company)


Posted on : 24 June 2017

Project Description

Description
  • Our company  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. 
  • Our company will continue to focus on advancing therapies that are the first or best of their kind.       
  • Our company s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market.
  •  These engineers, technicians, scientists and support staff build and maintain our company s cutting-edge manufacturing processes and sites,  provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.  Come join our team and make a meaningful impact on patients  lives.      
  • With 6 commercial products, 6 more in the pipeline and over half a billion dollars of revenue, a global footprint in 40 countries, and a personal connection to our patients, our company  is the recognized industry leader in rare disease development. Come work in an entrepreneurial environment where you ll have the resources and infrastructure combined with visibility and opportunity to tangibly impact patient s lives and the future of our company. 
  • This is your chance to be part of something amazing!             
  • The Associate Director, Clinical Data Management will be responsible for leading the data management activities for a number of concurrent oncology clinical trials, utilizing Medidata RAVE EDC.  
  • The candidate will be accountable for hands-on management of trials and resources while maintaining a high level of data quality by 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 company standards.  
  • Reporting to the Senior Director of Data Management, 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


EXPERIENCE:
  •  Minimum of 7 -10 years in pharma or CRO industry, with minimum of 5 years in hands on leadership functional/line role             
  • At least 5 years of recent Oncology trials data management experience is required             
  • Proficiency in Microsoft Office tools             
  • Knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements             
  • Experience using clinical data management systems and/or EDC products (e.g. RAVE, Inform, Oracle Clinical/RDC, etc.)             
  •  Strong interpersonal skills, demonstrated capability of working on multiple projects simultaneously             
  • Track record of completed deliverables on time and adjust priorities in a fast paced environment             
  • Has worked independently as well as collaboratively in a team environment             
  • Strong experience in CRO and vendor management for global clinical trials


EDUCATION:
BS  in life science discipline required; MS degree preferred


Equal Opportunity:
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.

Locations

San Rafael California

Find a Job Find Candidates

Similar Jobs

More jobs from Biomarin

Other jobs in United States

Other jobs in San Rafael

Other jobs from Biomarin in San Rafael

Other similar job in San Rafael

Other Jobs

Most Recent Searches

Most Famous Searches

You might also like