Position Summary:

Responsible for handling detailed Data Management issues, including oversight of CRO/Vendor data management activities for all phases of clinical trials (Phase 1-4).

Minimum Basic Qualifications:

• BS/BA in a scientific discipline or equivalent
• A minimum of 5 years experience as a Clinical Data Manager (2 years as a lead CDM and/or 2 years as a Data Management Project Manager) in a CRO or Pharmaceutical/Biologics/Medical Device company
• Demonstrated experience with an EDC data management system (e.g.,Rave, Datalabs or Oracle RDC)
• Experience as lead CDM managing studies from preparation through close-out (including data management activities related to study conduct, study completion, and archiving of study materials)
  • Provide oversight and participates in study setup and initiation procedures such as CRF design, database design, edit check design/review, DMP (Data Management Plan) review/approval and annotated CRF design
  • Familiarity with coding of medications, medical conditions, and AEs/SAEs using MedDRA and WHODRUG dictionaries

Experience Required:

• Contributed to the decision-making process involving data management (DM) issues for Phase 1-Phase 4 studies
• Ensured clinical databases, external data files and analysis datasets are designed in a standard, accurate, complete and consistent format conducive to analysis and a possible regulatory submission by working with lead CRO data manager or equivalent
• Developed Data Management guidelines and quality processes to ensure final database are accurate, complete and consistent

Desired Competencies and Qualifications:

• a Master’s degree or coursework toward a degree preferred
• Demonstrated experience in the development of  eClinical processes and procedures
• Demonstrated ability to facilitate communication among DM vendors/partners and the sponsor.
• Demonstrated ability to initiate and develop new and more efficient processes and procedures for study setup, maintenance, closure and archiving activities
• Developed/utilized study metrics to monitor project status, activities, timelines and budget and provided updates/recommendations to Manager/Sr. Management
• Developed documentation for regulatory submission and data analysis including SAS datasets, Data Definition Tables and submission-ready annotated CRF (Dataset Documentation)
• Participated in the review analysis tables/listings/figures and patient profiles for data consistency and accuracy
• Ability to work independently with minimal supervision
• Excellent written and oral communication skills
• Strong attention to detail
• Proficiency in basic SAS and/or JMP (preferred) or a demonstrated ability to learn basic programming skills is fundamental  
• Familiarity with ICH GCP as well as general knowledge of industry practices and standards such as the CDISC data standardization initiative is also helpful
• Participated in other key activities to support data management, clinical, medical and biostatistics as needed

Work Environment:

• Office setting with limited domestic/international overnight business travel

Physical Demands:

• Position primarily involves sitting/working at a computer terminal; walking between offices.  

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above.  Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position’s essential functions.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.