Genzyme

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Manager Clinical Data

Requisition ID 30580
Working Location Cambridge, MA

Position Overview
Provide operational leadership and management for data management staff responsible for developing and maintaining data collection tools and processing of clinical data for four international disease registries in support of scientific, clinical, regulatory and commercial goals. 
 
Job Responsibilities
·         Manage and mentor a team of experienced data management staff. 
·         Provide functional line management for multiple projects and prioritize with respect to project plans and timelines.
·         Set goals, evaluate, document performance, and prepare and deliver performance reviews based on HR polices and procedures.
·         Participate in cross-functional project team meetings, as needed, and serve as an escalation point for troubleshooting and resolving database issues, data issues and site data entry issues, etc.
·         Participate in the development and implementation of new technology.
·         Participate in the development of global, inter-departmental harmonized SOPs, and registry specific guidelines for patient workflow (enrollment, transfer) and processing and managing clinical data.
·         Assist with the development of training requirements and ensure the data management staff are trained and adhere to the above mentioned documents as well as required Genzyme policies.
·         Provide guidance and support to data management staff for CRF/e-CRF design, database design specifications, validation specifications, report specifications, bug fixes/enhancements (including user acceptance plan, scripts, etc.).
·         Work with data management staff to coordinate and develop operational type reports to assist with data exploration and metrics.
·         Participate and take leadership role in Registry Management Team meetings, Data Management & Analyses Quality Team meetings and Data Management Quality Committee (DMQC) meetings.
·         Work with Electronic Data Capture (EDC) vendors and project team to troubleshoot database bugs/issues, including reporting and resolution. 
·         Review and approve Electronic Data Capture (EDC) vendor contracts, change orders and invoices.
·         Work with manager and project managers to forecast FTE and external expenses.
·         Provide oversight and management of data validation engagement with Functional Service Provider.  
Minimum Qualifications

Bachelor's degree in related science/technical discipline required
Minimum of 8 years data management experience in Pharmaceutical/Biotechnology industry
Minimum of 3 years project management or management experience
Knowledge and experience with developing and implementing data management SOPs, Work Instructions, Guidelines and Forms
Experience with Electronic Data Capture (EDC) and other data management systems
Ability to juggle multiple tasks and priorities
Analytical and problem-solving skills, with good attention to detail
Excellent communication skills (oral and written) and interpersonal skills
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