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Senior/Lead Clinical Data Manager (Science & Biotech)
ANYWHERE USA , NJ 07726
Recruited by: Sheryl Horowitz | Owner | F-O-R-T-U-N-E Personnel Consultants, Inc. See all my Jobs

  • Hiring Company: F-O-R-T-U-N-E Personnel Consultants, Inc.
  • Industry: Science & Biotech
  • Compensation: Salary
  • Expires: Nov 15, 2020
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Job Description

Our client, a growing mid-sized company specializing in early phase clinical research, is looking for a Senior Clinical Data Manager/ Lead Clinical Data Manager to join their growing team!
This is a full time, home-based remote position.
Provide comprehensive data management expertise and efficient, quality data management services that meet sponsor needs. The Lead Clinical Data Manager is responsible for the data management for studies and oversight of the Clinical Data Managers.

REQUIRED EDUCATION, KNOWLEDGE, SKILLS AND ABILITIES
• The position requires at least a Bachelor’s Degree in clinical, biological, or mathematical sciences with minimum of 8-10 years of experience in clinical data management in clinical trials, at least 5 years Lead study, managing and overseeing team members
• At least 5 years of working experience on Medidata RAVE and Medrio platforms, build EDC in Medidata RAVE and Medrio. Certified RAVE builder is a plus.
• Thorough knowledge of all data management processes from study start-up to study close-out.
• Knowledge of medical terminology, pharmacology, anatomy, and physiology.
• Previous experience and proven competence in managing delivery of projects through full data management study life-cycle (Phase I, Phase II and Phase III).
• Comprehensive understanding of clinical drug development processes.
• Excellent computer, organizational, and communication skills.
• Experience working on both paper and electronic data management studies.
• Direct experience designing and creating paper and a clear understanding of electronic Case Report Forms (CRFs/eCRFs).
• Comprehensive experience with at least one clinical data management system (CDMS) including direct experience and/or understanding with database design, set-up and user acceptance testing; edit check development and/or programming and validation; management of data entry and queries; and study change control.
• Experience performing SAE Reconciliation.
• Experience with performing user acceptance testing and validation and associated documentation.
• Experience with creating and managing data management proposals, budget and study invoices.
• At least 5 years experience managing and overseeing team members
• Good Clinical Practices training.

RESPONSIBILITIES
• Provide leadership and guidance to the data management team
• Create, track, and manage data management timelines, proposals, budget and invoices
• Provide support and act as the data management point person to the Sponsor, CROs, vendors, clinical sites, and scorers
• Develop and maintain good communications and working relationships with the project team members as well as Sponsor, CRO, vendor, and clinical site project team members
• Develop presentations and present at Investigator or other meetings
• Train, track, and manage users (Sponsors, Sites, Investigators and other study personnel) on the CDMS
• Manage delivery of projects through full data management process life-cycle, including but not limited to:
o CRF/eCRF design from protocol
o Creation of CRF/eCRF Completion Guidelines
o Database design, set-up and Build, acceptance testing in the CDMS
o Creation of the study Data Management Plan and Edit Check Specifications
o Edit check programming and/or validation in the CDMS
o Perform study change control as needed
o Manage and oversee both site and internal data entry and query resolution
o Perform data reviews
o Generate requested data management reports
o Perform query generation/tracking and oversee query resolution
o Perform and oversee vendor data imports and transfers
o Perform and oversee MedDRA, WHODrug and other coding, as needed
o Perform database lock activities
• Creation, completion, organization, and tracking of all data management documentation
• Determine project and department resource needs and data management responsibilities
• Consult with supervisors for process issues and communicate ideas for process improvement
• Assist in developing and implementing new technology
• Develop, edit, and review Standard Operating Procedures and Work Instructions as needed
• Oversee, track, and document both internal training (e.g. Standard Operating Procedures/Work Instructions, study-specific training) and external training (e.g. site CRF and EDC training)
• Follow and ensure compliance with current Good Clinical Practices (cGCPs)
• Adhere to corporate policies and procedures
• Other duties as assigned